Guardant Health, Inc., a precision oncology company, focuses on guarding wellness and giving every person more time free from cancer.
The company is transforming patient care by providing critical insights into what drives disease through its advanced blood and tissue tests and real-world data. The company's 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 treatme...
Guardant Health, Inc., a precision oncology company, focuses on guarding wellness and giving every person more time free from cancer.
The company is transforming patient care by providing critical insights into what drives disease through its advanced blood and tissue tests and real-world data. The company's 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. For patients with advanced-stage cancer, the company has commercially launched the Guardant360 laboratory-developed test, or LDT, and Guardant360 CDx, the first comprehensive liquid biopsy test approved by the U.S. 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. The company has 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 the current standard-of-care imaging.
The company also collaborates with biopharmaceutical companies in clinical studies by providing the 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. Using data collected from its tests, the company has also developed the 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.
For early cancer detection, the company 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. The company announced that the ECLIPSE study, a registrational study evaluating the performance of its Shield blood test for detecting colorectal cancer in average-risk adults, met co-primary endpoints. In addition, the company submitted a premarket approval application, or PMA, for its Shield blood test to the FDA. In July 2024, the company received FDA approval of its 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, the Shield blood test became commercially available in the U.S. as the first blood test approved by the FDA for primary colorectal cancer screening. Shield is also the first blood test for colorectal cancer screening that meets coverage requirements by Medicare.
Strategy
The company’s strategies are to:
Increase awareness of its 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 its tests in treatment guidelines; and expanding access to its products globally through direct investment and by leveraging its global network of partners.
Expand clinical utility and increase reimbursement for its products by working with private and public payers to establish coverage and reimbursement for its 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 the use of its tests to patients, physicians, and payers; and pursuing FDA and other regulatory approval internationally of its tests to facilitate reimbursement and global market access.
Strengthen its relationships with customers by demonstrating the utility of its products in connection with standard of care treatments thereby encouraging clinical adoption; developing and seeking approval of its 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 its product portfolio by using its 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 its data, sample biobank, and insights into the biology of circulating tumor-related biomarkers in blood to develop new products; building on its regulatory and commercial infrastructure to accelerate new product launches and drive commercial efficiencies; and using its strategic relationships, including its partnerships with cancer centers, research organizations, and laboratory companies in Europe and Asia, to drive global commercialization of its products.
Products and Development Program
The company has launched various products and programs using its digital sequencing technology, which is enabled by robust, high-efficiency biochemistry at the front end, next-generation sequencing, and a machine learning-augmented bioinformatics pipeline.
Therapy Selection
Guardant360 CDx Test
The Guardant360 CDx test is a 74-gene test to provide tumor mutation profiling to be used by qualified health professionals in accordance with professional guidelines in oncology for cancer patients with any solid malignant neoplasm. The Guardant360 CDx test has also been approved by the FDA for use as a companion diagnostic to identify NSCLC patients. 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 the sample and delivered by a clinical report.
Guardant360 LDT
The number of personalized therapy options for advanced cancer patients continues to grow, giving patients. The Guardant360 LDT test measures 730+ genes and supports all guideline-recommended biomarkers to help inform. The Guardant360 LDT test has been migrated to the Smart Liquid Biopsy platform, which enables more sensitive epigenetic tumor fraction detection. Results are typically delivered within seven days following receipt of the sample and delivered by a clinical report.
Guardant360 Response Test
The Guardant360 Response test is the first blood-only liquid biopsy that enables doctors to view molecular response, or changes in circulating tumor DNA, or ctDNA, levels, from a simple blood draw to potentially gain early insight regarding patient response to treatment. For doctors, knowing early and confidently if a patient’s treatment is working is critical in deciding whether to continue, stop, or explore other options. Studies across cancers and therapies show the Guardant360 Response test predicted treatment response eight weeks earlier than current standard-of-care radiological and imaging scans.
Guardant360 TissueNext Test
To complement the company’s liquid biopsy-based products, Guardant360 TissueNext, its first tissue-based test with AI-powered PD-L1 detection, is designed to identify patients with advanced cancer. Tissue genotyping is widely available to physicians and patients.
Minimal Residual Disease Detection and Recurrence Monitoring
Guardant Reveal Test
In the management of early-stage cancer, tools do not identify all high-risk patients. In addition, the Guardant Reveal test has been migrated to the Smart Liquid Biopsy platform, which could maximize detection sensitivity without requiring tissue. Similar to its data development effort for its Guardant360 tests, the company is investing heavily in establishing clinical validity and utility for the use of Guardant Reveal in adjuvant treatment and surveillance settings. In return, these relationships could help the company establish clinical utility for its tests and create new testing opportunities related to emerging therapies. Results are typically delivered within seven days following receipt of the sample and delivered by a clinical report.
