GRAIL’s Galleri blood test is heading to a U.S. Food and Drug Administration (FDA) advisory committee meeting this week, where experts will review the company’s application for premarket approval of the test for early detection of multiple cancers.
According to FDA briefing materials, agency staff reviewers have no outstanding questions for the advisory panel regarding Galleri’s analytical performance, study design, or primary safety analyses. However, the FDA has asked the panel to consider whether the available evidence supports characterizing Galleri as an “early detection” test.
The Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will meet September 23 to discuss, make recommendations, and vote on information related to GRAIL’s premarket approval application. The meeting is open to the public and will be held both in person and virtually.
A blood-based approach to multicancer screening
The FDA describes Galleri as a prescription-only, qualitative, next-generation sequencing (NGS)-based in vitro diagnostic test. It is designed to detect cancer-specific methylation patterns in cell-free DNA isolated from peripheral whole blood.
The test is intended for cancer screening in adults aged 50 years or older. When a cancer signal is detected, Galleri is also designed to predict where the signal may have originated in the body, with the FDA specifying that this should be followed by a diagnostic workup by a qualified healthcare professional.
Multicancer early detection tests analyze molecular signals released by tumors into the bloodstream from a single blood draw. GRAIL has said Galleri is intended to complement, rather than replace, established cancer screening methods such as mammography and colonoscopy.
FDA review centers on early detection
Galleri is already available under Clinical Laboratory Improvement Amendments (CLIA) regulations but has not received FDA approval. GRAIL reported $136.8 million in US revenue from Galleri in 2025 in a recent Reuters article.
The upcoming advisory committee discussion follows questions about clinical outcomes from previous testing. Reuters reported that GRAIL’s shares fell more than 20% after the company said routine screening with Galleri did not significantly increase early detection or reduce late-stage diagnoses in a pivotal three-year UK trial.
The FDA advisory committee’s recommendations will be non-binding. The agency generally follows advisory committee recommendations but is not legally required to do so.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
