An FDA Panel Backs a Blood Test for Dozens of Cancers, but Only by a Split Vote
Seven of ten FDA advisers said on Wednesday that the benefits of Grail's Galleri blood test outweigh its risks. Two voted no and one abstained. No test of this kind has FDA approval today, so the vote moves a long-debated idea, one blood draw that hunts for dozens of cancers at once, a real step closer to routine medicine. The margins, though, say more than the headline does.
Start with what was not in doubt. All ten members of the Molecular and Clinical Genetics Devices Panel agreed there is reasonable assurance the Galleri blood test is safe. On whether it works, they split 6 to 4. On the overall balance of benefit and risk for adults 50 and older, the result was 7 to 2 with one abstention. These are recommendations. The FDA does not have to follow them, though it usually does, and it...