An expert panel advising the U.S. Food and Drug Administration (FDA) voted that the benefits of GRAIL’s Galleri multi-cancer screening test outweigh its risks. The panel considered the test for adults aged 50 and older, using a single blood sample to screen for multiple cancer types.
Reuters reported that the panel voted 10–0 in favour of the test’s safety and 6–4 in support of its effectiveness. Members voted 7–2, with one abstention, that the benefits outweighed the risks.
The vote is not FDA approval. The panel’s recommendation is advisory, and the FDA will make the final decision. The panel also stressed that a negative result does not rule out cancer and that Galleri should not replace established screening such as mammograms or colonoscopies.
Sources: Reuters; FDA advisory committee documents.