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GRAIL Submits FDA Premarket Approval Application for the Galleri® Multi-Cancer Early Detection Test

GRAIL, Inc. submitted the final PMA module to the U.S. Food and Drug Administration for the Galleri multi‑cancer early detection test, marking a key regulatory milestone.
GRAIL said the filing aims to expand access to the Galleri MCED test and advance earlier cancer detection to address unmet screening needs alongside standard‑of‑care cancer screening.
The PMA package relies on data from 25,490 consented PATHFINDER 2 participants with one year of follow‑up, more than 140,000 NHS‑Galleri participants aged 50 to 77, and a bridging analysis comparing study and PMA versions.
The FDA previously designated Galleri as a Breakthrough Device, and adding it to standard‑of‑care cancer screening could improve early detection, with the NHS‑Galleri goal being reduction in late‑stage cancers.
The press release notes forward‑looking statements subject to uncertainties, and GRAIL's targeted methylation‑based platform supports multiple precision oncology applications, the company stated.

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