10q10k10q10k.net

What changed in Guardant Health, Inc.'s 10-K — 2024 vs 2025

vs

Paragraph-level year-over-year comparison of Guardant Health, 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.

+351 added−348 removedSource: 10-K (2026-02-19) vs 10-K (2025-02-20)

Top changes in Guardant Health, Inc.'s 2025 10-K

351 paragraphs added · 348 removed · 261 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

81 edited+30 added−33 removed239 unchanged
Biggest changeTo achieve this, we intend to: • Increase awareness of our products by: ▪ building awareness of liquid biopsy and pioneering a blood-first paradigm for genotyping cancer patients; ▪ educating biopharmaceutical companies, key opinion leaders, or KOLs, and advocacy groups; ▪ advocating for inclusion of our tests in treatment guidelines; and ▪ expanding access to our products globally through direct investment and by leveraging our global network of partners. • Expand clinical utility and increase reimbursement for our products by: ▪ working with private and public payers to establish coverage and reimbursement for our tests; ▪ investing in clinical evidence directly and through relationships with academia and biopharmaceutical companies to establish expanded indications for use; ▪ demonstrating improved clinical utility and health economics from use of our tests to patients, physicians and payers; and ▪ pursuing FDA and other regulatory approval internationally of our tests to facilitate reimbursement and global market access. • Strengthen our relationships with customers by: ▪ demonstrating the utility of our products in connection with standard of care treatments thereby encouraging clinical adoption; ▪ developing and seeking approval of our products as companion diagnostics for targeted therapies and immuno-oncology therapies; ▪ providing earlier insights into emerging clinically relevant biomarkers; ▪ providing seamless customer experiences through collaborations with electronic medical record partners; and ▪ expanding lab capabilities and services through partnerships. • Expand our product portfolio by: ▪ using our commercial engine as a force multiplier of returns on research and development investment to generate data and analytical insights to enable development of new products; ▪ taking a disciplined and systematic approach to product and market development for cancer management across all stages of the disease; ▪ utilizing our data, sample biobank and insights into biology of circulating tumor-related biomarkers in blood to develop our new products; ▪ building on our regulatory and commercial infrastructure to accelerate new product launches and drive commercial efficiencies; and ▪ using our strategic relationships, including our partnerships with cancer centers, research organizations and laboratory companies in Europe and Asia, to drive global commercialization of our products.
Biggest changeTo achieve this, we intend to: • Increase awareness of our products by: ▪ building awareness of our product portfolio and developing both blood and tissue testing across all stages of care; ▪ employing screening awareness initiatives, including through direct-to-consumer channels, to support primary care clinician adoption, improve screening adherence and reach unscreened populations; ▪ educating biopharmaceutical companies, key opinion leaders, or KOLs, and advocacy groups; ▪ advocating for inclusion of our tests in treatment guidelines; and ▪ expanding access to our products globally through direct investment and by leveraging our global network of partners. • Expand clinical utility and increase reimbursement for our products by: ▪ working with commercial and government payers to establish coverage and reimbursement for our tests; ▪ investing in clinical and real-world evidence directly and through relationships with academia, biopharmaceutical companies and health systems to establish expanded indications for use; ▪ demonstrating improved clinical utility and health economics from use of our tests to patients, physicians and payers; and ▪ pursuing FDA and other regulatory approval internationally of our tests to facilitate reimbursement and global market access. • Strengthen our relationships with customers by: ▪ demonstrating the utility of our products in connection with standard of care treatments thereby encouraging clinical adoption; ▪ developing and seeking approval of our products as companion diagnostics for targeted therapies and immuno-oncology therapies; ▪ providing earlier insights into emerging clinically relevant biomarkers; ▪ providing seamless customer experiences through collaborations with electronic medical record partners and expanded phlebotomy access; and ▪ expanding lab capabilities and services through partnerships. • Expand our product portfolio by: ▪ using our commercial engine and research and our development investment to generate data and analytical insights to enable development of new products; ▪ taking a disciplined and systematic approach to product and market development for patient care across all stages of the disease; ▪ utilizing our data, sample biobank and insights into biology of circulating tumor-related biomarkers in blood to develop our new products; ▪ building on our regulatory and commercial infrastructure to accelerate new product launches and drive commercial efficiencies; and ▪ using our strategic relationships, including our partnerships with cancer centers, research organizations, distributors and laboratory companies in Europe and Asia, to drive global commercialization of our products. 3 Our products and development program We have launched various products and programs and we believe our product portfolio could address the full continuum of patient care, and has utility in both the clinical and biopharmaceutical markets.
Unless an exemption applies, each new or significantly modified medical device we seek to commercially distribute in the United States will require either a premarket notification to the FDA requesting permission for commercial distribution under Section 510(k) of the FDCA, also referred to as a 510(k) clearance, or approval from the FDA of a PMA application.
Unless an exemption applies, each new or significantly modified medical device we seek to commercially distribute in the United States will require either a premarket notification to the FDA requesting permission for commercial distribution under Section 510(k) of the FDCA, also referred to as a 510(k) clearance, or approval from the FDA of a premarket approval ("PMA") application.
The program is available to medical devices that 16 meet certain eligibility criteria, including that the device provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, and that the device meets one of the following criteria: (i) the device represents a breakthrough technology, (ii) no approved or cleared alternatives exist, (iii) the device offers significant advantages over existing approved or cleared alternatives, or (iv) the availability of the device is in the best interest of patients.
The program is available to medical devices that meet certain eligibility criteria, including that the device provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, and that the device meets one of the following criteria: (i) the device represents a breakthrough technology, (ii) no approved or cleared alternatives exist, (iii) the device offers significant advantages over existing approved or cleared alternatives, or (iv) the availability of the device is in the best interest of patients.
The initial term of the supply agreement, as amended, continues until January 2033, and automatically renews for additional one-year terms thereafter unless either we or Illumina terminate the supply agreement for the other’s uncured material breach, bankruptcy or insolvency-related events, or 10 in the event a regulatory authority notifies such party that continued performance under the supply agreement would violate applicable laws or regulations.
The initial term of the supply agreement, as amended, continues until January 2033, and automatically renews for additional one-year terms thereafter unless either we or Illumina terminate the supply agreement for the other’s uncured material breach, bankruptcy or insolvency-related events, or in the event a regulatory authority notifies such party that continued performance under the supply agreement would violate applicable laws or regulations.
During a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, study monitoring, selecting clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record keeping and prohibitions on the promotion of investigational devices or on making safety or effectiveness claims for them.
During a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, study monitoring, selecting clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record keeping and prohibitions on the promotion of investigational devices or on 16 making safety or effectiveness claims for them.
We believe the Guardant Reveal test has the potential to enable oncologists to improve the care of early-stage cancer patients by correctly identifying more high-risk patients than clinicopathologic review alone and by detecting recurrent disease months earlier than current standard of care methods like imaging carcinoembryonic antigen tests.
We believe the Guardant Reveal test has the potential to enable oncologists to improve 4 the care of early-stage cancer patients by correctly identifying more high-risk patients than clinicopathologic review alone and by detecting recurrent disease months earlier than current standard of care methods like imaging carcinoembryonic antigen tests.
PMA supplements often require submission of the same type of 15 information as a PMA, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA and may not require as extensive clinical data or the convening of an advisory panel.
PMA supplements often require submission of the same type of information as a PMA, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA and may not require as extensive clinical data or the convening of an advisory panel.
According to the guidance, if the FDA determines that a companion diagnostic device is essential to the safe and effective use of a novel therapeutic product for that indication, the FDA may will not approve the drug or new indication if the companion diagnostic device is not also approved or cleared for that indication.
According to the guidance, if the FDA determines that a companion diagnostic device is essential to the safe and effective use of a novel therapeutic product for that indication, the FDA may not approve the drug or new indication if the companion diagnostic device is not also approved or cleared for that indication.
Food and Drug Administration, or the FDA, to provide tumor mutation profiling with solid tumors and to be used as a companion diagnostic in connection with non-small cell lung cancer, or NSCLC, and breast cancer.
Food and Drug Administration, or the FDA, to provide tumor mutation profiling with solid tumors and to be used as a companion diagnostic in connection with non-small cell lung cancer, or NSCLC, colorectal cancer and breast cancer.
These enhancements are critical in the context of using the GuardantOMNI test in the retrospective testing of clinical study samples for translational science applications in collaboration with biopharmaceutical customers, as those samples are often available with only a limited volume of plasma. Validation data indicates that the GuardantOMNI test exceeds the Guardant360 LDT test’s sensitivity for detecting clinically actionable biomarkers.
These enhancements are critical in the context of using the GuardantOMNI test in the retrospective testing of clinical study samples for translational science applications in collaboration with biopharmaceutical customers, as those samples are often available with only a limited volume of plasma. Validation data indicates that the GuardantOMNI test exceeds the Guardant360 Liquid test’s sensitivity for detecting clinically actionable biomarkers.
Item 1. Business Overview We are a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. We are transforming patient care by providing critical insights into what drives disease through our advanced blood and tissue tests and real-world data.
Item 1. Business Overview We are a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. We are transforming patient care by providing critical insights into what drives disease through our advanced blood and tissue tests, real-world data and AI analytics.
At the same time, broader panel-wide performance of small variants is roughly similar to that of Guardant360 LDT test. In addition, the broad genomic footprint of our GuardantOMNI test enables accurate measurement of tumor mutational burden. GuardantINFORM GuardantINFORM complements our core diagnostic business with aggregated data obtained through real world genomic testing.
At the same time, broader panel-wide performance of small variants is roughly similar to that of Guardant360 Liquid test. In addition, the broad genomic footprint of our GuardantOMNI test enables accurate measurement of tumor mutational burden. GuardantINFORM GuardantINFORM complements our core diagnostic business with aggregated data obtained through real world genomic testing.
We received reimbursement for tests across the spectrum of these patients, though for amounts that on average were significantly lower than for participating providers.
We have received reimbursement for tests across the spectrum of these patients, though for amounts that on average were significantly lower than for participating providers.
As a result, the potential for more favorable reimbursement associated with becoming a participating provider may be offset by a potential loss of reimbursement for non-covered uses of our tests. We have provided testing services to patients covered by commercial payers with many cancer types and indications, some of the time as a non-participating provider through 2023.
As a result, the potential for more favorable reimbursement associated with becoming a participating provider may be offset by a potential loss of reimbursement for non-covered uses of our tests. We have provided testing services to patients covered by commercial payers with many cancer types and indications, some of the time as a non-participating provider.
Because we are not contracted with these payers, they determine the amount that they are willing to reimburse us for any of our tests and they can prospectively and retrospectively adjust the amount of reimbursement, subject to statue of limitations. Our tests are currently covered by various commercial payers and our reimbursement is directly impacted by their policies.
Because we are not contracted with these payers, they determine the amount that they are willing to reimburse us for any of our tests and they can prospectively and retrospectively adjust the amount of reimbursement, subject to statute of limitations. Our tests are currently covered by various commercial payers and our reimbursement is directly impacted by their policies.
Effective January 1, 2024, Medicare has increased the reimbursement rate for our Guardant360 LDT test to the same rate as our Guardant360 CDx test. In January 2025, Palmetto GBA granted coverage for our Guardant Reveal test to monitor disease recurrence in patients with colorectal cancer in the surveillance setting following curative intent therapy.
Effective January 1, 2024, Medicare has increased the reimbursement rate for our Guardant360 Liquid test to the same rate as our Guardant360 CDx test. In January 2025, Palmetto GBA granted coverage for our Guardant Reveal test to monitor disease recurrence in patients with colorectal cancer in the surveillance setting following curative intent therapy.
Additional gene content and immune-oncology biomarkers (e.g. microsatellite instability, or MSI) are reported in a professional services compendium to the FDA approved CDx report. Results are typically delivered within seven days following receipt of sample and delivered by a clinical report.
Additional gene content and immune-oncology biomarkers (e.g. microsatellite instability, or MSI) are reported in a professional services compendium to the FDA approved CDx report. Results are typically delivered within five days following receipt of sample and delivered by a clinical report.
The test has a significantly larger genomic panel footprint than the Guardant360 LDT test and has achieved comparable analytical performance in clinical studies, with the implemented additional enhancements to the assay efficiency and bioinformatics analysis to improve the sensitivity of our GuardantOMNI test.
The test has a significantly larger genomic panel footprint than the Guardant360 Liquid test and has achieved comparable analytical performance in clinical studies, with the implemented additional enhancements to the assay efficiency and bioinformatics analysis to improve the sensitivity of our GuardantOMNI test.
Specifically, we have demonstrated the ability to deploy our technology to partner laboratories such as cancer centers, research organizations and laboratory companies, for the development of test assays based on our technology platform. We believe that this capability will be important in accelerating adoption of our platform and the performance of our testing in certain countries.
Specifically, we have demonstrated the ability to deploy our technology to partner laboratories such as cancer centers, research organizations and laboratory companies, for the development of test assays based on our technology platform. We believe that this capability will be important in accelerating adoption of our platform and the performance of our testing globally.
Using data collected from our tests, we have also developed our GuardantINFORM platform to help biopharmaceutical companies accelerate precision oncology drug development through the use of this in-silico research platform to unlock further insights into tumor evolution and treatment resistance across various biomarker-driven cancers.
Using data collected from our tests and through AI-enabled analytical tools, we have also developed our GuardantINFORM platform to help biopharmaceutical companies accelerate precision oncology drug development through the use of this in-silico research platform to unlock further insights into tumor evolution and treatment resistance across various biomarker-driven cancers.
In March 2022, Palmetto GBA, the Medicare administrative contractor for MolDX, conveyed coverage for our Guardant360 TissueNext test under the existing local coverage determination. The policy covers our Guardant360 TissueNext test for Medicare fee-for-service patients with advanced solid tumor cancers.
In March 2022, Palmetto GBA, the Medicare administrative contractor for MolDX, conveyed coverage for our Guardant360 Tissue test under the existing local coverage determination. The policy covers our Guardant360 Tissue test for 9 Medicare fee-for-service patients with advanced solid tumor cancers.
Our Guardant360 LDT test measures 730+ genes and supports all guideline-recommended biomarkers, to help inform which therapy may be effective for advanced stage cancer patients with solid tumors, without the need to obtain archival tissue or subject the patient to another invasive biopsy.
Our Guardant360 Liquid test measures 740+ genes and supports all guideline-recommended biomarkers, to help inform which therapy may be effective for advanced stage cancer patients with solid tumors, without the need to obtain archival tissue or subject the patient to another invasive biopsy.
Our Guardant360 CDx test has also been approved by the FDA for use as a companion diagnostic to identify NSCLC patients who may benefit from treatment with TAGRISSO® (osimertinib), RYBREVANT® (amivantamab-vjmw), LUMAKRAS™ (sotorasib) and ENHERTU® (fam-trastuzumab deruxtecan-nxki), and breast cancer patients who may benefit from treatment with ORSERDU™ (elacestrant), marketed by biopharmaceutical companies.
Our Guardant360 CDx test has also been approved by the FDA for use as a companion diagnostic to identify NSCLC patients who may benefit from treatment with TAGRISSO® (osimertinib), RYBREVANT® (amivantamab-vjmw), LUMAKRAS™ (sotorasib) and ENHERTU® (fam-trastuzumab deruxtecan-nxki), breast cancer patients who may benefit from treatment with ORSERDU™ (elacestrant) and INLURIYO™ (imlunestrant), and colorectal cancer patients who may benefit from treatment with BRAFTOVI® (encorafenib), marketed by biopharmaceutical companies.
Issued U.S. patents and their international counterparts currently in our patent portfolio that relate to various aspects of our technology and products are expected to expire between 2026 and 2041. We also bolster our proprietary technology by acquiring or in-licensing technologies developed by third parties.
Issued U.S. patents and their international counterparts currently in our patent portfolio that relate to various aspects of our technology and products are expected to expire between 2028 and 2045. We also bolster our proprietary technology by acquiring or in-licensing technologies developed by third parties.
In addition, our Redwood City, San Diego and Palo Alto, California laboratories are currently operated as centers for our research and technology development. The proprietary validated methods utilize robust semi-automated workflows designed for high throughput sample testing. This methodology allows for rapid scaling of testing volume without impacting performance metrics.
In addition, our Redwood City, San Diego and Palo Alto, California laboratories are currently operated as centers for our research and technology development, and our Palo Alto laboratory is also CLIA licensed. 10 The proprietary validated methods utilize robust semi-automated workflows designed for high throughput sample testing. This methodology allows for rapid scaling of testing volume without impacting performance metrics.
In order to systematically address this need, in May 2022, we launched the Shield LDT test to address the needs of individuals eligible for colorectal cancer screening. From a simple blood draw, Shield uses a novel multimodal approach to detect colorectal cancer signals in the bloodstream, including DNA that is shed by tumors.
In order to systematically address this need, we offer the Shield blood test to address the needs of individuals eligible for colorectal cancer screening. From a simple blood draw, Shield uses a novel multimodal approach to detect colorectal cancer signals in the bloodstream, including DNA that is shed by tumors.
An RUO device is an IVD that is in the laboratory research phase of development. RUO devices must bear prominent labeling stating: “For Research Use Only. Not for use in diagnostic procedures.” An IUO device is an IVD that in the product testing phase of development. An IUO device must bear prominent labeling stating: “For Investigational Use Only.
Not for use in diagnostic procedures.” An IUO device is an IVD that in the product testing phase of development. An IUO device must bear prominent labeling stating: “For Investigational Use Only.
We believe the Guardant Reveal test can improve turnaround by simultaneously interrogating both genomic and epigenomic signals from a single blood draw without the need for tissue. In addition, our Guardant Reveal test has been migrated to the Smart Liquid Biopsy platform which could maximize detection sensitivity without requiring tissue.
We believe the Guardant Reveal test can improve turnaround by interrogating epigenomic signals from a single blood draw without the need for tissue. In addition, our Guardant Reveal test has been migrated to the Smart Platform which could maximize detection sensitivity without requiring tissue.
Other Considerations As of January 2025, 21 states, including California, have enacted laws that require biomarker testing to be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of disease or condition if the test is supported by medical and scientific evidence, and these enacted laws will mandate coverage for Guardant360 CDx, Guardant360 LDT, Guardant360 TissueNext, Guardant Response and Guardant Reveal when certain criteria are met.
Other Considerations As of January 2026, 23 states, including California, have enacted laws that require biomarker testing to be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of disease or condition if the test is supported by medical and scientific evidence, and these enacted laws will mandate coverage for Guardant360 CDx, Guardant360 Liquid, Guardant360 Tissue and Guardant Reveal when certain criteria are met.
Guardant360 LDT The number of personalized therapy options for advanced cancer patients continues to grow, giving patients who may have cycled through standard of care therapies additional options.
Guardant360 Liquid Test (formerly known as Guardant360 LDT Test) The number of personalized therapy options for advanced cancer patients continues to grow, giving patients who may have cycled through standard of care therapies additional options.
We also collaborate with biopharmaceutical companies in clinical studies by providing the above-mentioned tests, as well as the GuardantOMNI blood test for advanced-stage cancer, and the GuardantINFINITY blood test, a next-generation Smart Liquid Biopsy that provides new, multi-dimensional insights into the complexities of tumor molecular profiles and immune response to advance cancer research and therapy development.
We also collaborate with biopharmaceutical companies in clinical studies by providing the above-mentioned tests, as well as the GuardantINFINITY blood test, also powered by our Smart Platform, which provides new, multi-dimensional insights into the complexities of tumor molecular profiles and immune response to advance cancer research and therapy development, and the GuardantOMNI blood test for advanced-stage cancer.
Our tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and helping doctors select the best treatment for patients with advanced cancer.
Our tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer.
Our competitors within the liquid biopsy space for therapy selection include Foundation Medicine, Inc., which was acquired by Roche Holdings, Inc. in 2018; Caris Life Science; Tempus AI, Inc.; NeoGenomics Laboratories, Inc.; Exact Sciences Corp.; Myriad Genetics, Inc.; and Laboratory Corporation of America.
Our competitors within the liquid biopsy space for therapy selection include Foundation Medicine, Inc., which was acquired by Roche Holdings, Inc. in 2018; Caris Life Sciences, Inc.; Tempus AI, Inc.; NeoGenomics, Inc.; Exact Sciences Corporation; BillionToOne, Inc.; Quest Diagnostics, Inc.; and Laboratory Corporation of America.
In addition, we file for patent protection in connection with our on-going research and development activities, particularly those related to early-stage cancer detection. 11 Our patent portfolio includes owned and licensed patents and patent applications, generally falling into three broad categories: • issued patents and patent applications relating to our digital sequencing platform, including claims directed to methods for preparing and sequencing cell-free DNA, techniques for enriching nucleic acid samples, identifying CNVs, SNVs, indels and fusions in cell-free DNA, and detecting epigenomic variations (such DNA methylation) in biological samples; • issued patents and patent applications relating to detecting residual disease and monitoring cancer and other diseases by determining genetic and epigenomic variations in biological samples; and • issued patents and patent applications relating to early-stage cancer detection.
Our patent portfolio includes owned and licensed patents and patent applications, generally falling into three broad categories: • issued patents and patent applications relating to our digital sequencing platform, including claims directed to methods for preparing and sequencing cell-free DNA, techniques for enriching nucleic acid samples, identifying CNVs, SNVs, indels and fusions in cell-free DNA, and detecting epigenomic variations (such DNA methylation) in biological samples; • issued patents and patent applications relating to detecting residual disease and monitoring cancer and other diseases by determining genetic and epigenomic variations in biological samples; and • issued patents and patent applications relating to early-stage cancer detection.
We have supplemented the team with clinical oncology specialists with extensive medical affairs experience for molecular information support in the field. Our clinical commercial efforts are focused on driving adoption with academic research institutions and with community oncology practices, including through leading physician networks.
