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What changed in ORASURE TECHNOLOGIES INC's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of ORASURE TECHNOLOGIES INC's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+395 added−395 removedSource: 10-K (2026-03-09) vs 10-K (2025-03-07)

Top changes in ORASURE TECHNOLOGIES INC's 2025 10-K

395 paragraphs added · 395 removed · 293 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

92 edited+22 added−29 removed165 unchanged
Biggest changeThis product has received WHO pre-qualification and is eligible for procurement by purchasing entities entitled to access funding and other resources from the Global Fund, PEPFAR and other agencies. OraQuick ® HCV Rapid Antibody Test and Self-Test Another test available on the OraQuick ® platform is the OraQuick ® HCV rapid antibody test.
Biggest changeOraQuick ® HIV Self-Test (International) is sold for use by individuals in certain foreign countries, including under the CE mark in certain European countries, to meet the needs of those markets. This product has received WHO pre-qualification and is eligible for procurement by purchasing entities entitled to access funding and other resources from the Global Fund, PEPFAR and other agencies.
The Company also notes that from January 1, 2021, the United Kingdom (“UK”) has introduced a UK-specific route to market for medical devices. Compliance with these requirements may add further complexities to the Company's international strategy. The Company must also comply with certain registration and licensing requirements as dictated by Health Canada, prior to commencing sales in Canada.
The Company also notes that from January 1, 2021, the United Kingdom (“UK”) has introduced a UK-specific route to market for medical devices. Compliance with these UK requirements may add further complexities to the Company's international strategy. The Company must also comply with certain registration and licensing requirements as dictated by Health Canada, prior to commencing sales in Canada.
The Company's Oragene ® and ORAcollect ® products are also facing increasing competition from similarly designed collection systems which have entered the market. OMNIgene ® • GUT is being sold in the emerging microbiome market and competes with a variety of non-standard in-house solutions developed by various researchers, including simply freezing the sample after collection.
The Company's Oragene ® and ORAcollect ® products are also facing increasing competition from similarly designed collection systems which have entered the market. The Company's OMNIgene ® • GUT device is being sold in the emerging microbiome market and competes with a variety of non-standard in-house solutions developed by various researchers, including simply freezing the sample after collection.
The test, which uses fingerstick whole blood and delivers point of care results in 10 minutes, offers the ability to test in non-traditional 3 Table of Contents environments, such as outreach programs and mobile testing clinics. Syphilis Health Check ™ is approved for use with people aged 13 years and older.
The test, which uses fingerstick whole blood and delivers point of care results in 10 minutes, offers the ability to test in non-traditional environments, such as Table of Contents outreach programs and mobile testing clinics. Syphilis Health Check ™ is approved for use with people aged 13 years and older.
The Company's HIV, HCV and COVID-19 products are also sold in a consumer-friendly format in the over-the-counter (“OTC”) market in the U.S. and, in the case of the HIV and HCV products, as a self-test to individuals in a number of other countries, including, for the HIV products, as an oral swab in-home test for HIV-1 and HIV-2 in Europe.
The Company's HIV and COVID-19 products are also sold in a consumer-friendly format in the over-the-counter (“OTC”) market in the U.S. and, in the case of the HIV and HCV products, as a self-test to individuals in a number of other countries, including, for the HIV products, as an oral swab in-home test for HIV-1 and HIV-2 in Europe, and for the HCV products, as an OTC test.
Through its Sherlock subsidiary, the Company is also developing of a Covid/Flu molecular test, funded in part with Federal funds obtained from the HHS Administration for Strategic Preparedness and Response (ASPR) under contract number: 75A50124C00055. The Company acquired this program in connection with its Sherlock acquisition.
Through its Sherlock subsidiary, the Company is also developing a Covid/Flu molecular test, funded in part with Federal funds obtained from the HHS Administration for Strategic Preparedness and Response (ASPR) under contract number: 75A50124C00055. The Company acquired this program in connection with its Sherlock acquisition.
The OraQuick ® HCV test has received a CE mark for use with oral fluid, venous whole blood, finger-stick whole blood, plasma and serum and is sold in Europe. This CE-marked product is also registered and sold in other foreign countries and has received WHO pre-qualification.
OraQuick ® HCV test has received a CE mark for use with oral fluid, venous whole blood, finger-stick whole blood, plasma and serum and is sold in Europe. This CE-marked product is also registered and sold in other foreign countries and has received WHO pre-qualification.
Its patent portfolio includes pending applications and issued patents in diagnostics and testing, sampling tools and sample preservatives. The Company's portfolio protects its innovative sampling tools, sample preservatives, and diagnostics that provide access to accurate, essential information that advances global health and well-being.
Its patent portfolio includes pending applications, issued patents, and licensed patents in diagnostics and testing, sampling tools and sample preservatives. The Company's portfolio protects its innovative sampling tools, sample preservatives, and diagnostics that provide access to accurate, essential information that advances global health and well-being.
These regulations govern the entire life cycle of a medical device, including design, manufacture, testing, release, packaging, distribution, documentation and purchasing as well as complaint handling, corrective and preventative actions, and internal auditing. In complying with the QSRs, manufacturers must continue to expend time, money and effort in the area of production, quality, and post-market surveillance to ensure full compliance.
These regulations govern the entire life cycle of a medical device, including design, manufacture, testing, release, packaging, distribution, documentation and purchasing as well as complaint handling, corrective and preventative actions, and internal auditing. In complying with the QMSRs, manufacturers must continue to expend time, money and effort in the area of production, quality, and post-market surveillance to ensure full compliance.
The Company regularly searches for third-party patents in fields related to its business to shape its own patent and product commercialization strategies as effectively as possible and to identify licensing opportunities. United States patents generally have a maximum term of 20 years from the date an application is filed. The Company has patents throughout its product lines.
The Company regularly searches for third-party patents in fields related to its business to shape its own patent and product commercialization strategies as effectively as possible and to identify licensing opportunities. United States patents generally have a maximum term of 20 years from the date an application is filed. Table of Contents The Company has patents throughout its product lines.
A clinical trial may be required in support of a 510(k) submission and generally is required for a De Novo request or PMA application. These trials generally require an approved application for an Investigational Device Exemption (“IDE”) and compliance with other IDE requirements, unless the proposed study is deemed to be exempt from the IDE requirements.
A clinical trial may be required in support of a 510(k) submission and generally is required for a De Novo request or PMA application. These trials generally require an approved application for an Investigational Device Exemption (“IDE”) and Table of Contents compliance with other IDE requirements, unless the proposed study is deemed to be exempt from the IDE requirements.
There is a transitional period (which was extended in July 2024) during which products that have a declaration of conformity issued under the IVDD prior to May 26, 2022 may continue to be placed on the EU market for a certain period before requiring certification under the EU IVDR (subject to compliance with certain requirements under the EU IVDR, including in respect of post-market surveillance); however, class A non-sterile products do not benefit from such transitional provisions and have been required to be EU IVDR compliant since May 26, 2022.
There is a transitional period (which was extended in July 2024) during which products that have a declaration of conformity issued under the IVDD prior to May 26, 2022 may continue to be placed on the EU market for a certain period before requiring certification under the EU IVDR (subject to compliance with certain requirements under the EU IVDR, including in respect of post-market surveillance); however, Class A non-sterile devices do not benefit from such transitional provisions and have been required to fully comply with the EU IVDR compliant since May 26, 2022.
The Company sells its OraQuick ® In-Home HIV test in the U.S. retail or consumer market as well as to the same markets as the OraQuick ADVANCE ® test for use in public health-oriented programs. The product is also available for purchase online through certain retailers and from the Company's website, www.oraquick.com.
The Company sells its OraQuick ® HIV Self-Test in the U.S. retail or consumer market as well as to the same markets as the OraQuick ADVANCE ® test for use in public health-oriented programs. The product is also available for purchase online through certain retailers and from the Company's website, www.oraquick.com.
The purchasers of diagnostic products are expected to place increased emphasis on lowering costs, reducing inventory levels, obtaining better performing products, automation, service and volume discounts. The Company expects competition to intensify as technological advances are made and become more widely known, and as new products reach the market.
The purchasers of diagnostic products are expected to Table of Contents place increased emphasis on lowering costs, reducing inventory levels, obtaining better performing products, automation, service and volume discounts. The Company expects competition to intensify as technological advances are made and become more widely known, and as new products reach the market.
If the FDA determines that the Company's facilities or procedures do not comply with the QSR regulations, it may refuse to provide such certificates until the Company resolves the issues to the FDA’s satisfaction. Failure to obtain a CFG could inhibit the Company's ability to export its products to countries that require such certificates.
If the FDA determines that the Company's facilities or procedures do not comply with the QMSR regulations, it may refuse to provide such certificates until the Company resolves the issues to the FDA’s satisfaction. Failure to obtain a CFG could inhibit the Company's ability to export its products to countries that require such certificates.
Supply and Manufacturing The Company manufactures its InteliSwab ® COVID-19 Rapid Test, OraQuick ADVANCE ® Rapid HIV test, OraQuick ® In-Home HIV test, OraQuick ® HCV test, OraQuick ® Ebola test, OraSure ® , Intercept ® and Intercept i2 ® he collection devices, AUTO-LYTE ® and MICRO-PLATE assays and Q.E.D. ® saliva alcohol test in its Bethlehem, Pennsylvania facilities.
Supply and Manufacturing The Company manufactures its InteliSwab ® COVID-19 Rapid Test, OraQuick ADVANCE ® Rapid HIV test, OraQuick ® HIV Self-Test, OraQuick ® HCV test, OraQuick ® Ebola test, OraSure ® , Intercept ® and Intercept i2 ® he collection devices, AUTO-LYTE ® and MICRO-PLATE assays and Q.E.D. ® saliva alcohol test in its Bethlehem, Pennsylvania facilities.
The EU MDR and EU IVDR impose stricter pre-market and post-market requirements for the marketing and sale of medical devices and in vitro diagnostic medical devices than the previous Directives, including in the area of clinical evaluation requirements, quality systems and post-market surveillance. The EU IVDR became fully applicable on May 26, 2022.
The EU MDR and EU IVDR impose Table of Contents stricter pre-market and post-market requirements for the marketing and sale of medical devices and in vitro diagnostic medical devices than the previous Directives, including in the area of clinical evaluation requirements, quality systems and post-market surveillance. The EU IVDR became fully applicable on May 26, 2022.
The Company's Opus Way facility was customized to accommodate increased manufacturing capacity. Throughout 2024, the Company made progress on consolidating its manufacturing footprint by using the Opus Way facility for a more significant portion of its manufacturing and distribution needs, including re-shoring of capacity to the United States.
The Company's Opus Way facility was customized to accommodate increased manufacturing capacity. Throughout 2025, the Company made progress on consolidating its manufacturing footprint by using the Opus Way facility for a more significant portion of its manufacturing and distribution needs, including re-shoring of capacity to the United States.
In all cases, data from some form of performance testing is required and in some cases, the submission must include data from human clinical studies. An applicant must submit a 510(k) notification at least 90 days before commercial distribution of the product commences.
In all cases, data from some form of performance testing is required and in some cases, the submission must Table of Contents include data from human clinical studies. An applicant must submit a 510(k) notification at least 90 days before commercial distribution of the product commences.
The Company's OraQuick ® In-Home HIV oral fluid test is the only rapid HIV test approved by the FDA for sale in the U.S. OTC market. Outside the U.S., the Company's rapid HIV and HCV tests compete against other rapid and laboratory-based tests, which require blood as a sample.
The Company's OraQuick ® HIV Self-Test oral fluid test is the only rapid HIV test approved by the FDA for sale in the U.S. OTC market. Outside the U.S., the Company's rapid HIV and HCV tests compete against other rapid and laboratory-based tests, which require blood as a sample.
When blood-based specimens are to be tested, a loop collection device is used to collect a drop of the specimen and mix it in the developer solution, after which the collection pad is inserted into the solution and the test is allowed to develop.
When blood-based Table of Contents specimens are to be tested, a loop collection device is used to collect a drop of the specimen and mix it in the developer solution, after which the collection pad is inserted into the solution and the test is allowed to develop.
The information contained on the Company's website is not a part of this Annual Report. 20 Table of Contents
The information contained on the Company's website is not a part of this Annual Report. Table of Contents
Benefits include: • Reliable high-quality and stable genetic samples. 5 Table of Contents • Simple, non-invasive collection methods. • The ability to store and transport collected samples for extended periods at ambient temperatures. • Compatibility with fully automated laboratory testing systems. The Company also sells the Colli-Pee ® collection device for the volumetric collection of first void urine samples.
Benefits include: • Reliable high-quality and stable genetic samples. • Simple, non-invasive collection methods. • The ability to store and transport collected samples for extended periods at ambient temperatures. • Compatibility with fully automated laboratory testing systems. Colli-Pee ® Urine Collection Device The Company also sells the Colli-Pee ® collection device for the volumetric collection of first void urine samples.
The Company believes that when all voices are heard, it honors and exemplifies its core values and best serves its communities. 10 Table of Contents Competition The diagnostic industry is a multi-billion dollar international industry and is intensely competitive. Many of the Company's competitors are substantially larger than the Company, and have greater financial, research, manufacturing and marketing resources.
The Company believes that when all voices are heard, it honors and exemplifies its core values and best serves its communities. Competition The diagnostic industry is a multi-billion dollar international industry and is intensely competitive. Many of the Company's competitors are substantially larger than the Company, and have greater financial, research, manufacturing and marketing resources.
The Company believes that its facilities and procedures are in material compliance with the FDA’s QSR requirements, the European Union's Quality Management Systems requirements, ISO 13485:2016, and other post-market requirements, but the regulations are subject to change or may be unclear, and the Company cannot be sure that FDA investigators will agree with the Company's compliance with the FDA’s post-market requirements.
The Company believes that its facilities and procedures are in material compliance with the requirements of the FDA’s QMSR, the European Union's Quality Management Systems requirements, ISO 13485:2016, and other post-market requirements, but the regulations are subject to change or may be unclear, and the Company cannot be sure that FDA investigators will agree with the Company's compliance with the FDA’s post-market requirements.
If the FDA determines that the Company's promotional materials or training constitute promotion of an uncleared or unapproved use, it could request that the Company modify its training or promotional materials or subject the Company to regulatory or enforcement actions, including the issuance of an untitled letter, a notice 16 Table of Contents of violation, a warning letter, injunction, seizure, civil fine or criminal penalties.
If the FDA determines that the Company's promotional materials or training constitute promotion of an uncleared or unapproved use, it could request that the Company modify its training or promotional materials or subject the Company to regulatory or enforcement actions, including the issuance of an untitled letter, a notice of violation, a warning letter, injunction, seizure, civil fine or criminal penalties.
In recent years, there has been greater scrutiny of marketing practices in the 18 Table of Contents medical device industry which has resulted in several government investigations by various government authorities and the introduction and/or passage of federal and state legislation regulating interactions between medical device manufacturers and healthcare professionals and providers and requiring the disclosure by medical device manufacturers of payments to certain healthcare providers.
In recent years, there has been greater scrutiny of marketing practices in the medical device industry which has resulted in several government investigations by various government authorities and the introduction and/or passage of federal and state legislation regulating interactions between medical device manufacturers and healthcare professionals and providers and requiring the disclosure by medical device manufacturers of payments to certain healthcare providers.
Bribery Act 2010 (the “Bribery Act”), which proscribes giving and receiving bribes in the public and private sectors, bribing a foreign public official, and failing to have adequate procedures to prevent employees and other agents from giving bribes. U.S. companies that conduct business in the United Kingdom generally will be subject to the Bribery Act.
Bribery Act 2010 (the “Bribery Act”), which proscribes giving and receiving bribes in the public and private sectors, bribing a foreign public official, and failing to have adequate procedures to prevent employees and other agents from giving bribes. U.S. companies Table of Contents that conduct business in the United Kingdom generally will be subject to the Bribery Act.
The Company also licenses the SHERLOCK™ mark from The Broad Institute, Inc. The Company also owns many of these marks and others in several foreign countries and it is pursuing registration of several other trademarks.
The Company also licenses the SHERLOCK™ mark from The Broad Table of Contents Institute, Inc. The Company also owns many of these marks and others in several foreign countries and it is pursuing registration of several other trademarks.
In September 2023, the agreement was modified to add an additional $6.8 million in funding to be used to obtain the appropriate regulatory approvals for the product. InteliSwab ® COVID-19 Rapid Test The InteliSwab ® COVID-19 rapid test ("InteliSwab") is the Company's rapid immunoassay product designed to test nasal samples for the presence of antigen from SARS-CoV-2.
In September 2023, the agreement was modified to add an additional $6.9 million in funding to be used to obtain the appropriate regulatory approvals for the product. InteliSwab ® COVID-19 Rapid Test The InteliSwab ® COVID-19 rapid test (“InteliSwab”) is the Company's rapid immunoassay product designed to test nasal samples for the presence of antigen from SARS-CoV-2.
The FDA certifies that the product has been granted clearance or approval in the United States and that the manufacturing facilities were in compliance with QSR regulations at the time of the last FDA inspection.
The FDA certifies that the product has been granted clearance or approval in the United States and that the manufacturing facilities were in compliance with QMSR regulations at the time of the last FDA inspection.
If the FDA’s evaluation of the PMA or the manufacturing facility is not favorable, the FDA may deny approval of the PMA application or issue a “not approvable” 14 Table of Contents letter. The FDA may also require additional clinical trials, which can delay the PMA approval process by several years or prevent a PMA approval from being obtained.
If the FDA’s evaluation of the PMA or the manufacturing facility is not favorable, the FDA may deny approval of the PMA application or issue a “not approvable” letter. The FDA may also require additional clinical trials, which can delay the PMA approval process by several years or prevent a PMA approval from being obtained.
