FDA Panel to Review GRAIL Galleri PMA
Analysis based on 6 articles · First reported Aug 07, 2026 · Last updated Aug 10, 2026
The FDA advisory committee meeting is a critical regulatory milestone for Illumina — Holy Grail's Galleri test, potentially leading to market approval and significant revenue growth. Positive sentiment is reflected in Illumina — Holy Grail's stock price increase of 6.55% to $74.03 following the announcement.
Illumina — Holy Grail, Inc. announced that the U.S. United States — Food and Drug Administration's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will meet on September 23, 2026, to review the Premarket Approval (PMA) application for the Galleri multi-cancer early detection (MCED) blood test. The Galleri test detects cancer-specific methylation patterns across multiple cancer types before symptoms appear, including cancers without recommended screening. Illumina — Holy Grail submitted the PMA application on January 29, 2026, and the FDA designated Galleri as a Breakthrough Device in 2018. The submission includes data from the PATHFINDER 2 study (25,490 participants) and the NHS-Galleri trial (over 70,000 participants). Illumina — Holy Grail's CEO Joshua J. Ofman emphasized the test's potential to address unmet public health needs. The stock rose following the announcement, reflecting positive market sentiment.
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