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SUMMARY:FDA Panel Review of GRAIL’s Galleri Multi-Cancer Early Detection Test
DESCRIPTION:The U.S. Food and Drug Administration (FDA) will convene the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee on September 23\, 2026\, from 9:00 AM to 6:00 PM ET\, in Silver Spring\, Maryland\, with virtual access also available. \nDuring the open session\, the committee will discuss\, make recommendations\, and vote on GRAIL’s Premarket Approval application for the Galleri® multi-cancer early detection (MCED) blood test. \nGalleri is a prescription-only\, next-generation sequencing-based test designed to detect cancer-specific methylation patterns in cell-free DNA for early detection of multiple cancers in adults aged 50 and older and to predict the likely origin of a detected cancer signal. This will be the first FDA advisory committee review of a PMA application for an MCED test.
URL:https://oncodaily.com/event/multi-cancer-575897
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/ChatGPT-Image-Aug-27-2026-08_12_15-PM.webp
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