We have supplemented the team with clinical oncology and primary care specialists with extensive medical affairs experience support in the field. Our clinical commercial efforts are focused on driving adoption with community oncology practices, academic research institutions, primary care providers and health systems, and leading physician networks.
In return, these relationships could help us establish clinical utility for our tests and 4 create new testing opportunities related to emerging therapies. Results are typically delivered within seven days following receipt of sample and delivered by a clinical report.
In return, these relationships could help us establish clinical utility for our tests and create new testing opportunities related to emerging therapies. Results are typically delivered within seven days following receipt of sample and delivered by a clinical report. In addition, we expect to expand our MRD portfolio to include a tissue-informed test.
Our Redwood City laboratory is certified pursuant to the Clinical Laboratory Improvement Amendments of 1988, or CLIA, accredited by the College of American Pathologists, or CAP, permitted by the New York State Department of Health, or NYSDOH, and licensed in California and four other states. We also perform research use only tests in our laboratory located in San Diego, California.
Our Redwood City laboratory is licensed pursuant to the Clinical Laboratory Improvement Amendments of 1988, or CLIA, accredited by the College of American Pathologists, or CAP, permitted by the New York State Department of Health, or NYSDOH, and licensed in California and four other states.
In Japan, we have received regulatory approval of our Guardant360 CDx test as a companion diagnostic for identifying patients who may benefit from treatment with LUMAKRAS™ (sotorasib), Keytruda® (pembrolizumab), Opdivo® (nivolumab), and ENHERTU® (trastuzumab deruxtecan), from Japan's Ministry of Health, Labour and Welfare, or the MHLW.
In Japan, we have received regulatory approval of our Guardant360 CDx test as a companion diagnostic for identifying patients who may benefit from treatment with several therapies, from Japan's Ministry of Health, Labour and Welfare, or the MHLW.
Competitors within the broader genomics profiling space based on tissue include laboratory companies such as Bio-Reference Laboratories, Inc., Laboratory Corporation of America and Quest Diagnostics, Inc., and most if not all of the competitors within the liquid biopsy space for therapy selection, that sell molecular diagnostic tests for cancer to physicians and have or may develop tests that compete with our tests.
Competitors within the broader genomics profiling space based on tissue include most if not all of the competitors within the liquid biopsy space for therapy selection, that sell molecular diagnostic tests for cancer to physicians and have or may develop tests that compete with our tests.
In addition, in these circumstances, the FDA can impose significant regulatory fines or penalties for failure to submit the requisite application(s). 14 In addition, over the last several years, the FDA has proposed reforms to its 510(k) clearance process, and such proposals could include increased requirements for clinical data and a longer review period, or could make it more difficult for manufacturers to utilize the 510(k) clearance process for their products.
In addition, over the last several years, the FDA has proposed reforms to its 510(k) clearance process, and such proposals could include increased requirements for clinical data and a longer review period, or could make it more difficult for manufacturers to utilize the 510(k) clearance process for their products.
In approving a PMA, as a condition of approval, the FDA may require some form of post-approval study or post-market surveillance, whereby the applicant conducts a follow-up study or follows certain patient groups for a number of years and makes periodic reports to the FDA on the clinical status of those patients when necessary to protect the public health or to provide additional or longer term safety and effectiveness data for the device.
The PMA process can be expensive, uncertain and lengthy and a number of devices for which the FDA approval has been sought by other companies have never been approved for marketing. 15 In approving a PMA, as a condition of approval, the FDA may require some form of post-approval study or post-market surveillance, whereby the applicant conducts a follow-up study or follows certain patient groups for a number of years and makes periodic reports to the FDA on the clinical status of those patients when necessary to protect the public health or to provide additional or longer term safety and effectiveness data for the device.
U.S. clinical commercial efforts We sell our tests to clinical customers in the United States through our targeted sales organization. Our clinician-focused sales organization in the United States is engaged in sales efforts and promotional activities primarily targeting oncologists, cancer centers and primary care physicians. Our sales representatives typically have extensive sales-related backgrounds in laboratory testing, therapeutics and oncology.
Our clinician-focused sales organization in the United States is engaged in sales efforts and promotional activities primarily targeting oncologists, cancer centers and primary care physicians. Our sales representatives typically have extensive sales-related backgrounds, including in primary care, laboratory testing, therapeutics and oncology.
Biopharmaceutical Offerings GuardantINFINITY Test Our GuardantINFINITY test is a next-generation Smart Liquid Biopsy test that provides new, multi-dimensional insights into the complexities of tumor molecular profiles and immune response to advance cancer research and therapy development.
Biopharmaceutical Offerings GuardantINFINITY Test Our GuardantINFINITY test, powered by the Smart Platform, provides new, multi-dimensional insights into the complexities of tumor molecular profiles and immune response to advance cancer research and therapy development.
While we believe the benefits of early detection on clinical outcomes are widely known, early detection may also benefit biopharmaceutical companies by identifying a much larger at-risk population who may benefit from early therapeutic intervention or from preventative medicines.
While we believe the benefits of early detection on clinical outcomes are widely known, early detection may also benefit biopharmaceutical companies by identifying a much larger at-risk population who may benefit from early therapeutic intervention or from preventative medicines. We also believe Shield is a platform that can expand well beyond cancer into many other diseases.
As of December 31, 2024, women held 30% of the independent director seats on our Board. Culture, Compensation and Benefits We strive to recruit, hire and retain a talented and diverse team of people who align with our values. Our employees are supported with training and development opportunities to pursue their career paths and ensure compliance with our policies.
Culture, Compensation and Benefits We strive to recruit, hire and retain a talented and diverse team of people who align with our values. Our employees are supported with training and development opportunities to pursue their career paths and ensure compliance with our policies.
We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by applicable law. All employment is decided on the basis of qualifications, merit, and business need. Further, we have policies in place that prohibit harassment of all kinds.
We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by applicable law. All employment decisions are based on qualifications, merit, and business need, consistent with applicable law.
For patients with advanced-stage cancer, we have commercially launched Guardant360 laboratory developed test, or LDT, and Guardant360 CDx, the first comprehensive liquid biopsy test approved by the U.S.
For patients with advanced-stage cancer, we offer the Guardant360 Liquid test, formerly known as the Guardant360 LDT test, and the Guardant360 CDx test, the first comprehensive liquid biopsy test approved by the U.S.
Device classification Under the FDCA, medical devices are classified into one of three classes-Class I, Class II or Class III-depending on the degree of risk associated with each medical device and the extent of control needed to provide reasonable assurances with respect to safety and effectiveness.
Both the 510(k) clearance and PMA processes can be resource intensive, expensive, and lengthy, and require payment of significant user fees. 13 Device classification Under the FDCA, medical devices are classified into one of three classes-Class I, Class II or Class III-depending on the degree of risk associated with each medical device and the extent of control needed to provide reasonable assurances with respect to safety and effectiveness.
In September 2024, we signed a partnership agreement with the Agostino Gemelli University Polyclinic Foundation IRCCS, one of Italy’s largest and most renowned hospitals known for its advanced oncology services, including diagnostics, treatment, and research, to establish an in-house liquid biopsy testing service within its hospital system.
In September 2024, we signed a partnership agreement with Fondazione Policlinico Universitario Agostino Gemelli IRCCS, or Policlinico Gemelli, one of Italy’s largest and most renowned hospitals known for its advanced oncology services, including diagnostics, treatment, and research, to establish an in-house liquid biopsy testing service within its hospital system, and in December 2025, the liquid biopsy testing service based on our proprietary Guardant360® CDx technology became available at the Policlinico Gemelli facility in Italy.
Most Class II devices are subject to premarket review and clearance by the FDA.
Most Class II devices are subject to premarket review and clearance by the FDA. Premarket review and clearance by the FDA for Class II devices is accomplished through the 510(k) premarket notification process.
We have also engaged and may continue to engage independent contractors to assist us with our operations. None of our employees are represented by a labor union or covered by a collective bargaining agreement, except as required by local laws such as in some European countries, and we have never experienced any employment-related work stoppages.
None of our employees are represented by a labor union or covered by a collective bargaining agreement, except as required by local laws such as in some European countries, and we have never experienced any employment-related work stoppages. We also track voluntary and involuntary turnover rates and conduct periodic employee engagement surveys.
A manufacturer can submit a petition for direct de novo review if the manufacturer is unable to identify an appropriate predicate device and the new device or new use of the device presents a moderate or low risk. De novo classification may also be available after receipt of a “not substantially equivalent” letter following submission of a 510(k) to FDA.
A manufacturer can submit a petition for direct de novo review if the manufacturer is unable to identify an appropriate predicate device and the new device or new use of the device 14 presents a moderate or low risk.
As part of the PMA process, the applicant must submit data and information demonstrating reasonable assurance of the safety and effectiveness of the device for its intended use to the FDA’s satisfaction.
Therefore, these devices are subject to the PMA process, which is generally more costly and time-consuming than the 510(k) process. As part of the PMA process, the applicant must submit data and information demonstrating reasonable assurance of the safety and effectiveness of the device for its intended use to the FDA’s satisfaction.
In addition, Natera, Inc., Tempus AI, Inc., Exact Sciences Corp., Myriad Genetics, Inc., Caris Life Science, Foundation Medicine, Inc. and Quest Diagnostics, Inc., among others, are our competitors in minimal residual disease detection. Additionally, our competitors in the early screening testing space include GRAIL, Inc., Exact Sciences Corp., Freenome Holdings, Inc., and Delfi Diagnostics.
In addition, Natera, Inc., Tempus AI, Inc., Exact Sciences Corporation, Myriad Genetics, Inc., Caris Life Sciences, Inc. Foundation Medicine, Inc., BillionToOne, Inc., Personalis, Inc., and Quest Diagnostics, Inc., among others, are our competitors in minimal residual disease detection.
Shield is also the first blood test for colorectal cancer screening that meets coverage requirements by Medicare. We also expect to expand into lung cancer screening and multi-cancer detection, or MCD, with our Shield platform.
In addition, our Shield blood test is included in the National Comprehensive Cancer Network colorectal cancer screening guidelines. We also expect to expand into lung cancer screening and multi-cancer detection, or MCD, with our Shield platform.
Government regulations Federal and state laboratory licensing requirements Under CLIA, a laboratory is any facility that performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease, or the impairment of or assessment of health.
We also enter into invention disclosure and assignment agreements with our employees and consultants that obligate them to assign to us any inventions they have developed while working for us. 12 Government regulations Federal and state laboratory licensing requirements Under CLIA, a laboratory is any facility that performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease, or the impairment of or assessment of health.
We believe our product portfolio could address the full continuum of cancer care for selected indications, and has utility in both the clinical and biopharmaceutical markets. 3 Therapy Selection Guardant360 CDx Test We believe our Guardant360 CDx test was the first comprehensive liquid biopsy test approved by the FDA, and is the market leading comprehensive liquid biopsy test, based on the number of tests ordered.
Therapy Selection Guardant360 CDx Test We believe our Guardant360 CDx test was the first comprehensive liquid biopsy test approved by the FDA, and is the market leading comprehensive liquid biopsy test, based on the number of tests ordered.
Shield is also the first blood test for colorectal cancer screening that meets coverage requirements by Medicare.
Shield is the first blood test approved by the FDA for primary colorectal cancer screening and also the first blood test for colorectal cancer screening that meets coverage requirements by Medicare. In addition, our Shield blood test is included in the National Comprehensive Cancer Network colorectal cancer screening guidelines.
Premarket review and clearance by the FDA for Class II devices is accomplished through the 510(k) premarket notification process. 13 Class III devices include devices deemed by the FDA to pose the greatest risk such as life-supporting or life-sustaining devices, or implantable devices, in addition to those deemed novel and not substantially equivalent following the 510(k) process.
Class III devices include devices deemed by the FDA to pose the greatest risk such as life-supporting or life-sustaining devices, or implantable devices, in addition to those deemed novel and not substantially equivalent following the 510(k) process. The safety and effectiveness of Class III devices cannot be reasonably assured solely by the General Controls and special controls described above.
We believe key competitive factors affecting our success are the price and performance of our products, evidence of clinical differentiation, support by KOLs, commercial competitiveness, turnaround time and scope and quality of payer contracts. Our competitive landscape may change over the next few years as a result of new competitors entering through investment and acquisition activity.
Over the last year, that has included new and accelerated development programs by a number of potential competitors, and increasing levels of merger and acquisition activity by both existing and new competitors. 11 We believe key competitive factors affecting our success are the price and performance of our products, evidence of clinical differentiation, support by KOLs, commercial competitiveness, turnaround time and scope and quality of payer contracts.
In addition to our existing covered and contracted payers, various laboratory benefit managers and evidence review organizations working with commercial payers have endorsed coverage of Guardant360 CDx, Guardant360 LDT, Guardant360 TissueNext and Guardant Reveal.
In addition to our existing covered and contracted payers, various laboratory benefit managers and evidence review organizations working with commercial payers have endorsed coverage of our Guardant360 CDx, Guardant360 Liquid, Guardant360 Tissue and Guardant Reveal tests. Additionally, our Shield blood test has received coverage for patients receiving community care authorized by the U.S.
The regulatory and compliance standards applicable to any testing we perform may change over time and any such changes could have a material effect on our business. 12 CLIA provides that a state may adopt laboratory regulations that are more stringent than those under federal law, and a number of states have implemented their own more stringent laboratory regulatory requirements.
CLIA provides that a state may adopt laboratory regulations that are more stringent than those under federal law, and a number of states have implemented their own more stringent laboratory regulatory requirements.
We also expect to expand into lung cancer screening and multi-cancer detection with our Shield platform. 2 Our strategy Our objective is to be the leading provider of therapy selection, minimal residual disease detection, and early cancer screening products for cancer management across all stages of the disease and drive commercial adoption of our products.
In addition, we have expanded our Shield blood test to include an MCD results report with a data collection effort to better understand the clinical impact of MCD results. 2 Our strategy Our objective is to be the leading provider of therapy selection, minimal residual disease detection, and early cancer screening products for cancer management across all stages of the disease and drive commercial adoption of our products.
We are conducting studies in various jurisdictions, and have secured and will continue our efforts to secure reimbursement in several countries. In addition, we have established, and as these studies progress and we near commercial opportunities in these jurisdictions, will continue to seek to establish in-country laboratories and direct sales organizations.
We are conducting studies in various jurisdictions, and have secured and will continue our efforts to secure reimbursement in several countries.
For clinicians, endorsement by KOLs, utilization by academic centers and inclusion in national treatment guidelines are important, especially for adoption in the local community setting. We believe that our relationships 6 with key stakeholders across the oncology space have helped facilitate the use of our tests by clinicians and biopharmaceutical companies.
Commercialization Successful commercial adoption of our tests by clinicians and biopharmaceutical companies is critical to our business. For clinicians, endorsement by KOLs, utilization by academic centers and inclusion in national treatment guidelines are important, especially for adoption in the local community setting.
We are proud to employ a diverse workforce that, as of December 31, 2024, was 55% racially/ethnically diverse and 54% female. For leadership positions across the company, which is defined as director level and above, 32% self-identified as racially/ethnically diverse and 40% self-identified as women.
For leadership positions across the company, which are defined as director level and above, 32% self-identified as racially/ethnically diverse and 40% self-identified as women. As of December 31, 2025, women held 33% of the independent director seats on our Board.
Medicare’s National Coverage Determination, or NCD, for Next Generation Sequencing, or NGS, provides coverage for molecular diagnostic tests such as our Guardant360 CDx test, if, among other criteria, such tests are offered within their FDA-approved companion diagnostic labeling. 8 In March 2020, we began to receive reimbursement from Medicare for claims submitted with respect to Guardant360 clinical tests performed for qualifying patients diagnosed with solid tumor cancers of non-central nervous system origin other than NSCLC.
In March 2020, we began to receive reimbursement from Medicare for claims submitted with respect to Guardant360 clinical tests performed for qualifying patients diagnosed with solid tumor cancers of non-central nervous system origin other than NSCLC.
Employees and Human Capital Our Employees and Commitment to Diversity, Equity and Inclusion As of December 31, 2024, we had 2,021 employees, 1,999 of which are full-time employees and approximately 1,849 of which are in the U.S., with the remainder in Asia, Europe and Canada.
Employees and Human Capital Our Employees As of December 31, 2025, we had 2,506 employees, 2,490 of which are full-time employees and approximately 2,278 of which are in the U.S., with the remainder in Asia, Europe and Canada. We have also engaged and may continue to engage independent contractors to assist us with our operations.
We have also launched the Guardant360 TissueNext tissue test for advanced-stage cancer, Guardant Reveal blood test to detect residual and recurring disease in early-stage colorectal, breast and lung cancer patients, and Guardant360 Response blood test to predict patient response to immunotherapy or targeted therapy eight weeks earlier than current standard-of-care imaging.
We also offer the Guardant360 Tissue test for advanced-stage cancer and the Guardant Reveal test to detect residual and recurring disease in early-stage colorectal, breast and lung cancer patients. We have also expanded the Guardant Reveal test to include late-stage therapy response monitoring for patients with solid tumors.
CLIA requires analytical validation including accuracy, precision, specificity, sensitivity and establishment of a reference range for any LDT used in clinical testing.
CLIA requires analytical validation including accuracy, precision, specificity, sensitivity and establishment of a reference range for any LDT used in clinical testing. The regulatory and compliance standards applicable to any testing we perform may change over time and any such changes could have a material effect on our business.
This represents an expansion from the prior Medicare coverage of our Guardant Reveal test for colorectal cancer in the early post-surgical setting only. In August 2024, following the FDA approval, our Shield blood test met the coverage requirements by Medicare based on the criteria established in its NCD for blood-based colorectal cancer screening tests.
In August 2024, following the FDA approval, our Shield blood test met the coverage requirements by Medicare based on the criteria established in its National Coverage Determination for blood-based colorectal cancer screening tests. The test is covered once every three years for eligible Medicare beneficiaries.
Clinical Studies and Publications We are proactively pursuing studies to support the use of our tests as a preferred alternative or complementary to tissue testing to inform first line treatment right after diagnosis and at time of disease progression, with the goal to provide evidence that our tests detect genomic alterations at a similar rate compared to standard of care tissue testing and detects mutations that may not be detected by tissue based testing in the United States, Europe and Asia.
Clinical Studies and Publications We are proactively pursuing studies to support the use of our genotyping tests as a preferred alternative or complementary approach to tissue testing to inform treatment selection at diagnosis and at disease progression.
In preparation for wider commercialization in the European Union, or the EU, we obtained a CE mark for our Guardant360 CDx test.
In addition, we have established, and as these studies progress and we near commercial opportunities in these jurisdictions, will continue to seek to establish in-country laboratories and direct sales organizations. 7 In preparation for wider commercialization in the European Union, or the EU, we obtained a CE mark for our Guardant360 CDx test.
The promise of liquid biopsy is also leading to more companies attempting to enter the space and compete with us. Over the last year, that has included new and accelerated development programs by a number of potential competitors, and increasing levels of merger and acquisition activity by both existing and new competitors.
The promise of liquid biopsy is also leading to more companies attempting to enter the space and compete with us.
The test is covered once every three years for eligible Medicare beneficiaries. 9 State Medicaid programs make individual coverage decisions for diagnostic tests and have taken steps to control the cost, utilization and delivery of healthcare services.
In March 2025, CMS approved ADLT status for our Shield blood test for colorectal cancer screening, which initiated a specific, market-based approach to pricing the test for Medicare patients. State Medicaid programs make individual coverage decisions for diagnostic tests and have taken steps to control the cost, utilization and delivery of healthcare services.
We are actively engaged to expand coverage among existing commercial payers and to achieve coverage with the remaining key commercial payers, laboratory benefit managers and evidence review organizations. This includes addressing variable coverage requirements and evidence required, and the need for enhanced guideline support.
This includes addressing variable coverage requirements and evidence required, and the need for enhanced guideline support.
In July 2024, we received FDA approval of our Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease, and in August 2024, our Shield blood test became commercially available in the U.S. as the first blood test approved by the FDA for primary colorectal cancer screening, meaning healthcare providers can offer Shield in a manner similar to all other non-invasive methods recommended in screening guidelines.
For early cancer detection, we offer the Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease. Shield is the first blood test approved by the FDA for primary colorectal cancer screening and also the first blood test for colorectal cancer screening that meets coverage requirements by Medicare.
Smart Liquid Biopsy Platform Our Smart Liquid Biopsy platform drives significant research and development efficiencies and operating leverage, which supports performance improvements, cross-development of new applications, cost savings and improved turnaround time. While products continue to evolve by leveraging commonality in equipment, reagents, and staffing, this platform also provides a foundation for future product evolutions and data integration.
Smart Platform Our proprietary Smart Platform delivers multiomic insights leveraging genomic, epigenomic, and RNA-based data that are scalable from research to the clinic. Our Smart Platform drives significant research and development efficiencies and operating leverage, which supports performance improvements, faster turnaround time, cross-development of new applications and cost savings.
Intellectual property Protection of our intellectual property is fundamental to the long-term success of our business.
Our competitive landscape may change over the next few years as a result of new competitors entering through investment and acquisition activity. Intellectual property Protection of our intellectual property is fundamental to the long-term success of our business.
Moreover, legislative measures could result in a change to the approach to FDA’s regulation over LDTs, including a requirement for premarket review of LDTs, among other things. Research use only or investigational use only devices Some of our products are currently available for research use only, or RUO, or for investigational use only, or IUO, depending on the proposed application.
Research use only or investigational use only devices Some of our products are currently available for research use only, or RUO, or for investigational use only, or IUO, depending on the proposed application. An RUO device is an IVD that is in the laboratory research phase of development. RUO devices must bear prominent labeling stating: “For Research Use Only.

