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On September 23, 2026 the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee (the Committee) will meet in an open session to discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Galleri® test sponsored by GRAIL Inc. The Galleri® test is a prescription-only qualitative, next-generation sequencing (NGS)-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. GRAIL Inc. and FDA will present key information related to the PMA application. The meeting is open to the public. Registration is not required to attend the meeting.
The FDA has now made available the following September 23, 2026, meeting materials:
- Agenda
- Roster
- FDA and GRAIL Inc. Executive Summaries
- FDA Discussion Questions
- Committee Voting Questions
Meeting date and time: September 23, 2026 from 9:00 a.m. to 6:00 p.m. Eastern Time
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm.1503), Silver Spring, MD 20993-0002 and virtually
Weblink for virtual access: https://youtube.com/live/83XzLN7Dbg4
The meeting will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform.
Questions?
If you have questions about this communication, contact Division of Industry and Consumer Education (DICE).
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