The Company's OMNIgene ® • GUT product is an all-in-one system designed to enable an individual to easily self-collect high-quality microbial DNA from feces or stool samples for gut microbiome profiling for use in the clinical laboratory and research settings.
Table of Contents The Company's OMNIgene ® • GUT product is an all-in-one system designed to enable an individual to easily self-collect high-quality microbial DNA from feces or stool samples for gut microbiome profiling for use in the clinical laboratory and research settings.
The Company had no other customers that accounted for more than 10% of consolidated net revenues for the years ended December 31, 2024, 2023 and 2022.
The Company had no other customers that accounted for more than 10% of consolidated net revenues for the years ended December 31, 2025, 2024 and 2023.
ISO certification of the quality system in accordance with the relevant standard for medical devices or in vitro diagnostic devices creates a rebuttable presumption that the product satisfies the applicable requirements of the EU MDR or EU IVDR (as applicable) 17 Table of Contents with respect to the quality management system.
ISO certification of the quality system in accordance with the relevant standard for medical devices or in vitro diagnostic devices creates a rebuttable presumption that the product satisfies the applicable requirements of the EU MDR or EU IVDR (as applicable) with respect to the quality management system.
In September 2022, the Company entered into an agreement with the Biomedical Advanced Research and Development Authority ("BARDA"), pursuant to which BARDA will provide up to $8.6 million in funding to the Company to develop a 2nd generation Ebola test on the OraQuick ® testing platform with the objective of developing increased sensitivity, utilizing sustainable raw materials and increasing shelf life, with new chemistry and higher degrees of automation in the test’s manufacturing process.
In September 2022, the Company entered into an agreement with the Biomedical Advanced Research and Development Authority (“BARDA”), pursuant to which BARDA will provide up to $8.6 million in funding to the Company to develop an updated Ebola test on the OraQuick ® testing platform with the objective of developing increased sensitivity, utilizing sustainable raw materials and increasing shelf life, with new chemistry and higher degrees of automation in the test’s manufacturing process.
The majority of the Company's sales outside the U.S. are in Africa due to the greater incidence of HIV in that region. 11 Table of Contents The Company's OraQuick ® HIV Self-Test is CE marked, which enables it to participate in the European OTC market for HIV.
The majority of the Company's sales outside the U.S. are in Africa due to the greater incidence of HIV in that region. The Company's OraQuick ® HIV Self-Test is CE marked, which enables it to participate in the European OTC market for HIV.
The Company believes that its products and manufacturing processes at its facilities comply in all material respects with 19 Table of Contents applicable environmental laws and worker health and safety laws; however, the risk of environmental liabilities cannot be completely eliminated.
The Company believes that its products and manufacturing processes at its facilities comply in all material respects with applicable environmental laws and worker health and safety laws; however, the risk of environmental liabilities cannot be completely eliminated.
Diagnostics - OTC and Self-Test The Company sells its InteliSwab ® COVID-19 Rapid Test product in the U.S. retail and consumer markets, including for purchase by U.S. customers on Walmart's and Amazon’s online stores.
Table of Contents Diagnostics - OTC and Self-Test The Company sells its InteliSwab ® COVID-19 Rapid Test product in the U.S. retail and consumer markets, including for purchase by U.S. customers on Walmart's and Amazon’s online stores.
In the EU, products that fall under the scope of the MDR and the EU IVDR may not be placed on the EU market without a valid CE mark. Approval of a regulatory authority is not required to obtain CE certification, but, depending on the class of product, conformity assessment by a notified body may be required.
In the EU, products that fall under the scope of the MDR and the EU IVDR may not be placed on the EU market without a valid CE mark. Approval of a national regulatory authority is not required to obtain a CE mark; however, depending on the class of product, conformity assessment by a notified body may be required.
One related design patent is issued in the U.S. and will expire in November 2038, and other related design patent applications are pending in the U.S., Canada, and Europe. The Company has additional pending applications directed to new direct sample collection pads for its InteliSwab ® COVID-19 Rapid Test.
One related design patent is issued in the U.S. and will expire in August 2040, and other related design patent applications are pending in the U.S., Canada, and Europe. The Company has additional pending applications directed to new direct sample collection pads for its InteliSwab ® COVID-19 Rapid Test.
To facilitate talent attraction and retention, the Company strives to be a safe and rewarding workplace with opportunities for its employees to grow and develop in their careers. As of December 31, 2024, the Company had 501 full-time employees, which compares to 638 employees as of December 31, 2023.
To facilitate talent attraction and retention, the Company strives to be a safe and rewarding workplace with opportunities for its employees to grow and develop in their careers. As of December 31, 2025, the Company had 500 full-time employees, which compares to 501 employees as of December 31, 2024.
Sample Management Solutions In order to intersect evolving customer needs within the academic and commercial markets, the Company's sample management solutions business product development pipeline is focused on extending offerings across different sample types and analytes within both the genomics and microbiome areas.
Sample Management Solutions In order to intersect evolving customer needs within the academic and commercial markets, the Company's sample management solutions business product development pipeline is focused on extending offerings across different sample types and analytes within genomics, proteomics, microbiome and infectious disease areas.
This market consists of a broad range of clinics and laboratories and includes states, counties, and other 7 Table of Contents governmental agencies, family planning clinics, colleges and universities, correctional facilities and the military.
This market consists of a broad range of clinics and laboratories and includes states, counties, and other governmental agencies, family planning clinics, colleges and universities, correctional facilities and the military.
The Company has registered design patents for a collection funnel and corresponding plunger device in Europe, Canada China, India, and the U.S. The Company has two international families of patent applications filed in the United States and in numerous countries worldwide.
The Company has registered design patents for a collection funnel and corresponding plunger device in Europe, Canada China, India, and the U.S. The Company has an international family of patent applications filed in the United States and in numerous countries worldwide.
With the exception of its substance abuse testing products, the Company expects to continue to manufacture these products at this location for the foreseeable future. The Company has contracted with a third party in Thailand for the assembly of the OraQuick ® Rapid HIV test and the OraQuick ® HIV Self-Test in order to supply certain international markets.
The Company expects to continue to manufacture these products at this location for the foreseeable future. The Company has contracted with a third party in Thailand for the assembly of the OraQuick ® Rapid HIV test and the OraQuick ® HIV Self-Test in order to supply certain international markets.
The FDA regularly inspects companies to determine compliance with the QSRs and other post-market requirements.
The FDA regularly inspects companies to determine compliance with the QMSRs and other post-market requirements.
These applications are directed to novel nucleoside reverse transcriptase inhibitor-specific antibodies for use in assays to detect the presence of nucleoside reverse transcriptase inhibitor drug derivatives, including tenofovir, in fluid samples. Patents issuing from these applications will expire in October 2038 and December 2040.
These applications are directed to novel nucleoside reverse transcriptase inhibitor-specific antibodies for use in assays to detect the presence of nucleoside reverse transcriptase inhibitor drug derivatives, including tenofovir, in fluid samples. Patents issuing from these applications will expire between October 2038 and May 2041.
Products and Services The Company's business consists of the development, manufacture, marketing, sale and distribution of simple, easy to use diagnostic products and specimen collection devices using its proprietary technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests.
Products and Services The Company's business consists of the development, manufacture, marketing, sale and distribution of simple, easy to use diagnostic products and specimen collection devices using its proprietary technologies, as well as other diagnostic products, including immunoassays and other in vitro diagnostic tests that are used on other specimen types.
This test is available for use by laboratories located in the United States certified under CLIA, to perform moderately complex tests. The Company has also received a CLIA waiver for use of the test with oral fluid and finger-stick and venous whole blood.
This test is available for use by laboratories located in the United States certified under a Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), to perform moderately complex tests. The Company has also received a CLIA waiver for use of the test with oral fluid and finger-stick and venous whole blood.
Through 2024, the Company maintained its expanded United States production capacity for InteliSwab ® tests to meet capacity targets set out in its 2021 contract with the U.S. Department of Defense ("DOD") (in coordination with the U.S. Department of Health and Human Services ("HHS")), of more than 100 million tests annually.
Through 2025, the Company maintained its expanded United States production capacity for InteliSwab ® tests to meet capacity targets set out in its 2021 contract with the U.S. Department of Defense (“DOD”) (in coordination with the U.S. Department of Health and Human Services (“HHS”)), of more than 100 million tests annually.
The Company holds, through its subsidiary, DNAG, nineteen granted United States patents and numerous foreign patents issued for compositions, methods and apparatuses for the collection, stabilization, transportation, and storage of nucleic acids (DNA and RNA) from oral fluid and other bodily fluids and tissues. Certain patents expired in June 2023, and others will expire through November 2040.
The Company holds, through its subsidiary, DNAG, seventeen issued United States patents and numerous foreign patents issued for compositions, methods and apparatuses for the collection, stabilization, transportation, and storage of nucleic acids (DNA and RNA) from oral fluid and other bodily fluids and tissues. Certain patents expired in April 2026, and others will expire through November 2040.
The FDA does not currently regulate products used for these purposes, although other state and federal regulatory requirements may apply. 15 Table of Contents Most devices distributed in the United States must comply with the FDA’s Quality System Regulations (“QSRs”), including current good manufacturing practices.
The FDA does not currently regulate products used for these purposes, although other state and federal regulatory requirements may apply. Most devices distributed in the United States must comply with the FDA’s Quality Management System Regulations (“QMSRs”), including current good manufacturing practices.
The transition deadline for other classes of devices ranges between December 21, 2027 and December 31, 2029, provided certain transitional activities are performed by earlier deadlines (e.g. the manufacturer must sign a formal written agreement with a notified boy for assessment under the EU IVDR).
The transition deadline for other classes of devices ranges from December 31, 2027 to December 31, 2029, provided certain transitional activities are performed by earlier deadlines (e.g. the manufacturer must sign a formal written agreement with a notified body for assessment under the EU IVDR).
The Company considers the applicability of CLIA requirements in the design and development of its products. The Company has obtained a waiver of the CLIA requirements for its OraQuick ADVANCE ® rapid HIV-1/2 antibody test, its OraQuick ® HCV rapid antibody test and its Q.E.D. ® alcohol saliva test and may seek similar waivers for certain other products.
The Company has obtained a waiver of the CLIA requirements for its OraQuick ADVANCE ® rapid HIV-1/2 antibody test, its OraQuick ® HCV rapid antibody test and its Q.E.D. ® alcohol Table of Contents saliva test and may seek similar waivers for certain other products.
ITEM 1. Business. OTI transforms health through actionable insight by powering the shift that connects people to healthcare wherever they are. Our products and services reside under one reporting hierarchy, with commercial and innovation teams, which are part of a single business unit covering multiple product lines.
ITEM 1. Business. OTI transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are. Our products and services reside under one reporting hierarchy, with commercial and innovation teams, which are part of a single business unit covering multiple product lines.
The Company is developing this test and hopes to achieve FDA 510(k) clearance in whole or in part with federal funds obtained from the HHS Administration for Strategic Preparedness and Response (ASPR); BARDA under Other Transaction Number: 75A50123D00005.
The Company is developing this test and hopes to achieve FDA 510(k) clearance in whole or in part with federal funds obtained from the HHS Administration for Strategic Preparedness and Response (ASPR); BARDA under Other Transaction Number: 75A50123D00005. Through its Sherlock subsidiary, the Company is developing a rapid molecular self-test for CT/NG.
These applications entered their national phase in countries throughout the world in October 2023, and patents issuing from these applications will expire in December 2042. Two related design patents issued in 2022 in the 12 Table of Contents U.S. and corresponding design applications were registered in Canada, China, India, and Europe. These design patents will expire 2038 and 2039.
These applications entered their national phase in countries throughout the world in October 2023, and patents issuing from these applications will expire in November 2044. Two related design patents issued in 2024 in the U.S. and corresponding design applications were registered in Canada, China, India, and Europe. These design patents will expire 2038 and 2039.
Additionally, the OraQuick ® HCV Self-Test is an over the counter self-test that operates in substantially the same way as the OraQuick ® HCV rapid antibody test. The OraQuick ® HCV self-test received WHO pre-qualification in 2024 and is the first hepatitis C self-test to earn this designation.
Additionally, the OraQuick ® HCV Self-Test is an OTC self-test, available in certain markets outside the U.S., that operates in substantially the same way as the OraQuick ® HCV rapid antibody test. The OraQuick ® HCV self-test received WHO pre-qualification in 2024 and is the first hepatitis C self-test to earn this designation.
The table below shows a breakdown of those product lines (dollars in thousands): For the Years Ended December 31, 2024 2023 2022 OraQuick® HIV $ 60,804 $ 60,823 $ 38,812 InteliSwab® 45,136 257,493 233,666 Genomics 44,861 47,005 54,335 One non-commercial customer accounted for approximately 24% of the Company's consolidated net revenues for the year ended December 31, 2024 and 63% and 58% for the years ended December 31, 2023 and 2022, respectively.
The table below shows a breakdown of those product lines (dollars in thousands): For the Years Ended December 31, 2025 2024 2023 OraQuick ® HIV $ 49,802 $ 60,804 $ 60,823 InteliSwab ® 620 45,136 257,493 Genomics 31,546 44,861 47,005 Table of Contents One non-commercial customer accounted for approximately 3% of the Company's consolidated net revenues for the year ended December 31, 2025 and 24% and 63% for the years ended December 31, 2024 and 2023, respectively.
OraQuick ® In-Home HIV Test The OraQuick ® In-Home HIV test is an OTC oral-fluid only version of the Company's OraQuick ADVANCE ® HIV 1/2 Antibody Test. The Company received PMA approval to sell this test in the U.S. OTC market.
OraQuick ® HIV Self-Test The OraQuick ® HIV Self-Test is an OTC oral-fluid only version of the Company's OraQuick ADVANCE ® HIV 1/2 Antibody Test. The Company received PMA approval to sell this test in the U.S. OTC market for individuals 14 years of age and older.
The Company is leveraging its existing sales force and global research connections to engage microbiome customers around the world and establish itself as among the leaders in ease-of-collection, stabilization and transport of microbiome communities in a variety of challenging sample types such as stool, skin, vaginal and oral. 8 Table of Contents The Company's products include the Colli-Pee ® collection device for the volumetric collection of first void urine.
The Company is leveraging its existing sales force and global research connections to engage microbiome customers around the world and establish itself as among the leaders in ease-of-collection, stabilization and transport of microbiome communities in a variety of challenging sample types such as stool, skin, vaginal and oral.
The OraQuick® test has received World Health 2 Table of Contents Organization ("WHO") pre-qualification and registration in other countries for the detection of HIV-1 and HIV-2 antibodies in oral fluid, whole blood (fingerstick and venous), serum and plasma. The device uses a porous flat pad to collect an oral fluid specimen.
The OraQuick ® test has received World Health Organization ("WHO") pre-qualification and registration in other countries for the detection of HIV-1 and HIV-2 antibodies in oral fluid, whole blood (fingerstick and venous), serum and plasma.
Some suits filed under the FCA, known as “qui tam” actions, can be brought by a “whistleblower” or “relator” on behalf of the government, and such individuals may share in any amounts paid by the entity to the government in fines or settlement. Manufacturers can be held liable under false claims laws, even if they do not submit.
Some suits filed under the FCA, known as “qui tam” actions, can be brought by a “whistleblower” or “relator” on behalf of the Table of Contents government, and such individuals may share in any amounts paid by the entity to the government in fines or settlement.
Diagnostics Direct Syphilis Health Check ™ In February 2024, the Company entered into a strategic agreement with Diagnostics Direct to distribute its Syphilis Health Check ™ rapid diagnostic test. Syphilis Health Check ™ is the first CLIA-waived treponemal test.
Diagnostics Direct Syphilis Health Check ™ Pursuant to a strategic agreement with Diagnostics Direct, the Company distributes the Syphilis Health Check ™ rapid diagnostic test. Syphilis Health Check ™ is the first CLIA-waived treponemal test.
This product is in its early stages and initial sales are occurring primarily through distributors and collaborations for use in the liquid biopsy and sexually transmitted disease markets. The Colli-Pee ® collection device is registered as a class I urine collection device without a claim for preservative.
The Company's products include the Colli-Pee ® collection device for the volumetric collection of first void urine. This product is in its early stages and initial sales are occurring primarily through distributors and collaborations for use in the liquid biopsy and sexually transmitted disease markets.
Personal protective equipment is provided to those employees where needed for the employee to safely perform their job function. As part of its compensation philosophy, the Company believes that it must offer and maintain market competitive compensation and benefits programs for its employees in order to attract and retain superior talent.
As part of its compensation philosophy, the Company believes that it must offer and maintain market competitive compensation and benefits programs for its employees in order to attract and retain superior talent.
In the United States, the Company owns a number of trademarks, including the OraSure ® , Intercept ® , Intercept i2 ® he, Intercept i2 he ® , OraQuick ® , OraQuick ADVANCE ® , ORASURE QUICKFLU ® , SUREQUICK ® , Q.E.D. ® , InteliSwab ® , Oragene ® , DNA Genotek ® , OMNImet ® , ORAcollect ® , OMNIgene ® , Diversigen ® , CoreBiome ® , Boostershot ® , MetaGene ® , Benchmark ® , Novosanis ® , Colli-Pee ® , UCM ® , UAS™, THINK OUTSIDE THE CUP ® , AUTO-LYTE ® , prepIT ® , and HEMAgene ® trademarks.
In the United States, the Company owns a number of trademarks, including the OraSure ® , OTI™, OraQuick ® , OraQuick ADVANCE ® , ORASURE QUICKFLU ® , SUREQUICK ® , InteliSwab ® , SMART SCIENCE MADE SIMPLE ® , Oragene ® , DNA Genotek ® , OMNImet ® , ORAcollect ® , OMNIgene ® , Diversigen ® , CoreBiome ® , Boostershot ® , MetaGene ® , Benchmark ® , Novosanis ® , Colli-Pee ® , UCM ® , UAS™, prepIT ® , NucleoPrecision™, ProteoPrecision™, HEMAcollect™, and HEMAgene ® trademarks..