… 64 more changes not shown on this page.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

75 edited+22 added−11 removed669 unchanged
Biggest changeIf we are required to conduct such clinical studies delays in the commencement or completion of clinical testing could significantly increase our test development costs and delay commercialization of any currently-marketed tests that we may be required to cease selling or the commercialization of any future tests that we may develop, which could harm our financial prospects. 36 Table of Contents There is no guarantee that the FDA will grant 510(k) clearance or a premarket approval of our products or that similar foreign authorities or notified bodies will grant premarket approval or certify our products and failure to obtain necessary clearances or approvals or certifications for our products would adversely affect our ability to grow our business.
Biggest changeIf we are required to conduct such clinical studies delays in the commencement or completion of clinical testing could significantly increase our test development costs and delay commercialization of any currently-marketed tests that we may be required to cease selling or the commercialization of any future tests that we may develop, which could harm our financial prospects.
We believe that patients, clinicians and biopharmaceutical companies are likely to be particularly 28 sensitive to product defects and errors in the use of our products, including if our products fail to detect genomic alterations with high accuracy from samples or if we fail to list or inaccurately include certain treatment options and available clinical studies in our test reports, and there can be no guarantee that our products will meet their expectations.
We believe that patients, clinicians and biopharmaceutical companies are likely to be particularly sensitive to product defects 28 and errors in the use of our products, including if our products fail to detect genomic alterations with high accuracy from samples or if we fail to list or inaccurately include certain treatment options and available clinical studies in our test reports, and there can be no guarantee that our products will meet their expectations.
The FDA and foreign authorities or notified bodies can delay, limit or deny clearance or approval or certification of a device for many reasons, including: • our inability to demonstrate to the satisfaction of the FDA, similar foreign authorities or notified bodies that our products are safe or effective for their intended uses; 37 Table of Contents • the disagreement of the FDA, similar foreign authorities or notified bodies with the design, conduct or implementation of our clinical studies or the analysis or interpretation of data from our pre-clinical or clinical studies; • serious and unexpected adverse effects experienced by participants in our clinical studies; • the data from our pre-clinical and clinical studies may be insufficient to support clearance or approval, or certification where required; • our inability to demonstrate that the clinical and other benefits of any of our tests outweigh the risks; • an advisory committee, if convened by the FDA, may recommend against approval of our PMA or other application for any of our tests or may recommend that the FDA require, as a condition of approval, additional pre-clinical studies or clinical studies, limitations on approved labeling or distribution and use restrictions, or even if an advisory committee, if convened, makes a favorable recommendation, the FDA may still not approve the test; Similar requirements may apply in foreign jurisdictions; • the FDA, similar foreign authorities or notified bodies may identify deficiencies in our marketing application, or certification application and in our manufacturing processes, facilities or analytical methods or those of our third-party contract manufacturers; • the potential for approval or certification policies or regulations of the FDA or similar foreign authorities to change significantly in a manner rendering our clinical data or regulatory filings insufficient for the clearance or approval or certification; and • the FDA, similar foreign authorities or notified bodies may audit our clinical study data and conclude that the data is not sufficiently reliable to support a PMA or other applications.
The FDA and foreign authorities or notified bodies can delay, limit or deny clearance or approval or certification of a device for many reasons, including: • our inability to demonstrate to the satisfaction of the FDA, similar foreign authorities or notified bodies that our products are safe or effective for their intended uses; • the disagreement of the FDA, similar foreign authorities or notified bodies with the design, conduct or implementation of our clinical studies or the analysis or interpretation of data from our pre-clinical or clinical studies; • serious and unexpected adverse effects experienced by participants in our clinical studies; • the data from our pre-clinical and clinical studies may be insufficient to support clearance or approval, or certification where required; • our inability to demonstrate that the clinical and other benefits of any of our tests outweigh the risks; • an advisory committee, if convened by the FDA, may recommend against approval of our PMA or other application for any of our tests or may recommend that the FDA require, as a condition of approval, additional pre-clinical studies or clinical studies, limitations on approved labeling or distribution and use restrictions, or even if an advisory committee, if convened, makes a favorable recommendation, the FDA may still not approve the test; Similar requirements may apply in foreign jurisdictions; • the FDA, similar foreign authorities or notified bodies may identify deficiencies in our marketing application, or certification application and in our manufacturing processes, facilities or analytical methods or those of our third-party contract manufacturers; • the potential for approval or certification policies or regulations of the FDA or similar foreign authorities to change significantly in a manner rendering our clinical data or regulatory filings insufficient for the clearance or approval or certification; and 37 Table of Contents • the FDA, similar foreign authorities or notified bodies may audit our clinical study data and conclude that the data is not sufficiently reliable to support a PMA or other applications.
Due to the inherent variability and unpredictability of the reimbursement landscape, including related to the amount that payers reimburse us for any of our tests, we estimate the amount of revenue to be recognized at the time a test is provided and record revenue adjustments if and when the cash subsequently received for a test differs from the revenue recorded for the test.
Due to the inherent variability and unpredictability of the reimbursement landscape, including related to the amount that payers reimburse us for any of our tests, we estimate the amount of revenue to be recognized at the time a test is provided and record revenue adjustments if and when the cash subsequently received for a test differs from the revenue recorded for the test.
The option counterparties are financial institutions, and we will be subject to the risk that any or all of them may default under the 2027 Note Hedge transactions. Our exposure to the credit risk of the option counterparties will not be secured by any collateral.
The option counterparties are financial institutions, and we are subject to the risk that any or all of them may default under the 2027 Note Hedge transactions. Our exposure to the credit risk of the option counterparties will not be secured by any collateral.
Doing business internationally involves a number of risks, including: • multiple, conflicting and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, economic sanctions and embargoes, employment laws, regulatory requirements and other governmental approvals, permits and licenses; • failure by us, our distributors, or our local partners to obtain regulatory approvals or certifications for the use of our products in various countries; • presence of additional third-party patents or other intellectual property rights that may be relevant to our business and may potentially block our expansion; • complexities and difficulties in obtaining intellectual property protection and enforcing our intellectual property rights; • difficulties in staffing and managing foreign operations; 34 • complexities associated with managing multiple payer reimbursement regimes, government payers, or patient self-pay systems; • logistics and regulations associated with shipping blood samples, including infrastructure conditions and transportation delays; • limits in our ability to penetrate international markets if we are not able to perform our tests locally; • financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products and exposure to foreign currency exchange rate fluctuations, currency controls and cash repatriation restrictions; • natural disasters, political and economic instability, including wars, terrorism, and political unrest, boycotts, curtailment of trade and other business restrictions; • public health or similar issues, such as epidemics or pandemics, that could cause business disruption for our offices in Japan and Singapore, and make it more difficult to sell our tests in the affected countries or regions, and • regulatory and compliance risks that relate to maintaining accurate information and control over sales and distributors’ activities that may fall within the purview of the U.S.
Doing business internationally involves a number of risks, including: • multiple, conflicting and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, economic sanctions and embargoes, employment laws, regulatory requirements and other governmental approvals, permits and licenses; • failure by us, our distributors, or our local partners to obtain regulatory approvals or certifications for the use of our products in various countries; • presence of additional third-party patents or other intellectual property rights that may be relevant to our business and may potentially block our expansion; • complexities and difficulties in obtaining intellectual property protection and enforcing our intellectual property rights; • difficulties in staffing and managing foreign operations; • complexities associated with managing multiple payer reimbursement regimes, government payers, or patient self-pay systems; • logistics and regulations associated with shipping blood samples, including infrastructure conditions and transportation delays; • limits in our ability to penetrate international markets if we are not able to perform our tests locally; • financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products and exposure to foreign currency exchange rate fluctuations, currency controls and cash repatriation restrictions; • natural disasters, political and economic instability, including wars, terrorism, and political unrest, boycotts, tariffs, curtailment of trade and other business restrictions; • public health or similar issues, such as epidemics or pandemics, that could cause business disruption for our offices in Japan and Singapore, and make it more difficult to sell our tests in the affected countries or regions, and • regulatory and compliance risks that relate to maintaining accurate information and control over sales and distributors’ activities that may fall within the purview of the U.S.
If our operations are found to be in violation of any of these laws and regulations, we may be subject to administrative, civil and criminal penalties, damages, fines, individual imprisonment, exclusion from participation in federal healthcare programs or from coverage of commercial payers, refunding of payments received by us, and curtailment or cessation of our operations, any of which could harm our reputation and adversely affect our business, financial condition and results of operations.
If our 33 operations are found to be in violation of any of these laws and regulations, we may be subject to administrative, civil and criminal penalties, damages, fines, individual imprisonment, exclusion from participation in federal healthcare programs or from coverage of commercial payers, refunding of payments received by us, and curtailment or cessation of our operations, any of which could harm our reputation and adversely affect our business, financial condition and results of operations.
Competitors within the broader genomics profiling space based on tissue include laboratory companies such as Bio-Reference Laboratories, Inc., Laboratory Corporation of America and Quest Diagnostics, Inc., and most if not all of the competitors within the liquid biopsy space for therapy selection, that sell molecular diagnostic tests for cancer to physicians and have or may develop tests that compete with our tests.
Competitors within the broader genomics profiling space based on tissue include laboratory companies such as Bio-Reference Laboratories, Inc., Laboratory Corporation of America and Quest Diagnostics, Inc., and most if not all of the competitors within the liquid biopsy space for therapy selection, that sell molecular diagnostic tests for cancer to 30 physicians and have or may develop tests that compete with our tests.
In addition to reducing our revenue, the loss of one or more of these relationships may reduce our exposure to research and clinical studies that facilitate the collection and incorporation of new information into our platform and tests. We engage in conversations with biopharmaceutical companies regarding potential commercial opportunities on an ongoing basis.
In addition to reducing our revenue, the loss of one or more of these relationships may reduce our exposure to research and clinical studies that facilitate the 29 collection and incorporation of new information into our platform and tests. We engage in conversations with biopharmaceutical companies regarding potential commercial opportunities on an ongoing basis.
If a prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA or other regulatory authorities from conducting business as usual or conducting inspections, reviews or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
If a prolonged government shutdown occurs, or if global health concerns prevent the FDA or other regulatory authorities from conducting business as usual or conducting inspections, reviews or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
Although we are a participating provider with some commercial payers, certain other large, national commercial payers, including Anthem, Aetna and Humana, have issued non-coverage policies that consider tissue and liquid CGP testing which are not FDA approved, including our Guardant360 and TissueNext test, as experimental or investigational.
Although we are a participating provider with some commercial payers, certain other large, national commercial payers, including Anthem, Aetna and Humana, have issued non-coverage policies that consider tissue and liquid CGP testing which are not FDA approved, including our Guardant360 and Tissue test, as experimental or investigational.
These fluctuations may occur due to a variety of factors, many of which are outside of our control, including, but not limited to: • the level of demand for any of our products, which may vary significantly; • the timing and cost of, and level of investment in, research, development, regulatory approval or certification and commercialization activities relating to our products, which may change from time to time; • the volume and customer mix of our precision oncology testing; • the start and completion of projects in which our development services and other are utilized; • the introduction of new products or product enhancements by us or others in our industry; • coverage and reimbursement policies with respect to our products and products that compete with our products; • expenditures that we may incur to acquire, develop or commercialize additional products and technologies; • changes in governmental regulations or in the status of our regulatory approvals or certifications or applications; • future accounting pronouncements or changes in our accounting policies; • developments or disruptions in the business and operations of our clinical, commercial and other partners; • the impact of natural disasters, political and economic instability, including wars, terrorism, and political unrest, epidemics or pandemics, boycotts, curtailment of trade and other business restrictions; and • the effects of high inflation or other general market conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors.
These fluctuations may occur due to a variety of factors, many of which are outside of our control, including, but not limited to: • the level of demand for any of our products, which may vary significantly; • the timing and cost of, and level of investment in, research, development, regulatory approval or certification and commercialization activities relating to our products, which may change from time to time; • the volume and customer mix of our products; • the start and completion of projects in which our development services and other are utilized; • the introduction of new products or product enhancements by us or others in our industry; • coverage and reimbursement policies with respect to our products and products that compete with our products; • expenditures that we may incur to acquire, develop or commercialize additional products and technologies; • changes in governmental regulations or in the status of our regulatory approvals or certifications or applications; • future accounting pronouncements or changes in our accounting policies; • developments or disruptions in the business and operations of our clinical, commercial and other partners; • the impact of natural disasters, political and economic instability, including wars, terrorism, and political unrest, epidemics or pandemics, boycotts, curtailment of trade and other business restrictions; and • the effects of high inflation or other general market conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors.
These limited or sole suppliers could engage in diverse types of businesses, including selling products or providing services in competition with us, and there can be no assurance that we can continue to receive required equipment, instruments or materials from them.
These limited or sole suppliers could engage in diverse types of businesses, including selling products or providing services in competition with us, and there can be no assurance that we can continue to receive required equipment, software, instruments or materials from them.
Foreign Corrupt Practices Act, or FCPA, its books and records provisions, or its anti-bribery provisions. Any of these factors could significantly harm our future international expansion and operations and, consequently, our revenue and results of operations. We could be adversely affected by violations of the FCPA and other anti-bribery laws.
Foreign Corrupt Practices Act, or FCPA, its books and records provisions, or its anti-bribery provisions. 34 Any of these factors could significantly harm our future international expansion and operations and, consequently, our revenue and results of operations. We could be adversely affected by violations of the FCPA and other anti-bribery laws.
An interruption in our laboratory operations could occur if we encounter delays or difficulties in securing these laboratory equipment, instruments or materials, and if we cannot then obtain an acceptable substitute. Any such interruption could significantly and adversely affect our business, financial condition, results of operations and reputation.
An interruption in our laboratory operations could occur if we encounter delays or difficulties in securing these laboratory equipment, instruments or materials, and if we cannot then obtain an 32 acceptable substitute. Any such interruption could significantly and adversely affect our business, financial condition, results of operations and reputation.
We rely on a limited number of suppliers or, in some cases, sole suppliers, including Illumina Inc., or Illumina, for certain sequencers, reagents, blood tubes and other equipment, instruments and materials that we use in our laboratory operations.
We rely on a limited number of suppliers or, in some cases, sole suppliers, including Illumina Inc., or Illumina, for certain sequencers, reagents, blood tubes and other equipment, software, instruments and materials that we use in our laboratory operations.
Our facility and equipment could be harmed or rendered inoperable by natural or man-made disasters, including war, fire, earthquake, power loss, communications failure or terrorism, which may render it difficult or impossible for our laboratory operations.
Our facility and equipment could be harmed or rendered inoperable by natural or man-made disasters, including war, fire, earthquake, power loss, communications failure or terrorism, which may render operations difficult or impossible for our laboratory facility.
Areas of the regulatory environment that may affect our ability to conduct business include, without limitation: • federal, state and foreign laws applicable to test ordering, documentation of tests ordered, billing practices and claims payment and/or regulatory agencies enforcing those laws and regulations; • federal, state and foreign healthcare fraud and abuse laws; • federal, state and foreign laboratory anti-mark-up laws; • coverage and reimbursement levels by Medicare, Medicaid, other governmental payers and private insurers; • restrictions on coverage of and reimbursement for tests; 35 Table of Contents • federal, state and foreign laws governing laboratory testing, including CLIA, and state licensing laws; • federal, state and foreign laws and enforcement policies governing the development, use and distribution of diagnostic medical devices, including laboratory developed tests, or LDTs; • federal, state, local and foreign laws governing the handling and disposal of medical and hazardous waste; • federal and state Occupational Safety and Health Administration rules and regulations; • HIPAA, GDPR, APPI, CCPA, CPRA and similar state or foreign data privacy and security laws; and • consumer protection laws.
Areas of the regulatory environment that may affect our ability to conduct business include, without limitation: • federal, state and foreign laws applicable to test ordering, documentation of tests ordered, billing practices and claims payment and/or regulatory agencies enforcing those laws and regulations; • federal, state and foreign healthcare fraud and abuse laws; • federal, state and foreign laboratory anti-mark-up laws; • coverage and reimbursement levels by Medicare, Medicaid, other governmental payers and private insurers; • restrictions on coverage of and reimbursement for tests; • federal, state and foreign laws governing laboratory testing, including CLIA, and state licensing laws; • federal, state and foreign laws and enforcement policies governing the development, use and distribution of diagnostic medical devices, including laboratory developed tests, or LDTs; • federal, state, local and foreign laws governing the handling and disposal of medical and hazardous waste; • federal and state Occupational Safety and Health Administration rules and regulations; • HIPAA, GDPR, APPI, CCPA, CPRA and similar state or foreign data privacy and security laws; and • consumer protection laws.
The 2027 Note Hedge transactions are expected generally to reduce the potential dilution upon any conversion of the 2027 Notes and/or offset any cash payments we are required to make in excess of the principal amount of converted 2027 Notes.
The remaining 2027 Note Hedge transactions are expected generally to reduce the potential dilution upon any conversion of the 2027 Notes and/or offset any cash payments we are required to make in excess of the principal amount of converted 2027 Notes.
The market price of our common stock has been volatile and may fluctuate substantially in the future due to many factors, including: • volume and customer mix for our precision oncology testing; • the introduction of new products or product enhancements by us or others in our industry; • disputes or other developments with respect to our or others’ intellectual property rights; • our ability to develop, obtain regulatory clearance or approval for, and market new and enhanced products on a timely basis; • product liability claims or other litigation; • quarterly or annual variations in our results of operations or those of others in our industry; • media exposure of our products or of those of others in our industry; • changes in governmental regulations or in the status of our regulatory approvals or applications; • changes in earnings estimates or recommendations by securities analysts; and • the effects of high inflation or other general market conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors.
The market price of our common stock has been volatile and may fluctuate substantially in the future due to many factors, including: • volume and customer mix for our products; • the introduction of new products or product enhancements by us or others in our industry; • disputes or other developments with respect to our or others’ intellectual property rights; • our ability to develop, obtain regulatory clearance or approval for, and market new and enhanced products on a timely basis; • product liability claims or other litigation; • quarterly or annual variations in our results of operations or those of others in our industry; • media exposure of our products or of those of others in our industry; • changes in governmental regulations or in the status of our regulatory approvals or applications; • changes in earnings estimates or recommendations by securities analysts; and • the effects of high inflation or other general market conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors.
Furthermore, biopharmaceutical companies may decline to do business with us or decrease or discontinue their use of our tests 29 due to their broad strategic collaboration with any of our competitors.
Furthermore, biopharmaceutical companies may decline to do business with us or decrease or discontinue their use of our tests due to their broad strategic collaboration with any of our competitors.
If our products do not meet the expectations of patients and our customers, our operating results, reputation and business could suffer. Our success depends on the market’s confidence that we can provide reliable, high-quality precision oncology products that will improve clinical outcomes, lower healthcare costs and enable better biopharmaceutical development.
If our products do not meet the expectations of patients and our customers, our operating results, reputation and business could suffer. Our success depends on the market’s confidence that we can provide reliable, high-quality products that will improve clinical outcomes, lower healthcare costs and enable better biopharmaceutical development.
However, if we are unable to generate additional or compatible data and insights, then we may not be able to advance our products under development as quickly, or at all, or without significant additional investment. In addition, we recently migrated some of our existing products to our Smart Liquid Biopsy platform.
However, if we are unable to generate additional or compatible data and insights, then we may not be able to advance our products under development as quickly, or at all, or without significant additional investment. In addition, we recently migrated some of our existing products to our Smart Platform.
If so, in addition to the possibility of fines, lawsuits, regulatory investigations, public censure, other claims and penalties, and significant costs for remediation and damage to our reputation, we could be materially and adversely affected if legislation or regulations are expanded to require changes in our data processing practices and policies or if governing jurisdictions interpret or implement their legislation or regulations in ways that negatively impact our business, financial condition and results of operations.
If so, in addition to the possibility of fines, lawsuits, regulatory investigations, public censure, other claims and penalties, and significant costs for remediation and damage to our reputation, we could be materially and adversely affected if legislation or regulations are expanded to require 54 Table of Contents changes in our data processing practices and policies or if governing jurisdictions interpret or implement their legislation or regulations in ways that negatively impact our business, financial condition and results of operations.
We have provided testing services to patients with many cancer types and indications, some of the time as a non-participating provider through 2024. When we have received payment as a non-participating provider, the amounts, on average, were significantly lower than for participating providers.
We have provided testing services to patients with many cancer types and indications, some of the time as a non-participating provider through 2025. When we have received payment as a non-participating provider, the amounts, on average, were significantly lower than for participating providers.
In March 2022, Palmetto GBA established coverage for our Guardant360 TissueNext test under an existing LCD. The coverage, which is also applicable to Noridian, covers our Guardant360 TissueNext test for Medicare fee-for-service patients with advanced solid tumor cancers.
In March 2022, Palmetto GBA established coverage for our Guardant360 Tissue test under an existing LCD. The coverage, which is also applicable to Noridian, covers our Guardant360 Tissue test for Medicare fee-for-service patients with advanced solid tumor cancers.
Among other things, pursuant to the FDCA and its implementing regulations, the FDA regulates the research, design, testing, manufacturing, safety, labeling, storage, recordkeeping, premarket clearance or approval, marketing and promotion and sales and distribution of medical devices in the United States to ensure that medical devices distributed domestically are safe and effective for their intended uses.
Among other things, pursuant to the FDCA and its implementing regulations, the FDA regulates the research, design, testing, manufacturing, safety, labeling, storage, 35 Table of Contents recordkeeping, premarket clearance or approval, marketing and promotion and sales and distribution of medical devices in the United States to ensure that medical devices distributed domestically are safe and effective for their intended uses.
The 2027 Notes and the 2031 Notes may become in the future convertible at the option of the holders thereof prior to August 15, 2027 and November 15, 2030, respectively, under certain circumstances as provided in the respective indentures.
The 2027 Notes, the 2031 Notes and the 2033 Notes may become in the future convertible at the option of the holders thereof prior to August 15, 2027, November 15, 2030 and February 15, 2033, respectively, under certain circumstances as provided in the respective indentures.
