Guardant Health
32 named things its latest annual report says its results depend on, each in the company's own words. 17 of them are also named by other companies we've read.
Customers
Medicare
earns from · more than 10% of our total revenuenamed as a riskRevenue attributable to Medicare accounted for more than 10% of our total revenue in each of the years ended December 31, 2025, 2024 and 2023.Risk factors (Item 1A)
Also named by ABT, ARWR, AXGN, BAX, BDX, BMY, BSX, CAH and 48 more
Top five biopharmaceutical customers
earns from · 11%, 13% and 14% of our total revenuenamed as a riskIn 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.Risk factors (Item 1A)
Commercial payers
concentrated innamed as a riskWe receive a substantial portion of our revenue from a limited number of third-party commercial payers, most of which have not contracted with us to be a participating provider.Risk factors (Item 1A)
Also named by TEM
Anthem
subject tonamed as a riskAlthough 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.Risk factors (Item 1A)
Aetna
subject tonamed as a riskAlthough 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.Risk factors (Item 1A)
Humana
subject tonamed as a riskAlthough 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.Risk factors (Item 1A)
Suppliers
Illumina, Inc.
depends onnamed as a riskWe rely on Illumina as the sole supplier of the sequencers and as the sole provider of maintenance and repair services for these sequencers.Risk factors (Item 1A)
Third-party phlebotomy providers
depends onnamed as a riskWe rely on third-party phlebotomy providers, including physician offices, to collect blood samples for our tests.Risk factors (Item 1A)
Commercial courier delivery services
depends onnamed as a riskDisruptions in delivery services to transport samples to that facility, whether due to labor disruptions, bad weather, natural disaster, terrorist acts or threats or for other reasons could adversely affect specimen integrity and our ability to process samples in a timely manner, delay our provision of test results to our customers, and ultimately our reputation and our business.Risk factors (Item 1A)
Partners and platforms
Vall D'Hebron Institute of Oncology (VHIO)
depends onIn December 2020, we signed our first public private partnership agreement with Vall D'Hebron Institute of Oncology, or VHIO, one of Europe’s leading cancer research institutions, and in May 2022, the first blood-based cancer testing services in Europe based on our digital sequencing platform became available at the VHIO testing facility in Spain.Business (Item 1)
Adicon Holdings Limited
depends onIn 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.Business (Item 1)
Other companies
TwinStrand Biosciences, Inc.
named as a riskFor instance, TwinStrand Biosciences, Inc. and the University of Washington filed a lawsuit for patent infringement against us in August 2021 and a jury verdict was entered against us in November 2023.Risk factors (Item 1A)
Competitors
Exact Sciences Corporation
competes withnamed as a riskAdditionally, our competitors in the early screening testing space include GRAIL, Inc., Exact Sciences Corporation, Freenome Holdings, Inc., and Delfi Diagnostics.Risk factors (Item 1A)
Also named by ABT
Foundation Medicine, Inc.
competes withnamed as a riskOur 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.Risk factors (Item 1A)
Natera, Inc.
competes withnamed as a riskIn 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.Risk factors (Item 1A)
Places
Redwood City, California
concentrated in · the majority of our revenuenamed as a riskWe currently derive the majority of our revenue from tests performed at a single laboratory facility located in Redwood City, California.Risk factors (Item 1A)
Hazards
Earthquake
operates innamed as a riskOur 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.Risk factors (Item 1A)
Also named by A, ADBE, AEE, ARE, ARES, BLK, CDNA, CRC and 11 more
Regulators
U.S. Food and Drug Administration (FDA)
subject tonamed as a riskIf there are changes in FDA policy, or if the FDA disagrees that we are marketing our tests as LDTs within the scope of its policy of enforcement discretion, we may become subject to extensive regulatory requirements and may be required to stop selling our existing tests or launching any other tests we may develop and to conduct additional clinical studies or take other actions prior to continuing to market our tests.Risk factors (Item 1A)
Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more
Centers for Medicare & Medicaid Services (CMS)
subject tonamed as a riskIf this exception is repealed or curtailed by CMS, or the laboratory date of service regulation is otherwise changed to adversely impact our ability to bill Medicare directly, our revenue could be materially reduced.Risk factors (Item 1A)
Also named by A, ABT, AMGN, AXGN, BAX, BWIN, CNC, COO and 23 more
New York State Department of Health (NYSDOH)
subject tonamed as a riskTo the extent NYSDOH identified any non-compliance and we are unable to implement satisfactory corrective actions to remedy such non-compliance, the State of New York could withdraw approval for our tests.Risk factors (Item 1A)
College of American Pathologists (CAP)
subject tonamed as a riskFailure to maintain CAP accreditation could have a material adverse effect on the sales of our tests and the results of our operations.Risk factors (Item 1A)
Japan Ministry of Health, Labour and Welfare (MHLW)
subject toIn addition, in July 2023, the MHLW granted national reimbursement approval for our Guardant360 CDx test for patients with advanced or metastatic solid tumor cancers in Japan.Business (Item 1)
Palmetto GBA (MolDX)
subject toIn 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.Business (Item 1)
Also named by TEM
Noridian Healthcare Solutions
subject toIn May 2020, Noridian issued a coverage article and confirmed limited Medicare coverage for our Guardant360 test for qualifying patients diagnosed with solid tumor cancers of non-central nervous system origin who meet the criteria of Medicare’s National Coverage Determination for Next Generation Sequencing established in March 2018.Business (Item 1)
Also named by CDNA
Laws and programs
State biomarker testing coverage laws
subject to · 23 statesAs 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.Business (Item 1)
False Claims Act
subject tonamed as a riskIn January 2022, we 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.Business (Item 1)
Also named by ACN, ASTS, CDW, CHE, CI, CVS, DGX, FLR and 13 more
Clinical Laboratory Improvement Amendments (CLIA)
subject tonamed as a riskWe have a current CLIA certification to perform our tests at our laboratory in Redwood City, California.Risk factors (Item 1A)
EU In Vitro Diagnostic Regulation (IVDR)
subject tonamed as a riskThese 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.Risk factors (Item 1A)
Protecting Access to Medicare Act of 2014 (PAMA)
subject tonamed as a riskWe are subject to reporting requirements under PAMA and the Medicare rate for our tests will be calculated based on our private payer rates.Business (Item 1)
FDA companion diagnostic reclassification proposal
subject tonamed as a riskIf companion diagnostics are down-classified, regulatory barriers to entry may be reduced, potentially increasing competition from new and existing diagnostic developers and leading to pricing pressure, reduced market share, or the need for increased investment to maintain differentiation.Risk factors (Item 1A)
TRICARE
earns fromAdditionally, our Shield blood test has received coverage for patients receiving community care authorized by the U.S. Department of Veterans Affairs and for active-duty service members and their families through TRICARE, the U.S. military’s health insurance coverage, with no copay for average-risk individuals ages 45 and older.Business (Item 1)
Also named by CI
Medicare National Coverage Determination for Next Generation Sequencing
subject toEffective August 7, 2020, our Guardant360 CDx test obtained national coverage under the NGS NCD consistent with its FDA-approved indications.Risk factors (Item 1A)