When unstabilized, a microbiome sample can change when exposed to environmental fluctuations, such as temperature changes. The Company's microbiome collection products support collecting and stabilizing metabolites found in fecal samples by capturing and preserving the microbiome after collection until the desired analysis can be performed.
The Company's microbiome collection products support collecting and stabilizing metabolites found in fecal samples by capturing and preserving the microbiome after collection until the desired analysis can be performed.
Genomic Products The Company sells genomic products that provide all-in-one systems for the collection, stabilization, transportation, and storage of DNA, RNA, as well as both DNA and RNA together from human and animal biological samples. The Company's lead products are sold under the Oragene ® and ORAcollect ® brands and are used to collect genetic material from human saliva.
Table of Contents Genomic Products The Company sells genomic products that provide all-in-one systems for the collection, stabilization, transportation, and storage of DNA, RNA, as well as both DNA and RNA together from human and animal biological samples.
A significant portion of total sales are derived from repeat customers in both markets. The Company also has customers in the livestock, companion animal and pharmaceutical markets.
The Company's commercial customers provide consumer genetics and clinical diagnostic services and account for a majority of these revenues. A significant portion of total sales are derived from repeat customers in both markets. The Company also has customers in the livestock, companion animal and pharmaceutical markets.
All DNAG products are produced in Canada and the United States. The Company's Colli-Pee ® device is currently being manufactured in Canada by its existing contract manufacturers with components supplied by third party vendors. Human Capital Resources In order to achieve the Company's goals and expectations, it is crucial that it continues to attract and retain top talent.
All DNAG products are produced in Canada and the United States. Human Capital Resources In order to achieve the Company's goals and expectations, it is crucial that it continues to attract and retain top talent.
The Company believes that its products and procedures are in material compliance with all applicable regulations, but the regulations regarding the manufacture and sale of its products may be unclear and are subject to change.
The Company believes that its products and procedures are in material compliance with all applicable regulations, but the regulations regarding the manufacture and sale of its products may be unclear and are subject to change. The Company cannot predict the effect, if any, that these changes might have on its business, financial condition or results of operations.
After approval or clearance by the FDA, the Company must continue to comply with other FDA requirements applicable to marketed products and is subject to periodic inspections by the FDA and other regulatory bodies.
Many of the Company's FDA-regulated products require some form of review and action by the FDA before they can be marketed in the United States. After approval or clearance by the FDA, the Company must continue to comply with other FDA requirements applicable to marketed products and is subject to periodic inspections by the FDA and other regulatory bodies.
Substance Abuse Testing On November 6, 2024, the Company announced that it intended to exit the substance abuse testing business. Though the Company will continue to fulfill final orders for certain of its substance abuse testing products, it substantially ceased the production and sale of such products as of the end of 2024.
In November 2024, the Company announced that it intended to exit the substance abuse testing business. Though the Company continued to fulfill final orders for certain of the foregoing products through the first half of 2025, it has ceased the production and sale of substance abuse testing products.
Customers span the disease risk management, diagnostics, pharmaceutical, biotech, companion animal and environmental market segments. The Company has also developed collection devices for the emerging microbiome market, which focuses on studying microbiomes and their effect on human and animal health. The Company also has a urine collection device which allows for the volumetric collection of first void urine.
The revenues from sample management solutions are derived from product sales to commercial customers and sales into the academic and research markets. Customers span the disease risk management, diagnostics, pharmaceutical, biotech, companion animal market segments. The Company has also developed collection devices for the emerging microbiome market, which focuses on studying microbiomes and their effect on human and animal health.
The Colli-Pee ® collection device with preservative solution does not have FDA clearance and is labeled “For Research Use Only” in the U.S. Significant Products and Customers Several different product lines have contributed significantly to the Company's financial performance, accounting for 10% or more of its total revenues during the past three years.
In December 2025, the Company submitted a 510(k) to the FDA for clearance of its Colli-Pee ® at home urine collection device for sexually transmitted infections. Significant Products and Customers Several different product lines have contributed significantly to the Company's financial performance, accounting for 10% or more of its total revenues during the past three years.
The Company believes its employees are among its most important resources and are critical to its continued success. The Company focuses significant attention on attracting and retaining talented and experienced individuals to manage and support its operations, and its management team routinely reviews employee turnover rates at various levels of the organization.
The Company focuses significant attention on attracting and retaining talented and experienced individuals to manage and support its operations, and its management team routinely reviews employee turnover rates at various levels of the organization. Management also reviews employee engagement and satisfaction surveys to monitor employee morale and receive feedback on a variety of issues.
Our diagnostic products include tests for diseases including HIV, Hepatitis C, Syphilis and COVID-19 that are performed on a rapid basis at the point of care. These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations, and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities.
These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations, and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities.
However, in many international markets, distributors are used. Most of the Company's revenues from sample management products are derived from sales to commercial customers and sales into the academic and research markets. The Company's commercial customers provide consumer genetics and clinical diagnostic services and account for a majority of these revenues.
Sample Management Solutions and Molecular Services The Company's sample management products are sold directly to customers, primarily through its internal sales force in U.S. markets. However, in many international markets, distributors are used. Most of the Company's revenues from sample management products are derived from sales to commercial customers and sales into the academic and research markets.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeRisks Relating to Products, Marketing and Sales • Changes in the genomics market may adversely affect the Company's business. • The Company's future success depends upon market acceptance of its existing and future products and service offerings. • The Company may not realize revenue levels from its InteliSwab® COVID-19 Rapid Test consistent with prior years. • Marketing of the Company's COVID-19 tests and collection kits under EUAs from the FDA is subject to certain limitations and it is required to maintain compliance with the terms of the EUA, among other things, and the continuance of the EUAs is subject to government discretion. • If acceptance and adoption of oral fluid testing and collection products does not continue, the Company's future results may suffer. • The Company expects to face increasing competition from other providers of diagnostic tests, and sample collection products. • The Company's inability to expand international sales could adversely affect its business and results of operations. • The Company's international presence may increase its risks and expose its business to regulatory, cultural or other restraints. • The Company's U.S. government contracts require compliance with numerous laws and increase its risk and liability. • The Company's inability to manufacture products in accordance with applicable specifications, performance standards or quality requirements could adversely affect its business. • The Company's business will suffer if it does not effectively manage challenges to its manufacturing processes and it may be unable to successfully scale-up manufacturing of its products in sufficient quality and quantity to meet demand, which would negatively impact revenue expectations.
Biggest changeRisks Relating to Products, Marketing and Sales • Changes in the genomics market may adversely affect the Company's business. • The Company's future success depends upon market acceptance of its existing and future products and service offerings. • If acceptance and adoption of oral fluid testing and collection products does not continue, the Company's future results may suffer. • The Company expects to face increasing competition from other providers of diagnostic tests, and sample collection products. • The Company's inability to expand international sales could adversely affect its business and results of operations. • The Company's international presence may increase its risks and expose its business to regulatory, cultural or other restraints. • The Company's U.S. government contracts require compliance with numerous laws and increase its risk and liability. • The Company's inability to manufacture products in accordance with applicable specifications, performance standards or quality requirements could adversely affect its business. • The Company's business will suffer if it does not effectively manage challenges to its manufacturing processes and it may be unable to successfully scale-up manufacturing of its products in sufficient quality and quantity to meet demand, which would negatively impact revenue expectations.
Also in September, 2022, the Company was selected to provide its OraQuick ® In-Home HIV tests in support of the CDC "Together Take me Home," HIV self-test program. Under the program, the CDC is expected to provide $41.5 million over a five-year period to support community testing.
Also in September, 2022, the Company was selected to provide its OraQuick ® HIV Self-Tests in support of the CDC "Together Take me Home," HIV self-test program. Under the program, the CDC is expected to provide $41.5 million over a five-year period to support community testing.
These activities, and their impact on the Company's business, are subject to many risks, including the following: • Suitable acquisitions or investments may not be found or consummated on terms or schedules that are satisfactory to the Company or consistent with its objectives; • The Company may be unsuccessful in competing for acquisitions with other entities, some of which have greater financial resources or may be better able to realize synergies with a potential target; • The benefits expected to be derived from an acquisition or investment may not materialize and could be affected by numerous factors, such as regulatory developments, insurance reimbursement, the Company's inexperience with new businesses or markets, general economic conditions and increased competition; • The Company may be unable to successfully integrate an acquired company’s personnel, assets, management, information technology systems, accounting policies and practices, products, services and/or technology into the Company's business; • Worse than expected performance of an acquired business may result in the impairment of intangible assets; • Acquisitions may require substantial expense and management time and could disrupt the Company's business; • The Company may not be able to accurately forecast the performance or ultimate impact of an acquired business; • The Company may have difficulties in coordinating geographically separate organizations; • The Company may fail to successfully manage relationships with customers, distributors and suppliers of an acquired business; • An acquisition may result in a diversion of resources from the Company's existing products, business and technologies; • An acquisition and subsequent integration activities may require greater capital and other resources than originally anticipated at the time of acquisition; • To the extent the Company agrees to pay contingent consideration for an acquisition, if and how much of such consideration it is required to pay may be subject to dispute, resulting in the distraction of the Company's management team and the incurrence of legal costs; • An acquisition may result in employee anxiety, morale and/or engagement issues; • An acquisition may result in disparate information technology, internal control, financial reporting and record-keeping systems; • An acquisition may result in new partners or customers who may operate on terms and programs different than the Company's; • An acquisition may result in employees not familiar with the Company's operations; • An acquisition may result in new products and services, including the risk that any underlying intellectual property associated with such products and services may not have been adequately protected or that such products and services may infringe on the proprietary rights of others; • An acquisition may result in the incurrence of unexpected expenses, stockholder lawsuits, the dilution of the Company's earnings or its existing stockholders’ percentage ownership, or potential losses from undiscovered liabilities not covered by an indemnification from the seller(s) of the acquired business; • An acquisition may result in the loss of the Company's or the acquired company’s key personnel, customers, distributors or suppliers; and • An acquisition of a foreign business may involve additional risks, including, but not limited to, foreign currency exposure, liability or restrictions under foreign laws or regulations, and 33 Table of Contents the Company's inability to successfully assimilate differences in foreign business practices or overcome language or cultural barriers and other inherent risks of operating in unfamiliar legal and regulatory environments.
These activities, and their impact on the Company's business, are subject to many risks, including the following: • Suitable acquisitions or investments may not be found or consummated on terms or schedules that are satisfactory to the Company or consistent with its objectives; • The Company may be unsuccessful in competing for acquisitions with other entities, some of which have greater financial resources or may be better able to realize synergies with a potential target; • The benefits expected to be derived from an acquisition or investment may not materialize and could be affected by numerous factors, such as regulatory developments, insurance reimbursement, the Company's inexperience with new businesses or markets, general economic conditions and increased competition; • The Company may be unable to successfully integrate an acquired company’s personnel, assets, management, information technology systems, accounting policies and practices, products, services and/or technology into the Company's business; • Worse than expected performance of an acquired business may result in the impairment of intangible assets; • Acquisitions may require substantial expense and management time and could disrupt the Company's business; • The Company may not be able to accurately forecast the performance or ultimate impact of an acquired business; • The Company may have difficulties in coordinating geographically separate organizations; • The Company may fail to successfully manage relationships with customers, distributors and suppliers of an acquired business; Table of Contents • An acquisition may result in a diversion of resources from the Company's existing products, business and technologies; • An acquisition and subsequent integration activities may require greater capital and other resources than originally anticipated at the time of acquisition; • To the extent the Company agrees to pay contingent consideration for an acquisition, if and how much of such consideration it is required to pay may be subject to dispute, resulting in the distraction of the Company's management team and the incurrence of legal costs; • An acquisition may result in employee anxiety, morale and/or engagement issues; • An acquisition may result in disparate information technology, internal control, financial reporting and record-keeping systems; • An acquisition may result in new partners or customers who may operate on terms and programs different than the Company's; • An acquisition may result in employees not familiar with the Company's operations; • An acquisition may result in new products and services, including the risk that any underlying intellectual property associated with such products and services may not have been adequately protected or that such products and services may infringe on the proprietary rights of others; • An acquisition may result in the incurrence of unexpected expenses, stockholder lawsuits, the dilution of the Company's earnings or its existing stockholders’ percentage ownership, or potential losses from undiscovered liabilities not covered by an indemnification from the seller(s) of the acquired business; • An acquisition may result in the loss of the Company's or the acquired company’s key personnel, customers, distributors or suppliers; and • An acquisition of a foreign business may involve additional risks, including, but not limited to, foreign currency exposure, liability or restrictions under foreign laws or regulations, and the Company's inability to successfully assimilate differences in foreign business practices or overcome language or cultural barriers and other inherent risks of operating in unfamiliar legal and regulatory environments.
A number of factors could adversely affect the performance of the Company's business and/or cause it to incur substantially increased costs because of its international presence and sales, including, but not limited to those set forth below: • Uncertainty in the application of foreign laws and the interpretation of contracts with foreign parties; • The potential for inconsistent imposition of legal and regulatory requirements; • Cultural and political differences that favor local competitors or make it difficult to effectively market, sell and gain acceptance of the Company's products; • Cultural and language differences that make international operations and business management more difficult; • Inexperience in international markets and territories and difficulties in staffing and managing foreign operations; • Exchange rates, currency fluctuations, tariffs and other barriers, extended payment terms and dependence on international distributors or representatives; • Regulatory requirements, including compliance with applicable customs regulations and the need to obtain or maintain regulatory approvals, registrations or reimbursement approvals for the Company's products; 26 Table of Contents • Trade protection measures, additional trade sanctions and import/export licensing requirements, and tariffs; • The inability to obtain or maintain ISO certification for the Company's or the Company's suppliers’ manufacturing facilities; • The Company's inability to identify international distributors and negotiate acceptable terms for distribution agreements; • Diversion to the U.S. of the Company's products that are sold at lower prices into international markets; • The loss of one or more distributors and difficulties or delays in obtaining new or transferred product registrations or approvals for use by a replacement distributor; • Differing tax laws across jurisdictions, as well as changes in those laws; • An increase of withholding and other taxes on remittances and other payments by a foreign subsidiary; • The creditworthiness of foreign distributors and customers and difficulty in collecting foreign accounts receivable; • Difficulty of enforcing contractual obligations or recovering damages under foreign legal systems; • Difficulty collecting amounts owed by foreign governments or other customers; • Economic conditions, inflation, political instability, the absence of available funding sources, terrorism, civil unrest, war and natural disasters in foreign countries; • Exposure to infectious disease and epidemics, including the effects of the COVID-19 outbreak on the Company's business operations and on the business operations of the Company's customers and suppliers; • Long sales cycles in international markets, especially for sales to foreign governments, quasi-governmental agencies and international public health agencies; • The sale of competing products by foreign competitors at prices at or below the prices offered for the Company's products; • Restrictions on the Company's ability to repatriate investments and earnings from foreign operations; • Changes in shipping costs; • The unavailability of licenses to certain patents in force in a foreign country which cover the Company's products; and • Reduced protection for, or enforcement of, the Company's patents and other intellectual property rights in foreign countries.
A number of factors could adversely affect the performance of the Company's business and/or cause it to incur substantially increased costs because of its international presence and sales, including, but not limited to those set forth below: • Uncertainty in the application of foreign laws and the interpretation of contracts with foreign parties; • The potential for inconsistent imposition of legal and regulatory requirements; • Cultural and political differences that favor local competitors or make it difficult to effectively market, sell and gain acceptance of the Company's products; • Cultural and language differences that make international operations and business management more difficult; • Inexperience in international markets and territories and difficulties in staffing and managing foreign operations; • Exchange rates, currency fluctuations, tariffs and other barriers, extended payment terms and dependence on international distributors or representatives; • Regulatory requirements, including compliance with applicable customs regulations and the need to obtain or maintain regulatory approvals, registrations or reimbursement approvals for the Company's products; • Trade protection measures, additional trade sanctions and import/export licensing requirements, and tariffs; • The inability to obtain or maintain ISO certification for the Company's or the Company's suppliers’ manufacturing facilities; • The Company's inability to identify international distributors and negotiate acceptable terms for distribution agreements; • Diversion to the U.S. of the Company's products that are sold at lower prices into international markets; • The loss of one or more distributors and difficulties or delays in obtaining new or transferred product registrations or approvals for use by a replacement distributor; • Differing tax laws across jurisdictions, as well as changes in those laws; • An increase of withholding and other taxes on remittances and other payments by a foreign subsidiary; • The creditworthiness of foreign distributors and customers and difficulty in collecting foreign accounts receivable; • Difficulty of enforcing contractual obligations or recovering damages under foreign legal systems; Table of Contents • Difficulty collecting amounts owed by foreign governments or other customers; • Economic conditions, inflation, political instability, the absence of available funding sources, terrorism, civil unrest, war and natural disasters in foreign countries; • Exposure to infectious disease and epidemics, including the effects of the COVID-19 outbreak on the Company's business operations and on the business operations of the Company's customers and suppliers; • Long sales cycles in international markets, especially for sales to foreign governments, quasi-governmental agencies and international public health agencies; • The sale of competing products by foreign competitors at prices at or below the prices offered for the Company's products; • Restrictions on the Company's ability to repatriate investments and earnings from foreign operations; • Changes in shipping costs; • The unavailability of licenses to certain patents in force in a foreign country which cover the Company's products; and • Reduced protection for, or enforcement of, the Company's patents and other intellectual property rights in foreign countries.