Because the interpretation and application of laws, regulations, standards and other obligations relating to data privacy and security are still uncertain, it is possible that these laws, regulations, standards and other 54 Table of Contents obligations may be interpreted and applied in a manner that is inconsistent with our data processing practices and policies or the features of our products.
Because the interpretation and application of laws, regulations, standards and other obligations relating to data privacy and security are still uncertain, it is possible that these laws, regulations, standards and other obligations may be interpreted and applied in a manner that is inconsistent with our data processing practices and policies or the features of our products.
Medicare’s National Coverage Determination, or NCD, for Next Generation Sequencing, or NGS, first established in 2018 and subsequently updated in 2020 states that NGS tests, such as our Guardant360 test, are covered by Medicare nationally, when: (1) performed in a CLIA-certified laboratory, (2) ordered by a treating physician, (3) the patient meets certain clinical and treatment criteria, including having recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer, (4) the test is approved or cleared by the FDA as a companion in vitro diagnostic for an FDA approved or cleared indication for use in that patient’s cancer, and (5) results are provided to the treating physician for management of the patient using a report template to specify treatment options.
Medicare’s National Coverage Determination, or NCD, for Next Generation Sequencing, or NGS, states that NGS tests, such as our Guardant360 test, are covered by Medicare nationally, when: (1) performed in a CLIA-certified laboratory, (2) ordered by a treating physician, (3) the patient meets certain clinical and treatment criteria, including having recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer, (4) the test is approved or cleared by the FDA as a companion in vitro diagnostic for an FDA approved or cleared indication for use in that patient’s cancer, and (5) results are provided to the treating physician for management of the patient using a report template to specify treatment options.
To the extent that more competitors enter our markets, the availability of coverage and the reimbursement rate for our tests may decrease as we encounter pricing pressure from our competitors. Each payer makes its own decision as to whether to provide coverage for our tests, whether to enter into a contract with us and the reimbursement rate for a test.
To the extent that more competitors enter our markets, the availability of coverage and the reimbursement rate for our tests may decrease as we encounter pricing pressure from our competitors. 38 Table of Contents Each payer makes its own decision as to whether to provide coverage for our tests, whether to enter into a contract with us and the reimbursement rate for a test.
We will need additional certified laboratory scientists and other scientific and technical personnel to process higher volumes of our precision oncology products. Portions of our process are not automated and will require additional personnel to scale.
We will need additional certified laboratory scientists and other scientific and technical personnel to process higher volumes of our products. Portions of our process are not automated and will require additional personnel to scale.
We will need to generate substantial revenue to achieve and then sustain profitability, and even if we achieve profitability, we cannot be sure that we will remain profitable for any period of time. Our failure to achieve or maintain profitability could negatively impact the value of our common stock.
We will need to generate substantial revenue to achieve and then sustain profitability, and even if we achieve profitability, we cannot be sure that we will remain profitable for any period of time. Our failure to achieve or maintain profitability could negatively impact the trading price of our common stock.
In the years ended December 31, 2024, 2023 and 2022, revenue from our top five biopharmaceutical customers, including their affiliated entities, accounted for 13%, 14% and 18% of our total revenue, respectively. The revenue attributable to our biopharmaceutical customers may also fluctuate in the future, which could have an adverse effect on our financial condition and results of operations.
In the years ended December 31, 2025, 2024 and 2023, revenue from our top five biopharmaceutical customers, including their affiliated entities, accounted for 11%, 13% and 14% of our total revenue, respectively. The revenue attributable to our biopharmaceutical customers may also fluctuate in the future, which could have an adverse effect on our financial condition and results of operations.
We market some of our tests, Guardant360, Guardant360 Response, Guardant360 Tissue Next, Guardant Reveal and Shield, as LDTs. LDTs are in vitro diagnostic tests that are intended for clinical use and are designed, manufactured, and used within a single laboratory.
We market some of our tests, Guardant360 Liquid, Guardant360 Tissue, Guardant Reveal and Shield, as LDTs. LDTs are in vitro diagnostic tests that are intended for clinical use and are designed, manufactured, and used within a single laboratory.
In addition, some countries have stricter consumer notice and/or consent requirements relating to personal data collection, use or sharing, more stringent 53 Table of Contents requirements relating to organizations’ privacy programs and provide stronger individual rights. Moreover, international privacy and data security regulations may become more complex and have greater consequences.
In addition, some countries have stricter consumer notice and/or consent requirements relating to personal data collection, use or sharing, more stringent requirements relating to organizations’ privacy programs and provide stronger individual rights. Moreover, international privacy and data security regulations may become more complex and have greater consequences.
As a result of adverse geopolitical and macroeconomic developments, including economic inflation and the responses by central banking authorities to control such inflation, the global credit and financial markets have experienced extreme volatility and disruptions and there has been increasing uncertainty about economic stability.
As a result of adverse geopolitical and macroeconomic developments, including tariffs and other trade actions and economic inflation and the responses by central banking authorities to control such inflation, the global credit and financial markets have experienced extreme volatility and disruptions and there has been increasing uncertainty about economic stability.
Similar laws have passed in Virginia, Colorado, Connecticut, and Utah and have been proposed in other states and at the federal level, reflecting a trend toward more stringent privacy legislation in the United States. These laws and regulations are not necessarily preempted by HIPAA, particularly if a state affords greater protection to individuals than HIPAA.
Similar laws have passed or been proposed in other states and at the federal level, reflecting a trend toward more stringent privacy legislation in the United States. These laws and regulations are not necessarily preempted by HIPAA, particularly if a state affords greater protection to individuals than HIPAA.
In addition, Natera, Inc., Tempus AI, Inc., Exact Sciences Corp., Myriad Genetics, Inc., Caris Life Science, Foundation Medicine, Inc. and Quest Diagnostics, Inc., among others, are our competitors in minimal residual disease detection. Additionally, our competitors in the early screening testing space include GRAIL, Inc., Exact Sciences Corp., Freenome Holdings, Inc., and Delfi Diagnostics.
In addition, Natera, Inc., Tempus AI, Inc., Exact Sciences Corporation, Myriad Genetics, Inc., Caris Life Sciences, Inc., Foundation Medicine, Inc., BillionToOne, Inc., Personalis, Inc. and Quest Diagnostics, Inc., among others, are our competitors in minimal residual disease detection. Additionally, our competitors in the early screening testing space include GRAIL, Inc., Exact Sciences Corporation, Freenome Holdings, Inc., and Delfi Diagnostics.
Even though the FDA has since resumed standard inspection operations of domestic facilities where feasible, the FDA has continued to monitor and implement changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as it adapts to the evolving COVID-19 pandemic, and any resurgence of the virus or emergence of new variants may lead to further inspectional delays.
Even though the FDA has since resumed standard inspection operations of domestic facilities where feasible, the FDA has continued to monitor and implement changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates, and any resurgence of the virus or emergence of new variants may lead to further inspectional delays.
Our ability to execute our growth strategy and become profitable is highly dependent on the continued adoption and use of our tests, which accounted for 93%, 91% and 87% of our revenue in the years ended December 31, 2024, 2023 and 2022, respectively.
Our ability to execute our growth strategy and become profitable is highly dependent on the continued adoption and use of our tests, which accounted for 94%, 94% and 91% of our revenue in the years ended December 31, 2025, 2024 and 2023, respectively.
This coverage also applies to Noridian. 40 Table of Contents Under Medicare, payment for laboratory tests like ours is generally made under the Clinical Laboratory Fee Schedule, or CLFS, with payment amounts assigned to specific procedure billing codes.
This coverage, which also applies to Noridian, has an effective date of December 2021. 40 Table of Contents Under Medicare, payment for laboratory tests like ours is generally made under the Clinical Laboratory Fee Schedule, or CLFS, with payment amounts assigned to specific procedure billing codes.
In connection with the sale of the 2027 Notes, we entered into convertible note hedge, the 2027 Note Hedge, transactions with certain financial institutions, or option counterparties, certain of which are expected to be cancelled in connection with the Note Exchange.
In connection with the sale of the 2027 Notes, we entered into convertible note hedge, or the 2027 Note Hedge, transactions with certain financial institutions, or option counterparties, certain of which were cancelled in connection with the Note Exchange.
Further, the California Privacy Rights Act, or CPRA, generally went into effect in January 2023, and imposes additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data.
Further, the California Privacy Rights Act, or CPRA, imposes additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data.
States are also constantly amending existing laws, and creating new data privacy and security laws, requiring attention to frequently changing regulatory requirements. For example, the California Consumer Privacy Act, or CCPA went into effect on January 1, 2020, and creates certain data privacy rights for California residents.
States are also constantly amending existing laws, and creating new data privacy and security laws, requiring attention to frequently changing regulatory requirements. For example, the California Consumer Privacy Act, or CCPA, creates certain data privacy rights for California residents.
We carry insurance for damage to our property and disruption of our business, but this insurance may not cover all of the risks associated with damage or disruption to our facility and business, may not provide coverage in amounts sufficient to cover our potential losses and may not continue to be available to us on acceptable terms, if at all. 33 We are dependent on third parties for the collection of blood samples for our tests.
We carry insurance for damage to our property and disruption of our business, but this insurance may not cover all of the risks associated with damage or disruption to our facility and business, may not provide coverage in amounts sufficient to cover our potential losses and may not continue to be available to us on acceptable terms, if at all.
Our future growth could create strain on our organizational, administrative and operational infrastructure, including laboratory operations, quality control, customer service and sales organization management. We expect to continue to increase headcount and to hire more specialized personnel as we grow our business.
Since our inception, we have experienced rapid growth and anticipate further growth in our business operations. Our future growth could create strain on our organizational, administrative and operational infrastructure, including laboratory operations, quality control, customer service and sales organization management. We expect to continue to increase headcount and to hire more specialized personnel as we grow our business.
In July 2022, Palmetto GBA established coverage under an existing LCD for our Guardant Reveal test for fee-for-service Medicare patients in the United States with stage II or III colorectal cancer whose testing is initiated within three months following curative intent therapy. This coverage, which also applies to Noridian, has an effective date of December 2021.
In July 2022, Palmetto GBA established coverage under an existing LCD for our Guardant Reveal test for fee-for-service Medicare patients in the United States with stage II or III colorectal cancer whose testing is initiated within three months following curative intent therapy.
In the EU, notified bodies must be officially designated to certify products and services in accordance with the IVDR. Only a few notified bodies have been designated to date. Without IVDR designation, notified bodies may not yet start certifying devices in accordance with the new Regulation.
In the EU, notified bodies must be officially designated to certify products and services in accordance with the IVDR. Without IVDR designation, notified bodies may not yet start certifying devices in accordance with the new regulation. As only a few notified bodies have been IVDR-designated to date, they are facing a heavy workload and their review times have lengthened.
CMS adopted an exception to its laboratory date of service regulation, and if certain conditions are met, molecular pathology testing laboratories such as us can rely on that exception to bill Medicare directly, instead of seeking payment from the hospital.
In addition, pursuant to CMS regulations, we cannot bill Medicare directly for tests provided for Medicare beneficiaries in some situations. CMS adopted an exception to its laboratory date of service regulation, and if certain conditions are met, molecular pathology testing laboratories such as us can rely on that exception to bill Medicare directly, instead of seeking payment from the hospital.
We rely on third-party phlebotomy providers, including physician offices, to collect blood samples for our tests.
We are dependent on third parties for the collection of blood samples for our tests. We rely on third-party phlebotomy providers, including physician offices, to collect blood samples for our tests.
Our industry is characterized by rapid changes, including technological and scientific breakthroughs, frequent new product introductions and enhancements and evolving industry standards, all of which could make our current and future products obsolete.
The precision oncology industry is subject to rapid change, which could make our current products and any future products we may develop, obsolete. Our industry is characterized by rapid changes, including technological and scientific breakthroughs, frequent new product introductions and enhancements and evolving industry standards, all of which could make our current and future products obsolete.
We believe that there are only a limited number of other manufacturers that are capable of supplying and servicing the equipment and materials necessary for our laboratory operations, including sequencers and various associated reagents, and potentially replacing our current suppliers. The use of equipment or materials furnished by these replacement suppliers would require us to alter our laboratory operations.
We believe that there are only a limited number of other manufacturers that are capable of supplying and servicing the equipment, software, and materials necessary for our laboratory operations, including sequencers and various associated reagents, and potentially replacing our current suppliers.
Transitioning to a new supplier would be time-consuming and expensive, may result in interruptions in our laboratory operations, could affect the performance specifications of our laboratory operations or could require that we revalidate our tests.
The use of equipment , software, or materials furnished by these replacement suppliers would require us to alter our laboratory operations. Transitioning to a new supplier would be time-consuming and expensive, may result in interruptions in our laboratory operations, could affect the performance specifications of our laboratory operations or could require that we revalidate our tests.
If the actual number of patients who would benefit from our products, the price at which we can sell our products, or the annual total addressable market for our products is smaller than we have estimated, it may impair our sales growth and have an adverse impact on our business. 31 The precision oncology industry is subject to rapid change, which could make our current products and any future products we may develop, obsolete.
If the actual number of patients who would benefit from our products, the price at which we can sell our products, or the annual total addressable market for our products is smaller than we have estimated, it may impair our sales growth and have an adverse impact on our business.
Our revenue and commercial success depend on achieving coverage and reimbursement for our tests from payers, including both commercial and government payers. If payers do not provide coverage of, or do not provide adequate reimbursement for our tests, we may need to seek payment from the patient, which may adversely affect demand for our tests.
If payers do not provide coverage of, or do not provide adequate reimbursement for our tests, we may need to seek payment from the patient, which may adversely affect demand for our tests.
In February 2025, we issued $600 million aggregate principal amount of 1.25% convertible senior notes due 2031, or the 2031 Notes (together with the 2027 Notes, the Notes) in exchange for the retirement of approximately $659.3 million aggregate principal amount of the 2027 Notes, or the Note Exchange. We may also incur additional indebtedness to meet future needs.
In February 2025, we issued $600 million aggregate principal amount of 1.25% convertible senior notes due 2031, or the 2031 Notes in exchange for the retirement of approximately $659.3 million aggregate principal amount of the 2027 Notes, or the Note Exchange.
We may not develop additional proprietary products, services, methods and technologies that are patentable. Assuming that other requirements for patentability are met, prior to March 16, 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent.
We may not develop additional proprietary products, services, methods and technologies that are patentable. Assuming that other requirements for patentability are met, in the United States, the first inventor to file a patent application is entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention.
A third party that files a patent application in the USPTO on or after March 16, 2013, but before us could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party.
A third party that files a patent application in the USPTO before us could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party. This requires us to be cognizant of the time from invention to filing of a patent application.
As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future. Our indebtedness could expose us to risks that could adversely affect our business, financial condition and results of operations. In 2020, we sold $1,150,000,000 aggregate principal amount of 0% convertible senior notes due 2027, or the 2027 Notes.
As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future. Our indebtedness could expose us to risks that could adversely affect our business, financial condition and results of operations.
For instance, in the EU, we must inform the notified body that carried out the conformity assessment of the devices that we market or sell in the EU and EEA of any planned substantial changes to our quality system or substantial changes to our in vitro diagnostic medical devices that could affect compliance with the essential requirements or cause a substantial change to the intended use for which the device has been CE marked. 38 Table of Contents If third-party payers, including commercial payers and government healthcare programs, do not provide coverage of, or adequate reimbursement for, our tests, our business and results of operations will be negatively affected.
For instance, in the EU, we must inform the notified body that carried out the conformity assessment of the devices that we market or sell in the EU and EEA of any planned substantial changes to our quality system or substantial changes to our in vitro diagnostic medical devices that could affect compliance with the essential requirements or cause a substantial change to the intended use for which the device has been CE marked.
For instance, the General Data Protection Regulation, or GDPR, went into effect in May 2018 and imposes stringent data protection requirements for the processing of personal data of persons within the EEA.
For 53 Table of Contents instance, the General Data Protection Regulation, or GDPR, imposes stringent data protection requirements for the processing of personal data of persons within the EEA.
Currently, our main competition is from diagnostic companies with products and services to profile genes in cancers based on either single-marker or comprehensive genomic profile testing, based on next-generation sequencing in either blood or tissue.
Currently, our main competition is from diagnostic companies with products and services to profile genes in cancers based on either single-marker or comprehensive genomic profile testing, based on next-generation sequencing in either blood or tissue. This may change over the next few years as a result of new competitors entering through investment and acquisition activity.
If we do not update our product offerings to reflect new scientific knowledge about cancer biology, information about new cancer therapies or relevant clinical studies, our products could become obsolete and sales of our current products and any new products we may develop could decline or fail to grow as expected.
If we do not update our product offerings to reflect new scientific knowledge about cancer biology, information about new cancer therapies or relevant clinical studies, our products could become obsolete and sales of our current products and any new products we may develop could decline or fail to grow as expected. 31 If we continue to experience challenges attracting and retaining qualified personnel due to competitive labor markets, we may be unable to manage our future growth effectively, all of which could make it difficult to execute our business strategy.
We maintain cyber liability insurance; however, this insurance may not be sufficient to cover the financial, legal, business or reputational losses that may result from an interruption or breach of our systems. 72 Table of Contents Item 1B. Unresolved Staff Comments None.
We maintain cyber liability insurance; however, this insurance may not be sufficient to cover the financial, legal, business or reputational losses that may result from an interruption or breach of our systems. Our increasing usage of artificial intelligence technologies may expose us to operational, regulatory, legal, and reputational risks.
This may change over the next few years as a result of new competitors entering through investment and acquisition activity. 30 Our competitors within the liquid biopsy space for therapy selection include Foundation Medicine, Inc., which was acquired by Roche Holdings, Inc. in 2018; Caris Life Science; Tempus AI, Inc.; NeoGenomics Laboratories, Inc.; Exact Sciences Corp.; Myriad Genetics, Inc.; and Laboratory Corporation of America.
Our competitors within the liquid biopsy space for therapy selection include Foundation Medicine, Inc., which was acquired by Roche Holdings, Inc. in 2018; Caris Life Sciences, Inc.; Tempus AI, Inc.; NeoGenomics, Inc.; Exact Sciences Corporation; BillionToOne, Inc.; Quest Diagnostics, Inc.; and Laboratory Corporation of America.
Locating, qualifying, engaging and maintaining relationships with distribution partners and hospitals with local industry experience and knowledge will be necessary to effectively market and sell our products outside the United States. We may not be successful in finding, attracting and retaining distribution partners or local hospitals, or we may not be able to enter into such arrangements on favorable terms.
In other territories, such as Europe, we sell our tests primarily through distributor relationships or direct contracts with hospitals. Locating, qualifying, engaging and maintaining relationships with distribution partners and hospitals with local industry experience and knowledge will be necessary to effectively market and sell our products outside the United States.
Our expected future growth will impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate additional employees.
Our expected future growth will impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate additional employees. Our future financial performance and our ability to commercialize our products, to increase our sales and to compete effectively will depend, in part, on our ability to manage this potential future growth effectively, without compromising quality.
Modifications to our FDA-cleared or approved products may require new 510(k) clearances or premarket approvals, or may require us to cease marketing or recall the modified products until clearances are obtained.
Any significant changes to the regulation of companion diagnostics could have a material adverse effect on our business, financial condition, and results of operations. Modifications to our FDA-cleared or approved products may require new 510(k) clearances or premarket approvals, or may require us to cease marketing or recall the modified products until clearances are obtained.
In September 2018, we began to receive reimbursement from Medicare for claims submitted with respect to our precision oncology tests. Precision oncology revenue from clinical tests for patients covered and administered by Medicare represented approximately 39%, 43% and 45% of our precision oncology revenue from clinical customers for the years ended December 31, 2024, 2023 and 2022, respectively.
In September 2018, we began to receive reimbursement from Medicare for claims submitted with respect to our tests. Revenue attributable to Medicare accounted for more than 10% of our total revenue in each of the years ended December 31, 2025, 2024 and 2023.
Effective January 1, 2024, Medicare has increased the reimbursement rate for our Guardant360 LDT test to the same rate as our Guardant360 CDx test.
In July 2022, a CPT PLA code was issued for Guardant360 Tissue with an effective date in October 2022. Effective January 1, 2024, Medicare has increased the reimbursement rate for our Guardant360 Liquid test to the same rate as our Guardant360 CDx test.
For the years ended December 31, 2024, 2023 and 2022, we incurred net losses of $436.4 million, $479.4 million and $654.6 million, respectively. As of December 31, 2024, we had an accumulated deficit of $2.6 billion.
For the years ended December 31, 2025, 2024 and 2023, we incurred net losses of $416.3 million, $436.4 million and $479.4 million, respectively. As of December 31, 2025, we had an accumulated deficit of $3.0 billion. To date, we have financed our operations principally from the sale of stock or convertible securities, and generation of our revenue.
In order to sell our products in member states of the EU, our products must comply with the essential requirements of the new In Vitro Diagnostic Regulation (IVDR) 2017/746 issued and implemented by the European Union (EU) in May 2022.
In order to sell our products in member states of the EU, our products must comply with the essential requirements of the new In Vitro Diagnostic Regulation (IVDR) 2017/746 issued and implemented by the European Union (EU) in May 2022. 36 Table of Contents These regulations introduced risk-based classification for IVDs and require notified body involvement for various high complexity devices including next generation sequencing tests such as Guardant360 Liquid, Guardant360 Tissue, and Guardant Reveal.
As only a few notified bodies has been IVDR-designated they are facing a heavy workload and their review times have lengthened. This situation could impact the way we are conducting or intend to conduct our business in the EU and the EEA.
This situation could impact the way we are conducting or intend to conduct our business in the EU and the EEA.
If the sales and marketing efforts for our products in those regions are not successful, our business would be materially and adversely affected. In other territories, such as Europe, we sell our tests primarily through distributor relationships or direct contracts with hospitals.
Outside the United States, we established Guardant AMEA for sales of our products throughout Asia, the Middle East and Africa. If the sales and marketing efforts for our products in those regions are not successful, our business would be materially and adversely affected.
Removed
To date, we have financed our operations principally from the sale of stock or convertible securities, and revenue from precision oncology testing, and development services and other.
Added
For example, recent merger and acquisition activity includes both completed and potential transactions with new and larger participants, some with greater resources than our legacy competitors.
Removed
Revenue attributable to Medicare accounted for more than 10% of our total revenue in each of the years ended December 31, 2024, 2023 and 2022. In addition, pursuant to CMS regulations, we cannot bill Medicare directly for tests provided for Medicare beneficiaries in some situations.
Added
We may not be successful in finding, attracting and retaining distribution partners or local hospitals, or we may not be able to enter into such arrangements on favorable terms.
Removed
If we continue to experience challenges attracting and retaining qualified personnel due to competitive labor markets, we may be unable to manage our future growth effectively, all of which could make it difficult to execute our business strategy. Since our inception, we have experienced rapid growth and anticipate further growth in our business operations.

