The FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will meet Sept. 23 to discuss and vote on Grail’s premarket approval application for its Galleri blood test, according to a notice published Aug. 10 in the Federal Register.
Several health systems, including Renton, Wash.-based Providence and St. Louis-based Mercy, have already built patient testing and navigation programs around Galleri without an FDA approval in hand. Medicare does not currently cover the test, though TRICARE added limited coverage in 2025 and CMS and Grail are running a real-world evidence study on Medicare beneficiaries. An approval would be a step toward broader payer coverage.
Here are three things to know:
- The Galleri test is a qualitative, next-generation sequencing-based in vitro diagnostic test designed to detect cancer-specific methylation patterns in cell-free DNA from peripheral whole blood. It is intended to screen for early detection of multiple types of cancer in adults 50 and older.
- The test also predicts the origin of a detected cancer signal. A result showing a signal was detected, including a predicted origin, may indicate an invasive solid tumor or hematologic malignancy and should be followed by a diagnostic workup from a qualified healthcare professional, the FDA said. A result showing no signal detected does not rule out cancer, and patients should continue with guideline-recommended single-cancer screening tests.
- The meeting is open to the public and the FDA is accepting public comments through Sept. 16. Those interested in giving oral testimony must notify the agency by Aug. 28.
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