|
|
The U.S. Food and Drug Administration announces a forthcoming public advisory committee meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee (the Committee).
On September 23, 2026, 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. 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 meeting will be open to the public and held in-person at the FDA White Oak Campus and virtually. The FDA is establishing a docket for public comment. Registration is not required to attend the meeting.
Important Participation Due Dates:
Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee.
-
August 28, 2026: Email CDRH_MDAC@fda.hhs.gov to request to make oral presentations during the public comment session of the meeting.
-
September 8, 2026: Submit written comments to the public docket FDA-2026-N-8004 to be reviewed by the Committee prior to the meeting.
-
September 16, 2026: Request special accommodations for the meeting.
-
September 16, 2026: Submit written comments to the docket for review and consideration by the FDA.
Questions?
If you have questions about this communication, contact Division of Industry and Consumer Education (DICE).
|
|
|
|
