FDA Advisory Panel Recommends Approval of First Multi-Cancer Blood Test
An independent panel of experts has cautiously recommended approval of Grail's Galleri test, which the company says can detect up to 50 forms of cancer.
An FDA advisory panel has recommended approval of what would be the first multi-cancer blood test to reach the market, according to a report from NPR.
The test, called Galleri, is made by the company Grail, which says it can detect signals associated with up to 50 forms of cancer from a single blood draw. An independent panel of experts reviewed the available evidence and issued a cautious recommendation in favor of approval.
A Cautious Endorsement
The panel's recommendation reflects careful consideration of the test's potential benefits for early cancer detection, balanced against questions that remain about its accuracy and real-world performance across different cancer types. Multi-cancer early detection tests represent a new and closely watched category within cancer screening.
The report does not specify when the FDA is expected to issue a final decision on approval, though the panel's recommendation marks a significant step toward the test potentially becoming available to patients.
Sources
EGazette summarizes reporting from multiple sources; follow the links for the originals.
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