FDA APPROVED FOR COLON
CANCER SCREENING

Guardant Health
Annual Notice

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 855-722-7335 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 entire TRF enables appropriate determination of coverage for rendered services.

Medicare Coverage Determinations

Shield™ is FDA approved for CRC cancer screening and meets the coverage criteria for Medicare defined in NCD 210.3. 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 that are applicable to the testing that is being ordered.

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 855.722.7335.

Test Ordering

Colorectal cancer screening

Guardant Health Screening offers the following FDA approved test performed in our CLIA certified, CAP accredited laboratory:

The Shield™ test is a qualitative, in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Shield Blood Collection Kit. Shield is indicated for colorectal cancer screening in individuals at average risk for the disease, age 45 years or older. Patients with a positive result should be followed by colonoscopy. Shield is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals. This test is performed at Guardant Health, Inc.

To order the Shield test, the requisition or online order must be fully completed and signed by the ordering provider or other authorized medical professional. The order can be placed through the Guardant Health online portal at OrderShield.com.

Multicancer detection

Providers can opt in to receive a multicancer detection results report, in addition to the FDA-approved CRC results, by checking the appropriate box on the requisition form. A positive MCD result indicates that additional medical evaluation may be appropriate to determine whether the abnormal signal detected by the test could be derived from another cancer. The “Cancer Signal of Origin Prediction” provides information about the cancer type or organ that may be associated with the positive result. No additional testing is performed; a bioinformatic analysis provides these MCD results.

The cancer types evaluated include: bladder, breast, colorectal, esophageal/gastric (also called stomach), liver (also called hepatocellular), lung, ovarian, pancreatic, and prostate. This analysis is intended for individuals 45 years of age or older, without a known diagnosis of cancer. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA).

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

In some circumstances, 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. In the event that a specimen is forwarded to a reference laboratory, the final report will list the name and address of the reference laboratory.

Custom Profiles

Guardant Health does not offer custom profiles to ordering physicians.

Martina Lefterova, MD PhD
Laboratory Director

Important Product Information

Intended Use

The Shield™ test is a qualitative, in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Shield Blood Collection Kit.
Shield is intended for colorectal cancer screening in individuals at average risk for the disease, age 45 years or older. Patients with a positive result should be followed by colonoscopy. Shield is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals. This test is performed at Guardant Health, Inc.

Precaution: Based on data from clinical studies, Shield has limited detection (55%-65%) of Stage I colorectal cancer and does not detect 87% of precancerous lesions. One out of 10 patients with a negative Shield result may have a precancer that would have been detected by a screening colonoscopy. Shield demonstrated high detection of Stages II, III, and IV colorectal cancer.

Limitations and Other Important Information: The Shield test is not indicated for patients that have personal history of colorectal cancer, adenomas, or other related cancers; or those who had a positive result on another colorectal cancer screening method within the last six months, have been diagnosed with a condition associated with high risk for colorectal cancer such as Inflammatory Bowel Disease (IBD), chronic ulcerative colitis (CUC), Crohn’s disease; or who have a family history of colorectal cancer, or certain hereditary syndromes. Providers should discuss the most appropriate screening test to use with patients depending on their medical history and individual circumstances. Shield may produce a false negative or false positive result. A false negative result may occur when the Shield test does not detect a colorectal tumor signal while a colonoscopy identifies a colorectal cancer. A negative result does not guarantee the absence of colorectal cancer or advanced adenoma, and patients should continue participating in colorectal cancer screening programs at the appropriate guideline-recommended intervals. A false positive result may occur when the Shield test generates a positive result while a colonoscopy will not find colorectal cancer or advanced adenoma.

Please read our Provider Brochure for complete product information about the Shield test including full safety information.

*The USPSTF is an independent advisory body that issues evidence-based recommendations for preventive services. Cancer screenings that receive an A or B grade from the Task Force are covered with $0 cost-sharing for insured patients.

||Shield™ is a qualitative laboratory-developed test intended to detect colorectal cancer, currently under review for FDA approval.

Centers for Medicare and Medicaid Services (CMS) NCD 210.3, Colorectal Cancer Screening Tests, includes coverage for blood-based biomarker tests that meet certain performance characteristics

†The Agency for Health Care Quality and Research (AHRQ) provides support for the USPSTF.

‡President Biden’s Fiscal Year 2024 budget proposal included $18.0 million for AHRQ for its administration of the USPSTF, an increase of $6.5 million over the FY2023 enacted level.

  1. References:
  2. Kim ST, Raymond VM, Park JO, et al. Combined genomic and epigenomic assessment of cell-free circulating tumor DNA (ctDNA) improves assay sensitivity in early-stage colorectal cancer (CRC). Cancer Res. 2019;79(suppl 13):916. doi:10.1158/1538-7445.AM2019-916
  3. Westesson O, Axelrod H, Dean J, et al. Integrated genomic and epigenomic cell-free DNA (cfDNA) analysis for the detection of early-stage colorectal cancer. Cancer Res. 2020;80(suppl 16):2316. doi:10.1158/1538-7445.AM2020-2316
  4. Data on file. Guardant Health, Inc.
  5. Guardant Health reaches target enrollment of 12,750 patients in ECLIPSE pivotal study for its LUNAR™-2 blood test to detect colorectal cancer. News release. Guardant Health, Inc; December 17, 2021. Accessed March 17, 2022. https://investors.guardanthealth.com/press-releases/press-releases/2021/Guardant-Health-Reaches-Target-Enrollment-of-12750-Patients-in-ECLIPSE-Pivotal-Study-for-its-LUNAR-2-Blood-Test-to-Detect-Colorectal-Cancer/default.aspx
  6. US Food and Drug Administration. Guardant360® CDx approval letter. August 2020. https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200010A.pdf. Accessed March 18, 2022.
  7. American Society of Clinical Oncology. Colorectal cancer: statistics. Cancer.net website. Updated January 2021. Accessed May 10, 2021. https://www.cancer.net/cancer-types/colorectal-cancer/statistics
  8. Adler A, Geiger S, Keil A, et al. Improving compliance to colorectal cancer screening using blood and stool based tests in patients refusing screening colonoscopy in Germany. BMC Gastroenterol>. 2014;14:183. doi:10.1186/1471-230X-14-183