FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23

MedDevice Startups Staff · 2 days ago · 2 min read · Via FDA advisory committee calendar

FDA posted meeting materials on September 21 for the Molecular and Clinical Genetics Panel, which reviews GRAIL's premarket approval application for the Galleri multi-cancer early detection test on September 23. The meeting runs 9 a.m. to 6 p.m. Eastern at White Oak under docket FDA-2026-N-8004.

GRAIL filed the PMA on January 29, 2026, eight years after FDA granted Galleri a Breakthrough Device designation. The submission draws on PATHFINDER 2, with 25,490 consented participants and one year of follow-up, and on the first prevalent screening round of the NHS-Galleri trial, which enrolled more than 70,000 people.

Galleri reads cancer-specific methylation patterns in blood and predicts where the signal came from. It is prescription only and intended for adults 50 and older. GRAIL, based in Menlo Park, California, says the test supplements guideline screening rather than replacing it.

Anyone building a screening test should read the transcript when it posts. The questions FDA puts to this panel on positive predictive value and on the diagnostic workup that follows a positive signal will shape what the agency expects from the next asymptomatic-population submission.

Questions & Answers

When is the FDA advisory panel on GRAIL's Galleri test?

The Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee meets September 23, 2026, at FDA's White Oak campus in Silver Spring, Maryland. FDA posted the meeting materials on September 21 under docket FDA-2026-N-8004.

What data is behind GRAIL's Galleri PMA?

GRAIL filed the PMA on January 29, 2026. It rests on PATHFINDER 2, with 25,490 consented participants and one year of follow-up, and on the first prevalent screening round of the NHS-Galleri trial, which enrolled more than 70,000 people.

What is the Galleri test intended to do?

Galleri is a prescription-only, next-generation sequencing blood test that screens adults 50 and older for signals from multiple cancer types and predicts the likely tissue of origin. GRAIL positions it as an addition to guideline screening, not a replacement.

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