2025 Annual Notice to Physicians

This letter serves as an annual notice on updates regarding the ordering and processing of clinical laboratory tests performed by Guardant Health, Inc. Guardant may update you more than once a year if there are material changes to the testing panel, such as FDA approval or a new product release.

Please review the attached information in this notice and contact Client Services at 855.698.8887 if you have any questions.

Medical Necessity

Medicare pays for services that are reasonable and necessary and meet specified Medicare coverage criteria for the beneficiary’s unique medical condition.

As a participating Medicare provider, Guardant Health has the responsibility to make good faith efforts to ensure that all tests requested are performed and billed in a manner that is consistent with federal and state statutes and regulations. The OIG takes the position that ordering providers authorized by law to order clinical laboratory tests for Medicare beneficiaries share the burden of ensuring that only medically necessary services are ordered and billed to Federally funded programs. Providers who submit false claims may be subject to sanctions or remedies available under civil and administrative law. 

Guardant attempts to have a comprehensive set of attestations on the Test Requisition Form (TRF) to determine the coverage status for Medicare services. Completion of the “Relevant Clinical History” section of the TRF enables appropriate determination of coverage for rendered services.

Medicare Coverage Determinations

Services rendered by Guardant Health are typically documented in either Local Coverage Determinations (LCDs) or National Coverage Determinations (NCDs). LCDs and NCDs have sections describing what medical conditions are covered and the ICD-10 codes that are covered. All clinical orders sent to Guardant Health must include at least one ICD-10 code and should include all appropriate ICD-10 codes which describe the patient’s unique medical condition.

Advance Beneficiary Notice of Noncoverage (ABN)

Not all services are covered by Medicare. For services that do not meet the coverage criteria established by Medicare, prior notice to a patient and completion of an ABN by the patient is required before completing the test. This will document the patient’s understanding that the services may not be covered by Medicare and the patient assumes the responsibility for payment in the event services are not covered. To facilitate the above notice requirement, our reimbursement team will reach out to the patient within 1-2 business days of receiving their specimen to get the ABN signed. 

Clinical Consultant

Guardant Health offers clinical consulting by our Laboratory Directors. Discussions related to appropriate testing and test ordering as well as questions related to the reports may be scheduled by Client Services at 855.698.8887.

Test Ordering

Guardant Health offers a comprehensive set of cancer tests that aim to support clinical decision making across a cancer patient’s treatment journey. One of the tests is approved by the FDA while others are offered as laboratory developed tests performed (LDT) in our CLIA-certified, CAP-accredited laboratories. Details on ordering can be found at GuardantComplete.com/Ordering.

Guardant360® CDx (FDA-approved) is a next generation sequencing (NGS)-based test for the detection of somatic genetic alterations in advanced cancer. The test analyzes 74 genes and is FDA-approved to report variants in 55 genes and as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed here. Additionally, the test is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with any solid malignant neoplasm. Additional genomic findings may be reported in a professional services report and are not prescriptive or conclusive for labeled use of any specific therapeutic product. 

Guardant360® Liquid is a next generation sequencing (NGS)-based liquid biopsy, powered by the Guardant Infinity platform, and intended to provide comprehensive tumor genomic profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with advanced-stage solid malignancies. This laboratory developed test (LDT) has not been cleared or approved by the FDA.

  • Leveraging the multiomic capabilities of Guardant Infinity, Guardant360 Liquid assesses a range of new biomarkers, including molecular tumor typing and subtyping, confirmation of the absence of actionable biomarkers associated with FDA approved therapies, oncology-relevant pharmacogenomic results, EBV/HPV viral status in select tumor types, and therapy predictors to give clinicians critical insights to guide optimal treatment. Further information can be found here. 
  • In select circumstances, if no alterations with associated FDA-approved therapies were identified on a patient’s Guardant360 CDx report, Guardant360 Liquid may be helpful in the patient’s further evaluation. Confirmation of medical necessity is required by signing a confirmatory Test Requisition Form after the Guardant360 CDx results are delivered*. Providers can opt out from this testing cascade by checking the appropriate box on the Guardant Health TRF. This additional testing is not recommended if no tumor-related somatic alterations were detected in this patient’s sample, which may indicate low levels of circulating tumor-derived cell-free DNA (ctDNA).

