Pipeline tracker

Galleri multi-cancer early detection test

Under reviewEvidence reviewed by an editor
Galleri multi-cancer early detection testGRAIL · Multi-cancer screening in adults 50+
Under review · Cell-free DNA methylation blood test (NGS + machine learning)As of Sep 25, 2026

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.

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.

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Under review means a regulator is assessing an application. Approval is not guaranteed and the decision may be narrower than requested.

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