GRAIL’s Galleri multi-cancer blood test received a favorable recommendation from an FDA advisory panel on September 23, 2026.
The panel voted 10–0 that Galleri was reasonably safe, 6–4 that there was reasonable assurance it was effective, and 7–2—with one abstention—that its benefits outweighed its risks for adults aged 50 and older.
The vote is a major step toward approval, particularly because Galleri aims to detect multiple cancers, including cancers without routine screening methods.
However, the effectiveness vote was closely divided, and panelists raised concerns about limited evidence, false positives, and false reassurance.
The FDA is not bound by the advisory committee’s recommendation. It is expected to issue a final decision on GRAIL’s premarket approval application in the coming months.
Galleri is already available in the U.S. by prescription as a laboratory-developed test and reportedly costs about $949; FDA approval could support broader adoption and potential insurance coverage.
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