FDA Advisory Panel Recommends GRAIL's Multi-Cancer Test
An advisory committee for the U.S. Food and Drug Administration (FDA) has voted in favor of recommending approval for GRAIL, Inc.'s Galleri multi-cancer early detection test. The test is intended for adults aged 50 and older.
SUNNYVALE, Calif. – An expert panel advising the U.S. Food and Drug Administration (FDA) has recommended the approval of GRAIL, Inc.'s Galleri test, a blood test designed for the early detection of multiple cancer types. The committee's vote in September 2026 marks a significant step toward potential regulatory clearance for the test, which is intended for adults aged 50 and older.
The Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory Committee reviewed Galleri's safety, effectiveness, and benefit-risk profile. In three separate votes, the panel concluded that the benefits of Galleri outweigh its risks (7-2, with one abstention), found it safe (unanimous), and effective (6-4).
"Today's vote reinforces the strength of Galleri's clinical evidence," said GRAIL CEO Josh Ofman. He highlighted the test's potential to improve cancer screening by detecting cancers earlier, when they are often more treatable and less costly to manage. The Galleri test is designed to be used in addition to, not as a replacement for, existing guideline-recommended screenings.
The Galleri test works by detecting cancer-specific methylation patterns in the blood. When a cancer signal is detected, the test aims to predict the cancer's origin to help guide diagnostic follow-up. The FDA is not bound by the committee's recommendation but typically considers it in its final decision, which is expected in the coming months.