FDA Advisory Committee to Review Galleri MCED Test's PMA Application

The FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to meet Sept. 23, 2026, to review the premarket approval (PMA) application for GRAIL's Galleri multi-cancer early detection (MCED) blood test, according to a news release from the company.¹ The meeting will mark the FDA's first advisory committee review of a PMA application for an MCED test.

GRAIL submitted the PMA application for Galleri on Jan. 29, 2026. The submission is built on test performance and safety data from 25,490 consented participants with 1 year of follow-up in the US-based PATHFINDER 2 study (NCT05155605), along with data from more than 70,000 participants in the intervention arm of the prevalent, first-year screening round of the NHS-Galleri trial (NCT05611632; ISRCTN91431511)—described by the company as the largest randomized, controlled trial of an MCED test in an intended-use population. The application also includes a bridging analysis comparing the performance of the Galleri test version used in PATHFINDER 2 and NHS-Galleri with the updated version submitted for the PMA.

About Galleri

Galleri is designed to detect cancer-specific methylation patterns shared across many cancer types before symptoms appear, including cancers that lack recommended screening today. When a cancer signal is detected, the test is designed to predict the cancer signal origin with high accuracy to help guide diagnostic evaluation. Galleri is intended for use in addition to, not as a replacement for, guideline-recommended cancer screenings.

Regulatory Path

The FDA designated Galleri a Breakthrough Device in 2018. At the Sept. 23 meeting, the Molecular and Clinical Genetics Panel will discuss Galleri's clinical data and the broader question of how an MCED test could fit into a cancer screening program; the panel's recommendation does not bind the FDA's final decision on the PMA.

“Today, the status quo in cancer screening is simply unacceptable...Galleri is the only MCED test supported by large interventional and randomized, controlled studies in intended use populations. We appreciate the FDA's leadership in advancing the review of the first premarket approval application for an MCED, and we look forward to discussing Galleri's clinical data...with the Advisory Committee,” said Josh Ofman, MD, MSHS, CEO at GRAIL, in a news release.

REFERENCES

1. GRAIL announces FDA advisory committee meeting to review premarket approval application for the Galleri multi-cancer early detection test. News release. GRAIL, Inc. August 7, 2026. Accessed August 10, 2026. https://www.biospace.com/press-releases/grail-announces-fda-advisory-committee-meeting-to-review-premarket-approval-application-for-the-galleri-multi-cancer-early-detection-test