Aug 7 (Reuters) – Grail said on Friday the U.S. FDA plans to hold a meeting of outside experts to review its multi-cancer screening test Galleri in September, sending its shares up 4% in morning trade.
The panel will review Grail’s request for premarket approval, the Food and Drug Administration’s most stringent review process for medical devices. The agency is not required to follow the panel’s recommendation.
The review follows disappointing results for Galleri earlier this year from a three-year UK trial, which found it did not significantly boost early cancer detection or reduce late-stage diagnoses.
Galleri is a blood-based cancer screening test that aims to detect signals of more than 50 cancers from a single blood sample.
(Reporting by Sneha S K and Padmanabhan Ananthan; Editing by Vijay Kishore)