The Company's ability to achieve and continue profitable operations in the future will be dependent upon a number of factors including, without limitation, the following: • The Company's ability to continue growing sales of its sample management solutions and related genomic and microbiome laboratory services; • The Company's ability to successfully commercialize its products in the United States and internationally; • Changes in the markets in which the Company operates; • Changes in customer buying patterns or a buildup of significant quantities in the Company's distributors’ inventories or distribution channels; • The level of expenditures the Company is required to make in order to develop, obtain regulatory approvals for and successfully commercialize its new products; • The Company's ability to expand its business through the acquisition of other companies or technologies or through internal development of new or improved products; • The Company's ability to realize revenues and other anticipated benefits from its acquisitions and strategic transactions; • The Company's ability to improve manufacturing efficiencies and reduce cost of goods sold; • The Company's ability to successfully launch new products after receipt of required regulatory approvals or the acquisition of rights to those products; • The degree to which the Company's major distributors and customers comply with their contractual obligations, including minimum purchase commitments; 45 Table of Contents • Whether the Company or entities in which it invests are successful in obtaining and maintaining required regulatory approvals and registrations for its new products; • The level of competition, including the degree to which competitors sell lower priced products or more attractive offerings to compete with the Company's products; • Changes in economic conditions in domestic or international markets, such as economic downturns, reduced demand, inflation, currency fluctuations and tariffs; • Global economic and political instability and conflicts, such as terrorism, civil unrest, war and natural disasters in foreign countries; • Failure to achieve the Company's revenue growth targets; and • The costs and results of patent infringement, product liability and other litigation or claims asserted by or against the Company.
The Company's ability to achieve and continue profitable operations in the future will be dependent upon a number of factors including, without limitation, the following: • The Company's ability to continue growing sales of its sample management solutions and related genomic and microbiome laboratory services; • The Company's ability to successfully commercialize its products in the United States and internationally; • Changes in the markets in which the Company operates; • Changes in customer buying patterns or a buildup of significant quantities in the Company's distributors’ inventories or distribution channels; • The level of expenditures the Company is required to make in order to develop, obtain regulatory approvals for and successfully commercialize its new products; • The Company's ability to expand its business through the acquisition of other companies or technologies or through internal development of new or improved products; • The Company's ability to realize revenues and other anticipated benefits from its acquisitions and strategic transactions; • The Company's ability to improve manufacturing efficiencies and reduce cost of goods sold; • The Company's ability to successfully launch new products after receipt of required regulatory approvals or the acquisition of rights to those products; • The degree to which the Company's major distributors and customers comply with their contractual obligations, including minimum purchase commitments; • Whether the Company or entities in which it invests are successful in obtaining and maintaining required regulatory approvals and registrations for its new products; • The level of competition, including the degree to which competitors sell lower priced products or more attractive offerings to compete with the Company's products; • Changes in economic conditions in domestic or international markets, such as economic downturns, reduced demand, inflation, currency fluctuations and tariffs; • Global economic and political instability and conflicts, such as terrorism, civil unrest, war and natural disasters in foreign countries; • Failure to achieve the Company's revenue growth targets; and • The costs and results of patent infringement, product liability and other litigation or claims asserted by or against the Company.
The Company is also subject to the California Consumer Privacy Act (“CCPA”), which creates individual privacy rights and places stringent privacy and security obligations on businesses covered by the law, including obligations to provide detailed disclosures to California consumers about their data collection, use and sharing practices and provide such 42 Table of Contents consumers with ways to opt out of certain uses of sensitive personal information, including health information.
Table of Contents The Company is also subject to the California Consumer Privacy Act (“CCPA”), which creates individual privacy rights and places stringent privacy and security obligations on businesses covered by the law, including obligations to provide detailed disclosures to California consumers about their data collection, use and sharing practices and provide such consumers with ways to opt out of certain uses of sensitive personal information, including health information.
To the extent that such a large customers fail to meet their purchase commitments, change their ordering patterns or business strategies, or otherwise reduce their purchases or stop purchasing the Company's products, or if it experiences difficulty in meeting the high demand by these larger customers for its products, the Company's revenues and results of operations could be adversely affected.
To the extent that such large customers fail to meet their purchase commitments, change their ordering patterns or business strategies, or otherwise reduce their purchases or stop purchasing the Company's products, or if it experiences difficulty in meeting the high demand by these larger customers for its products, the Company's revenues and results of operations could be adversely affected.
As a result, there can be no assurance that the Company will be able to expand the use of its oral fluid testing products in these or other markets. However, clinical reference laboratories and hospital-based laboratories currently provide the majority of diagnostic tests used by physicians and other healthcare providers in the U.S.
As a result, there can be no assurance that the Company will be able to expand the use of its oral fluid testing products in these or other markets. Clinical reference laboratories and hospital-based laboratories currently provide the majority of diagnostic tests used by physicians and other healthcare providers in the U.S.
As such, the Company's involvement in litigation or other legal proceedings with respect to patents or other intellectual property and proprietary technology, either as a plaintiff or defendant, could adversely affect its revenues, market share, results of operations and business because: • It could consume a substantial portion of managerial and financial resources; • Its outcome would be uncertain and a court may find that the Company's patents are invalid or unenforceable in response to claims by another party or that the third-party patent claims are valid and infringed by the Company's products or services; • An adverse outcome could subject the Company to the loss of the protection of its patents or to liability in the form of past royalty payments, penalties, reimbursement of litigation costs and legal fees, special and punitive damages, or future royalty payments, any of which could significantly affect the Company's future earnings; • Governmental agencies may commence investigations or criminal proceedings against the Company's employees, former employees and the Company itself relating to claims of misappropriation or misuse of another party’s proprietary rights; • Failure to obtain a necessary license upon an adverse outcome could prevent the Company from selling its current products or services or other products or services it may develop or acquire; 38 Table of Contents • The Company may be required to alter its product or services, given the proprietary rights of others; • The pendency of any litigation may in and of itself cause the Company's distributors and customers to reduce or terminate purchases of its products or services; and • A court could award a preliminary and/or permanent injunction, which would prevent the Company from selling its current or future products or services.
As such, the Company's involvement in litigation or other legal proceedings with respect to patents or other intellectual property and proprietary technology, either as a plaintiff or defendant, could adversely affect its revenues, market share, results of operations and business because: • It could consume a substantial portion of managerial and financial resources; • Its outcome would be uncertain and a court may find that the Company's patents are invalid or unenforceable in response to claims by another party or that the third-party patent claims are valid and infringed by the Company's products or services; • An adverse outcome could subject the Company to the loss of the protection of its patents or to liability in the form of past royalty payments, penalties, reimbursement of litigation costs and legal fees, special and punitive damages, or future royalty payments, any of which could significantly affect the Company's future earnings; • Governmental agencies may commence investigations or criminal proceedings against the Company's employees, former employees and the Company itself relating to claims of misappropriation or misuse of another party’s proprietary rights; • Failure to obtain a necessary license upon an adverse outcome could prevent the Company from selling its current products or services or other products or services it may develop or acquire; • The Company may be required to alter its product or services, given the proprietary rights of others; • The pendency of any litigation may in and of itself cause the Company's distributors and customers to reduce or terminate purchases of its products or services; and • A court could award a preliminary and/or permanent injunction, which would prevent the Company from selling its current or future products or services.
The GDPR also imposes strict rules on the transfer of personal data out of the EEA to third countries, including the United States in certain circumstances, unless a derogation exists or a valid GDPR transfer mechanism (for example, the European Commission approved Standard Contractual Clauses, or SCCs, or the EU-US Data Privacy Framework) applies.
The GDPR also imposes strict rules on the transfer of personal data out of the EEA/UK to third countries, including the United States in certain circumstances, unless a derogation exists or a valid GDPR transfer mechanism (for example, the European Commission approved Standard Contractual Clauses, or SCCs, or the EU-US Data Privacy Framework) applies.
Relying on collaborative relationships could be risky to the Company's business for a number of reasons, including: • The Company may be required to transfer material rights to such strategic collaborators, government agencies, licensees and others; • The Company's collaborators may not devote sufficient resources or attach a sufficiently high priority to the success of its collaboration; • The Company's collaborators may not obtain regulatory approvals necessary to continue the collaborations in a timely manner; • The Company has limited access to its collaborator’s confidential corporate information and sudden unexpected changes in ownership or strategy or other material events affecting a collaborator of which the Company is not made aware of in a timely manner, or at all, could adversely impact the Company's relationship; • The Company's collaborators may be acquired by another company, sell the part of their business related to the Company's collaboration, decide to terminate the Company's collaborative arrangement or become insolvent; 36 Table of Contents • The Company's collaborators may develop technologies or components competitive with its products; • The Company's collaborators may fail to deliver technologies or components that satisfy market requirements or such products may fail to perform properly; • Disagreements with collaborators could result in the termination of the relationship or litigation; • Collaborators may not have sufficient capital resources; and • The Company may not be able to negotiate future collaborative arrangements, or renewals of existing collaborative agreements, on acceptable terms or at all.
Relying on collaborative relationships could be risky to the Company's business for a number of reasons, including: • The Company may be required to transfer material rights to such strategic collaborators, government agencies, licensees and others; • The Company's collaborators may not devote sufficient resources or attach a sufficiently high priority to the success of its collaboration; • The Company's collaborators may not obtain regulatory approvals necessary to continue the collaborations in a timely manner; • The Company has limited access to its collaborator’s confidential corporate information and sudden unexpected changes in ownership or strategy or other material events affecting a collaborator of which the Company is not made aware of in a timely manner, or at all, could adversely impact the Company's relationship; • The Company's collaborators may be acquired by another company, sell the part of their business related to the Company's collaboration, decide to terminate the Company's collaborative arrangement or become insolvent; • The Company's collaborators may develop technologies or components competitive with its products; • The Company's collaborators may fail to deliver technologies or components that satisfy market requirements or such products may fail to perform properly; • Disagreements with collaborators could result in the termination of the relationship or litigation; • Collaborators may not have sufficient capital resources; and • The Company may not be able to negotiate future collaborative arrangements, or renewals of existing collaborative agreements, on acceptable terms or at all.
The Company is selling the InteliSwab ® COVID-19 Rapid Test and the OraQuick ® In-Home HIV test in the United States OTC market, and it offers HIV Self-Tests to consumers internationally. The Company believes the sale of products for use by consumers increases its potential exposure to product liability and other claims.
The Company is selling the InteliSwab ® COVID-19 Rapid Test and the OraQuick ® HIV Self-Test in the United States OTC market, and it offers HIV Self-Tests to consumers internationally. The Company believes the sale of products for use by consumers increases its potential exposure to product liability and other claims.
Risks Relating to the Economy, Company Financial Results, Investments, Credit Facilities and Need for Financing • The Company has experienced losses in the past and may not be able to again achieve and maintain profitable operations. Risks Relating to the Company's Common Stock • The Company's stock price could continue to be volatile.
Risks Relating to the Economy, Company Financial Results, Investments, Credit Facilities and Need for Financing • The Company has experienced losses in the past and may not be able to again achieve and maintain profitable operations. Risks Relating to the Company's Common Stock • The Company's stock price could be volatile.
The GDPR imposes several mandatory requirements on companies that process personal data, including requirements relating to the processing of special category personal data (such as health sensitive data), ensuring a legal basis or condition applies to the processing of personal data, which may include obtaining the consent of the individuals to whom the personal data relates, providing notice to individuals about personal data processing activities, having data processing agreements with third parties who process personal data, notification of personal data breaches to data protection authorities and individuals, and the implementing of safeguards to protect the security and confidentiality of the personal data.
The GDPR imposes several mandatory requirements on companies that process personal data, including requirements relating to the processing of special category personal data (such as health sensitive data), ensuring a legal basis or condition applies to the processing of personal data, which may include obtaining the consent of the individuals to whom the personal data relates, providing notice to individuals about personal data processing activities, having data processing agreements with third parties who process personal data, notification of personal data breaches to Table of Contents data protection authorities and individuals, and the implementing of safeguards to protect the security and confidentiality of the personal data.
Any inability to transfer personal data from the EEA to the United States in compliance with data protection laws may impede the Company's ability to conduct trials and may adversely affect its business and financial position.
Any inability to transfer personal data from the EEA/UK to the United States in compliance with data protection laws may impede the Company's ability to conduct trials and may adversely affect its business and financial position.
The Company has outsourced significant elements of its IT infrastructure and, as a result, it manages relationships with third-party providers who may or could have access to the Company's sensitive and confidential information. The Company relies on technology developed, supplied and/or maintained by third-parties that may make the Company vulnerable to “supply chain” style cyber-attacks.
The Company has outsourced significant elements of its IT infrastructure and, as a result, it manages relationships with third-party providers who may or could have access to the Company's sensitive and confidential information. The Company relies on technology developed, supplied and/or maintained by third-parties that may make the Company Table of Contents vulnerable to “supply chain” style cyber-attacks.
If that were to occur, then in order to market the Company's diagnostic products or collection kits for the purpose of detecting COVID-19 the Company would be required to obtain the necessary regulatory clearances or approvals and be subject to the full and usual regulatory obligations for device manufacturers, including the QSR under 21 CFR Part 820.
If that were to occur, then in order to market the Company's diagnostic products or collection kits for the purpose of detecting COVID-19 the Company would be required to obtain the necessary regulatory clearances or approvals and be subject to the full and usual regulatory obligations for device manufacturers, including the QMSR under 21 CFR Part 820.
Although this can vary from quarter to quarter, many customers make purchase decisions late in a quarter due to budgetary or financial requirements. In addition, certain governmental customers must fully spend budgeted funds by the end of their fiscal year or risk losing these funds, which can contribute to fluctuations in the Company's sales from year-to-year.
Although this can vary from quarter to quarter, many customers make purchase decisions late in a quarter due to budgetary or financial requirements. In addition, certain governmental customers must fully spend budgeted funds by the end of their fiscal year or risk losing these funds, which can contribute to fluctuations in the Table of Contents Company's sales from year-to-year.
The Company's revenues relating to the Company's COVID-19 testing products have declined, and it expects they will continue to decline in the future if the prevalence of COVID-19 remains low. Further, if the COVID-19 pandemic becomes a seasonal virus or experiences fluctuations in prevalence, the Company could experience fluctuations in its revenues associated with its InteliSwab® COVID-19 Rapid Tests.
The Company's revenues relating to the Company's COVID-19 testing products have declined, and it expects they will continue to decline in the future if the prevalence of COVID-19 remains low. Further, if COVID-19 becomes a seasonal virus or experiences additional fluctuations in prevalence, the Company could experience fluctuations in its revenues associated with its InteliSwab® COVID-19 Rapid Tests.
Any such delays could allow the Company's competitors to seize market advantage, which could have a material, adverse effect on the Company's reputation, revenues, results of operations, cash flow and financial position. The Company's Business Results Depend on Its Ability to Manage Disruptions in Its Domestic and Global Supply Chains and Distribution Channels.
Any such delays could allow the Company's Table of Contents competitors to seize market advantage, which could have a material, adverse effect on the Company's reputation, revenues, results of operations, cash flow and financial position. The Company's Business Results Depend on Its Ability to Manage Disruptions in Its Domestic and Global Supply Chains and Distribution Channels.
The Company's operations consume substantial amounts of cash, and it intends to continue to make significant investments to support its business growth, respond to business challenges or opportunities, develop new solutions, retain or expand its current levels of personnel, improve its existing solutions, enhance its operating infrastructure, and potentially acquire complementary businesses and technologies.
The Company's operations consume substantial amounts of cash, and it intends to continue to make significant investments to support its business growth, respond to business challenges or opportunities, develop new solutions, retain or expand its current levels of personnel, improve its existing solutions, enhance its operating infrastructure, and potentially acquire Table of Contents complementary businesses and technologies.
We believe that our facilities and procedures are in material compliance with the FDA’s QSR requirements, the European Union’s Quality Management Systems requirements, ISO 13485:2016, but the regulations are subject to change or may be unclear, and we cannot be sure that FDA investigators will agree with our compliance with the FDA’s post-market requirements.
We believe that our facilities and procedures are in material compliance with the FDA’s QMSR requirements, the European Union’s Quality Management Systems requirements, ISO 13485:2016, but the regulations are subject to change or may be unclear, and we cannot be sure that FDA investigators will agree with our compliance with the FDA’s post-market requirements.
The ability of the Company's suppliers to supply critical components or materials and of its distributors to sell its products could also be adversely affected if their operations are determined to be out of compliance. Such actions by the FDA and other regulatory bodies could adversely affect the Company's revenues, costs and results of operations.
The ability of the Company's suppliers to supply critical Table of Contents components or materials and of its distributors to sell its products could also be adversely affected if their operations are determined to be out of compliance. Such actions by the FDA and other regulatory bodies could adversely affect the Company's revenues, costs and results of operations.
The Company's expectation is that the businesses of its foreign subsidiaries will continue to grow and its exposure to foreign currency exchange rates may be more significant than in past years. Exchange rate fluctuations may affect the revenues and expenses of the Company's foreign subsidiaries and the translation of those financial results into U.S. dollars.
The Company's expectation is that the businesses of its foreign subsidiary will continue to grow and its exposure to foreign currency exchange rates may be more significant than in past years. Exchange rate fluctuations may affect the revenues and expenses of the Company's foreign subsidiary and the translation of those financial results into U.S. dollars.
In particular, the Company must perform system and process evaluation, document its controls and perform testing of its key controls over financial reporting to allow management and its independent public accounting firm to report on the effectiveness of its internal control over financial reporting, as required by Section 404 of SOX.
In Table of Contents particular, the Company must perform system and process evaluation, document its controls and perform testing of its key controls over financial reporting to allow management and its independent public accounting firm to report on the effectiveness of its internal control over financial reporting, as required by Section 404 of SOX.
Further, the conflict in Ukraine or Israel could exacerbate supply chain challenges, lead to an increase in cyberattacks, affect the global price and availability of key commodities, reduce the Company’s sales and earnings or otherwise have an adverse effect on its business and results of operations.
