- GRAIL's Galleri multi-cancer early detection test won a favorable FDA advisory committee vote: 7-2 with one abstention on overall benefit-risk, unanimous on safety, and 6-4 on effectiveness.
- The FDA is not bound by the committee's recommendations and is expected to make a final decision on the Galleri PMA in the coming months.
- GRAIL submitted its PMA application for Galleri to the FDA on Jan. 29, 2026; it is the first PMA submission for a multi-cancer early detection test.
- In clinical studies, Galleri detected approximately four to seven times more cancers compared to standard of care alone, with most Galleri-detected cancers found at earlier stages and a low false-positive rate.
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“Today's vote reinforces the strength of Galleri's clinical evidence. We believe the panel's recommendations reaffirm a high evidence bar that GRAIL has set for a multi-cancer early detection test.”
“The Galleri test was developed to improve the effectiveness and efficiency of our national cancer screening program by adding multi-cancer early detection to recommended screening—helping find more cancers safely, when they may be easier and less costly to treat, and it still may be possible for a patient to receive treatment with curative intent”