… 28 more changes not shown on this page.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

1 edited+0 added−0 removed16 unchanged
Biggest changeHowever, we and our customers have 73 Table of Contents experienced cybersecurity incidents and routinely face risks of cybersecurity incidents, wholly or partially beyond our control, as we rely heavily on our information technology systems. While we devote resources to our security measures to protect our systems and information, these measures cannot provide absolute security. See Part I, Item 1A.
Biggest changeHowever, we and our customers have 74 Table of Contents experienced cybersecurity incidents and routinely face risks of cybersecurity incidents, wholly or partially beyond our control, as we rely heavily on our information technology systems. While we devote resources to our security measures to protect our systems and information, these measures cannot provide absolute security. See Part I, Item 1A.

Item 2. Properties

Properties — owned and leased real estate

1 edited+0 added−1 removed1 unchanged
Biggest changeIn addition, we have approximately 200,000 square feet of additional office and lab space in Redwood City and San Diego, California, with current lease expiration dates ranging from 2025 to 2029. We also maintain domestic leased office spaces in Dallas and Spring, Texas; Seattle, Washington; Long Island City, New York; and Washington, D.C.; and warehouse space in Union City, California.
Biggest changeIn addition, we have approximately 205,000 square feet of additional office and lab space in Redwood City and San Diego, California, and Long Island City, New York, with current lease expiration dates ranging from 2028 to 2031. We also maintain several additional domestic leased office and warehouse spaces and international leased office spaces.
Removed
In addition, for international locations, we maintain leased office space in Japan, Singapore and India. While we believe our existing facilities are adequate to meet our current requirements, we expect to expand our facilities as our operations grow over time. We believe we will be able to obtain such additional space on acceptable and commercially reasonable terms.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

1 edited+0 added−0 removed1 unchanged
Biggest changeThe resolution of any such legal proceeding is subject to inherent uncertainty and could have a material adverse effect on our financial condition, cash flows or results of operations.
Biggest changeThe resolution of any such legal proceeding is subject to inherent uncertainty and could have a material adverse effect on our financial condition, cash flows or results of operations. Item 4. Mine Safety Disclosures. Not applicable. PART II

