An outside advisory panel told the U.S. FDA that the benefits of GRAIL's Galleri blood test outweigh its risks for adults aged 50 and older. The panel voted 7-2 with one abstention on benefit, unanimously on safety, and 6-4 on whether evidence established effectiveness. The mixed effectiveness vote highlighted continuing questions about the test's clinical value, but the favorable benefit-risk advisory could support a potentially landmark approval for multi-cancer early detection.
Source: https://aol.com/articles/fda-advisers-back-safety-grails-220516000.html
