FDA announced a forthcoming hybrid meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee on Sept. 23 to discuss, make recommendations, and vote on information regarding the premarket approval application for the Galleri test sponsored by GRAIL, Inc.
The Galleri test is a prescription-only qualitative, next-generation sequencing-based in vitro diagnostic test intended to detect cancer-specific methylation patterns in cell-free DNA isolated from peripheral whole blood. The Galleri test is intended for screening for the early detection of multiple types of cancer in adults aged 50 years or older. The test is also intended to predict where a detected cancer signal may have originated in the body and should be followed by a diagnostic workup by a qualified health care professional.
The FDA is establishing a docket (FDA-2026-N-8004) for public comment on this meeting. The docket will close on Sept. 16 at 11:59 ET. The electronic filing system will accept comments. Late, untimely filed comments will not be considered.
In the event that the meeting is cancelled, the FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.