Item 7. Management's Discussion & Analysis

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

97 edited+38 added−42 removed69 unchanged
Biggest changeFinancing activities Cash used in financing activities during the year ended December 31, 2024 was $1.0 million, which was primarily attributable to employee taxes paid related to settlement of restricted stock units of $15.7 million, partially offset by proceeds from issuances of common stock under our employee stock purchase plan of $11.7 million and proceeds from exercise of stock options of $3.1 million.
Biggest changeFinancing activities Cash provided by financing activities during the year ended December 31, 2025 was $671.1 million, which was primarily attributable to proceeds from issuance of convertible senior notes of $402.5 million, proceeds from equity offering of $257.1 million, proceeds from treasury stock reissuance upon equity offering of $87.9 million, proceeds from exercise of stock options of $19.2 million, and proceeds from issuances of common stock under our employee stock purchase plan of $13.6 million; partially offset by repurchase of treasury stock of $45.0 million, employee taxes paid related to net share settlement of restricted stock units of $30.5 million, payment of debt issuance costs of $24.6 million, and payment of equity offering costs of $17.7 million. 89 Table of Contents Cash used in financing activities during the year ended December 31, 2024 was $1.0 million, which was primarily attributable to employee taxes paid related to net share settlement of restricted stock units of $15.7 million, partially offset by proceeds from issuances of common stock under our employee stock purchase plan of $11.7 million and proceeds from exercise of stock options of $3.1 million.
Investing activities Cash used in investing activities during the year ended December 31, 2024 was $261.3 million, which resulted primarily from purchases of marketable debt securities of $307.3 million, purchases of property and equipment of $35.1 million, and purchases of non-marketable equity security investments of $7.5 million; partially offset by sales of marketable equity security investment in Lunit, Inc. of $53.6 million and maturities of marketable debt securities of $35.0 million.
Cash used in investing activities during the year ended December 31, 2024 was $261.3 million, which resulted primarily from purchases of marketable debt securities of $307.3 million, purchases of property and equipment of $35.1 million, and purchases of non-marketable equity security investments of $7.5 million; partially offset by sales of marketable equity security investment in Lunit, Inc. of $53.6 million and maturities of marketable debt securities of $35.0 million.
We analyze actual cash collections over the expected reimbursement period and compare it with the estimated variable consideration for each portfolio and any difference is recognized as an adjustment to estimated revenue after the expected reimbursement period, subject to assessment of the risk of cumulative future revenue reversal.
We analyze the actual cash collections over the expected reimbursement period and compare it with the estimated variable consideration for each portfolio and any difference is recognized as an adjustment to estimated revenue, subject to assessment of the risk of cumulative future revenue reversal.
With the exception of certain limited contracted arrangements with insurance carriers and other institutions where the transaction price is fixed, a stated contract price does not exist and the transaction price for each implied contract with our clinical customers represents variable consideration.
With the exception of certain limited contracted arrangements with insurance carriers and other institutions where the transaction price is fixed, a stated contract price does not exist and the transaction price for each implied contract with clinical customers represents variable consideration.
Food and Drug Administration, or the FDA, to provide tumor mutation profiling with solid tumors and to be used as a companion diagnostic in connection with non-small cell lung cancer, or NSCLC, and breast cancer.
Food and Drug Administration, or the FDA, to provide tumor mutation profiling with solid tumors and to be used as a companion diagnostic in connection with non-small cell lung cancer, or NSCLC, colorectal cancer and breast cancer.
Payments made prior to the receipt of goods or services to be used in research and development are deferred and recognized as expense in the period in which the related goods are received or services are rendered.
Payments made prior to the receipt of goods or services to be used in research and development are deferred and recognized as an expense in the period in which the related goods are received or services are rendered.
A component of our long-term growth strategy is to expand our commercial footprint internationally, and we expect to increase our sales and marketing expense to execute on this strategy. We currently offer our tests in countries outside the United States primarily through distributor relationships, direct contracts with hospitals, and partnerships with local research organizations and laboratory companies.
A component of our long-term growth strategy is to expand our commercial footprint internationally, and we expect to increase our sales and marketing expense to execute on this strategy. We currently offer our oncology and screening tests in countries outside the United States primarily through distributor relationships, direct contracts with hospitals, and partnerships with local research organizations and laboratory companies.
Factors that could cause or contribute to such differences include, but are not limited to, those discussed in Part I, Item 1A, “Risk Factors,” of this Annual Report on Form 10-K. The following generally compares our results of operations for the years ended December 31, 2024 and 2023.
Factors that could cause or contribute to such differences include, but are not limited to, those discussed in Part I, Item 1A, “Risk Factors,” of this Annual Report on Form 10-K. The following generally compares our results of operations for the years ended December 31, 2025 and 2024.
Due to the inherent variability and unpredictability of the reimbursement landscape, including related to the amount that payers reimburse us for any of our tests, we estimate the amount of revenue to be recognized at the time a test is provided and record revenue adjustments if and when the cash subsequently received differs from the revenue recorded.
Due to the inherent variability and unpredictability of the reimbursement landscape, including related to the amount that payers reimburse us for any of our tests, we estimate the amount of our oncology and screening revenue to be recognized at the time a test is provided and record revenue adjustments if and when the cash subsequently received differs from the revenue recorded.
Effective January 1, 2024, Medicare has increased the reimbursement rate for our Guardant360 LDT test to the same rate as our Guardant360 CDx test. In January 2025, Palmetto GBA granted coverage for our Guardant Reveal test to monitor disease recurrence in patients with colorectal cancer in the surveillance setting following curative intent therapy.
Effective January 1, 2024, Medicare has increased the reimbursement rate for our Guardant360 Liquid test to the same rate as our Guardant360 CDx test. In January 2025, Palmetto GBA granted coverage for our Guardant Reveal test to monitor disease recurrence in patients with colorectal cancer in the surveillance setting following curative intent therapy.
A detailed discussion comparing our results of operations for the years ended December 31, 2023 and 2022 can be found in Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our Annual Report on Form 10-K for the year ended December 31, 2023.
A detailed discussion comparing our results of operations for the years ended December 31, 2024 and 2023 can be found in Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our Annual Report on Form 10-K for the year ended December 31, 2024.
Precision oncology tests to biopharmaceutical customers are generally billed at a fixed price for each test performed. For agreements involving testing volume to be satisfied over a defined period, revenue is recognized over time based on the number of tests performed as the performance obligation is satisfied over time.
Tests for biopharmaceutical customers are generally billed at a fixed price for each test performed. For agreements involving testing volume to be satisfied over a defined period, revenue is recognized over time based on the number of tests performed as the performance obligation is satisfied over time.
In assessing whether a promised service is capable of being distinct, we consider whether the customer could benefit from the service either on its own or together with other resources that are readily available to the customer, including factors such as the research, development, and commercialization capabilities of a third party as well as the availability of the associated expertise in the general 89 Table of Contents marketplace.
In assessing whether a promised service is capable of being distinct, we consider whether the customer could benefit from the service either on its own or together with other resources that are readily available to the customer, including factors such as the research, development, and commercialization capabilities of a third party as well as the availability of the associated expertise in the general marketplace.
The increase in reimbursement for our tests for the year ended December 31, 2024 was primarily attributable to an increase in Medicare reimbursement for our Guardant360 LDT test to $5,000, effective January 1, 2024; and increases in Medicare Advantage and commercial payer reimbursement.
The increase in reimbursement for our tests for the year ended December 31, 2024 was primarily attributable to an increase in Medicare reimbursement for our Guardant360 Liquid test to $5,000, effective January 1, 2024; and increases in Medicare Advantage and commercial payer reimbursement.
In July 77 Table of Contents 2022, Palmetto GBA conveyed coverage for our Guardant Reveal test for fee-for-service Medicare patients in the United States with stage II or III colorectal cancer whose testing is initiated within three months following curative intent therapy, with an effective date of December 2021.
In July 2022, Palmetto GBA conveyed coverage for our Guardant Reveal test for fee-for-service Medicare patients in the United States with stage II or III colorectal cancer whose testing is initiated within three months following curative intent therapy, with an effective date of December 2021.
Our financial results might fluctuate significantly based upon the impact of our other operating expense, and in particular, our legal settlement costs, which could potentially decrease or increase significantly. While each of these areas presents significant opportunities for us, they also pose significant risks and challenges that we must address.
Our financial results might fluctuate significantly based upon the impact of our other operating expense, and in particular, our legal reserves, which could potentially decrease or increase significantly. While each of these areas presents significant opportunities for us, they also pose significant risks and challenges that we must address.
Using data collected from our tests, we have also developed our GuardantINFORM platform to help biopharmaceutical companies accelerate precision oncology drug development through the use of this in-silico research platform to unlock further insights into tumor evolution and treatment resistance across various biomarker-driven cancers.
Using data collected from our tests and through AI-enabled analytical tools, we have also developed our GuardantINFORM platform to help biopharmaceutical companies accelerate precision oncology drug development through the use of this in-silico research platform to unlock further insights into tumor evolution and treatment resistance across various biomarker-driven cancers.
We have expended considerable resources, and expect to increase such expenditures over the next few years, to support our research and development programs with the goal of fueling further innovation. 78 Table of Contents • International expansion.
We have expended considerable resources, and expect to increase such expenditures over the next few years, to support our research and development programs with the goal of fueling further innovation. • International expansion.
The provision for income taxes includes the effects of any accruals that we believe are appropriate, as well as the related net interest and penalties. 81 Table of Contents Results of operations The following tables set forth the significant components of our results of operations for the periods presented.
The provision for (benefit from) income taxes includes the effects of any accruals that we believe are appropriate, as well as the related net interest and penalties. 83 Table of Contents Results of operations The following tables set forth the significant components of our results of operations for the periods presented.
We expect that our research and development expenses will continue to increase in absolute dollars as we continue to innovate and develop additional products, expand our genomic and medical data management resources and conduct our ongoing and new clinical studies. 80 Table of Contents Sales and marketing expense.
We expect that our research and development expenses will continue to increase in absolute dollars as we continue to innovate and develop additional products, expand our genomic and medical data management resources and conduct our ongoing and new clinical studies. Sales and marketing expense.
The policy covers our Guardant360 TissueNext test for Medicare fee-for-service patients with advanced solid tumor cancers.
The policy covers our Guardant360 Tissue test for Medicare fee-for-service patients with advanced solid tumor cancers.
Non-cash charges primarily consisted of $140.4 million of stock-based compensation, $44.4 million of net unrealized and realized losses on marketable equity security investment in Lunit, inc., $42.4 million of depreciation and amortization, and $31.1 million of operating lease costs, partially offset by $6.8 million of amortization of discount on marketable debt securities.
Reconciliation adjustments primarily consisted of $140.4 million of stock-based compensation, $44.4 million of net unrealized and realized losses on marketable equity security investment in Lunit, inc., $42.4 million of depreciation and amortization, and $31.1 million of operating lease costs; partially offset by $6.8 million of amortization of discount on marketable debt securities.
Our revenue depends on achieving broad coverage and reimbursement for our tests from third-party payers, including both commercial and government payers. Precision oncology revenue from tests for clinical customers is calculated based on our expected cash collections, using the estimated variable consideration.
Our revenue depends on achieving broad coverage and reimbursement for our tests from third-party payers, including both commercial and government payers. Our oncology and screening revenue is calculated based on our expected cash collections, using the estimated variable consideration.
Effective January 1, 2022, Medicare started to reimburse Guardant360 CDx services at the median rate of claims paid by commercial payers. In March 2022, Palmetto GBA, the Medicare administrative contractor for MolDX, conveyed coverage for our Guardant360 TissueNext test under the existing local coverage determination.
Effective January 1, 2022, Medicare started to reimburse Guardant360 CDx services at the median rate of claims paid by commercial 78 Table of Contents payers. In March 2022, Palmetto GBA, the Medicare administrative contractor for MolDX, conveyed coverage for our Guardant360 Tissue test under the existing local coverage determination.
Expected Volatility Prior to the commencement of trading of our common stock on the Nasdaq Global Select Market on October 4, 2018 in connection with our initial public offering, there was no active trading market for our common stock.
Expected Volatility Prior to the commencement of trading of our common stock on the Nasdaq Global Select Market on October 4, 2018 in connection with our IPO, there was no active trading market for our common stock.
We may consider raising additional capital to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons. As revenue from precision oncology testing and development services and other is expected to grow long-term, we expect our accounts receivable and inventory balances to increase.
We may consider raising additional capital to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons. As our revenue is expected to grow long-term, we expect our accounts receivable and inventory balances to increase.
Cost of precision oncology testing generally consists of cost of materials, including inventory write-downs; cost of labor, including employee benefits, bonus, and stock-based compensation; equipment and infrastructure expenses associated with processing test samples, such as sample accessioning, library preparation, sequencing, and quality control analyses; freight; curation of test results for physicians; phlebotomy; and license fees due to third parties.
Costs associated with performing our tests generally consists of cost of materials, including inventory write-downs; cost of labor, including employee benefits, bonus, and stock-based compensation; equipment and infrastructure expenses associated with processing test samples, such as sample preparation, library preparation, sequencing, and quality control analyses; freight; curation of test results for physicians; phlebotomy; and license fees due to third parties.
No stock-based compensation expense is recorded for PSUs, unless it is determined to be probable that the related performance metrics will be met. In addition, a cumulative adjustment will be recorded in the period when the probability of achieving the related performance metrics is adjusted. Any PSUs that remain unvested at the end of the performance period will be forfeited.
No stock-based compensation expense is recorded for PSUs, unless it is determined to be probable that the related performance metrics will be met. In addition, a cumulative adjustment will be recorded in the period when the probability of achieving the related performance metrics is adjusted.
Revenue from sales of precision oncology tests to biopharmaceutical customers are based on a negotiated price per test or on the basis of an agreement to provide certain testing volume over a defined period. We identify our promise to transfer a number of distinct tests to biopharmaceutical customers as a single performance obligation.
Revenue from the delivery of our tests for biopharmaceutical customers are based on a negotiated price per test or on the basis of an agreement to provide certain testing volume over a defined period. We identify our promise to transfer a series of distinct tests to biopharmaceutical customers as a single performance obligation.
We also collaborate with biopharmaceutical companies in clinical studies by providing the above-mentioned tests, as well as the GuardantOMNI blood test for advanced-stage cancer, and the GuardantINFINITY blood test, a next-generation Smart Liquid Biopsy that provides new, multi-dimensional insights into the complexities of tumor molecular profiles and immune response to advance cancer research and therapy development.
We also collaborate with biopharmaceutical companies in clinical studies by providing the above-mentioned tests, as well as the GuardantINFINITY blood test, also powered by our Smart Platform, which provides new, multi-dimensional insights into the complexities of tumor molecular profiles and immune response to advance cancer research and therapy development, and the GuardantOMNI blood test for advanced-stage cancer.
As of December 31, 2024, we had cash, cash equivalents, restricted cash and marketable debt securities of $944.2 million. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to provide liquidity while ensuring capital preservation.
As of December 31, 2025, we had cash, cash equivalents, restricted cash and marketable debt securities of $1.3 billion. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to provide liquidity while ensuring capital preservation.
The Vanguard study is a four-year pilot study which will enroll up to 24,000 people to inform the design of a randomized controlled trial evaluating the use of MCD tests for cancer screening.
The Vanguard study is a four-year pilot study which initiated patient enrollment in June 2025 and will enroll up to 24,000 people to inform the design of a randomized controlled trial evaluating the use of MCD tests for cancer screening.
In addition, our Redwood City, San Diego and Palo Alto, California laboratories are currently operated as centers for our research and technology development. We generated total revenue of $739.0 million, $563.9 million and $449.5 million for the years ended December 31, 2024, 2023 and 2022, respectively.
In addition, our Redwood City, San Diego and Palo Alto, California laboratories are currently operated as centers for our research and technology development, and our Palo Alto laboratory is also CLIA licensed. We generated total revenue of $982.0 million, $739.0 million and $563.9 million for the years ended December 31, 2025, 2024 and 2023, respectively.
We expect the cost of precision oncology testing to generally increase in line with the increase in the number of tests we perform, but we expect the cost per test to decrease modestly over time due to the efficiencies we may gain as test volume increases, and from automation and other cost reductions. Cost of development services and other .
We expect the costs associated with performing our tests to generally increase in line with the increase in the number of tests we perform, but we expect the cost per test to decrease modestly over time due to the efficiencies we may gain as test volume increases, and from automation and other cost reductions.
Shield is also the first blood test for colorectal cancer screening that meets coverage requirements by Medicare. To clinically validate the performance of our next-generation Shield blood test in lung cancer screening in high-risk individuals ages 50-80, in January 2022, we initiated a nearly 10,000-patient prospective, registrational study, which we refer to as the SHIELD LUNG study.
To clinically validate the performance of our next-generation Shield blood test in lung cancer screening in high-risk individuals ages 50-80, in January 2022, we initiated a nearly 10,000-patient prospective, registrational study, which we refer to as the SHIELD LUNG study.
Most precision oncology tests requested by clinical customers are sold without a written agreement; however, we determine an implied contract exists with our clinical customers. We identify each sale of our test to a clinical customer as a single performance obligation.
Oncology revenue is recognized at the time results of the test are reported to physicians. Most oncology tests requested by clinical customers are sold without a written agreement; however, we determine an implied contract exists with our clinical customers. We identify each sale of our test to a clinical customer as a single performance obligation.
Other income (expense), net Year Ended December 31, Change 2024 2023 $ % (in thousands) Other income (expense), net $ (42,605) $ 53,174 $ (95,779) (180) % Other income (expense), net was a $42.6 million expense for the year ended December 31, 2024, primarily attributable to $44.4 million of net unrealized and realized losses recorded for our marketable equity security investment in Lunit, Inc. during the period.
Other income (expense), net was a $42.6 million expense for the year ended December 31, 2024, primarily due to $44.4 million of net unrealized and realized losses recorded for our marketable equity security investment in Lunit, Inc. during the period.
Black-Scholes Assumptions The weighted-average assumptions used in our Black-Scholes option-pricing model were as follows for stock option granted to our employees, directors and non-employees for the periods presented: Year Ended December 31, 2024 2023 2022 Expected term (in years) 5.50 – 6.09 5.50 – 6.10 5.50 – 6.10 Expected volatility 67.4% – 69.4% 69.3% – 70.5% 63.3% – 67.6% Risk-free interest rate 3.8% – 4.5% 3.4% – 4.5% 1.9% – 4.4% Expected dividend yield —% —% —% We will continue to use judgment in evaluating the assumptions related to our stock-based compensation on a prospective basis, including probabilities of meeting performance metrics for our PSUs.
Expected Dividend Yield We do not anticipate paying any dividends in the foreseeable future and, therefore, use an expected dividend yield of zero. 92 Table of Contents Black-Scholes Assumptions The weighted-average assumptions used in our Black-Scholes option-pricing model were as follows for stock option granted to our employees, directors and non-employees for the periods presented: Year Ended December 31, 2025 2024 2023 Expected term (in years) 5.50 – 6.10 5.50 – 6.09 5.50 – 6.10 Expected volatility 65.4% – 67.2% 67.4% – 69.4% 69.3% – 70.5% Risk-free interest rate 3.7% – 4.3% 3.8% – 4.5% 3.4% – 4.5% Expected dividend yield —% —% —% We will continue to use judgment in evaluating the assumptions related to our stock-based compensation on a prospective basis, including probabilities of meeting performance metrics for our PSUs.
Our Redwood City laboratory is certified pursuant to the Clinical Laboratory Improvement Amendments of 1988, or CLIA, accredited by the College of American Pathologists, or CAP, permitted by the New York State Department of Health, or NYSDOH, and licensed in California and four other states. We also perform research use only tests in our laboratory located in San Diego, California.
Our Redwood City laboratory is licensed pursuant to the Clinical Laboratory Improvement Amendments of 1988, or CLIA, accredited by the College of American Pathologists, or CAP, permitted by the New York State Department of Health, or NYSDOH, and licensed in California and four other states.
We determine standalone selling price by considering the historical selling price of these performance obligations in similar transactions as well as other factors, including, but not limited to, the price that customers in the market would be willing to pay, competitive pricing of other vendors, industry publications and current pricing practices, and expected costs of satisfying each performance obligation plus appropriate margin; or by using the residual approach if standalone selling price is not observable, by reference to the total transaction price less the sum of the observable standalone selling prices of other performance obligations promised in the contract.
We determine standalone selling price by considering the historical selling price of these performance obligations in similar transactions as well as other factors, including, but not limited to, the price that customers in the market would be willing to pay, competitive pricing of other vendors, industry publications and current pricing practices, and expected costs of satisfying each performance obligation plus appropriate margin; or by using the residual approach if standalone selling price is not observable, by reference to the total transaction price less the sum of the observable standalone selling prices of other performance obligations promised in the contract. 91 Table of Contents Stock-based compensation We measure the grant date fair value of our service-based and performance-based restricted stock units issued to employees and non-employees based on the closing market price of the common stock on the date of grant.
Total tests for clinical customers increased to approximately 206,700 for the year ended December 31, 2024, from approximately 172,900 for the year ended December 31, 2023.
Total oncology test volume increased to approximately 206,700 for the year ended December 31, 2024, from approximately 172,900 for the year ended December 31, 2023.
As demand for our tests are expected to continue to increase from physicians and biopharmaceutical companies, we anticipate that our capital expenditure requirements could also increase if we require additional laboratory capacity. We have funded our operations to date principally from the sale of stock, convertible debt and through revenue from precision oncology testing and development services and other.
As demand for our tests are expected to continue to increase from physicians and biopharmaceutical companies, we anticipate that our capital expenditure requirements could also increase if we require additional laboratory capacity. We have funded our operations to date principally from the sales of our common stock, issuances of convertible notes and generation of our revenue.
