(RTTNews) - GRAIL Inc. (GRAL), a healthcare company, announced the submission of the final module of the Premarket Approval or PMA application to the U.S. Food and Drug Administration or FDA for its Galleri multi-cancer early detection or MCED test.
The Galleri multi-cancer early detection (MCED) test can detect more than 50 types of cancer before symptoms appear — when they are easier to treat and potentially curable, with a simple blood draw, according to the company. The PMA submission focuses on performance and safety results from the PATHFINDER 2 study, one-year follow-up results, and results from the prevalent screening round of the NHS-Galleri trial.
The submission is also supported by a bridging analysis comparing the performance of the Galleri version used in the PATHFINDER 2 study and the NHS-Galleri trial with the updated PMA version submitted to the FDA for premarket approval.
"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," said Josh Ofman, MD, MSHS, President at GRAIL.
In 2018, the FDA designated the MCED test as a Breakthrough Device.
PATHFINDER 2 study
PATHFINDER 2 is a multi-centre, interventional study evaluating the safety and performance of Galleri in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States.
NHS-Galleri trial
The NHS-Galleri trial is a randomized, controlled trial to assess the clinical utility and performance of a multi-cancer early detection test for population screening when added to standard care.
Galleri is currently available as a laboratory-developed test ("LDT") in the United States for the early detection of multiple types of cancer. Launched in mid-2021, the company has sold approximately 420,000 commercial Galleri tests through September 30, 2025.
The FDA approval is being sought to help support broad access to Galleri in the United States.
The Galleri revenue in the third quarter of 2025, grew 29% year-over-year to $32.8 million.
Over the past year, GRAL has traded between $20.44 and $118.84. The stock closed Thursday's trade at $100.98, down 0.02%.
In the overnight market, GRAL is down 1.96%, at $99.
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