The FDA's Molecular and Clinical Genetics Panel meets September 23 to review the premarket approval application for Galleri, the first multi-cancer early detection blood test to reach a full advisory committee review in the United States. GRAIL submitted the application in late January, and GRAIL's announcement of the advisory committee meeting confirmed the date.
The panel vote is a recommendation, not a decision. According to the FDA's meeting announcement for the panel, advisory committees make non-binding recommendations that the agency generally follows but is not legally bound to accept. The test is currently sold in the U.S. as a prescription-only laboratory test, so approval would change its regulatory status rather than introduce it.
