FDA panel recommends benefits of Grail's Galleri cancer blood test outweigh risks

An FDA advisory panel has recommended that the benefits of Grail Inc.’s Galleri multi-cancer early detection (MCED) blood test outweigh its risks for adults aged 50 and older. In a vote on September 23, 2026, the panel's Molecular and Clinical Genetics Devices Committee voted 7-2, with one abstention, in favor of the test's benefit-risk profile.

The panel reached a unanimous decision regarding the test's safety, though votes on its effectiveness were more divided, with a 6-4 split. The Galleri test works by analyzing DNA methylation patterns in cell-free DNA from a single blood draw to identify potential cancer signals and their likely origin. It is intended to supplement, rather than replace, existing standard screenings like mammograms or colonoscopies.

While the panel's recommendation is nonbinding, it represents a significant step toward potential FDA approval. Such approval could lead to widespread adoption and coverage by Medicare and private insurers. Currently, the test is available in the U.S. primarily through out-of-pocket payments. Medical experts noted that while the technology is promising, further research is needed to address concerns regarding false positives and the clinical value of chasing detected signals.