FDA shared on LinkedIn:
”The FDA is announcing an upcoming meeting on Sept. 23 of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee (the Committee) to discuss, make recommendations, and vote on information regarding GRAIL Inc.’s Galleri® test premarket approval application.
The Galleri® test is a prescription-only blood test intended for screening for the early detection of multiple types of cancer in adults aged 50 years or older. The meeting will be open to the public and the FDA is establishing a docket for public comment.
The FDA is holding this meeting regarding the Galleri® test. Meeting materials, including agendas and briefing documents, will be made publicly available. The Committee’s deliberations will be conducted openly, and its recommendations will be documented and accessible to the public. While the Committee’s recommendations are advisory, the FDA will carefully consider them as part of a rigorous, evidence-based evaluation of the safety and effectiveness of this device.”
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