On August 7, 2026 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported that the U.S. Food and Drug Administration’s (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 (PMA) application for the Galleri multi-cancer early detection (MCED) blood test.
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The Galleri 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, Galleri is designed to predict the cancer signal origin with high accuracy to help guide diagnostic evaluation. 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. The Galleri technology is unique in how it is designed to examine the methylome using proprietary technology and artificial intelligence. We have generated extensive data in multiple studies to evaluate the impact of adding Galleri to standard of care screening with positive results showing evidence of increases in screen detected cancers, a low false positive rate and high signal origin prediction accuracy. Adding Galleri to recommended screening could result in a more effective and efficient cancer screening program in the U.S.," said Josh Ofman, MD, MSHS, CEO at GRAIL. "Galleri is the only MCED test supported by large interventional and randomized, controlled studies in intended use populations. We appreciate the FDA’s leadership in advancing the review of the first premarket approval application for an MCED, and we look forward to discussing Galleri’s clinical data and the opportunity for multi-cancer early detection to address a significant unmet public health need, with the Advisory Committee."
GRAIL submitted its PMA application for Galleri to the FDA on Jan. 29, 2026. The FDA designated Galleri as a Breakthrough Device in 2018. The PMA submission is focused on the test performance and safety results from 25,490 consented participants with one year of follow up in the US-based PATHFINDER 2 study as well as data from over 70,000 participants from the intervention arm of the prevalent screening round (first year) of the NHS-Galleri trial, the largest and only randomized, controlled trial of an MCED test in an intended use population. The submission is also supported by an 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.
(Press release, Grail, AUG 7, 2026, View Source [SID1234669881])