Menlo Park, California-based GRAIL, Inc. (Nasdaq: GRAL) has announced that the US FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to meet on September 23, 2026 to review the Premarket Approval (PMA) application for Galleri, the company's multi-cancer early detection (MCED) liquid biopsy test — marking the first time an FDA advisory panel has convened to evaluate an MCED test.
GRAIL submitted the PMA application to the FDA on January 29, 2026. The FDA had previously designated Galleri as a Breakthrough Device in 2018. The test is intended for use alongside, not as a replacement for, existing guideline-recommended cancer screenings.
The PMA submission draws on data from two large studies. The US-based PATHFINDER 2 study enrolled 25,490 consented participants with one year of follow-up, providing test performance and safety data. The submission also incorporates data from over 70,000 participants in the intervention arm of the prevalent screening round of the NHS-Galleri trial — described by GRAIL as the largest and only randomized, controlled trial of an MCED test in an intended use population. An additional bridging analysis comparing the versions of Galleri used in both studies to the updated PMA version was included to support regulatory review.
Galleri uses targeted methylation sequencing combined with machine learning to detect cancer-associated DNA methylation patterns in cell-free DNA circulating in blood. When a cancer signal is detected, the test is designed to predict the cancer signal origin tissue to help direct diagnostic follow-up. The test is intended to identify signals across more than 50 cancer types, including many for which no standard screening currently exists.