FDA's Molecular and Clinical Genetics Panel convenes in open session — hybrid at the agency's White Oak campus and virtual, , 9 a.m.–6 p.m. ET — to discuss, make recommendations, and vote on GRAIL, Inc.'s premarket approval application for Galleri, a next-generation-sequencing multi-cancer early detection blood test.
Dates and format
- Date: 23 September 2026, 9 a.m.–6 p.m. ET, open session
- Format: hybrid — in person at FDA's White Oak campus, Silver Spring, MD, plus virtual participation
- Docket: FDA-2026-N-8004; comment window closed 16 September 2026
- Organizer: FDA Center for Devices and Radiological Health, Medical Devices Advisory Committee — Molecular and Clinical Genetics Panel
What it covers
Galleri is GRAIL's prescription-only, next-generation-sequencing in vitro diagnostic that screens a single blood draw for cancer-specific methylation patterns in cell-free DNA, aiming to flag a signal shared across dozens of cancer types before symptoms appear. The Panel's open session reviews the premarket approval application's clinical evidence and votes on non-binding recommendations to FDA — a vote that, whichever way it lands, sets a visible marker for how the agency evaluates multi-cancer early detection tests going forward.
Who should attend
Regulatory and clinical affairs leads running IVD or companion-diagnostic PMAs, laboratory medicine and oncology diagnostics teams tracking the evidentiary bar FDA applies to multi-cancer screening claims, and anyone who wants to hear the Committee's own questions before a Galleri decision is made. The session is free and open to the public, in person or online.
The same committee structure takes up pathogen-agnostic sequencing in November, and the full events directory lists everything we have verified.
Frequently asked questions
When is the FDA Genetics Panel meeting on GRAIL's Galleri test?
23 September 2026, 9 a.m. to 6 p.m. Eastern Time, held in hybrid format — in person at FDA's White Oak campus in Silver Spring, Maryland, and virtually.
What is the Committee deciding?
The Molecular and Clinical Genetics Panel of FDA's Medical Devices Advisory Committee meets in open session to discuss, make recommendations, and vote on GRAIL's premarket approval application (PMA) for the Galleri test, a blood-based multi-cancer early detection diagnostic.
Can the public attend or comment?
Yes, the meeting is open to the public. FDA established public docket FDA-2026-N-8004 for written comment; the docket closed 16 September 2026, with comments received by 8 September 2026 guaranteed to reach the Committee in advance of the meeting.
Is there a fee to attend?
FDA states no attendance fee for its advisory committee meetings; none is stated for this sitting.
Sources & further reading
- FDA. September 23, 2026: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting Announcement. fda.gov
- Federal Register / FDA. Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments — GRAIL, Inc. Galleri, 08/10/2026. federalregister.gov
Event details are published by the organizer and can change. This listing was verified via WebSearch corroboration of FDA's own meeting-announcement page and the Federal Register notice rather than a direct fetch, because this session's network egress could not reach fda.gov or federalregister.gov directly — confirm dates and access with FDA before making plans. Last verified 16 September 2026.
