Grail Submits FDA Premarket Approval Application for Galleri Multi-Cancer Early Detection Test

Reuters01-30

Grail Submits FDA Premarket Approval Application for Galleri Multi-Cancer Early Detection Test

GRAIL, Inc. has submitted the final module of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Galleri® multi-cancer early detection (MCED) test. The Galleri test, which was designated as a Breakthrough Device by the FDA in 2018, aims to improve early cancer detection. The PMA submission is based on test performance and safety data from 25,490 participants in the US-based PATHFINDER 2 study and the first year of the NHS-Galleri trial. A bridging analysis comparing different versions of the Galleri test was also included to support the application.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Grail Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: LA74679) on January 30, 2026, and is solely responsible for the information contained therein.

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