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SUMMARY:FDA Panel Review of GRAIL’s Galleri Test
DESCRIPTION:The September 23\, 2026 Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting\, organized by the U.S. Food and Drug Administration (FDA)\, will take place on 23 September 2026\, from 9:00 a.m. to 6:00 p.m. ET\, at the FDA White Oak Campus in Silver Spring\, Maryland\, with virtual access also available. \nDuring the open public session\, the committee will review\, discuss\, make recommendations\, and vote on the premarket approval application for GRAIL’s Galleri® test\, a prescription-only\, next-generation sequencing–based in vitro diagnostic designed to detect cancer-specific methylation patterns in cell-free DNA from peripheral whole blood. \nThe test is intended for multi-cancer early detection screening in adults aged 50 years or older and to predict the likely tissue or organ of origin of a detected cancer signal. The FDA advisory committee will provide independent\, non-binding recommendations to the agency. Public comments may be submitted under docket FDA-2026-N-8004 through 16 September 2026\, with comments received by 8 September provided to the committee in advance.
URL:https://oncodaily.com/event/grails-galleri-565242
LOCATION:FDA White Oak Campus\, Building 31 Conference Center – Great Room (Room 1503)\, 10903 New Hampshire Avenue\, Silver Spring\, MD\, 20993-0002\, United States
ATTACH;FMTTYPE=image/webp:https://oncodaily.com/pub/uploads/2026/08/1786113785016.webp
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