Factors affecting our performance We believe there are several important factors that have impacted and that we expect will impact our operating performance and results of operations, including: • Testing volume, pricing and customer mix . Our revenue and costs are affected by the volume of testing and mix of customers from period to period.
Factors affecting our performance We believe there are several important factors that have impacted and that we expect will impact our operating performance and results of operations, including: • Testing volume, pricing, and product and customer mix .
Additionally, we have investments held in marketable debt securities consisting primarily of United States treasury securities that can be immediately liquid.
Additionally, we have investments held in marketable debt securities consisting primarily of commercial paper and U.S. treasury securities that can be immediately liquid.
Interest expense Year Ended December 31, Change 2024 2023 $ % (in thousands) Interest expense $ (2,581) $ (2,578) $ (3) — % Interest expense was primarily attributable to the amortization of debt issuance costs related to our convertible senior notes issued in November 2020, for the years ended December 31, 2024, and 2023.
Interest expense Year Ended December 31, Change 2025 2024 $ % (in thousands) Interest expense $ (3,897) $ (2,581) $ (1,316) 51 % Interest expense was primarily related to the coupon interest, amortization of debt issuance costs, net of amortization of debt premium of our convertible senior notes for the years ended December 31, 2025, and 2024.
For patients with advanced-stage cancer, we have commercially launched Guardant360 laboratory developed test, or LDT, and Guardant360 CDx, the first comprehensive liquid biopsy test approved by the U.S.
For patients with advanced-stage cancer, we offer the Guardant360 Liquid test, formerly known as the Guardant360 LDT test, and the Guardant360 CDx test, the first comprehensive liquid biopsy test approved by the U.S.
Sales and marketing expense Year Ended December 31, Change 2024 2023 $ % (in thousands) Sales and marketing expense $ 364,935 $ 295,227 $ 69,708 24 % Sales and marketing expenses were $364.9 million for the year ended December 31, 2024, compared to $295.2 million for the year ended December 31, 2023, an increase of $69.7 million, or 24%.
Sales and marketing expense Year Ended December 31, Change 2025 2024 $ % (in thousands) Sales and marketing expense $ 494,661 $ 364,935 $ 129,726 36 % Sales and marketing expenses were $494.7 million for the year ended December 31, 2025, compared to $364.9 million for the year ended December 31, 2024, an increase of $129.7 million, or 36%.
General and administrative expense Year Ended December 31, Change 2024 2023 $ % (in thousands) General and administrative expense $ 180,123 $ 155,800 $ 24,323 16 % General and administrative expenses were $180.1 million for the year ended December 31, 2024, compared to $155.8 million for the year ended December 31, 2023, an increase of $24.3 million, or 16%.
General and administrative expense Year Ended December 31, Change 2025 2024 $ % (in thousands) General and administrative expense $ 211,410 $ 180,123 $ 31,287 17 % General and administrative expenses were $211.4 million for the year ended December 31, 2025, compared to $180.1 million for the year ended December 31, 2024, an increase of $31.3 million, or 17%.
Precision oncology revenue from tests for clinical customers was $542.8 million for the year ended December 31, 2024, up 34% from $403.9 million for the year ended December 31, 2023. This increase in clinical testing revenue was driven primarily by an increase in sample volume and an increase in reimbursement for our tests.
Oncology revenue was $542.8 million for the year ended December 31, 2024, compared to $403.9 million for the year ended December 31, 2023, an increase of $139.0 million, or 34%. This increase was driven primarily by an increase in oncology test volume and an increase in reimbursement for our oncology tests.
We evaluate both the volume of tests that we perform for patients on behalf of clinicians and the number of tests we perform for biopharmaceutical companies. Our performance depends on our ability to retain and broaden adoption with existing customers, as well as attract new customers.
We evaluate the volume of tests performed both for patients on behalf of clinicians and for biopharmaceutical companies, including tests delivered by labs operated by our strategic partners. Our performance depends on our ability to retain and broaden adoption of our existing and new products, with existing customers, as well as attract new customers. • Payer coverage and reimbursement .
Interest income Interest income consists of interest earned on our cash, cash equivalents, restricted cash and marketable debt securities. Interest expense Interest expense consists primarily of charges relating to amortization of debt issuance costs.
Interest income Interest income consists of interest earned on our cash, cash equivalents, restricted cash and marketable debt securities.
In particular, we have invested heavily in clinical studies as we believe these studies are critical to gaining physician adoption and driving favorable coverage decisions by payers.
A significant aspect of our business is our investment in research and development, including the development of new products. In particular, we have invested heavily in clinical studies as we believe these studies are critical to gaining physician adoption and driving favorable coverage decisions by payers.
We also incurred net losses of $436.4 million, $479.4 million and $654.6 million in the years ended December 31, 2024, 2023 and 2022, respectively. We have funded our operations to date 76 Table of Contents principally from the sale of our stock, convertible senior notes, and revenue from our precision oncology testing and development services and other.
We also incurred net losses of $416.3 million, $436.4 million and $479.4 million in the years ended December 31, 2025, 2024 and 2023, respectively. We have funded our operations to date principally from the sales of our common stock, issuances of convertible senior notes, and generation of our revenue.
Operating Expenses Research and development expense Year Ended December 31, Change 2024 2023 $ % (in thousands) Research and development expense $ 347,753 $ 367,194 $ (19,441) (5) % Research and development expenses were $347.8 million for the year ended December 31, 2024, compared to $367.2 million for the year ended December 31, 2023, a decrease of $19.4 million, or 5%.
Operating Expenses Research and development expense Year Ended December 31, Change 2025 2024 $ % (in thousands) Research and development expense $ 364,191 $ 347,753 $ 16,438 5 % 85 Table of Contents Research and development expenses were $364.2 million for the year ended December 31, 2025, compared to $347.8 million for the year ended December 31, 2024, an increase of $16.4 million, or 5%.
Cash used in operating activities during the year ended December 31, 2023 was $325.0 million, which resulted from a net loss of $479.4 million, partially offset by non-cash charges of $100.6 million and changes in our operating assets and liabilities of $53.8 million.
Cash used in operating activities during the year ended December 31, 2024 was $239.9 million, which resulted from a net loss of $436.4 million and changes in our operating assets and liabilities of $60.9 million, partially offset by reconciliation adjustments of $257.4 million.
Due to limited historical data for the trading of our common stock, expected volatility is estimated based on the average volatility for comparable publicly traded peer group companies in the same industry plus our expected volatility for the available periods. The comparable companies are chosen based on their similar size, stage in the life cycle or area of specialty.
Due to limited historical data for the trading of our common stock, for awards granted prior to fiscal year 2025, expected volatility was estimated based on the average volatility for comparable publicly traded peer group companies in the same industry plus our expected volatility for the available periods.
Our equity awards, including market-based and performance-based restricted stock units, are intended to retain and incentivize employees to lead us to sustained, long-term superior financial and operational performance. • Other operating expense .
Our financial results have historically, and will likely continue to, fluctuate significantly based upon the impact of our general and administrative expense, and in particular, our stock-based compensation expense. Our equity awards, including performance-based restricted stock units, are intended to retain and incentivize employees to lead us to sustained, long-term superior financial and operational performance. • Other operating expense .
Cost of Revenue Year Ended December 31, Change 2024 2023 $ % (in thousands) Cost of precision oncology testing $ 260,581 $ 205,528 $ 55,053 27 % Cost of development services and other 29,218 21,524 7,694 36 % Total cost of revenue $ 289,799 $ 227,052 $ 62,747 28 % Total cost of revenue was $289.8 million for the year ended December 31, 2024, compared to $227.1 million for the year ended December 31, 2023, an increase of $62.7 million, or 28%.
Cost of Revenue Year Ended December 31, Change 2024 2023 $ % (in thousands) Cost of revenue $ 289,799 $ 227,052 $ 62,747 28 % Cost of revenue was $289.8 million for the year ended December 31, 2024, compared to $227.1 million for the year ended December 31, 2023, an increase of $62.7 million, or 28%.
See Part I, Item 1A, “Risk Factors ” of this Annual Report on Form 10-K for more information. 79 Table of Contents Components of results of operations Revenue We derive our revenue from two sources: (i) precision oncology testing, and (ii) development services and other. Precision oncology testing.
See Part I, Item 1A, “Risk Factors ” of this Annual Report on Form 10-K for more information. Components of results of operations Revenue We derive our revenue from four major sources, including oncology, biopharma and data, screening, and licensing and other. Oncology. Oncology revenue was previously presented as precision oncology revenue from tests for clinical customers.
Year Ended December 31, 2024 2023 (in thousands) Revenue: Precision oncology testing $ 687,936 $ 514,249 Development services and other 51,080 49,699 Total revenue 739,016 563,948 Costs and operating expenses: Cost of precision oncology testing (1) 260,581 205,528 Cost of development services and other (1) 29,218 21,524 Research and development expense (1) 347,753 367,194 Sales and marketing expense (1) 364,935 295,227 General and administrative expense (1) 180,123 155,800 Other operating expense — 83,400 Total costs and operating expenses 1,182,610 1,128,673 Loss from operations (443,594) (564,725) Interest income 53,691 35,365 Interest expense (2,581) (2,578) Other income (expense), net (42,605) 53,174 Loss before provision for income taxes (435,089) (478,764) Provision for income taxes 1,284 685 Net loss $ (436,373) $ (479,449) (1) Amounts include stock-based compensation expense as follows: Year Ended December 31, 2024 2023 (in thousands) Cost of precision oncology testing $ 5,315 $ 4,614 Cost of development services and other 4,050 1,851 Research and development expense 50,566 34,682 Sales and marketing expense 36,479 24,764 General and administrative expense 44,001 24,848 Total stock-based compensation expense $ 140,411 $ 90,759 In November 2020 and May 2021, we granted restricted stock units with certain performance metrics, or PSUs, consisting of a performance period of 4 years combined with an additional service period requirement of six months should the vesting criteria be met, with a grant date fair value of $113.40 per share and $148.19 per share, respectively.
Year Ended December 31, 2025 2024 (in thousands) Revenue $ 982,021 $ 739,016 Costs and operating expenses: Cost of revenue (1) 349,007 289,799 Research and development expense (1) 364,191 347,753 Sales and marketing expense (1) 494,661 364,935 General and administrative expense (1) 211,410 180,123 Total costs and operating expenses 1,419,269 1,182,610 Loss from operations (437,248) (443,594) Interest income 34,095 53,691 Interest expense (3,897) (2,581) Other income (expense), net (10,490) (42,605) Loss before (benefit from) provision for income taxes (417,540) (435,089) (Benefit from) provision for income taxes (1,263) 1,284 Net loss $ (416,277) $ (436,373) (1) Amounts include stock-based compensation expense as follows: Year Ended December 31, 2025 2024 (in thousands) Cost of revenue $ 10,699 $ 9,365 Research and development expense 50,937 50,566 Sales and marketing expense 44,724 36,479 General and administrative expense 59,857 44,001 Total stock-based compensation expense $ 166,217 $ 140,411 In November 2020 and May 2021, we granted restricted stock units with certain performance metrics, or PSUs, consisting of a performance period of 4 years combined with an additional service period requirement of six months should the vesting criteria be met, with a grant date fair value of $113.40 per share and $148.19 per share, respectively.
This increase was related to commercial team expansion and marketing activities to support existing products and the Shield product launch, primarily resulting in an increase of $34.1 million in other personnel costs; an increase of $14.9 million in marketing activity related costs; an increase of $11.7 million in stock-based compensation, including $6.5 million related to the PSUs discussed in the Result of operations section above; and an increase of $10.5 million in information technology infrastructure costs.
This increase was related to commercial team expansion and marketing activities to support both the Shield product launch and existing products growth, primarily resulting in an increase of $77.0 million in personnel costs, an increase of $35.1 million in marketing activity related costs, an increase of $8.2 million in stock-based compensation, an increase of $4.8 million in office and administrative costs, and an increase of $4.7 million in information technology infrastructure costs.
In June 2022, we signed a strategic partnership agreement with Adicon Holdings Limited, or Adicon, a leading independent clinical laboratory company based in China, and in December 2023, the blood-based cancer testing services based on our digital sequencing platform became available at Adicon's testing facility, which offers our industry-leading comprehensive genomic profiling tests to biopharmaceutical companies to advance clinical research and the development of new cancer therapies in China.
In September 2024, we signed a partnership agreement with Fondazione Policlinico Universitario Agostino Gemelli IRCCS, or Policlinico Gemelli, one of Italy’s largest and most renowned hospitals known for its advanced oncology services, including diagnostics, treatment, and research, to establish an in-house liquid biopsy testing service within its hospital system, and in December 2025, the liquid biopsy testing service based on our proprietary Guardant360® CDx technology became available at the Policlinico Gemelli facility in Italy. 80 Table of Contents In June 2022, we signed a strategic partnership agreement with Adicon Holdings Limited, or Adicon, a leading independent clinical laboratory company based in China, and in December 2023, the blood-based cancer testing services based on our digital sequencing platform became available at Adicon's testing facility, which offers our industry-leading comprehensive genomic profiling tests to biopharmaceutical companies to advance clinical research and the development of new cancer therapies in China.
In 2024, the performance metrics of these PSUs were considered to be achieved; as such we recorded $24.8 million in stock-based compensation expense related to these PSUs, based on 219,161 shares granted with fair values of $113.40 per share and $148.19 per share, of which $2.4 million was recorded to cost of development services and other, and $11.8 million, $6.5 million and $4.1 million was recorded as components of research and development expense, sales and marketing expense, and general and administrative expense, respectively. 82 Table of Contents Comparison of the Years Ended December 31, 2024 and 2023 Revenue Year Ended December 31, Change 2024 2023 $ % (in thousands) Precision oncology testing $ 687,936 $ 514,249 $ 173,687 34 % Development services and other 51,080 49,699 1,381 3 % Total revenue $ 739,016 $ 563,948 $ 175,068 31 % Total revenue was $739.0 million for the year ended December 31, 2024, compared to $563.9 million for the year ended December 31, 2023, an increase of $175.1 million, or 31%.
In 2024, the performance metrics of these PSUs were considered to be achieved; as such we recorded $24.8 million in stock-based compensation expense related to these PSUs, based on 219,161 shares granted with fair values of $113.40 per share and $148.19 per share, of which $2.4 million was recorded to cost of revenue, and $11.8 million, $6.5 million and $4.1 million was recorded as components of research and development expense, sales and marketing expense, and general and administrative expense, respectively.
Stock-based compensation We measure the grant date fair value of our service-based and performance-based restricted stock units issued to employees and non-employees based on the closing market price of the common stock on the date of grant. For restricted stock units with only service-based vesting conditions, compensation expense is recognized on a straight-line basis over the requisite service period.
For restricted stock units with only service-based vesting conditions, compensation expense is recognized on a straight-line basis over the requisite service period.
This represents an expansion from the prior Medicare coverage of our Guardant Reveal test for colorectal cancer in the early post-surgical setting only. In August 2024, following the FDA approval, our Shield blood test met the coverage requirements by Medicare based on the criteria established in its National Coverage Determination for blood-based colorectal cancer screening tests.
In August 2024, following the FDA approval, our Shield blood test met the coverage requirements by Medicare based on the criteria established in its National Coverage Determination for blood-based colorectal cancer screening tests. The test is covered once every three years for eligible Medicare beneficiaries.
As we continue to develop these relationships, we expect to support a growing number of clinical studies globally and continue to have opportunities to offer our platform to such customers for development services, including companion diagnostic development, novel target discovery and validation, as well as clinical study enrollment.
As we continue to develop these relationships, we expect to support a growing number of clinical studies globally and continue to have opportunities to offer our services to such customers, primarily including companion diagnostic development and regulatory approval, monitoring and maintenance, GuardantINFORM data services and GuardantConnect referral services. 79 Table of Contents • Research and development.
Cash provided by investing activities during the year ended December 31, 2023 was $840.3 million, which resulted primarily from maturities of marketable debt securities of $1.5 billion; partially offset by purchases of marketable debt securities of $629.9 million, purchases of property and equipment of $20.5 million, and purchases of non-marketable equity security investments and other related assets of $5.6 million.
Investing activities Cash used in investing activities during the year ended December 31, 2025 was $627.2 million, which resulted primarily from purchases of marketable debt securities of $818.2 million, business acquisition net of cash acquired of $59.0 million, purchases of property and equipment of $48.3 million, and purchases of non-marketable equity security investments of $9.0 million; partially offset by maturities of marketable debt securities of $307.3 million.
See Note 17, Subsequent Events , to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional information related to this transaction.
See Revenue Recognition section of Note 2, Summary of Significant Accounting Policies, to the consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional information related to the disaggregation of revenue.
The constraint for variable consideration is applied to the transaction price such that it is probable a significant cumulative reversal of revenue will not occur when the uncertainty associated with the contingency is resolved. Application of the constraint for variable consideration is assessed and updated at each reporting period as a revision to the estimated transaction price.
The constraint for variable consideration is applied to the contract price such that it is probable a significant cumulative reversal of revenue will not occur when the uncertainty associated with the contingency is resolved. We also provide other services to our biopharmaceutical customers, such as monitoring and maintenance, GuardantINFORM data services and GuardantConnect referral services.
The changes in our operating assets and liabilities was primarily the result of a legal accrual of $83.4 million in connection with a jury verdict entered in favor of TwinStrand Biosciences, Inc. and the University of Washington in November 2023, a $8.4 million decrease in accounts receivable, net, and a $5.2 million increase in accounts payable and accrued liabilities; partially offset by a $31.5 million payment of operating lease liabilities net of receipt of tenant improvement allowance, a $10.4 million increase in inventory, net due to forecasted higher testing volumes, and a $4.3 million increase in prepaid expenses and other current assets, net.
The changes in our operating assets and liabilities was primarily the result of a $37.5 million payment of operating lease liabilities net of receipt of tenant improvement allowance, a $28.2 million increase in accounts receivable, net, a $14.8 million increase in inventory, net, and a $6.4 million increase in prepaid expenses and other current assets, net; partially offset by a $52.7 million increase in accounts payable and accrued liabilities, and a $19.5 million increase in deferred revenue.
We have also launched the Guardant360 TissueNext tissue test for advanced-stage cancer, Guardant Reveal blood test to detect residual and recurring disease in early-stage colorectal, breast and lung cancer patients, and Guardant360 Response blood test to predict patient response to immunotherapy or targeted therapy eight weeks earlier than current standard-of-care imaging.
We also offer the Guardant360 Tissue test for advanced-stage cancer and the Guardant Reveal test to detect residual and recurring disease in early-stage colorectal, breast and lung cancer patients. We have also expanded the Guardant Reveal test to include late-stage therapy response monitoring for patients with solid tumors.
Contracts with multiple performance obligations Contracts with biopharmaceutical customers and international laboratory partners may include multiple distinct performance obligations, such as provision of precision oncology testing, the above-mentioned development services, and digital sequencing technology licensing, among others.
Contracts with multiple performance obligations Our contracts with biopharmaceutical customers and international laboratory partners may include multiple distinct performance obligations, such as delivery of our tests, performance of the above-mentioned services, and licensing our technologies, among others. We evaluate the terms and conditions included within our contracts with biopharmaceutical customers and international laboratory partners to ensure appropriate revenue recognition.
Our tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and helping doctors select the best treatment for patients with advanced cancer.
We are transforming patient care by providing critical insights into what drives disease through our advanced blood and tissue tests, real-world data and AI analytics. Our tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer.
Cost of precision oncology testing was $260.6 million for the year ended December 31, 2024, compared to $205.5 million for the year ended December 31, 2023, an increase of $55.1 million, or 27%.
Oncology revenue was $683.6 million for the year ended December 31, 2025, compared to $542.8 million for the year ended December 31, 2024, an increase of $140.8 million, or 26%.
We currently receive payments from third-party commercial and governmental payers, certain hospitals and oncology centers and individual patients, as well as biopharmaceutical companies, research institutes, international laboratory partners and distributors. Revenues are recognized when control of services is transferred to customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those services.
Revenues are recognized when control of services is transferred to customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those services.
Revenue recognition We derive revenue from the provision of precision oncology testing services, as well as from development services and other. Precision oncology testing revenue includes amounts derived from the delivery of our precision oncology tests, including those tests delivered by labs operated by our strategic partners.
Oncology Oncology revenue was previously presented as precision oncology revenue from tests for clinical customers. Oncology revenue includes amounts derived from the delivery of our oncology tests for clinical customers, including hospitals, cancer centers, research institutions and patients, and oncology tests delivered by labs operated by our strategic partners.
Development services revenue primarily represents services that we provide to biopharmaceutical companies, large medical institutions and international laboratory partners. We collaborate with biopharmaceutical companies in the development and clinical studies of new drugs. As part of these collaborations, we provide services related to regulatory filings to support companion diagnostic device submissions for our test panels.
Results of our tests are delivered electronically, and as such there are no shipping or handling fees incurred by us or billed to customers. In addition, we collaborate with biopharmaceutical companies in the development of new drugs. As part of these collaborations, we provide services related to regulatory filings to support companion diagnostic device submissions for our testing panels.
This decrease was primarily due to a decrease of $31.8 million in outside services costs primarily driven by a reduction in the ECLIPSE clinical study costs as the study nears completion, a decrease of $9.7 million in material costs, and a decrease of $3.7 million in information technology infrastructure costs; partially offset by an increase of $15.9 million in stock-based compensation, primarily related to the PSUs of $11.8 million discussed in the Results of operations section above; and an increase of $10.0 million in other personnel costs.
This increase was related to continued investment in the development of our technologies and products, primarily including an increase of $9.6 million in personnel costs, an increase of $6.7 million in material costs, and an increase of $3.8 million in information technology infrastructure costs; partially offset by a decrease of $6.5 million in outside services costs related to clinical studies.
For the companion diagnostic development and regulatory approval services performed, we are compensated through a combination of an upfront fee and performance-based, non-refundable regulatory and other developmental milestone payments. The transaction price of these contracts typically represents variable consideration. Application of the constraint for variable consideration to milestone payments is an area that requires significant judgment.
Under these collaborations, we generate revenue from achievement of milestones. The transaction price of these contracts typically represents variable consideration. Application of the constraint for variable consideration to milestone payments is an area that requires significant judgment.
The increase in other revenue was also attributable to $4.1 million derived from the delivery of approximately 6,400 of our Shield screening tests for the three months ended December 31, 2024, following the FDA approval.
Screening revenue was $5.1 million for the year ended December 31, 2024, primarily generated from the delivery of approximately 6,400 of our Shield screening tests for the three months ended December 31, 2024, following the FDA approval. 87 Table of Contents Licensing and other revenue was $13.5 million for the year ended December 31, 2024, compared to $23.7 million for the year ended December 31, 2023, a decrease of $10.2 million, or 43%, primarily due to a decrease of $7.2 million associated with our partnership agreements and a reduction of $3.2 million in royalty revenue.

