Grail's Multi-Cancer Blood Test Gets FDA Committee Vote for Premarket Approval
By Katherine Hamilton
Grail Inc. received a favorable vote from a Food and Drug Administration panel regarding premarket approval for its Galleri multi-cancer early detection test.
The cancer-detection company said the FDA's medical devices advisory committee voted 7-2, with one abstention, to greenlight a premarket approval application for Galleri.
The FDA isn't bound to the committee's recommendation, but it takes them into consideration when making the final regulatory decision. The FDA is expected to make its final ruling on Galleri's premarket approval in the coming months.
In three separate votes, the 10 voting members of the committee considered Galleri's safety, effectiveness and overall benefit-risk profile for screening and early detection of multiple types of cancer in adults aged 50 and older.
The Galleri test is designed to detect cancer-specific methylation patterns shared by many types of cancer before symptoms appear, including cancers that don't have recommended screening today.
When a cancer signal is detected, Galleri is designed to predict the cancer signal origin with high accuracy to help guide diagnostic evaluation. The test is intended to be used in addition to recommended screenings, rather than as a replacement.
The FDA designated Galleri as a breakthrough device in 2018. Grail submitted its application for premarket approval on Jan. 29.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
September 23, 2026 18:50 ET (22:50 GMT)
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