Guardant Health Receives Medicare Coverage for Guardant Reveal™ Test

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PALO ALTO, Calif.–(BUSINESS WIRE)–Guardant Health, Inc. (Nasdaq: GH), a number one precision oncology company, announced today that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), has conveyed coverage for the Guardant Reveal™ molecular residual disease (MRD) test. Guardant Reveal is a blood test that detects circulating tumor DNA (ctDNA) in blood after surgery to assist oncologists discover cancer patients with residual or recurring disease who may profit most from adjuvant therapy. It’s the primary blood-only liquid biopsy test available for MRD testing in patients with colorectal cancer (CRC).

The choice means Guardant Reveal is roofed for fee-for-service Medicare patients in america with stage II or III CRC whose testing is initiated inside three months following curative intent therapy. “We’re pleased that Medicare has taken this essential step to make MRD testing more widely available and help oncologists make more informed treatment decisions for his or her patients with colorectal cancer,” said Helmy Eltoukhy, Guardant Health co-CEO.

Medicare’s policy decision adds to the coverage of Guardant Health tests for cancer patients. In December 2019, Palmetto GBA expanded local coverage determination (LCD) of the Guardant360® assay, making it the primary liquid biopsy to be broadly covered to be used across the overwhelming majority of advanced solid tumors. In March 2022, Palmetto GBA also conveyed coverage for Guardant360 TissueNext™, the corporate’s first tissue-based test to assist oncologists discover patients with advanced cancer who may profit from biomarker-informed treatment.

About Guardant Health

Guardant Health is a number one precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive business adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the commercially launched Shield™ test, goals to handle the needs of people eligible for cancer screening. For more information, visit guardanthealth.com and follow the corporate on LinkedIn and Twitter.

Forward-Looking Statements

This press release incorporates forward-looking statements throughout the meaning of federal securities laws, including statements regarding the potential utilities, values, advantages and benefits of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that would cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements attributable to various aspects. These and extra risks and uncertainties that would affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made on this press release include those discussed under the captions “Risk Aspects” and “Management’s Discussion and Evaluation of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the yr ended December 31, 2021, and any current and periodic reports filed with the Securities and Exchange Commission thereafter. The forward-looking statements on this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is predicated, except as required by law. These forward-looking statements shouldn’t be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

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