AUS Food and Drug Administration (FDA) advisory panel has voted in favour of approving GRAIL’s Galleri, cuing up a potential landmark approval for the multi-cancer early detection (MCED) test.
In three separate votes, the 10 voting members of the FDA’s Molecular and Clinical Genetics Devices advisory panel considered Galleri’s safety, effectiveness and overall benefit-risk profile for screening for the early detection of multiple types of cancer in adults aged 50 years and older.
The panel voted seven to two in favour of Galleri’s market approval (with one abstention), concluding that the test’s benefits outweighed its risks, unanimously supported Galleri’s safety profile, and voted six to four in support of Galleri’s effectiveness.