On August 2, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported 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 (Press release, Guardant Health, AUG 2, 2022, View Source [SID1234617303]). Guardant Reveal is a blood test that detects circulating tumor DNA (ctDNA) in blood after surgery to help oncologists identify cancer patients with residual or recurring disease who may benefit most from adjuvant therapy. It is the first blood-only liquid biopsy test available for MRD testing in patients with colorectal cancer (CRC).
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The decision means Guardant Reveal is covered for fee-for-service Medicare patients in the United States with stage II or III CRC whose testing is initiated within three months following curative intent therapy. "We are pleased that Medicare has taken this important step to make MRD testing more widely available and help oncologists make more informed treatment decisions for their 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 first liquid biopsy to be broadly covered for use across the vast majority of advanced solid tumors. In March 2022, Palmetto GBA also conveyed coverage for Guardant360 TissueNext, the company’s first tissue-based test to help oncologists identify patients with advanced cancer who may benefit from biomarker-informed treatment.