FDA advisory panel to vote on Grail’s Galleri multicancer blood test
An FDA advisory panel is set to vote on recommending Grail's Galleri multicancer blood test, a potential first FDA-authorized multi-cancer screening. While the FDA is not bound by panel guidance, a favorable outcome would increase regulatory validation for the category and strengthen reimbursement prospects via Medicare coverage rules. The news is mainly sector-specific to oncology diagnostics, with limited immediate spillover to broader macro or crypto markets.
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A U.S. FDA advisory panel is set to vote on whether to recommend authorization of Grail’s Galleri blood test, which the company says can detect up to 50 types of cancer and costs $949. The test is under expedited FDA review, and an approval could make it the first FDA-authorized multicancer screening blood test and potentially open the door to insurance reimbursement. Abbott is also pursuing FDA clearance for a competing multicancer test.