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Guardant Health Receives Medicare Coverage for MRD Liquid Biopsy in Stage II and III Colon Cancer

NEW YORK – Guardant Health said Tuesday that Medicare administrative contractor Palmetto GBA has granted coverage for its liquid biopsy residual cancer detection test, Guardant Reveal.

The assay is designed to detect circulating tumor DNA in the blood of early-stage cancer patients after surgery, to help oncologists identify individuals with residual or recurring disease who may benefit the most from adjuvant therapy. Unlike competitors that use tissue-based sequencing data to inform the design of patient-specific panels, it is a blood-only, fixed panel test.

Palmetto, and other contractors who have aligned their policies with the MAC, will now cover the cost of the test for Medicare patients with stage II or III colorectal cancer whose testing is initiated within three months following curative intent therapy.

The MAC finalized a local coverage determination late last year for blood tests that detect residual disease in solid tumor patients. Under the LCD, tests must undergo a technical assessment to confirm analytical and clinical validity and clinical utility, and to establish the test as reasonable and necessary.