FDA advisers back GRAIL’s Galleri test; final decision remains pending

An FDA advisory committee voted in favor of the benefit-risk profile of GRAIL ($GRAL)’s Galleri multicancer early-detection test for adults aged 50 and older. The benefit-risk vote was seven to two, with one abstention. Panel members unanimously supported safety, while the effectiveness assessment passed six to four, showing that the individual questions attracted different levels of support.

The recommendation moves the application forward but does not constitute FDA approval. The agency is not required to follow its advisers, and GRAIL expects a decision in the coming months. Galleri analyzes DNA methylation patterns to identify a cancer signal and its likely origin. It is intended to complement, rather than replace, established screening programs and subsequent diagnostic investigation.

Sources:

• GRAIL — FDA panel results, corporate release reprint