Screening
Shield Test
The company 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. For this reason, the company has incorporated epigenomic signatures to enhance the performance of its Shield assay in these settings. The company announced that the ECLIPSE study, a registrational study evaluating the performance of its Shield blood test for detecting colorectal cancer in average-risk adults, met co-primary endpoints. The test demonstrated 83% sensitivity in detecting individuals with colorectal cancer. Specificity was 90% in both individuals without advanced neoplasia and in those who had a negative colonoscopy result. These results exceed the performance criteria set forth by the Centers for Medicare and Medicaid Services, or CMS, for reimbursement. This test also demonstrated 13% sensitivity in detecting advanced adenomas. Based on these study results, the company submitted a PMA for its Shield blood test to the FDA. In July 2024, the company received FDA approval of its 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, the Shield blood test became commercially available in the U.S. as the first blood test approved by the FDA for primary colorectal cancer screening. Shield is also the first blood test for colorectal cancer screening that meets coverage requirements by Medicare.
To clinically validate the performance of its next-generation Shield blood test in lung cancer screening in high-risk individuals ages 50-80, the company initiated a nearly 10,000-patient prospective, registrational study, which it refers to as the SHIELD LUNG study. In addition, in January 2025, the company’s Shield MCD test was selected for the Vanguard study funded by the National Cancer Institute, part of the National Institutes of Health. The Vanguard study is a four-year pilot study that 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.
Biopharmaceutical Offerings
GuardantINFINITY Test
The 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. The GuardantINFINITY assay provides a more comprehensive molecular profile of tumors than earlier assays, giving researchers access to novel genomic and epigenomic insights to provide a simultaneously deeper and more complete understanding of a tumor’s biology, its system-wide interactions, and the associated immune response in a range of applications, from therapy selection to molecular response and longitudinal monitoring. The assay’s extensive methylome panel helps identify the unique methylation pattern that each tumor delivers, providing an important new dimension of research insights that has been unexplored in clinical development to date. GuardantINFINITY is available as a single modular assay with flexible configurations. The core module offers genotyping coverage of more than 800 genes with sample-level methylation detection and tumor fraction score for biomarker discovery, clinical research, therapy selection, and response monitoring.
GuardantOMNI Test
The GuardantOMNI test covers 500 genes, including genes associated with homologous recombination repair deficiency and biomarkers for immuno-oncology applications, such as tumor mutational burden and microsatellite instability. 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 the GuardantOMNI test. 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. At the same time, broader panel-wide performance of small variants is roughly similar to that of the Guardant360 LDT test. In addition, the broad genomic footprint of the GuardantOMNI test enables accurate measurement of tumor mutational burden.
GuardantINFORM
GuardantINFORM complements the company’s core diagnostic business with aggregated data obtained through real-world genomic testing. This genomic and epigenetic data is first matched with clinically relevant information, and through AI-enabled analytical tools and expertise, unlocks important insights into disease progression and treatment impact, as well as clinical research and practice. Given the trend for oncologists to use liquid biopsy to monitor changes over time, the GuardantINFORM database uniquely provides longitudinal biological insight into tumor evolution alongside longitudinal clinical outcomes, which is particularly valuable for both resistance characterization of disease and as testing moves earlier in the cancer journey.
GuardantConnect
Because cancer patients often exhaust standard of care treatment options as the disease progresses and guidelines recommend clinical studies for cancer patients, clinical study matching is an acute need in oncology. At the same time, biopharmaceutical companies need to fill clinical studies that require screening hundreds of thousands of patients. Despite these needs, clinical study enrollment in oncology has severely lagged. GuardantConnect is the company’s integrated software-based solution designed for its clinical and biopharmaceutical customers, seeking to connect patients tested with its assays with actionable alterations with potentially relevant clinical studies.
Smart Liquid Biopsy Platform
The 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.
Clinical Studies and Publications
The company is proactively pursuing studies to support the use of its tests as a preferred alternative or complementary to tissue testing to inform first-line treatment right after diagnosis and at the time of disease progression, with the goal to provide evidence that its tests detect genomic alterations at a similar rate compared to standard of care tissue testing and detect mutations. Such a strategy is predicated on the tests’ abilities to offer accurate, reliable, and fast guideline-directed comprehensive genotyping for all adult solid tumors without exposing patients to invasive biopsy procedures’ risks, delays, or chance of failure. The company publishes peer-reviewed studies to influence treatment guidelines, to educate clinicians and other oncology stakeholders about the value proposition of its test, and to set the stage for reimbursement with private and public payers.
