The upcoming meeting will evaluate the Premarket Approval application for a blood test designed to detect methylation patterns across multiple cancer types.
The Food and Drug Administration (FDA) Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to meet on Sept 23, 2026, to review the Premarket Approval application for the Galleri multi-cancer early detection blood test.
The test is designed to detect cancer-specific methylation patterns shared by many types of cancer before symptoms appear, including cancers that do not have recommended screening today. When a cancer signal is detected, the test is intended to predict the cancer signal origin to help guide diagnostic evaluation, according to a press release from GRAIL. The test is intended to be used in addition to, and not as a replacement for, guideline-recommended screenings.
“Today, the status quo in cancer screening is simply unacceptable. Many cancers are detected too late, after symptoms appear and the disease is too advanced for effective or curative-intent treatments. In fact, 70-80% of cancer deaths occur due to cancers we are not screening for at all. GRAIL has pioneered a breakthrough technology, the Galleri test, designed to transform cancer screening by detecting more cancers before symptoms appear, including many of the deadly cancers that lack recommended screenings today,” says Josh Ofman, MD, MSHS, CEO at GRAIL, in a release.
GRAIL submitted its Premarket Approval application for the test to the FDA on Jan 29, 2026. The FDA designated the test as a Breakthrough Device in 2018.
The submission is focused on the test performance and safety results from 25,490 participants with one year of follow up in the US-based PATHFINDER 2 study. It also includes data from over 70,000 participants from the intervention arm of the NHS-Galleri trial, which the company says is the largest randomized, controlled trial of a multi-cancer early detection test in an intended use population.
The submission is also supported by an analysis to compare the performance of the version of the test used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated version that has been submitted to the FDA for approval.
The company says the technology is designed to examine the methylome using proprietary technology and artificial intelligence. According to the company, data from multiple studies show evidence of increases in screen detected cancers, a low false positive rate, and high signal origin prediction accuracy.
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