A panel of outside experts advising the U.S. Food and Drug Administration voted Wednesday, Sept. 23, that the benefits of Galleri, a blood test that screens for signals from many types of cancer, outweigh its risks for adults 50 and older. The panel was more divided on the question that matters most to patients, whether the test works well enough. That vote was 6 to 4.
The panel also voted 10 to 0 that there is reasonable assurance the test is safe and 7 to 2, with one abstention, that its benefits outweigh its risks, STAT reported. The votes are recommendations only. The FDA is not bound by them and has not decided whether to approve Galleri, which is the furthest along of the multi-cancer blood tests seeking agency approval.
