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

Jan. 30, 2026 at 3:31am

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GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced the submission of the final module of the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Galleri® multi-cancer early detection (MCED) test. The FDA designated the test as a Breakthrough Device in 2018.

Why it matters

Cancer is now the leading killer of adults over 50 years old in the U.S., and most deadly cancers are often discovered too late, when they are difficult to treat and typically have worse outcomes. Adding Galleri to standard-of-care single cancer screening tests has the potential to dramatically improve the performance of the nation's current screening program and expand opportunities for earlier treatment and improved outcomes.

The details

The PMA submission is focused on the test performance and safety results from 25,490 consented participants in the US-based PATHFINDER 2 study with one year of follow up and from the prevalent screening round (first year) of the NHS-Galleri trial, the largest, and only, randomized, controlled trial of any MCED test in an intended use population. The submission is also supported by a bridging analysis to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated PMA version that has been submitted to the FDA for premarket approval.

  • The FDA designated the Galleri test as a Breakthrough Device in 2018.
  • GRAIL submitted the final module of the Premarket Approval (PMA) application to the FDA on January 29, 2026.

The players

GRAIL, Inc.

A healthcare company whose mission is to detect cancer early when it can be cured, focused on alleviating the global burden of cancer by using next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages.

Josh Ofman, MD, MSHS

President at GRAIL.

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What they’re saying

“Cancer is now the leading killer of adults over 50 years old in the U.S., and most deadly cancers are often discovered too late, when they are difficult to treat and typically have worse outcomes. There is nothing acceptable about the status quo in cancer screening. Adding Galleri to standard-of-care single cancer screening tests has the potential to dramatically improve the performance of the nation's current screening program and expand opportunities for earlier treatment and improved outcomes.”

— Josh Ofman, President at GRAIL

What’s next

The FDA will review the PMA submission and make a decision on whether to approve the Galleri multi-cancer early detection test.

The takeaway

This FDA submission marks a critical step toward making the Galleri test available to more people and advancing early cancer detection, which has the potential to provide significant public health benefits by enabling earlier treatment and improved outcomes for cancer patients.