FDA advisers are preparing to examine GRAIL’s blood test designed to detect signals associated with multiple types of cancer.

SILVER SPRING, Md. — September 22, 2026 — The U.S. Food and Drug Administration is preparing for a major review of GRAIL’s Galleri multi-cancer early detection blood test, which is designed to identify cancer-related signals from a blood sample.

FDA staff reviewers reported no major concerns about the test’s analytical performance, study design or primary safety analyses in briefing documents released ahead of Wednesday’s advisory committee meeting, according to Reuters.

The FDA’s Molecular and Clinical Genetics Panel is scheduled to meet September 23 to discuss and vote on information related to GRAIL’s premarket approval application. The agency says Galleri is intended for screening adults age 50 and older for multiple types of cancer and can also help predict where a detected cancer signal may have originated.

However, the review is not simply an approval formality. FDA advisers have been asked to examine whether the available evidence supports describing Galleri as an “early detection” test. Reuters noted that a previous large U.K. trial did not significantly improve early cancer detection or reduce late-stage diagnoses.

Galleri is already available in the United States under laboratory regulations, but it has not received FDA approval. FDA approval could affect its wider distribution, clinical adoption and potential insurance coverage.

The advisory committee’s recommendation will be non-binding, meaning the FDA will make the final regulatory decision.