FDA Advisory Panel Meets to Vote on Grail's Galleri Multi-Cancer Blood Test
An FDA advisory committee met on September 23, 2026, to vote on whether the agency should approve the Galleri blood test, made by Grail, which the company says can detect up to 50 types of cancer with a single blood draw. The panel of independent experts heard from Grail, FDA officials, and the public before issuing a recommendation that the FDA is not required to follow. FDA approval would open the door to Medicare reimbursement and is widely seen as a bellwether for the multi-cancer early detection industry.
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The Galleri test is the first multi-cancer blood test to reach this stage of the FDA approval process, drawing attention from patients, physicians, and competing companies across the industry. Approval would make Galleri eligible for Medicare coverage, a pathway Congress established specifically for multi-cancer detection tests cleared by the agency. The test currently costs $949.
The FDA's advisory committee reviewed two major clinical studies supporting Galleri: one involving more than 140,000 patients enrolled through the United Kingdom's National Health Service, and another of more than 35,000 North American patients all over the age of 50. The interpretation of those studies has been a central point of discussion among scientists.
Neither study met its primary endpoints. Galleri did not demonstrate an overall reduction in mortality, nor a reduction in combined Stage III and IV cancer diagnoses over the three-year study period. However, in a subsequent update to the NHS study, Grail reported that Stage IV cancer diagnoses — considered separately from Stage III — did decrease, suggesting the test may have shifted diagnoses to earlier stages.