The U.S. FDA scheduled an advisory committee meeting for September 23, 2026, to review Grail's Premarket Approval application for its Galleri multi-cancer early detection blood test. The review follows mixed clinical results, including a UK trial where Galleri failed its primary endpoint but reduced stage IV diagnoses by 26% for 12 deadly cancers. While Galleri is currently sold as an unapproved laboratory-developed test, FDA approval could unlock Medicare coverage starting in 2029.
FDA advisory committee meeting
- ▪The U.S. Food and Drug Administration's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will meet on September 23, 2026, to review Grail's Premarket Approval application for its Galleri multi-cancer early detection blood test.
- ▪Grail's shares rose by 5% on August 7, 2026, after the company announced that the U.S. Food and Drug Administration scheduled an advisory committee meeting to review its Galleri test.
- ▪The FDA's Molecular and Clinical Genetics Panel will review Grail's request for premarket approval, which is the agency's most stringent review process for medical devices, though the agency is not required to follow the panel's recommendation.
Galleri methylation detection technology
- ▪Grail's Galleri multi-cancer early detection blood test is designed to analyze molecular signals, specifically cancer-specific methylation patterns, shed by tumors into the bloodstream from a single blood draw to detect potential cancers and predict their tissue of origin.
- ▪The Galleri test and Abbott Laboratories' Cancerguard are currently available on the market as laboratory-developed tests under Clinical Laboratory Improvement Amendments regulations, though neither has received FDA approval.
- ▪The Galleri test is intended to complement, rather than replace, guideline-recommended cancer screenings such as mammograms and colonoscopies.
NHS-Galleri trial results
- ▪Full results from the UK trial presented in May 2026 showed that by the third round of screening, the Galleri test reduced stage IV cancer diagnoses by 26% for 12 deadly cancers and increased cancer detection fourfold compared to standard screening alone.
- ▪In a three-year UK trial of asymptomatic adults aged 50 to 77 years, the Galleri test did not significantly improve early cancer detection or reduce late-stage diagnoses compared to standard care.
PMA submission data
- ▪Grail's Premarket Approval submission includes performance and safety data from 25,490 participants tracked for one year in the U.S.-based PATHFINDER 2 study, alongside data from over 70,000 participants in the NHS-Galleri trial.
- ▪Grail submitted its Premarket Approval application for the Galleri test to the FDA on January 29, 2026, after the FDA previously designated the test as a Breakthrough Device in 2018.
Medicare coverage pathway
- ▪A January 2026 U.S. congressional funding bill established a pathway for Medicare coverage of FDA-approved multi-cancer early detection tests for individuals aged 50 to 65 starting in 2029, subject to clinical benefit.
- ▪Analysts have questioned the reimbursement prospects for Grail's Galleri test despite the newly created Medicare coverage pathway.
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