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GRAIL Submits FDA Premarket Approval Application for the Galleri® Multi-Cancer Early Detection Test
GRAIL submitted safety and performance data from over 25,000 U.S. participants and the largest randomized trial in England to seek FDA approval for Galleri.
- On Jan 29, 2026 GRAIL, Inc. submitted the final PMA module to the U.S. Food and Drug Administration for the Galleri MCED test.
- GRAIL said the filing aims to expand access and improve early cancer detection using the Galleri MCED test, addressing unmet screening needs.
- Clinical support includes NHS‑Galleri and a bridging analysis; the PMA relies on data from 25,490 PATHFINDER 2 participants and over 140,000 NHS‑Galleri participants, GRAIL said.
- The FDA previously designated Galleri as a Breakthrough Device, and GRAIL said the submission could improve screening performance and expand earlier treatment opportunities.
- The press release notes forward‑looking statements subject to risks and uncertainties, and GRAIL highlights its targeted methylation‑based platform supports multiple precision oncology applications.
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Helena Independent Record+21 Reposted by 21 other sources
GRAIL Submits FDA Premarket Approval Application for the Galleri® Multi-Cancer Early Detection Test
FDA Submission Marks a Pivotal Milestone in Advancing Early Cancer Detection, Addressing Unmet Needs in Cancer Screening
·Helena, United States
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