FDA Advisory Panel Endorses Grail Galleri Multi-Cancer Blood Test
An FDA advisory panel has favorably recommended Grail Inc.'s Galleri blood test, marking the first time a federal advisory group has endorsed a multi-cancer detection test. The Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted on the test's safety, effectiveness, and overall benefit-risk profile for adults aged 50 and older. The panel voted 7-2, with one abstention, that the test's benefits outweigh its risks, and unanimously supported its safety. However, the vote on effectiveness was split 6-4 in favor. The FDA's advisory panels provide input, but their recommendations are not binding. A definitive decision on Galleri's nationwide commercial availability is expected within the next few months. The Galleri test screens for multiple cancer types from a single blood draw by detecting cancer-specific methylation patterns in cell-free DNA. It is designed to predict the origin of a cancer signal to guide further diagnostic evaluation and is intended to complement, not replac...