Further, the conflict in Ukraine or Iran could exacerbate supply chain challenges, lead to an increase in cyberattacks, affect the global price and availability of key commodities, reduce the Company’s sales and earnings or otherwise have an adverse effect on its business and results of operations.
The Company cannot guarantee that the process of filing patents, the laws governing trade secrets and proprietary information, or any agreements the Company enters into with employees, consultants, advisors or collaborators will provide adequate protection of its intellectual property rights.
Table of Contents The Company cannot guarantee that the process of filing patents, the laws governing trade secrets and proprietary information, or any agreements the Company enters into with employees, consultants, advisors or collaborators will provide adequate protection of its intellectual property rights.
The Company cannot predict the broader or longer-term consequences of the conflict in Ukraine or Israel, or of the sanctions imposed to date, which could include embargoes, regional instability, geopolitical shifts, exchange rate fluctuations, financial market disruptions and economic recession.
The Company cannot predict the broader or longer-term consequences of the conflict in Ukraine or Iran, or of the sanctions imposed to date, which could include embargoes, regional instability, geopolitical shifts, exchange rate fluctuations, financial market disruptions and economic recession.
In addition, the impacts of political unrest, including as a result geopolitical tension, such as a deterioration in the relationship between the United States and China, escalation of tensions between China and Taiwan, or escalation in conflict between Russia and Ukraine or the Israel-Hamas war, including any resulting sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries against governmental or other entities in, for example, Russia, also could lead to disruption, instability and volatility in the global markets, which may have an adverse impact on the Company's business or ability to access the capital markets.
In addition, the impacts of political unrest, including as a result geopolitical tension, such as a deterioration in the relationship between the United States and China, escalation of tensions between China and Taiwan, or escalation in conflict between Russia and Ukraine or the conflict in Iran, including any resulting sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries against governmental or other entities in, for example, Russia, also could lead to disruption, instability and volatility in the global markets, which may have an adverse impact on the Company's business or ability to access the capital markets.
Future governmental responses to public health crises, including pandemics and epidemics could result in social, economic and labor instability of foreign countries, which could have a material adverse effect on the Company's business, results of operations and financial condition. 27 Table of Contents The Company's U.S. Government Contracts Require Compliance With Numerous Laws and Increases Its Risk and Liability.
Future governmental responses to public health crises, including pandemics and epidemics could result in social, economic and labor instability of foreign countries, which could have a material adverse effect on the Company's business, results of operations and financial condition. The Company's U.S. Government Contracts Require Compliance With Numerous Laws and Increases Its Risk and Liability.
The Company may be held liable if any of its products, or any product which is made with the use or incorporation of any of its technologies, causes injury of any type or is found otherwise unsuitable during product testing, manufacturing, marketing, sale or usage.
The Company may be held liable if any of its products, or any product which is made with the use or incorporation of any of its technologies, causes injury of any type or is found otherwise unsuitable during product testing, manufacturing, Table of Contents marketing, sale or usage.
In addition, governmental agencies could commence investigations or criminal proceedings against the Company's employees or the Company itself relating to claims of misuse or misappropriation of another party’s proprietary rights. Intellectual property litigation is costly.
In addition, governmental agencies could commence investigations or criminal proceedings against the Company's employees or the Company itself relating to claims of misuse or misappropriation of another party’s proprietary rights. Table of Contents Intellectual property litigation is costly.
As a result, the Company may expend considerable resources on unsuccessful sales efforts or it 25 Table of Contents may not be able to complete transactions at all or on a schedule and in an amount consistent with its objectives or previous order patterns. The Company's Inability To Expand International Sales Could Adversely Affect its Business and Results of Operations.
As a result, the Company may expend considerable resources on unsuccessful sales efforts or it may not be able to complete transactions at all or on a schedule and in an amount consistent with its objectives or previous order patterns. The Company's Inability To Expand International Sales Could Adversely Affect its Business and Results of Operations.
The Company has also received government funding for certain research and development projects, including, most recently, through the Rapid Response Partnership Vehicle ("RRVP") for the development of a Marburg Virus Disease ("MVD") rapid antigen test.
The Company has also received government funding for certain research and development projects, including, most recently, through the Rapid Response Partnership Vehicle ("RRVP") for the development of a Marburg Virus Disease Table of Contents ("MVD") rapid antigen test.
The size and complexity of the Company's IT and information security systems, and those of its third-party providers (and the large amounts of confidential information that is present on them), make such systems potentially vulnerable to service interruptions or to security incidents from inadvertent or intentional actions by, but not limited to, Company employees, service providers, business partners, customers or malicious attackers.
The size and complexity of the Company's IT and information security systems, and those of its third-party providers (and the amount of confidential information that is present on them), make such systems potentially vulnerable to service interruptions or to security incidents from inadvertent or intentional actions by, but not limited to, Company employees, service providers, business partners, customers or malicious attackers.
The Company is subject to routine inspection by the FDA and other agencies to determine compliance with QSR and FDA regulatory requirements in the United States and other applicable regulations worldwide, including but not limited to ISO standards.
The Company is subject to routine inspection by the FDA and other agencies to determine compliance with QMSR and FDA regulatory requirements in the United States and other applicable regulations worldwide, including but not limited to ISO standards.
The following factors, among others, could have a significant impact on the market for the Company's Common Stock: • The performance of the Company's business, including its efforts to increase sales of OraQuick ® HIV, HCV and sample management solutions and its OraQuick ® In-Home HIV test and HIV Self-Test; • Future announcements concerning the Company and its products or services, including with respect to significant acquisitions, strategic collaborations and joint ventures; • Ability to achieve the expected benefits, enhanced revenue growth and synergies from strategic acquisitions, including the Company's recent acquisition of Sherlock; • Clinical results with respect to the Company's products or services or those of its competitors; • The status of clinical studies and pending submissions for required regulatory approvals; • The announcement of regulatory or enforcement actions by the FDA or other agencies against the Company, its products or services, or one or more of its customers; • The gain or loss of significant contracts and availability of funding for the purchase of the Company's products and services; • Delays in the development, regulatory approval or commercialization of new or enhanced products or services; • Legislative developments and industry or competitive trends; • Biological or medical discoveries; • Disputes or developments with key customers, distributors or suppliers; • Developments in patent or other proprietary rights; • Litigation or threatened litigation; • Complaints or concerns about the performance or safety of the Company's products and publicity about those issues, including publicity expressed through social media or otherwise over the internet; • Failure to achieve, or changes in, financial estimates by securities analysts and comments or opinions about the Company by securities analysts or major stockholders; • Governmental regulation; • Changes in the level of competition; • Loss of or declines in sales to major distributors or customers or changes in the mix of products sold; • Period-to-period fluctuations in the Company's operating results; • Additions or departures of key personnel; • General market and economic conditions; and • Terrorist attacks, civil unrest, war and national disasters, including pandemics.
The following factors, among others, could have a significant impact on the market for the Company's Common Stock: • The performance of the Company's business, including its efforts to increase sales of OraQuick ® HIV, HCV and sample management solutions and its OraQuick ® HIV Self-Test; • Future announcements concerning the Company and its products or services, including with respect to significant acquisitions, strategic collaborations and joint ventures; • Ability to achieve the expected benefits, enhanced revenue growth and synergies from strategic acquisitions, including the Company's recent acquisition of Sherlock; • Clinical results with respect to the Company's products or services or those of its competitors; • The status of clinical studies and pending submissions for required regulatory approvals; Table of Contents • The announcement of regulatory or enforcement actions by the FDA or other agencies against the Company, its products or services, or one or more of its customers; • The gain or loss of significant contracts and availability of funding for the purchase of the Company's products and services; • Delays in the development, regulatory approval or commercialization of new or enhanced products or services; • Legislative developments and industry or competitive trends; • Biological or medical discoveries; • Disputes or developments with key customers, distributors or suppliers; • Developments in patent or other proprietary rights; • Litigation or threatened litigation; • Complaints or concerns about the performance or safety of the Company's products and publicity about those issues, including publicity expressed through social media or otherwise over the internet; • Failure to achieve, or changes in, financial estimates by securities analysts and comments or opinions about the Company by securities analysts or major stockholders; • Governmental regulation; • Changes in the level of competition; • Loss of or declines in sales to major distributors or customers or changes in the mix of products sold; • Period-to-period fluctuations in the Company's operating results; • Additions or departures of key personnel; • General market and economic conditions, including those related to inflation, interest rates, tariffs and foreign currency exchange rates; and • Terrorist attacks, civil unrest, war and national disasters, including pandemics.
If significant reforms continue to be made to the healthcare system in the United States, or in other jurisdictions, those reforms may increase the Company's costs or otherwise have an adverse effect on its financial condition and results of operations. 34 Table of Contents New or Changed Testing Guidelines Could Affect Sales of the Company's Diagnostic Products.
If significant reforms continue to be made to the healthcare system in the United States, or in other jurisdictions, those reforms may increase the Company's costs or otherwise have an adverse effect on its financial condition and results of operations. New or Changed Testing Guidelines Could Affect Sales of the Company's Diagnostic Products.
Even if the Company can 24 Table of Contents demonstrate that its products are more cost effective, save time, or have better performance or other benefits, physicians, other healthcare providers and consumers may resist changing to rapid point-of-care tests and instead may choose to obtain diagnostic results through laboratory tests.
Even if the Company can demonstrate that its products are more cost effective, save time, or have better performance or other benefits, physicians, other healthcare providers and consumers may resist changing to rapid point-of-care tests and instead may choose to obtain diagnostic results through laboratory tests.
Moreover, if any administrative process or system related to such contracts is found not to comply with governmental requirements, the Company may be subjected to government scrutiny that could delay or otherwise adversely affect its ability to compete for or perform government contracts or collect its revenue in a timely manner.
Moreover, if any administrative process or system related to such contracts is found not to comply with governmental requirements, the Company may be subjected to government scrutiny that could delay or otherwise adversely affect its Table of Contents ability to compete for or perform government contracts or collect its revenue in a timely manner.
Regardless of merit or eventual outcome, product liability claims could result in: • Decreased demand for the Company's products; • Lost revenues; • Damage to the Company's image or reputation; • Costs related to litigation; • Increased product liability insurance costs; 49 Table of Contents • Diversion of management time and attention; and • Incurrence of damages payable to plaintiffs.
Regardless of merit or eventual outcome, product liability claims could result in: • Decreased demand for the Company's products; • Lost revenues; • Damage to the Company's image or reputation; • Costs related to litigation; • Increased product liability insurance costs; • Diversion of management time and attention; and • Incurrence of damages payable to plaintiffs.
The Oragene ® product line sold by the Company's subsidiary, DNAG, competes against other sample management solutions, such as blood collection kits and buccal swabs and will likely face additional competition from collection devices similar in design and operation to the Company's Oragene ® and ORAcollect ® products.
The Oragene ® product line sold by the Company's subsidiary, DNAG, competes against other sample management solutions, such as blood collection kits and buccal swabs and will likely face additional competition from collection devices similar in design and operation to the Company's Oragene ® and Table of Contents ORAcollect ® products.
For example, it could incur damages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of consumers’ personal information. 41 Table of Contents Failure to Comply With Data Protection Requirements or Privacy Laws Could Increase the Company's Costs .
For example, it could incur damages under state laws pursuant to an action brought by a private party for the wrongful use or disclosure of consumers’ personal information. Failure to Comply With Data Protection Requirements or Privacy Laws Could Increase the Company's Costs .
Risks Relating to the Company's Reliance on Third Parties • The use of third party supply sources for critical components of the Company's products could adversely affect its business. 21 Table of Contents • The Company's failure to maintain existing distribution channels, or develop new distribution channels, may result in lower revenues.
Risks Relating to the Company's Reliance on Third Parties • The use of third party supply sources for critical components of the Company's products could adversely affect its business. • The Company's failure to maintain existing distribution channels, or develop new distribution channels, may result in lower revenues.
Risks Relating to Intellectual Property • The Company's success depends on its ability to protect its proprietary technology. • The Company may become involved in intellectual property disputes, which could increase its costs and limit or eliminate its ability to sell products, provide services or use certain technologies.
Risks Relating to Intellectual Property • The Company's success depends on its ability to protect its proprietary technology. Table of Contents • The Company may become involved in intellectual property disputes, which could increase its costs and limit or eliminate its ability to sell products, provide services or use certain technologies.
The Company has obtained the CE mark for several of its existing products under the IVDD. It also intends to apply for CE marks for certain of its future 39 Table of Contents products and is not aware of any material reason why it would be unable to obtain those marks.
The Company has obtained the CE mark for several of its existing products under the IVDD. It also intends to apply for CE marks for certain of its future products and is not aware of any material reason why it would be unable to obtain those marks.
To the extent the Company is unable to obtain or is delayed in obtaining such approvals, its ability to meet the demand for its products and services could be adversely affected. If the Company is unable to develop necessary manufacturing or laboratory capabilities in a timely manner, its sales could be adversely affected.
To the extent the Company is unable to obtain or is delayed in obtaining such approvals, its ability to meet the demand for its products and services could be adversely affected. Table of Contents If the Company is unable to develop necessary manufacturing or laboratory capabilities in a timely manner, its sales could be adversely affected.
In addition, the reimbursement approval process may delay the market introduction of the Company's products. Changes in Healthcare Regulation Could Affect the Company's Revenues, Costs and Financial Condition.
In addition, the reimbursement approval process may delay the market introduction of the Company's products. Table of Contents Changes in Healthcare Regulation Could Affect the Company's Revenues, Costs and Financial Condition.
Terrorist Attacks, Natural Disasters, Public Health Crises, Political Unrest or Other Catastrophic Events Outside of the Company's Control May Adversely Affect Its Business.
Table of Contents Terrorist Attacks, Natural Disasters, Public Health Crises, Political Unrest or Other Catastrophic Events Outside of the Company's Control May Adversely Affect Its Business.
Our vendors may in turn incorporate AI tools into their own offerings, and the providers of these AI tools may not meet existing or rapidly evolving regulatory or industry standards, including with 43 Table of Contents respect to privacy and data security.
Our vendors may in turn incorporate AI tools into their own offerings, and the providers of these AI tools may not meet existing or rapidly evolving regulatory or industry standards, including with respect to privacy and data security.
To the extent these international sales comprise a large or increasing part of the Company's business, the Company's gross margins will be negatively affected.
To the extent these international sales comprise a large or Table of Contents increasing part of the Company's business, the Company's gross margins will be negatively affected.
The Company's costs may also be impacted by laws to increase minimum wages, 29 Table of Contents including the potential increase to the federal minimum wage in the United States that has been recently proposed by the current administration. The Company's ability to recover such increased costs may depend upon its ability to raise prices on its products.
The Company's costs may also be impacted by laws to increase minimum wages, including the potential increase to the federal minimum wage in the United States that has been recently proposed by the current administration. The Company's ability to recover such increased costs may depend upon its ability to raise prices on its products.
If the Company's sole-source suppliers were to be acquired by a competitor, they may elect not to provide it with the product, raw materials or other components, as applicable.
If the Company's Table of Contents sole-source suppliers were to be acquired by a competitor, they may elect not to provide it with the product, raw materials or other components, as applicable.
Risks Relating to the Economy, the Company's Financial Results, Investments, and Need for Financing The Company Has Experienced Losses in the Past and May Not Be Able to Again Achieve and Maintain Profitable Operations .
Table of Contents Risks Relating to the Economy, the Company's Financial Results, Investments, and Need for Financing The Company Has Experienced Losses in the Past and May Not Be Able to Again Achieve and Maintain Profitable Operations .
In September 2022, the Company entered into an $8.6 million contract with BARDA to develop a second generation Ebola test on the OraQuick ® testing platform, which was subsequently modified in September 2023 to add an additional $6.8 in funding to be used to obtain the appropriate regulatory approvals.
In September 2022, the Company entered into an $8.6 million contract with BARDA to develop an updated Ebola test on the OraQuick ® testing platform, which was subsequently modified in September 2023 to add an additional $6.8 in funding to be used to obtain the appropriate regulatory approvals.
Government Contracts May Affect Its Intellectual Property Rights. 30 Table of Contents Provisions in the Company's U.S. government contracts may affect its intellectual property rights. Certain of the Company's activities have been funded, and may in the future be funded, by the U.S. government, including its contracts with BARDA.
Government Contracts May Affect Its Intellectual Property Rights. Provisions in the Company's U.S. government contracts may affect its intellectual property rights. Certain of the Company's activities have been funded, and may in the future be funded, by the U.S. government, including its contracts with BARDA.
As previously disclosed, the Company has in the past and may in the future experience cybersecurity incidents. If successful, these attacks could lead to service interruptions, extortion, theft of confidential, personal or proprietary information, the compromise of data integrity or unauthorized information disclosure.
As previously disclosed, the Company has, like others in its industry, in the past and may in the future experience cybersecurity incidents. If successful, these attacks could lead to service interruptions, extortion, theft of confidential, personal or proprietary information, the compromise of data integrity or unauthorized information disclosure.
This would result in a loss of revenues and adversely affect the Company's results of operations, cash flow and business. Customer Concentration Creates Risk for the Company's Business. One of the Company's customers accounted for approximately 24% of its net consolidated revenues for the year ended December 31, 2024.
This would result in a loss of revenues and adversely affect the Company's results of operations, cash flow and business. Customer Concentration Creates Risk for the Company's Business. One of the Company's customers accounted for approximately 3% of its net consolidated revenues for the year ended December 31, 2025.
If the Company is unable to successfully hedge against unfavorable foreign currency exchange rate movements, its consolidated financial results may be adversely impacted. 47 Table of Contents Risks Relating to the Company's Common Stock The Company's Stock Price Could Continue to be Volatile.
If the Company is unable to successfully hedge against unfavorable foreign currency exchange rate movements, its consolidated financial results may be adversely impacted. Risks Relating to the Company's Common Stock The Company's Stock Price Could Continue to be Volatile.