… 97 more changes not shown on this page.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

5 edited+0 added−0 removed3 unchanged
Biggest changeAs of December 31, 2024, a hypothetical 100 basis point increase or decrease in interest rates would have resulted in immaterial decline or increase of the fair value of our investments. This estimate is based on a sensitivity model that measures market value changes when changes in interest rates occur.
Biggest changeOur primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of the interest rates in the United States. As of December 31, 2025, a hypothetical 100 basis point increase or decrease in interest rates would have resulted in immaterial decline or increase of the fair value of our investments.
As of December 31, 2024, the effect of a hypothetical 10% change in foreign currency exchange rates would not be material to our financial condition or results of operations. To date, we have not entered into any hedging arrangements with respect to foreign currency risk.
As of December 31, 2025, the effect of a hypothetical 10% change in foreign currency exchange rates would not be material to our financial condition or results of operations. To date, we have not entered into any hedging arrangements with respect to foreign currency risk.
As our international operations grow, we will continue to reassess our approach to manage our risk relating to fluctuations in currency rates. 91
As our international operations grow, we will continue to reassess our approach to manage our risk relating to fluctuations in currency rates. 93
Foreign currency risk The majority of our revenue is generated in the United States. Through December 31, 2024, we have generated an insignificant amount of revenues denominated in foreign currencies.
This estimate is based on a sensitivity model that measures market value changes when changes in interest rates occur. Foreign currency risk The majority of our revenue is generated in the United States. Through December 31, 2025, we have generated an insignificant amount of revenues denominated in foreign currencies.
As of December 31, 2024, we had cash, cash equivalents, restricted cash and marketable debt securities of $944.2 million held primarily in cash deposits, money market funds and U.S. government debt securities. Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of the interest rates in the United States.
As of December 31, 2025, we had cash, cash equivalents, restricted cash and marketable debt securities of $1.3 billion held primarily in cash deposits, money market funds, commercial paper and U.S. government debt securities.

Other GH 10-K year-over-year comparisons