FDA advisory panel will vote on Grail’s Galleri multi‑cancer blood test, which claims to detect up to 50 cancers, amid mixed trial results and industry interest.
A key FDA advisory committee is meeting to vote on whether to recommend approval of Grail’s Galleri blood test, which the company says can detect up to 50 cancer types. The panel will hear testimony from Grail, FDA officials and the public before casting its recommendation; the agency is not required to follow the panel’s advice, but often does. Approval could enable insurance reimbursement for the $949 test and would be the first multi‑cancer screening test cleared by the FDA.
The FDA has outlined questions about the test’s clinical data, focusing on whether it reliably detects cancers early enough to justify its marketing claims and what harms might arise from false‑positive or false‑negative results. The committee will review two large studies—one with more than 140,000 UK National Health Service participants and another with over 35,000 North American participants aged 50 and older. The studies did not meet their primary endpoints of overall mortality reduction or combined Stage III/IV cancer reduction, though later NHS data suggested a decrease in Stage IV diagnoses.
Cristian Tomasetti, director of early‑detection at City of Hope, noted that the trials missed ambitious short‑term goals but argued that longer‑term data are needed to assess whether regular testing shifts diagnoses to earlier stages. He said the FDA appears poised to approve Galleri. Oncologist Tom Beer, chief medical officer for Abbott Cancer Diagnostics, echoed optimism, citing the lack of screening for many lethal cancers such as pancreatic cancer.
The panel’s vote will determine whether the advisory committee recommends FDA approval, but the final decision remains uncertain pending the committee’s recommendation.