The Food and Drug Administration’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to meet Wednesday, Sept. 23, 2026, from 9 a.m. to 6 p.m. Eastern Time in a hybrid session at FDA’s White Oak Campus in Silver Spring, Maryland, and online, according to the agency’s meeting announcement and an Aug. 10 Federal Register (opens in new tab) notice.
Agenda materials say the committee will discuss, make recommendations, and vote on the premarket approval application for the Galleri test sponsored by GRAIL Inc. Galleri is described as a prescription-only, next-generation sequencing in vitro diagnostic intended to detect cancer-specific methylation patterns in cell-free DNA from peripheral whole blood and to screen for early detection of multiple cancer types in adults aged 50 or older, with a predicted Cancer Signal Origin when a signal is detected.
The Federal Register (opens in new tab) notice states a Cancer Signal Detected result, including a predicted origin, may indicate an invasive solid tumor or hematologic malignancy and should be followed by diagnostic workup; a No Cancer Signal Detected result does not rule out cancer, and people should continue guideline-recommended single-cancer screening. Testing is performed at GRAIL.
FDA established public docket FDA-2026-N-8004; comments were due by Sept. 16, with submissions by Sept. 8 provided to the committee. Background materials posted for the meeting include FDA and GRAIL executive summaries, panel questions, voting questions, a roster, and related PDFs. Advisory committee recommendations are non-binding.
As of draft time, The Event Record is reporting the scheduled hearing and agenda only. This draft does not invent or report a panel vote or FDA final decision.