It is possible that the Company's expenses to develop and market any such products, including, without limitation the Company's InteliSwab ® tests, will exceed any benefit in revenues, which may be short-lived. In addition, other products that compete with the Company's may achieve 510(k) clearance earlier than the Company's do, providing market advantages.
It is possible that the Company's expenses to develop and market any such products will exceed any benefit in revenues, which may be short-lived. In addition, other products that compete with the Company's may achieve 510(k) clearance earlier than the Company's do, providing market advantages.
Its sales depend to a substantial degree on its ability to sell products to these customers and on the marketing and distribution abilities of the companies with which it collaborates. 35 Table of Contents Relying on distributors or others to market and sell the Company's products could harm its business for various reasons, including: • The Company may not be able to find suitable distributors to distribute its products on satisfactory terms, or at all; • The Company's distributors or other customers may not fulfill their contractual obligations to it or otherwise market and distribute its products in the manner or at the levels it expects; • The Company does not control the incentives provided by its distributors to their sales personnel and the effectiveness of these incentives could affect sales of the Company's products; • Agreements with distributors may terminate prematurely due to disagreements or may result in litigation between the parties; • The Company may not be able to renew existing distribution agreements on acceptable terms, or at all; • The Company's distributors may not devote sufficient resources or priority to the sale of its products; • The Company's distributors may prioritize their own private label products that compete with its products; • The Company's existing distributor relationships or contracts may preclude or limit it from entering into arrangements with other distributors; and • The Company may not be able to negotiate future distribution agreements on acceptable terms, or at all.
Relying on distributors or others to market and sell the Company's products could harm its business for various reasons, including: • The Company may not be able to find suitable distributors to distribute its products on satisfactory terms, or at all; • The Company's distributors or other customers may not fulfill their contractual obligations to it or otherwise market and distribute its products in the manner or at the levels it expects; • The Company does not control the incentives provided by its distributors to their sales personnel and the effectiveness of these incentives could affect sales of the Company's products; • Agreements with distributors may terminate prematurely due to disagreements or may result in litigation between the parties; • The Company may not be able to renew existing distribution agreements on acceptable terms, or at all; • The Company's distributors may not devote sufficient resources or priority to the sale of its products; • The Company's distributors may prioritize their own private label products that compete with its products; • The Company's existing distributor relationships or contracts may preclude or limit it from entering into arrangements with other distributors; and • The Company may not be able to negotiate future distribution agreements on acceptable terms, or at all.
In addition, the revenues and expenses of the Company's subsidiary, DNAG, are recorded in Canadian dollars and the revenues and expenses of its subsidiary Novosanis are recorded in Euros. Revenues and expenses denominated in foreign currencies are translated into U.S. dollars for purposes of reporting consolidated financial results.
In addition, the revenues and expenses of the Company's subsidiary, DNAG, are recorded in Canadian dollar. Revenues and expenses denominated in foreign currencies are translated into U.S. dollars for purposes of reporting consolidated financial results.
The Company believes that its products and procedures are in material compliance with all applicable FDA regulations, ISO requirements, and other applicable regulatory requirements, but the regulations regarding the manufacture and sale of 40 Table of Contents its products, the QSR and ISO requirements, and other requirements may be unclear and are subject to change.
The Company believes that its products and procedures are in material compliance with all applicable FDA regulations, ISO requirements, and other applicable regulatory requirements, but the regulations regarding the manufacture and sale of its products, the QMSR and ISO requirements, and other requirements may be unclear and are subject to change.
Factors include, but are not limited to, the market acceptance of the Company's products, available funding, cost containment strategies implemented by customers, increasing competition and regulatory constraints could limit sales of the Company's genomics products.
Factors that may impact the success of our genomics products include, but are not limited to, the market acceptance of the Company's products, available funding, cost containment strategies implemented by customers, increasing competition and regulatory constraints could limit sales of the Company's genomics products.
Regulatory Risks • The need to obtain regulatory approvals, clearances, authorizations or certifications could increase the Company's costs and adversely affect its financial performance. • Failure to comply with FDA or other regulatory requirements may require the Company to suspend production or sale of its products or institute a recall which could result in higher costs and loss of revenues. • The Company is subject to numerous government regulations in addition to FDA requirements, which could increase its costs and affect its operations. • Failure to comply with privacy, security and breach notification regulations may increase our costs. • Failure to comply with data protection requirements or privacy laws could increase our costs.
Regulatory Risks • Delay or failure to obtain FDA approval for new products could delay commercialization of new products and prevent the Company from achieving revenue growth. • The need to obtain regulatory approvals, clearances, authorizations or certifications could increase the Company's costs and adversely affect its financial performance. • Failure to comply with FDA or other regulatory requirements may require the Company to suspend production or sale of its products or institute a recall which could result in higher costs and loss of revenues. • The Company is subject to numerous government regulations in addition to FDA requirements, which could increase its costs and affect its operations. • Failure to comply with privacy, security and breach notification regulations may increase our costs. • Failure to comply with data protection requirements or privacy laws could increase our costs.
The Company has experienced annual net losses during the five years prior to 2015, between 2020 through 2022 and again recorded net losses for the year ended December 31, 2024 . In addition, as of December 31, 2024, the Company had an accumulated deficit of $103.4 million.
The Company has experienced annual net losses during the five years prior to 2015, between 2020 through 2022 and again recorded net losses for the years ended December 31, 2024 and 2025 . In addition, as of December 31, 2025, the Company had an accumulated deficit of $172.2 million.
In addition, changes in or evolving interpretations of these laws, regulations, or administrative or judicial interpretations, may require the Company to change its business practices or subject its business practices to legal challenges, which could have a material adverse effect on its business, financial condition and results of operations. 53 Table of Contents The Company May Experience Fluctuations in Its Financial Results or Fail to Meet Its Financial Projections.
In addition, changes in or evolving interpretations of these laws, regulations, or administrative or judicial interpretations, may require the Company to change its business practices or subject its business practices to legal challenges, which could have a material adverse effect on its business, financial condition and results of operations.
The end-users of certain of the Company's products include hospitals, physicians and other healthcare providers. Use of the Company's products could be adversely impacted if these end-users do not receive adequate reimbursement for the cost of its products from their patients’ healthcare insurers or payors.
The Company's Revenues Could be Affected by Third-Party Reimbursement Policies and Potential Cost Constraints. The end-users of certain of the Company's products include hospitals, physicians and other healthcare providers. Use of the Company's products could be adversely impacted if these end-users do not receive adequate reimbursement for the cost of its products from their patients’ healthcare insurers or payors.
In 2024, approximately $13.9 million of the Company's consolidated net revenues were generated from sales in a variety of foreign countries. These international activities subject the Company to the FCPA, the U.K.
In 2025, approximately $36.8 million of the Company's consolidated net revenues were generated from sales in a variety of foreign countries. These international activities subject the Company to the FCPA, the U.K.
As a result of this consolidation, competition to provide goods and services to customers has increased. In addition, group purchasing organizations and integrated health delivery networks have served to concentrate purchasing decisions for some customers, which has also placed pricing pressure on medical device suppliers. The Company may not be able to compete successfully in such a consolidated industry.
In addition, group purchasing organizations and integrated health delivery networks have served to concentrate purchasing decisions for some customers, which has also placed pricing pressure on medical device suppliers. The Company may not be able to compete successfully in such a consolidated industry.
In Europe, the EU’s Artificial Intelligence Act (“AI Act”) — which entered into force on August 1, 2024 and, with some exceptions, will begin to apply as of August 2, 2026 — imposes significant obligations on providers and deployers of high-risk artificial intelligence systems, and encourages providers and deployers of artificial intelligence systems to account for EU ethical principles in their development and use of these systems.
As currently enacted, the AI Act, which may be amended as part of the EU’s Digital Omnibus, which entered into force on August 1, 2024 and, with some exceptions, will begin to apply as of August 2, 2026, imposes significant obligations on providers and deployers of high-risk artificial intelligence systems, and encourages providers and deployers of artificial intelligence systems to account for EU ethical principles in their development and use of these systems.
In the past, the FDA has taken the position that it has regulatory authority over laboratory-developed tests ("LDTs"), but has exercised enforcement discretion in not regulating most LDTs performed by high complexity CLIA-certified laboratories. LDTs are tests designed, developed, and performed in-house by a laboratory.
FDA Regulation of Laboratory-Developed Tests and Genetic Testing Could Affect Demand For the Company's Products. In the past, the FDA has taken the position that it has regulatory authority over laboratory-developed tests ("LDTs"), but has exercised enforcement discretion in not regulating most LDTs performed by high complexity CLIA-certified laboratories. LDTs are tests designed, developed, and performed in-house by a laboratory.
The Company's International Sales Create Potential Exposure Under Anti-Corruption Laws . The Company has a policy in place prohibiting its employees, distributors and agents from engaging in corrupt business practices, including activities prohibited by the FCPA and similar foreign laws.
Such a reduction in testing could result in decreased sales of the Company's DNA collection devices. The Company's International Sales Create Potential Exposure Under Anti-Corruption Laws . The Company has a policy in place prohibiting its employees, distributors and agents from engaging in corrupt business practices, including activities prohibited by the FCPA and similar foreign laws.
These trends in the ancestry testing market may continue and revenues in this market may continue to be volatile. 22 Table of Contents In an effort to increase the Company's molecular revenues, it has devoted increasing time and attention to expanding sales of its genomics products both domestically and internationally, with both new and existing accounts, including co-clearances and co-promotions with strategic partners.
In an effort to increase the Company's molecular revenues, it has devoted increasing time and attention to expanding sales of its genomics products both domestically and internationally, with both new and existing accounts, including co- Table of Contents clearances and co-promotions with strategic partners.
Moreover, issued patents remain in effect for a fixed period and after expiration will not provide protection of the inventions they cover. Once the Company's patents expire, it may be faced with increased competition, which could reduce its revenues.
Moreover, issued patents remain in effect for a fixed period and after expiration will not provide protection of the inventions they cover. Once the Company's patents expire, it may be faced with increased competition, which could reduce its revenues. It may also not be able to successfully protect its rights to unpatented trade secrets and know-how.
Although the Company encourages and expect all of its employees to abide by any confidentiality agreement with a prior employer, competing companies may allege trade secret violations and similar claims against the Company.
Some of the Company's employees, including scientific and management personnel, were previously employed by competing companies. Although the Company encourages and expect all of its employees to abide by any confidentiality agreement with a prior employer, competing companies may allege trade secret violations and similar claims against the Company.
The Use of New And Evolving Technologies, Such As Artificial Intelligence (“AI”), In Our Offerings May Present Risks And Challenges That Can Impact Our Business Including by Posing Security Risks to Our Confidential Information, Proprietary Information, and Personal Data.
The Use of New And Evolving Technologies, Such As Artificial Intelligence (“AI”), In Our Offerings May Present Risks And Challenges That Can Impact Our Business Including by Posing Security Risks to Our Confidential Information, Proprietary Information, and Personal Data. We may use and integrate AI into our business practices, including through the adoption of commercially available tools.
The rise of economic nationalism could make it more difficult for us to attract new customers, retain existing customers, continue to produce and source in an optimal manner, maintain our supply chain, or maintain sales at existing levels, both in the United States and in other countries.
These actions could increase the cost of materials, components, or finished goods, make it more difficult for us to attract new customers, retain existing customers, continue to produce and source in an optimal manner, maintain our supply chain, or maintain sales at existing levels, both in the United States and in other countries.
Similar laws have been passed and proposed in other states and at the federal level, and if passed, such laws may have potentially conflicting requirements that would make compliance challenging.In addition to these comprehensive consumer privacy laws and proposals, a number of other states have passed or proposed more limited privacy laws that focus on specific privacy issues such as biometric data and the privacy of health and medical information, such as Washington state’s My Health My Data Act, which went into effect in March 2024.
In addition to these comprehensive consumer privacy laws and proposals, a number of other states have passed or proposed more limited privacy laws that focus on specific privacy issues such as biometric data and the privacy of health and medical information, such as Washington state’s My Health My Data Act, which went into effect in March 2024.
All in vitro diagnostic products that are to be sold in the EU must bear the CE mark indicating conformance with the requirements of the relevant EU in vitro diagnostic medical devices legislation. The EU IVDR became applicable on May 26, 2022 and repealed the previous IVDD.
All in vitro diagnostic devices that are to be placed on the market in the EU must bear a CE mark indicating conformity with the applicable requirements of the EU IVDR. The EU IVDR became applicable on May 26, 2022 and repealed the previous IVDD.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeOur subsidiary, DNAG, also leases a 36,000 square foot facility in Ottawa, Canada, which is used as its primary corporate office and houses sales and marketing, manufacturing, distribution, research and development, and regulatory and quality operations.
Biggest changeThe Company also leases a 139,000 square foot manufacturing facility. Each of these facilities is located in Bethlehem, Pennsylvania. The Company's subsidiary, DNAG, also leases a 36,000 square foot facility in Ottawa, Canada, which is used as its primary corporate office and houses sales and marketing, manufacturing, distribution, research and development, and regulatory and quality operations.
ITEM 2. Properties. We own a 31,700 square foot facility that houses our primary corporate office, our sales and marketing, research and development, human resources, and regulatory and quality offices. We also own a 48,000 square foot facility and a 33,500 square foot facility which are used for manufacturing activities.
ITEM 2. Properties. The Company owns a 31,700 square foot facility that houses its primary corporate office, sales and marketing, research and development, human resources, and regulatory and quality offices. The Company also owns a 48,000 square foot facility and a 33,500 square foot facility which are used for manufacturing activities.
Our subsidiary, Sherlock, leases various facilities in the United Kingdom totaling approximately 37,600 square feet, as well as outside Boston, Massachusetts, totaling approximately 5,000 square feet. These facilities house its corporate offices, production, and research and development activities. Our other subsidiary, Diversigen, also leases facilities for its remaining operations. Novosanis's facility lease terminated on December 31, 2024.
The Company's subsidiary, Sherlock, leases various facilities in the United Kingdom totaling approximately 37,600 square feet, as well as outside Boston, Massachusetts, totaling approximately 5,000 square feet. These facilities house Sherlock's corporate offices, production, and research and development activities. The Company's subsidiary, BioMedomics, leases a building in North Carolina totaling approximately 2,000 square feet.
Removed
We lease a 23,000 square foot storage facility as well as an additional 139,000 square foot manufacturing facility. Each of these facilities is located in Bethlehem, Pennsylvania.
Added
The facility houses BioMedomics' corporate offices, production, and research and development activities. The Company believes that the facilities described above are adequate for its current requirements.
Removed
The Company believes that the facilities described above are adequate for its current requirements. ITEM 3. Legal Proceedings. Discussion of legal matters is incorporated by reference from Note 15, Commitments and Contingencies, to the Consolidated Financial Statements included in this Annual Report on Form 10-K. ITEM 4. Mine Safety Disclosures. Not Applicable. 58 Table of Contents PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changePurchases of Equity Security by the Issuer and Affiliated Purchasers Period Total number of shares purchased Average price paid per Share Total number of shares purchased as part of publicly announced plans or programs Maximum number (or approximate dollar value) of shares that may yet be repurchased under the plans or programs (1, 2) October 1, 2024 - October 31, 2024 669 (3) $ 4.21 — $11,984,720 November 1, 2024 - November 30, 2024 2,654 (3) $ 4.25 — $11,984,720 December 1, 2024 - December 31, 2024 0 (3) $ — — $11,984,720 3,323 — (1) On August 5, 2008, the Board of Directors approved a share repurchase program pursuant to which the Company is permitted to acquire up to $25.0 million of outstanding shares.
Biggest changePurchases of Equity Security by the Issuer and Affiliated Purchasers Period Total number of shares purchased Average price paid per Share Total number of shares purchased as part of publicly announced plans or programs Maximum number (or approximate dollar value) of shares that may yet be repurchased under the plans or programs (1) October 1, 2025 - October 31, 2025 551,044 (2) 2.90 531,201 $28,459,997 November 1, 2025 - November 30, 2025 144,162 2.45 144,162 $28,106,600 December 1, 2025 - December 31, 2025 1,262,230 2.49 1,262,230 $24,960,000 1,957,436 1,937,593 (1) In March 2025, the Company's board of directors authorized a stock repurchase program (the “Repurchase Program”) effective March 21, 2025, whereby the Company may purchase up to $40.0 million in shares of its common stock over a period of up to two years.
The graph assumes that $100 was invested on December 31, 2019 in the Company’s Common Stock and in each of the above-mentioned indices, and that all dividends, if any, were reinvested. The Nasdaq Composite Index was chosen because it is a broad index of companies whose equity securities are traded on Nasdaq.
The graph assumes that $100 was invested on December 31, 2020 in the Company’s Common Stock and in each of the above-mentioned indices, and that all dividends, if any, were reinvested. The Nasdaq Composite Index was chosen because it is a broad index of companies whose equity securities are traded on Nasdaq.
The following graph compares the cumulative total returns to investors in the Company’s Common Stock, the Nasdaq Composite Index, and the Nasdaq Health Care Index for the period from December 31, 2019 through December 31, 2024.
The following graph compares the cumulative total returns to investors in the Company’s Common Stock, the Nasdaq Composite Index, and the Nasdaq Health Care Index for the period from December 31, 2020 through December 31, 2025.
On February 24, 2025, there were 253 holders of record and approximately 22,476 holders in street name of the Company's Common Stock, and the closing price of its Common Stock was $3.99 per share. Dividends The Company has never paid any cash dividends and its Board of Directors does not anticipate paying cash dividends in the foreseeable future.
On February 23, 2025, there were 241 holders of record and approximately 19,647 holders in street name of the Company's Common Stock, and the closing price of its Common Stock was $2.75 per share. Dividends The Company has never paid any cash dividends and its Board of Directors does not anticipate paying cash dividends in the foreseeable future.