Guardant360® Tissue is a tissue-based multiomic NGS test built on the same platform as Guardant360 Liquid. Guardant 360 Tissue RNA is a tissue-based NGS test for detection of >300 fusions and splice site variants.  

  • If Guardant360 Tissue is ordered alongside Guardant360 CDx, a confirmatory Test Requisition Form will be required to attest medical necessity after the Guardant360 CDx results are delivered.*
  • If Guardant360 Tissue is ordered alongside Guardant360 LDT, the liquid biopsy test will automatically be converted to Guardant360 CDx.
  • Providers can opt out from Guardant360 Tissue RNA by checking the “Remove Tissue RNA” box on the Guardant Health TRF.
  • An expanded immunohistochemistry (IHC) menu is now available, alongside the Guardant360 Tissue order, and may be selected by checking the appropriate boxes on the Guardant Health TRF.

Guardant Reveal® is a liquid biopsy assay for tissue-independent detection and quantification of ctDNA for recurrence monitoring in patients with early-stage cancer following curative-intent therapy, as well as for therapy response monitoring in patients with advanced cancer. 

  • The recurrence monitoring indication is available for patients with early-stage and oligometastatic colorectal cancer, breast cancer, or non-small cell lung cancer. Providers can choose to submit samples as a one-time order or part of a program:
    • post-surgery program: up to three test bundle to be initiated 3-13 weeks after curative-intent therapy
    • surveillance program: guideline-based cadence, every 3 months, or every 6 months (for details on the guideline-based cadences, please visit www.GuardantComplete.com/Ordering).
    • Providers are offered the option to test available blood samples from qualifying** positive Reveal samples (indicative of recurrent disease) on Guardant360 Liquid for ease of obtaining comprehensive genomic profiling. This process is automatically included for qualifying** samples but providers can opt out on the Guardant Health TRF.
  • The therapy response monitoring indication is available for all patients with advanced stage solid tumors undergoing treatment. Providers can choose to submit samples at a standard cadence of every 3 months or at a custom cadence.
    • In the event that Guardant Reveal reports increasing tumor fraction relative to the prior time point qualifying it as molecular progression**, a confirmatory test requisition form will be provided to indicate whether to conduct comprehensive genomic profiling with Guardant360 Liquid on available blood samples.

Guardant Testing Programs: providers can order liquid and tissue comprehensive genomic profiling, including PD-L1 IHC, and measurement of treatment response with a single checkbox. Signing of confirmatory TRFs may be required to affirm the medical necessity for the test(s).

Guardant Hereditary Cancer is a next-generation sequencing test that identifies germline variants associated with hereditary cancer predisposition across 82 genes. The test can be ordered as an add-on to Guardant’s liquid biopsy tests or Guardant 360 Tissue, or as a standalone order, if the patient’s diagnosis is among the eligible guideline-recommended tumor types. 

In certain localities, a given Guardant Health test may not be approved (e.g., New York State). If the test is ordered in those regions, Guardant Health may change the order to a version that is approved (if available), which may not include some features ordered by the provider. Alternatively, Guardant Health may cancel the ordered test. The ordering provider will be notified.

Test Reporting

While Guardant Health will issue a Guardant360 CDx report that includes both an FDA-approved Content section and a Professional Services section, in some cases as noted below, Guardant Health may only issue the Professional Services report. This process is anticipated to be performed in a small percentage of cases (<5%). Examples of when this process change occurs include cases where the metrics used for Guardant360 CDx are not met but are acceptable within the scope of a CLIA laboratory developed test (LDT). In these cases, the same reagents, processes, and bioinformatics pipeline will be used for the LDT test as would otherwise have been used with the CDx test, but with the application of slightly different acceptance criteria and reporting of the results. 

In some circumstances, for example when immunohistochemistry and/or germline testing is ordered, Guardant Health may forward the specimen to another laboratory, certified under the Clinical Laboratory Improvement Act of 1988 (CLIA) and licensed in all applicable localities. If a specimen is forwarded to a reference laboratory, the final report will list the name and address, and directorship of the reference laboratory.

Custom Profiles

Guardant Health does not offer custom profiles to ordering physicians.

Martina Lefterova, MD PhD 

Laboratory Director

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*Patients who have a negative Guardant360 CDx test result for an indicated companion diagnostic biomarker should be reflexed to tissue biopsy testing using an FDA approved tumor tissue test.

**For current details regarding qualifying samples for this reflex option, please see here.