A blood draw that looks for dozens of cancers at once sounds like a screening revolution. The harder question begins after the result arrives.
On September 23, the FDA's Molecular and Clinical Genetics Devices Panel voted 10 to 0 that GRAIL's Galleri test is safe, 6 to 4 that it is effective, and 7 to 2, with one abstention, that its benefits outweigh its risks for adjunct screening in adults aged 50 and older. The recommendation is consequential, but it is not approval. FDA still has to decide the premarket approval application.
