An FDA advisory committee voted in favor of GRAIL's Galleri multicancer early detection test, a significant step toward premarket approval and wider accessibility. The Molecular and Clinical Genetics Panel of the Medical Devices (MCGP) advisory committee discussed the test's risk-benefit profile, considering data from the NHS-Galleri and PATHFINDER 2 studies.
The panel addressed three key questions: safety, effectiveness, and whether benefits outweigh risks. For safety, the vote was 10 to 0 in favor. For effectiveness, the vote was 6 to 4 in favor. For the overall benefit-risk assessment, the panel voted 7 to 2 in favor, with one abstention. This positive outcome brings GRAIL closer to FDA approval, which would open the door for Medicare and private insurance coverage, potentially lowering the current out-of-pocket cost, which can be $700 or more.
The Galleri test is designed for adults aged 50 or older for the early detection of multiple cancer types and the prediction of Cancer Signal Origin. While promising, the test has limitations: it's not a substitute for existing recommended single-cancer screenings, a "no cancer signal detected" result doesn't rule out cancer, and a "cancer signal detected" result requires further diagnostic testing. The test may also produce false positives or false negatives, and the benefits and risks of programmatic screening are still under study. In the PATHFINDER 2 study, the test had a cancer detection rate of 0.54%, a positive predictive value of 60.3%, and a specificity of 99.64%.
