An FDA advisory panel meets Wednesday, Sept. 23, to discuss and vote on GRAIL's application for premarket approval of its Galleri blood test, the first time an FDA advisory committee has reviewed such an application for a multi-cancer early detection test. The public docket drew 232 comments before it closed on Sept. 16, according to the Federal Register notice, which also said the agency intended to post background materials no later than two business days before the meeting.
That timing puts a practical question in front of families. For adults 50 and older who are already weighing an out-of-pocket blood test, the panel's discussion turns on two issues: how often a "cancer signal detected" result turns out to be real, and what a clean result actually rules out.
