FDA Advisory Committee Backs GRAIL's Galleri Multi-Cancer Early Detection Test

On September 23, 2026, the U.S. FDA's Molecular and Clinical Genetics Advisory Committee reviewed GRAIL's Galleri multi-cancer early detection test and voted to support the product. In three key votes, the committee determined 10:0 that safety is reasonably assured, 6:4 that effectiveness is reasonably assured, and 7:2 (with one abstention) that the benefits outweigh the risks. The FDA's final decision on approval is expected within months.

Galleri uses targeted methylation sequencing to analyze cell-free DNA in blood and employs machine learning models to detect cancer signals and predict their tissue of origin. In the PATHFINDER 2 study, the test demonstrated an overall specificity of approximately 99.85% and sensitivity of about 35.0%. For a group of high-mortality cancers lacking established screening methods, sensitivity reached approximately 61.3%.

The advisory committee emphasized that Galleri is intended as a complement to, not a replacement for, standard cancer screenings. The product's benefits were weighed alongside results from the NHS-Galleri trial involving more than 140,000 participants in the UK. Although that trial did not meet its primary endpoint of reducing late-stage cancers overall, it showed reductions of 22% and 26% in the most lethal late-stage cancers during later screening rounds.

The Galleri test under FDA review currently relies on locked machine-learning classifiers and is not designed to continuously update automatically in clinical use. Whether the test will ultimately receive marketing authorization remains subject to the FDA's final decision.