FDA advisory panel backs GRAIL's Galleri multi-cancer blood test

What's the deal? An advisory panel to the U.S. Food and Drug Administration (FDA( voted on 23 September ️2026 to support GRAIL's Galleri blood test as a screening tool for multiple cancers, a step toward the first-ever approval of a multi-cancer early detection (MCED( test.

Why it matters: The panel voted ️7-2 (with one abstention( that the test's benefits outweigh its risks when used in addition to routine screening for adults aged 50 and older; it voted unanimously on the test's safety and ️6-4 on its effectiveness. The recommendation is non-binding — the FDA makes the final approval decision, which remained pending after the vote — but an advisory green light is generally seen as a strong signal of how the agency will rule.

Galleri works by scanning a blood sample for cancer-related DNA methylation patterns — chemical markers on DNA that can point to the presence of cancer — and can flag several cancer types at once, including some, like pancreatic and ovarian cancer, that have no recommended routine screening today. The approval filing draws on results from GRAIL's U.S. PATHFINDER ️2 study (about 25,500 participants( and the U.K. NHS-Galleri trial (more than 70,000 participants in the intervention arm(, the largest randomised controlled study of an MCED test in its intended population.

GRAIL submitted its premarket approval application to the FDA on ️29 January 2026, and the test has held U.S. Breakthrough Device designation since 2018.

Read more: GRAIL, 7 August ️2026 · FDA advisory committee calendar, 23 September 2026