The regulatory review follows a January 29, 2026, submission by the Menlo Park-based company. The Galleri test, which received Breakthrough Device designation from the FDA in 2018, is intended to supplement, rather than replace, standard screening procedures. It utilizes artificial intelligence to analyze the methylome, targeting cancers that currently lack established screening protocols. According to GRAIL, approximately 70-80% of cancer deaths stem from malignancies that are not addressed by existing screening guidelines.
FDA Panel to Review GRAIL’s Galleri Cancer Detection Blood Test
The U.S. Food and Drug Administration has scheduled a September 23, 2026, meeting for its Molecular and Clinical Genetics Panel to evaluate the premarket approval application for GRAIL’s Galleri test. The blood-based screening tool aims to identify multiple cancer types by detecting specific methylation patterns before clinical symptoms emerge.
To support its application, GRAIL presented performance and safety data derived from over 95,000 participants. This includes findings from 25,490 individuals in the U.S.-based PATHFINDER 2 study and data from more than 70,000 participants involved in the NHS-Galleri trial. CEO Josh Ofman noted that the company intends to highlight the test’s ability to predict cancer signal origin with high accuracy while maintaining a low false-positive rate during the upcoming advisory committee discussion.
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