FDA advisers back GRAIL’s Galleri test in 7-2 vote

The U.S. Food and Drug Administration’s Molecular and Clinical Genetics Panel recommended on September 23 that Galleri, GRAIL’s multicancer blood test, has benefits that outweigh its risks for the proposed screening population. The vote was 7-2, with one abstention. The recommendation is nonbinding, and the FDA must still decide whether to approve the test. Advisers also voted 10-0 that there was reasonable assurance Galleri is safe and 6-4 that it is effective. Those were separate votes on the proposed use, not an authorization to market the test. The FDA has not announced when it will decide on GRAIL’s premarket approval application. Galleri is proposed as a prescription screening test for adults aged 50 and older. It analyzes patterns in cell-free DNA from a blood sample to look for signals associated with multiple cancers and can indicate where a signal may have originated. Under the proposed use, a detected signal would prompt further diagnostic evaluation by a health professional. The test would supplement, not replace, recommended screening for individual cancers. A result showing no cancer signal does not rule out cancer.