Grail Galleri multi‑cancer test FDA approval process

Regulatory approval of the Galleri multi-cancer early detection test would provide the first FDA-cleared blood test capable of screening for dozens of cancers simultaneously in adults aged 50 and older [1][2]. An FDA advisory panel voted 7-2 on September 23, 2026, that the clinical benefits of the test outweigh its risks [1][8]. The panel also voted 10-0 in favor of the test's safety and 6-4 in favor of its clinical effectiveness [1][3].

The test uses next-generation sequencing to identify cancer-specific methylation patterns in cell-free DNA [3][4]. It is designed to supplement, rather than replace, existing standard cancer screenings [3][7]. While the panel endorsed the technology, members stated that further research is required to determine how the test performs across broader, more diverse populations [5].

A final decision from the FDA on the Premarket Approval application would determine if the test can be marketed in the United States [4]. A Medicare coverage determination from the Centers for Medicare & Medicaid Services would establish whether the federal government will pay for the test for eligible beneficiaries. A ruling from a federal court would resolve pending class action litigation regarding trial disclosures [11]. The filing of a supplemental New Drug Application or an appeal by Grail would follow any potential denial of the current application.