FDA officials will consider approval of Grail’s Galleri blood test. A study of nearly 143,000 people missed its primary endpoints, but Grail said annual testing with standard screening increased screen-detected cancers and reduced stage IV cases and emergency presentations.
The study’s primary endpoints called for statistically significant reductions in stage III/IV cancers across 12 pre-specified types. According to Grail, Galleri analyzes blood DNA fragments for cancer signals and tries to identify the likely origin after a positive result; it is intended for use alongside recommended screenings and to target nearly 50 cancer types.
Galleri is already available for purchase. FDA approval, if granted, would allow broader coverage through other payors and Medicare.
