Galleri multi-cancer early detection test
PMA submitted Jan. 29, 2026; an FDA advisory panel voted 7–2 (one abstention) on Sept. 23, 2026 that benefits outweigh risks, with a final FDA decision pending.
What this stage means
Under review means a regulator is assessing an application. Approval is not guaranteed and the decision may be narrower than requested.
A development stage describes where the evidence stands for one specific use. It does not mean the product works for everyone, is available everywhere, or will succeed commercially.