Stock Award Plan, and in connection with the vesting of restricted and performance shares, these shares were retired to satisfy minimum tax withholdings.
(2) Includes shares retired to satisfy minimum tax withholdings, in connection with the vesting of restricted and performance shares, pursuant to the OraSure Technologies Inc. Stock Award Plan.
Stockholders are cautioned that the graph shows the returns to investors only as of the dates noted and may not be representative of the returns for any other past or future period. 59 Table of Contents Fiscal Year Ending December 31, 2019 2020 2021 2022 2023 2024 OraSure Technologies, Inc. 100.00 131.82 108.22 60.02 102.12 44.96 NASDAQ Composite 100.00 144.92 177.06 119.45 172.77 223.87 NASDAQ Health Care 100.00 127.18 114.41 86.04 86.74 84.53 Securities Authorized for Issuance Under Equity Compensation Plans For certain information concerning securities authorized for issuance under the Company's equity compensation plan, see Item 12, “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.” Item 6.
Table of Contents Fiscal Year Ending December 31, 2020 2021 2022 2023 2024 2025 OraSure Technologies, Inc. 100.00 82.10 45.54 77.47 34.10 22.86 NASDAQ Composite 100.00 122.18 82.43 119.22 154.48 187.14 NASDAQ Health Care 100.00 89.96 67.65 68.20 66.46 81.27 Securities Authorized for Issuance Under Equity Compensation Plans For certain information concerning securities authorized for issuance under the Company's equity compensation plan, see Item 12, “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.” Item 6.
Removed
This share repurchase program may be discontinued at any time. (2) This column represents the amount that remains available under the $25.0 million repurchase plan, as of the period indicated. The Company has made no commitment to purchase any shares under this plan. (3) Pursuant to the OraSure Technologies, Inc.
Added
The amount and timing of share repurchases under the Repurchase Program may be carried out at the discretion of management through various methods in compliance with applicable state and federal securities laws, including through the use of trading plans intended to qualify under Rule 10b5-1 under the Exchange Act, in accordance with applicable securities laws and regulations.
Added
Stockholders are cautioned that the graph shows the returns to investors only as of the dates noted and may not be representative of the returns for any other past or future period.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

49 edited+20 added−27 removed17 unchanged
Biggest changeFor the Years Ended December 31, Dollars % Change Percentage of Total Net Revenues 2024 2023 2024 2023 Diagnostics (1) $ 75,917 $ 73,694 3 % 41 % 18 % Sample Management Solutions (2) 51,046 54,274 (6) 28 13 COVID-19 Diagnostics 45,136 257,493 (82) 24 64 Risk Assessment Testing (3) 8,354 9,736 (14) 4 2 Other products and services 2,417 2,265 7 1 1 Molecular Services 1,705 4,474 (62) 1 1 COVID-19 Molecular Products 36 286 (87) — — Net product and services revenues 184,611 402,222 (54) 99 99 Non-product and services revenues (4) 1,216 3,250 (63) 1 1 Net revenues $ 185,827 $ 405,472 (54) % 100 % 100 % (1) Includes HIV, HCV and Syphilis product revenues.
Biggest changeCONSOLIDATED NET REVENUES The table below shows a summary of total consolidated net revenues (dollars in thousands) for the years ended December 31, 2025 and 2024: For the Years Ended December 31, Dollars % Change Percentage of Total Net Revenues 2025 2024 2025 2024 Diagnostics (1) $ 66,497 $ 75,917 (12) % 58 % 41 % Sample Management Solutions (2) 38,356 51,046 (25) 33 28 Risk Assessment Testing (3) 1,866 8,354 (78) 2 4 Other products and services (4) 1,716 2,453 (30) 1 1 COVID-19 Diagnostics 620 45,136 (99) 1 24 Molecular Services — 1,705 (100) — 1 Net product and services revenues 109,055 184,611 (41) 95 99 Non-product and services revenues (5) 5,966 1,216 391 5 1 Net revenues $ 115,021 $ 185,827 (38) % 100 % 100 % (1) Includes HIV, HCV, Syphilis, and SureQuick ® product revenues.
Revenue from product sales is recognized upon transfer of control of a product to a customer based on an amount that reflects the consideration the Company is entitled to, net of allowances for any discounts or rebates.
Revenue Recognition Product sales Revenue from product sales is recognized upon transfer of control of a product to a customer based on an amount that reflects the consideration the Company is entitled to, net of allowances for any discounts or rebates.
Discussion of 2022 items and year-to-year comparisons between 2023 and 2022 that are not included in this Annual Report can be found in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
Discussion of 2023 items and year-to-year comparisons between 2024 and 2023 that are not included in this Annual Report can be found in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.
Business Overview The Company's business consists of the development, manufacture, marketing and sale of simple, easy to use diagnostic products and specimen collection devices using the Company's proprietary technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types.
Business Overview The Company's business consists of the development, manufacture, marketing, sale and distribution of simple, easy to use diagnostic products and specimen collection devices using its proprietary technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types.
The consideration under the arrangement is then allocated to each separate distinct performance obligation based on each respective relative stand-alone selling price. The estimated selling price of each deliverable is determined using an observable cost plus margin approach.
Table of Contents The consideration under the arrangement is then allocated to each separate distinct performance obligation based on each respective relative stand-alone selling price. The estimated selling price of each deliverable is determined using an observable cost plus margin approach.
This section of this Annual Report on Form 10-K for the year ended December 31, 2024 (this "Annual Report") generally discusses 2024 and 2023 items and year-to-year comparisons between 2024 and 2023.
This section of this Annual Report on Form 10-K for the year ended December 31, 2025 (this "Annual Report") generally discusses 2025 and 2024 items and year-to-year comparisons between 2025 and 2024.
CONSOLIDATED INCOME TAXES The Company continues to believe the full valuation allowance established against its total U.S. deferred tax asset is appropriate as the facts and circumstances necessitating the allowance have not changed.
Table of Contents CONSOLIDATED INCOME TAXES The Company continues to believe the full valuation allowance established against its total U.S. deferred tax asset is appropriate as the facts and circumstances necessitating the allowance have not changed.
The Company generally does not grant product return rights to its customers, except for warranty returns and return rights on sales of its OraQuick ® In-Home HIV test to the retail trade, and InteliSwab ® products to the retail trade and certain customers. Historically, returns arising from warranty issues have been infrequent and immaterial.
The Company generally does not grant product return rights to its customers, except for warranty returns and return rights on sales of its OraQuick ® HIV Self-Test to the retail trade, and InteliSwab ® products to the retail trade and certain other customers. Historically, returns arising from warranty issues have been infrequent and immaterial.
Resources The Company's contractual obligations are included in Note 15 of its consolidated financial statements. The Company expects existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements over the next twelve months.
Resources Table of Contents The Company's contractual obligations are included in Note 14 of its consolidated financial statements. The Company expects existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements over the next twelve months.
The Company's COVID-19 and HIV products are also sold in a consumer-friendly format in the over-the-counter (“OTC”) market in the U.S. and, in the case of the HIV product, as a self-test to individuals in a number of other countries, including as an oral swab in-home test for HIV-1 and HIV-2 in Europe.
The Company's HIV and COVID-19 products are also sold in a consumer-friendly format in the OTC market in the U.S. and, in the case of the HIV and HCV products, as a self-test to individuals in a number of other countries, including, for the HIV products, as an oral swab in-home test for HIV-1 and HIV-2 in Europe, and for the HCV products, as an OTC test.
The Company considers the following accounting policies, which have been discussed with its Audit Committee, to be most critical in understanding the more complex judgments that are involved in preparing its financial statements and the uncertainties that could impact its results of operations, financial condition, and cash flows. 65 Table of Contents Revenue Recognition . Product sales .
The Company considers the following accounting policies, which have been discussed with its Audit Committee, to be most critical in understanding the more complex judgments that are involved in preparing its financial statements and the uncertainties that could impact its results of operations, financial condition, and cash flows.
Inventories The Company's inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis, and include the cost of raw materials, labor and overhead. The majority of the Company's inventories are subject to expiration dating, which can be extended in certain circumstances.
Inventories The Company's inventories are stated at the lower of cost or net realizable value, with cost determined on an average cost method, and include the cost of raw materials, labor and overhead. The majority of the Company's inventories are subject to expiration dating, which can be extended in certain circumstances.
Factors that could affect results are discussed more fully under the Item 1A, entitled “Risk Factors,” and elsewhere in this Annual Report. Although forward-looking statements help to 60 Table of Contents provide complete information about the Company, readers should keep in mind that forward-looking statements may not be reliable.
Factors that could affect results are discussed more fully under the Item 1A, entitled “Risk Factors,” and elsewhere in this Annual Report. Although forward-looking statements help to provide complete information about the Company, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements.
All of the above contributed to the Company's operating loss of $28.3 million for the year ended December 31, 2024, which included non-cash impairment charges of $4.4 million, non-cash charges of $10.9 million for depreciation and amortization, and $11.9 million for stock-based compensation.
The Company's operating loss of $28.3 million for the year ended December 31, 2024 included a non-cash charge of $11.9 million for stock-based compensation, $10.9 million for depreciation and amortization, and impairment charges of $4.4 million.
The Company continually evaluates quantities on hand and the carrying value of its inventories to determine the need for net realizable value adjustments for excess and obsolete inventories, based primarily on prior experience with consideration of expected changes in the business and estimated forecasts of product sales. The Company reserves for unidentified scrap or spoilage based on historical write-off rates.
The Company continually evaluates quantities on hand and the carrying value of its inventories to determine the need for net realizable value adjustments for excess and obsolete inventories, based primarily on prior experience with consideration of expected changes in the business and estimated forecasts of product sales.
COVID-19 Diagnostics revenues decreased 82% to $45.1 million for the year ended December 31, 2024 from $257.5 million for the year ended December 31, 2023 due to decreased sales of the Company's InteliSwab ® tests through its U.S. government procurement contracts.
COVID-19 Diagnostics revenues decreased 99% to $0.6 million for the year ended December 31, 2025 from $45.1 million for the year ended December 31, 2024 due to decreased sales of the Company's InteliSwab ® tests through its U.S. government procurement contracts.
Results of Operations The Company's consolidated net loss for the year ended December 31, 2024 was $19.5 million, or $0.26 per share on a fully diluted basis, compared to consolidated net income of $53.7 million, or $0.72 per share on a fully diluted basis, for the year ended December 31, 2023.
Table of Contents Results of Operations The Company's consolidated net loss for the year ended December 31, 2025 was $68.7 million, or $0.94 per share on a fully diluted basis, compared to consolidated net loss of $19.5 million, or $0.26 per share on a fully diluted basis, for the year ended December 31, 2024.
Molecular Services revenues, which are largely derived from the Company's microbiome molecular sequencing services, decreased 62% to $1.7 million for the year ended December 31, 2024 from $4.5 million for the year ended December 31, 2023. The decrease in services revenues was due to the decision to exit this line of business.
Molecular Services revenues, which were largely derived from the Company's microbiome molecular sequencing services, were nil for the year ended December 31, 2025 compared to $1.7 million for the year ended December 31, 2024. The decrease in services revenues was due to the decision to exit this line of business.
Customers span the disease risk management, diagnostics, pharmaceutical, biotech, companion animal and environmental markets. The Company has also developed collection devices for the emerging microbiome market, which focuses on studying microbiomes and their effect on human and animal health. The Company also has a urine collection device which allows for the volumetric collection of first void urine.
The Company has also developed collection devices for the emerging microbiome market, which focuses on studying microbiomes and their effect on human and animal health. The Company also has a urine collection device which allows for the volumetric collection of first void urine.
It also considers items identified through specific identification procedures in assessing the adequacy of its reserve. Although the Company makes every effort to ensure the accuracy of its forecasts of future product demand, any significant unanticipated changes in demand could have a significant impact on the carrying value of its inventories and reported operating results.
Although the Company makes every effort to ensure the accuracy of its forecasts of future product demand, any significant unanticipated changes in demand could have a significant impact on the carrying value of its inventories and reported operating results.
These products include tests for diseases including COVID-19, HIV, Hepatitis C, and Syphilis that are performed on a rapid basis at the point of care, and tests for drugs of abuse that are processed in a laboratory.
Our diagnostic products include tests for diseases including HIV, Hepatitis C, Syphilis, Sickle Cell and COVID-19 that are performed on a rapid basis at the point of care.
Financing Activities Net cash used in financing activities was $4.2 million for the year ended December 31, 2024, which reflects $3.5 million used for the repurchase of common stock to satisfy withholding taxes related to the vesting of restricted awarded to the Company's employees and payments for lease liabilities of $0.8 million.
Financing Activities Net cash used in financing activities was $16.9 million for the year ended December 31, 2025, which was largely comprised of $15.0 million to repurchase common stock pursuant to the Company's stock repurchase plan and $1.8 million used for the repurchase of common stock to satisfy withholding taxes related to the vesting of restricted stock awarded to the Company's employees.
Changes in the fair value of the contingent consideration liabilities are recognized each reporting period and included in our consolidated statements of operations. Our estimates of fair value are based on assumptions we believe to be reasonable, but the assumptions are uncertain and involve significant judgment by management.
Our estimates of fair value are based on assumptions we believe to be reasonable, but the assumptions are uncertain and involve significant judgment by management.
The following discussion should be read in conjunction with the consolidated financial statements contained herein and the notes thereto, along with the Section entitled “Critical Accounting Policies and Estimates,” set forth below.
The Company undertakes no duty to update any forward-looking statements made herein after the date of this Annual Report. The following discussion should be read in conjunction with the consolidated financial statements contained herein and the notes thereto, along with the Section entitled “Critical Accounting Policies and Estimates,” set forth below.
Although the Company has achieved U.S. cumulative pre-tax earnings based on a rolling three year window the Company has not achieved a level of sustained profitability that would, in its judgement, support the release of the valuation allowance.
The Company has not achieved U.S. cumulative pre-tax earnings based on a rolling three year window as the Company has not achieved a level of sustained profitability that would, in its judgment, support the release of the valuation allowance. For the years ended December 31, 2025 and 2024, the Company recorded income tax expense of $1.8 million.
Accordingly, the Company expenses warranty returns as incurred. Service Revenues Service revenues represent microbiome laboratory testing and analytical services. The Company recognizes revenues when it satisfies its performance obligations for services rendered.
Accordingly, the Company expenses warranty returns as incurred. The Company records shipping and handling charges billed to the Company's customers as product revenue and the related expense as cost of products sold. Service revenues Service revenues represent microbiome laboratory testing and analytical services. The Company recognizes revenues when it satisfies its performance obligations for services rendered.
The Company experienced a significant decline in COVID-19 revenues during 2024 due to the fulfillment of these contracts and lower overall demand for COVID-19 testing, and expects further declines in 2025.
The Company experienced a significant decline in COVID-19 revenues during 2024 Table of Contents due to the fulfillment of these contracts and lower overall demand for COVID-19 testing and anticipates that this trend will continue into the foreseeable future.
Risk Assessment Testing 61 Table of Contents In October 2024, the Company announced the discontinuance of the sales of its risk assessment product line which is expected to be completed in the first half of 2025. Sales of its risk assessment products contributed $8.4 million and $9.7 million to revenues during the years ended December 31, 2024, and 2023, respectively.
Recent Developments Risk Assessment Testing In the third quarter of 2024, the Company announced the discontinuance of sales of its risk assessment product line which was completed in the second quarter of 2025. Sales of its risk assessment products contributed $1.9 million and $8.4 million to revenues during the twelve months ended December 31, 2025 and 2024, respectively.
As part of our consideration for the Sherlock acquisition, we are contractually obligated to pay certain consideration resulting from the outcome of future events. Therefore, we are required to update our underlying assumptions each reporting period, based on new developments, and record such contingent consideration liabilities at fair value until the contingency is resolved.
Therefore, we are required to update our underlying assumptions each reporting period, based on new developments, and record such contingent consideration liabilities at fair value until the contingency is resolved. Changes in the fair value of the contingent consideration liabilities are recognized each reporting period and included in our consolidated statements of operations.
General and administrative expenses decreased 21% to $46.2 million for the year ended December 31, 2024 from $58.2 million for the year ended December 31, 2023 largely due to lower legal fees relating to the Spectrum litigation (discussed further in Note 15, Commitments and Contingencies, to the consolidated financial statements included herein) and lower employee costs associated with reduced headcount partially offset by increase in non-cash stock compensation expense and transaction expenses associated with the Company's acquisition of Sherlock in December.
General and administrative expenses increased 3% to $47.7 million for the year ended December 31, 2025 from $46.2 million for the year ended December 31, 2024 largely due to higher legal fees relating to the NowDx litigation (discussed further in Note 14, Commitments and Contingencies, to the consolidated financial statements included herein) and costs associated with the Sherlock acquisition.
Consolidated operating loss for the year ended December 31, 2024 was $28.3 million, a $60.9 million decline from the $32.7 million operating income reported for the year ended December 31, 2023. Results for the year ended December 31, 2024 were negatively impacted by the decrease in revenues and were positively impacted by reduced operating expenses.
Consolidated operating loss for the year ended December 31, 2025 was $72.0 million, compared to a $28.3 million operating loss reported for the year ended December 31, 2024. Results for the year ended December 31, 2025 were negatively impacted by the decrease in revenues, lower gross margins earned on the revenues and by higher operating expenses.
Business Combinations and Contingent Consideration 66 Table of Contents Acquired businesses are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values. Any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill.
In addition, if the Company's weighted-average cost of capital is not aligned with guideline companies, this could negatively affect the goodwill impairment outcome. Business Combinations and Contingent Consideration Acquired businesses are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values.
The Company expects research and development expense to increase in 2025 as we invest in the development of Sherlock's test for CT/NG and other innovative projects. 63 Table of Contents Sales and marketing expenses decreased 15% to $31.0 million for the year ended December 31, 2024 from $36.3 million for the year ended December 31, 2023 primarily due to decreased employee costs associated with a reduction in headcount, and lower advertising and consulting spend.