Commercialization
Successful commercial adoption of its tests by clinicians and biopharmaceutical companies is critical to the company's 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.
The U.S. Clinical Commercial Efforts
The company sells its tests to clinical customers in the United States through its targeted sales organization. Its 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. The sales representatives typically have extensive sales-related backgrounds in laboratory testing, therapeutics, and oncology. The company has supplemented the team with clinical oncology specialists with extensive medical affairs experience for molecular information support in the field.
The company’s clinical commercial efforts are focused on driving adoption with academic research institutions and with community oncology practices, including through physician networks. As the company continues to grow its sales organization, it is also expanding its reach to include community practices, community oncology networks, integrated delivery/payer-owned systems, and government medical facilities that are looking for a reliable partner for comprehensive molecular information testing.
Biopharmaceutical Commercial Efforts
The company’s business development team is focused on enterprise selling to biopharmaceutical companies in the United States and internationally, and it supports its biopharmaceutical customers across many applications, including discovery of new targets and mechanisms of acquired resistance; retrospective sample analysis to rapidly identify biomarkers associated with response and lack of response; prospective screening and referral services to accelerate clinical study enrollment; and companion diagnostic development to support the approval and commercialization of therapeutics.
International Commercial Efforts and Expansion
A component of the company’s long-term growth strategy is to expand its commercial footprint internationally. The company offers its tests in countries outside the United States primarily through direct contacts with insurers and hospitals, distributor relationships, and laboratory partnerships. Specifically, the company has demonstrated the ability to deploy its technology to partner laboratories, such as cancer centers, research organizations, and laboratory companies, for the development of test assays based on its technology platform. The company is conducting studies in various jurisdictions and has secured partnerships. In addition, the company has established, and as these studies progress, it nears commercial opportunities in these jurisdictions.
In preparation for wider commercialization in the European Union, or the EU, the company obtained a CE mark for its Guardant360 CDx test. The company signed a partnership agreement with Vall D'Hebron Institute of Oncology, or VHIO, one of Europe’s cancer research institutions, and the first blood-based cancer testing services in Europe based on its digital sequencing platform became available at the VHIO testing facility in Spain. Then, the company signed a partnership agreement with The Royal Marsden NHS Foundation Trust, or Royal Marsden, a premier cancer center within the United Kingdom, or the UK, for patient care, research, and teaching of all types of cancer, and the blood-based cancer testing services based on its digital sequencing platform became available at Royal Marsden testing facility in the UK. In September 2024, the company signed a partnership agreement with the Agostino Gemelli University Polyclinic Foundation IRCCS, one of Italy’s 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.
The company formed and capitalized Guardant Health AMEA, Inc., with SoftBank, which it refers to as Guardant AMEA, relating to the sale, marketing, and distribution of its tests generally outside the Americas and Europe and to accelerate commercialization of its products in Asia, the Middle East, and Africa. Then, the company purchased all of the shares held by SoftBank and its affiliates, and upon completion of the transaction, it obtained full control over operations of Guardant AMEA throughout the Asia, Middle East, and Africa region. In Japan, the company has received regulatory approval of its Guardant360 CDx test as a companion diagnostic for identifying patients. In addition, the MHLW granted national reimbursement approval for its Guardant360 CDx test for patients with advanced or metastatic solid tumor cancers in Japan.
The company also signed a strategic partnership agreement with Adicon Holdings Limited, or Adicon, an independent clinical laboratory company based in China, and later, the blood-based cancer testing services based on its digital sequencing platform became available at Adicon's testing facility, which offers its genomic profiling tests to biopharmaceutical companies to advance clinical research and the development of new cancer therapies in China.
Operations
The company performs clinical, research use only, and investigation use only tests in its laboratory located in Redwood City, California. The company's 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. The company also performs research use only tests in its laboratory located in San Diego, California. In addition, the company's Redwood City, San Diego, and Palo Alto, California laboratories are operated as centers for its 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. The company's testing process includes sample collection, laboratory processing, analysis, and reporting. All major processing steps utilize quality control to ensure consistent and reproducible results.
