STAT+: FDA advisory panel endorses Grail blood test for cancer, saying benefits outweigh risks

An FDA advisory panel on Wednesday endorsed Galleri, a blood test developed by biotech firm Grail to screen for multiple types of cancer, after concluding that the benefits of the test outweighed its risks. The panel voted 10 to 0 that it believed there is “reasonable assurance” the test is safe.

It voted 6 to 4 that there was reasonable assurance the test is effective, and voted 7 to 2 with one abstention that “the benefits of Galleri outweigh the risk for use in patients who meet the criteria specified in the proposed indication.” The FDA is not obliged to follow the advice of these panels, but it often does.