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Grail Galleri cancer test faces coverage uncertainty after study limits
A major study found the Galleri blood test failed to prove it could detect later-stage cancers, adding pressure to win FDA approval to clear Medicare and other insurer coverage.
MarketWatch reports that Grail’s Galleri cancer screening test, which is designed to look for 50 cancers from a blood draw, has coverage uncertainty tied to whether it can secure FDA approval.
According to MarketWatch, a major study did not prove the test could detect later-stage cancers, a result that could affect how Medicare and other health insurers decide whether to pay for it.
The outcome of the FDA approval process will be a key determinant for coverage, MarketWatch adds, given that insurers typically rely on regulatory determinations for reimbursement decisions.