Sales and marketing expenses decreased 16% to $26.1 million for the year ended December 31, 2025 from $31.0 million for the year ended December 31, 2024 primarily due to decreased employee costs associated with a reduction in headcount, and lower market research and advertising spend.
Amounts allocated to contingent consideration are recorded to the balance sheet at the date of acquisition based on their relative fair values. The purchase price allocation requires us to make significant estimates and assumptions, especially at the acquisition date, with respect to intangible assets.
Any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. Amounts allocated to contingent consideration are recorded to the balance sheet at the date of acquisition based on their relative fair values.
Cash flows from operations can be significantly impacted by factors such as timing of receipt from customers, inventory purchases, and payments to vendors.
Analysis of the Company's Cash Flows Operating Activities During the year ended December 31, 2025, net cash used in operating activities was $49.0 million. Cash flows from operations can be significantly impacted by factors such as timing of receipts from customers, inventory purchases, and payments to vendors.
Although we believe the assumptions and estimates we have made are reasonable, they are based in part on historical experience and information obtained from the management of the acquired companies and are inherently uncertain. We account for contingent consideration in accordance with applicable guidance provided within the business combination accounting guidance.
The purchase price allocation requires us to make significant estimates and assumptions, especially at the acquisition date, with respect to intangible assets. Although we believe the assumptions and estimates we have made are reasonable, they are based in part on historical experience and information obtained from the management of the acquired companies and are inherently uncertain.
CONSOLIDATED OTHER INCOME Other income for the year ended December 31, 2024 was $12.2 million compared to $23.6 million for the year ended December 31, 2023.
CONSOLIDATED OTHER INCOME Other income for the year ended December 31, 2025 was $7.4 million compared to $12.2 million for the year ended December 31, 2024. The decrease in other income is primarily due to lower interest income and lower foreign currency gains.
Liquidity and Capital Resources December 31, 2024 December 31, 2023 (in thousands) Cash and cash equivalents $ 267,763 $ 290,407 Working capital 299,737 346,923 The Company's cash and cash equivalents decreased to $267.8 million at December 31, 2024 from $290.4 million at December 31, 2023. $82.0 million, or 31%, of the Company's $267.8 million in cash, cash equivalents and available-for-sale securities is held by DNAG, the Company's Canadian subsidiary.
Liquidity and Capital Resources December 31, 2025 December 31, 2024 (in thousands) Cash and cash equivalents $ 199,278 $ 267,763 Working capital 222,113 299,737 The Company's cash and cash equivalents decreased to $199.3 million at December 31, 2025 from $267.8 million at December 31, 2024.
(2) Includes Genomics, Microbiome and Colli-Pee product revenues. (3) Includes substance abuse testing product revenues. (4) Includes funded research and development contracts, royalty income and grant revenues. Product and Services Revenues Consolidated net revenues decreased 54% to $185.8 million for the year ended December 31, 2024 from $405.5 million for the year ended December 31, 2023.
(2) Includes Genomics, Microbiome, and Colli-Pee ® product revenues. (3) Includes substance abuse testing product revenues. (4) Includes COVID-19 Sample Management Solutions product revenues. (5) Includes funded research and development contracts, royalty income, and grant revenues.
The Company's net loss of $19.5 million included non-cash charges of depreciation and amortization expense of $10.9 million, stock-based compensation expense of $11.9 million, impairment charges taken for idle equipment and right-of-use assets associated with Diversigen and Novosanis of $4.4 million, a loss on equity investment of 1.7 million and other non-cash charges aggregating to $0.8 million.
The Company's net loss of $68.7 million included non-cash charges of depreciation and amortization expense of $10.2 million, stock-based compensation expense of $10.1 million, change in estimated fair value of acquisition-related contingent consideration of $4.6 million, a loss on equity investment of $2.3 million, and other non-cash charges aggregating to $1.2 million.
Offsetting these increases in revenues is a decline in HIV domestic revenue resulting from funding delays or reductions in funding for HIV products and customer ordering patterns. 62 Table of Contents Sample Management Solutions revenues decreased by 6% to $51.0 million for the year ended December 31, 2024 compared to $54.3 million for the year ended December 31, 2023.
Offsetting these decreases in revenues is an increase in Syphilis revenue resulting from the launch in the second quarter of 2024. Sample Management Solutions revenues decreased by 25% to $38.4 million for the year ended December 31, 2025 compared to $51.0 million for the year ended December 31, 2024.
The Company's business also includes sample management solutions and services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers. The revenues from sample management solutions are derived from product sales to commercial customers and sales into the academic and research markets.
The revenues from sample management solutions are derived from product sales to commercial customers and sales into the academic and research markets. Customers span the disease risk management, diagnostics, pharmaceutical, biotech, and companion animal market segments.
Sales of the Company's Diagnostics products increased 3% to $75.9 million for the year ended December 31, 2024 from $73.7 million for the year ended December 31, 2023. This increase in revenues is largely due to higher international HIV revenues primarily driven by customer ordering patterns in Africa offset by lower sales into Asia.
This decrease in revenues is largely due to lower international HIV revenues primarily driven by a decrease in funding and customer ordering patterns in Africa and Asia. Lower sales of the Company's HIV domestic products due to a decrease in overall funding impacting HIV programs also contributed to the decline in diagnostic revenues.
Offsetting these improvement to margins was lower gross margins generated from product mix primarily driven by the decline in InteliSwab® revenues and the mix of higher international sales of the Company's HIV products. Other non-product revenues which contribute 100% to gross margins also declined for the year ended December 31, 2024.
CONSOLIDATED OPERATING RESULTS Consolidated gross profit margin decreased to 41.9% for the year ended December 31, 2025 from 42.7% for the year ended December 31, 2024. The largest driver of the margin decline was a negative product mix driven by lower InteliSwab® sales that generate higher gross margins and lower genomics sales that also generate higher gross margins.
Cash provided by the Company's working capital accounts included a decrease in accounts receivable of $15.9 million largely associated with lower overall sales and collections of balances due, a decrease in inventory of $13.1 million as the Company fulfilled demand for its InteliSwab® product, and a decrease in prepaid and other assets of $4.1 million.
Offsetting these uses of cash is a decrease in inventory balances of $3.6 million related to the discontinuance of sales of the Company's Risk Assessment products and lower demand for its InteliSwab ® COVID-19 Rapid test, and a decrease in accounts receivable of $1.9 million as the Company experienced a decline in overall sales.
The Company's operating income of $32.7 million for the year ended December 31, 2023 included a non-cash impairment charge of $10.8 million, non-cash charges of $20.9 million for depreciation and amortization, and $10.7 million for stock-based compensation.
All of the above contributed to the Company's operating loss of $72.0 million for the year ended December 31, 2025, which included non-cash charges of $10.2 million for depreciation and amortization, $10.1 million for stock-based compensation, and $4.6 million for change in the estimated fair value of acquisition-related contingent consideration.
Investing Activities Net cash used in investing activities was $39.0 million for the year ended December 31, 2024, which reflects proceeds from the maturities and redemptions of investments of $53.1 million, offset by $53.2 million used to purchase investments and $30.0 million used to purchase an equity stake in Sapphiros.
Investing Activities Net cash used in investing activities was $6.8 million for the year ended December 31, 2025, associated with proceeds from sale of property and equipment offset by the acquisition of new property and equipment. Investing activities also includes $3.6 million of cash used for the acquisition of BioMedomics .
Working capital is primarily a function of sales, purchase volumes, inventory requirements, and vendor payment terms. Analysis of the Company's Cash Flows 64 Table of Contents Operating Activities During the year ended December 31, 2024, net cash provided by operating activities was $27.4 million.
The Company has $86.9 million, or 44% of its $199.3 million of cash, cash equivalents and available-for-sale securities held by DNAG, the Company's Canadian subsidiary. The Company's working capital decreased to $222.1 million at December 31, 2025 from $299.7 million at December 31, 2024. Working capital is primarily a function of sales, purchase volumes, inventory requirements, and vendor payment terms.
Results for the year ended December 31, 2024 included $4.4 million of impairment losses compared to $10.8 million for the year ended December 31, 2023.
Year ended December 31, 2025 compared to December 31, 2024.
Removed
Readers are cautioned not to place undue reliance on the forward-looking statements. The Company undertakes no duty to update any forward-looking statements made herein after the date of this Annual Report.
Added
In December 2025, the Company submitted a 510(k) to the FDA for clearance of its rapid molecular self-test for CT/NG, which is currently under review. The Company's business also includes sample management solutions and services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers.
Removed
This product is in its early stages, and initial sales are occurring primarily through distributors and collaborations in the liquid biopsy and sexually transmitted disease markets. Recent Developments Diversigen During the first quarter of 2024, the Company initiated steps to wind down and exit the molecular services business offered by its Diversigen subsidiary.
Added
Initial sales of this product for research use only are occurring primarily through distributors and collaborations in the liquid biopsy and sexually transmitted disease markets. In December 2025, the Company also submitted a 510(k) to the FDA for clearance of its Colli-Pee ® at-home urine collection device for sexually transmitted infections, which is currently under review.
Removed
This strategic action was largely completed in June 2024. Diversigen contributed $1.7 million and $4.5 million, to revenues during the years ended December 31, 2024 and 2023, respectively. Novosanis During the first quarter of 2024, the Company also made a strategic decision to commence wind-down of its operations at it Novosanis subsidiary located in Belgium.
Added
During the first quarter of 2025, the Company sold certain assets that made up the risk assessment product line including certain intellectual property, contracts, permits, and equipment. Acquisition of BioMedomics, Inc. In November 2025, the Company acquired BioMedomics, Inc. (“BioMedomics”), pursuant to which BioMedomics became a wholly-owned subsidiary of the Company.
Removed
The Company intends to continue to sell and manufacture its Colli-Pee® product under the DNAG product line of collection devices. As of December 31, 2024, this strategic plan was largely completed.
Added
The BioMedomics acquisition expands the Company's diagnostic portfolio by adding SickleSCAN ® , a rapid, point-of-need test for sickle cell disease that is sold outside of the United States.
Removed
Sapphiros In January 2024, the Company announced that it led the Series B financing and entered into wide-ranging strategic distribution agreements with Sapphiros, a privately held consumer diagnostic portfolio company based in Boston, and certain of its related entities.
Added
Product and Services Revenues Consolidated net revenues decreased 38% to $115.0 million for the year ended December 31, 2025 from $185.8 million for the year ended December 31, 2024. Sales of the Company's Diagnostics products decreased 12% to $66.5 million for the year ended December 31, 2025 from $75.9 million for the year ended December 31, 2024.
Removed
Through this strategic relationship, the Company expects to be able to offer a more comprehensive range of low-cost diagnostic test and sample management solutions to the Company's customers globally. The Company has funded $30.0 million for its interest in Sapphiros.
Added
Sales of the Company's Sample Management Solutions are being impacted by a large customer's bankruptcy. Risk Assessment testing revenues decreased 78% to $1.9 million for the year ended December 31, 2025 from $8.4 million for the year ended December 31, 2024.
Removed
Sherlock Acquisition In December 2024, the Company acquired Sherlock and its subsidiaries. The Sherlock acquisition expands the Company's innovation pipeline with the addition of Sherlock’s molecular diagnostics platform, which is in Phase 3 clinical trials and is expected to provide rapid results with strong sensitivity and specificity in a disposable format that is well-suited for OTC usage.
Added
The Company discontinued this line of business at the end of 2024 and the business wound down in early 2025.
Removed
Sherlock has operations in the United States and the United Kingdom.
Added
Non-Product and Services Revenues Non-product and services revenues increased 391% to $6.0 million for the year ended December 31, 2025 from $1.2 million for the year ended December 31, 2024 primarily due to the recognition of revenue under funded R&D contracts that were assumed by the Company as a result of the Sherlock acquisition at the end of 2024 as well as an increase in funded R&D under other BARDA contracts.
Removed
Year ended December 31, 2024 compared to December 31, 2023. CONSOLIDATED NET REVENUES The table below shows a summary of total consolidated net revenues (dollars in thousands) for the years ended December 31, 2024 and 2023.
Added
Also contributing to the decline in margins was lower absorption of fixed overhead costs due to lower revenues and production. The termination of the microbiome molecular sequencing services business which historically dragged down the gross margin rate helped to improve the gross margin rate during the period along with the higher non-product revenues which contribute 100% to gross margin.
Removed
Also contributing to the diagnostic revenue increase is an increase in sales of the Company's HCV domestic product and higher Syphilis revenues.
Added
Results for the year ended December 31, 2025 included change in the estimated fair value of acquisition-related contingent consideration of $4.6 million offset by gain on sale of assets of $0.7 million. Results for the year ended December 31, 2024 included impairment charges of $4.4 million.
Removed
Sales of the Company's Sample Management Solutions are being impacted by reduced consumer demand for products in which the Company's genomics collection devices are used, economic pressures, and the overall decline in the microbiome market.
Added
Research and development expenses increased 63% to $42.5 million for the year ended December 31, 2025 from $26.0 million for the year ended December 31, 2024 largely due to higher spend incurred for clinical trials for the CT/NG device and additional research and development operational expense layered in from the acquired Sherlock companies.
Removed
Risk assessment testing revenues decreased 14% to $8.4 million for the year ended December 31, 2024 from $9.7 million for the year ended December 31, 2023 due to the loss of customers to competing products. The Company has announced the discontinuance this product line and expects minimal sales through the first half of 2025 as it fulfills existing customer orders.
Added
Also contributing to the increase were additional general and administrative expenses layered in from the acquired Sherlock companies which occurred in December 2024. Lower stock compensation expense, consulting fees, and decreased employee costs partially offset the increase in general and administrative spend.
Removed
Non-Product and Services Revenues Non-product and services revenues decreased 63% to $1.2 million for the year ended December 31, 2024 from $3.3 million for the year ended December 31, 2023 as a result lower funding for research and development activities and lower royalty income.
Added
Cash used by the Company's working capital accounts included a decrease in accrued expenses and other liabilities of $8.7 million largely attributable to lower bonus accruals, an increase in prepaid expenses and other assets of $2.4 million associated with an increase in the Company's Canadian income tax receivable and increased prepayment of costs associated with the Company's efforts to prepare for production of the CT/NG device, a decrease of $1.7 million in accounts payable, and a decrease in deferred revenue of $1.5 million as work on grant projects is completed and earned.
Removed
CONSOLIDATED OPERATING RESULTS Consolidated gross profit margin increased to 43% for the year ended December 31, 2024 from 42% for the year ended December 31, 2023. Gross margins increased in 2024 despite the significant decrease in revenues due to following factors.
Added
Service revenue was discontinued with the closure of the molecular services line of business in 2024.
Removed
Results for the year ended December 31, 2024 included lower depreciation expense as a result of the inclusion in 2023 results of $6.9 million of accelerated depreciation associated with the wind-down of InteliSwab® manual assembly in Thailand as the Company on-shored and automated the manufacturing of this product at its Pennsylvania facilities and $0.5 million from the exit from one of its leased warehouse in an effort to consolidate facilities and further lower costs.
Added
The Company reserves for inventory expiring within ninety days, with the exception of inventory that will be consumed or will have expiration dates extended. It also considers items identified through specific identification procedures in assessing the adequacy of its reserve.
Removed
Results for the year ended December 31, 2024 also included improved manufacturing overhead absorption largely resulting from reduced salary and benefits due to the reduction of workforce put in place in 2024 and 2023. 2024 also included lower product scrap expense as compared to the prior year.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

4 edited+1 added−0 removed1 unchanged
Biggest changeA 10% unfavorable change in the Canadian-to-U.S. dollar and Euro-to-U.S. dollar exchange rates would have increased the Company's comprehensive loss by approximately $11.3 million as of December 31, 2024.
Biggest changeA 10% unfavorable change in the Canadian-to-U.S. dollar exchange rate would have increased the Company's comprehensive loss by approximately $11.2 million as of December 31, 2025. ITEM 8. Financial Statements and Supplementary Data. Information with respect to this Item is contained in the Company's Consolidated Financial Statements included under Item 15 of this Annual Report. ITEM 9.
The Company does not hold any amounts of derivative financial instruments or derivative commodity instruments and, accordingly, has no material derivative risk to report under this Item. As of December 31, 2024, the Company did not have any foreign currency exchange contracts or purchase currency options to hedge local currency cash flows.
The Company does not hold any amounts of derivative financial instruments or derivative commodity instruments and, accordingly, has no material derivative risk to report under this Item. As of December 31, 2025, the Company did not have any foreign currency exchange contracts or purchase currency options to hedge local currency cash flows.
Fluctuations in the exchange rate between the U.S. dollar and these foreign currencies could affect year-to-year comparability of operating results and cash flows. The Company's foreign subsidiaries had net assets, subject to translation, of $113.4 million in U.S. Dollars, which are included in the Company’s consolidated balance sheet as of December 31, 2024.
Fluctuations in the exchange rate between the U.S. dollar and the Canadian dollar could affect year-to-year comparability of operating results and cash flows. The Company's Canadian foreign subsidiary had net assets, subject to translation, of $112.1 million in U.S. dollars, which are included in the Company’s consolidated balance sheet as of December 31, 2025.
Sales denominated in foreign currencies comprised 3% of the Company's total revenues for the year ended December 31, 2024. The Company does have foreign currency exchange risk related to its operating subsidiaries in Canada and Belgium. The principal foreign currencies in which it conducts business are the Canadian dollar and the Euro.
Sales denominated in foreign currencies comprised 5% of the Company's total revenues for the year ended December 31, 2025. The Company does have foreign currency exchange risk related to its operating subsidiary in Canada. The principal foreign currency in which the subsidiary conducts business is the Canadian dollar.
Added
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. Not applicable.

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