Grail, a healthcare company focused on detecting cancer at earlier, more treatable stages, has announced the submission of 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 test previously received Breakthrough Device designation from the FDA in 2018.

Galleri is designed to complement existing single-cancer screening tests by identifying signals associated with multiple cancer types through a simple blood draw. According to the company, the goal is to improve early detection rates, particularly for cancers that currently lack recommended screening options and are often diagnosed at advanced stages.

Josh Ofman, MD, MSHS, President at Grail, highlighted the urgency of improving cancer screening, noting that cancer has become the leading cause of death among adults over 50 in the United States. He stated that incorporating Galleri alongside standard-of-care screenings could enhance the overall effectiveness of national screening programmes, potentially enabling earlier intervention and improved patient outcomes.

The PMA submission is supported by performance and safety data from 25,490 participants enrolled in the U.S.-based Pathfinder 2 study, with one year of follow-up. It also includes results from the first-year prevalent screening round of the NHS-Galleri trial, the largest randomised controlled trial conducted for an MCED test in its intended use population.

In addition, the application features a bridging analysis comparing the version of Galleri used in Pathfinder 2 and the NHS-Galleri trial with the updated version submitted for FDA review. The company described the filing as a regulatory milestone toward broader availability of the test and advancing multi-cancer early detection as a potential public health strategy.