The FDA panel unanimously backed the safety of Grail's Galleri blood-based cancer test, but voted 6-4 that evidence supports its effectiveness. The agency is expected to decide in coming months whether the test can be sold nationwide.
Panel members also voted 7-2 that the test's benefits outweigh its risks, with one abstention. The FDA is not bound by the advisory panel's votes, though it weighs them heavily.
Galleri is designed for adults aged 50 and older and looks for signs of multiple cancers in one blood draw. No other test approved in the U.S. currently screens for many cancer types at once. A U.S. study found it detected 35% of cancers within 12 months and had 99.85% specificity; a British trial showed similar results.