Supply Chain
The company utilizes vendors for its supply chain. Most reagents and materials are sourced from a limited number of vendors and would require qualification to transition to a different vendor. To mitigate risk, the company employs a multi-month, multi-lot safety stock strategy to ensure an uninterrupted supply of reagents and materials to its laboratories. In the event that a latent defect is identified, the experience with its vendors has provided the company confidence in their ability to produce consistent and quality instrumentation, reagents, and materials.
The company had entered into a supply agreement with Illumina, Inc., or Illumina, for Illumina to provide products and services. The initial term of the supply agreement, as amended, continues until January 2033, and automatically renews for additional one-year terms thereafter unless either the company or Illumina terminates 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.
Competition
The company's competitors within the liquid biopsy space for therapy selection include Foundation Medicine, Inc., which was acquired by Roche Holdings, Inc.; Caris Life Science; Tempus AI, Inc.; NeoGenomics Laboratories, Inc.; Exact Sciences Corp.; Myriad Genetics, Inc.; and Laboratory Corporation of America. 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 competitors in minimal residual disease detection. Additionally, the company's competitors in the early screening testing space include GRAIL, Inc., Exact Sciences Corp., Freenome Holdings, Inc., and Delfi Diagnostics.
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 of the competitors within the liquid biopsy space for therapy selection that sell molecular diagnostic tests for cancer to physicians.
Government Regulations
To renew the company’s CLIA certificate, the company is subject to survey and inspection every two years to assess compliance with program standards. The company maintains a current license with NYSDOH for its laboratory.
The company markets its Guardant360 CDx test and the Shield test pursuant to an approved PMA.
The Guardant360 CDx test has been approved by the FDA for use as a companion diagnostic to identify NSCLC and breast cancer patients who may respond to certain therapies marketed by its biopharmaceutical customers.
In February 2021, Guardant Health Japan, an affiliate of Guardant AMEA, submitted an application to the MHLW for regulatory approval of Guardant360 CDx. In December 2021, the MHLW granted regulatory approval of Guardant360 CDx in patients with advanced solid cancers. The Guardant360 CDx test was also granted approval as a companion diagnostic to identify patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda (pembrolizumab) and patients with MSI-High advanced colorectal cancer who may benefit from Opdivo (nivolumab). The MHLW additionally granted regulatory approval of the Guardant360 CDx liquid biopsy test as a companion diagnostic for identifying patients with metastatic NSCL cancer who may benefit from treatment with LUMAKRASTM (sotorasib), a KRAS G12C inhibitor developed and manufactured by Amgen.
To be sold in Japan, most medical devices must undergo thorough safety examinations and demonstrate medical efficacy before they are granted approval, or ‘shonin.’ The Japanese government, through the MHLW, regulates medical devices under the Pharmaceutical Affairs Law, or PAL. Oversight for medical devices is conducted with participation by the Pharmaceutical and Medical Devices Agency, or PMDA, a quasi-government organization performing many of the review functions for the MHLW. Penalties for a company’s noncompliance may apply. The MHLW and PMDA also assess the quality management systems of the manufacturer and product conformity to the requirements of the PAL. The company is subject to compliance inspections by these agencies.
The company is subject to federal fraud and abuse laws, such as the federal Anti-Kickback Statute, or AKS, the federal Eliminating Kickbacks in Recovery Act, or EKRA, the federal prohibition against physician self-referral, or Stark Law, and the federal false claims law, or the False Claims Act, or FCA. The company is also subject to similar state and foreign fraud and abuse laws.
Other federal fraud and abuse laws to which the company is subject include, but are not limited to, the federal civil and criminal false claims laws, including the FCA, which imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment to the federal government, and the federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transfer of remuneration to a Medicare or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state healthcare program, unless an exception applies.
In addition, the Physician Payments Sunshine Act imposes, among other things, reporting requirements on manufacturers of certain devices, drugs, and biologics for certain payments and transfers of value by them and, in some cases, their distributors to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors), certain other healthcare providers, such as physician assistants and nurse practitioners, and teaching hospitals, as well as ownership and investment interests held by physicians (as defined by the statute) and their immediate family members. Manufacturers must submit reports by the 90th day of each calendar year. Because the company manufactures its own LDTs solely for use by or within its own laboratory, it is subject to these requirements.
In January 2022, the company received a civil investigative demand, or CID, from the United States Attorney for the Northern District of California in connection with an investigation under the False Claims Act. The CID requests information and documents regarding billing government-funded programs for its panel of genetic tests known as Guardant360. The company is fully cooperating with the investigation.
Research and Development
The company’s research and development expenses were $347.8 million for the year ended December 31, 2024.
History
Guardant Health, Inc. was incorporated in Delaware in 2011.
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