An FDA advisory committee has voted in favor of approving GRAIL’s Galleri multi-cancer early detection (MCED) test, marking a significant regulatory development for blood-based cancer screening. The 10-member Molecular and Clinical Genetics Devices Panel voted 7–2, with one abstention, that the test’s benefits outweigh its risks. The committee voted unanimously in favor of safety and 6–4 in favor of effectiveness.
Galleri uses cancer-specific methylation patterns in blood to detect signals from multiple cancer types and predict the likely tissue of origin. It is designed to be used alongside, rather than replace, existing guideline-recommended screening tests. GRAIL says its clinical studies have detected approximately four to seven times more cancers than standard screening alone, with many detected at earlier stages; these are company-reported findings from its clinical development program.
The FDA is not bound by the advisory committee’s recommendation and is expected to make the final decision on the PMA in the coming months.