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GRAIL Submits FDA Premarket Approval Application for the Galleri® Multi-Cancer Early Detection Test
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.
About this update from Grail, Inc.
[{"type":"text","content":"FDA Submission Marks a Pivotal Milestone in Advancing Early Cancer Detection, Addressing Unmet Needs in Cancer Screening","length":120,"tagName":"p","attribs":{}},{"type":"text","content":"MENLO PARK, Calif., Jan. 29, 2026 /PRNewswire/ -- 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.","length":434,"tagName":"p"},{"type":"image","alt":"GRAIL, Inc. is a healthcare company whose mission is to detect cancer early when it can be cured. (PRNewsfoto/GRAIL, Inc.)","displaySize":"","headline":null,"caption":"GRAIL, Inc. is a healthcare company whose mission is to detect cancer early when it can be cured. (PRNewsfoto/GRAIL, Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":76,"url":"https://media.zenfs.com/en/prnewswire.com/df6f1c041e7249704f56bfd0aaad45cf"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/meakvH1b1gc304gFRr9obw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTEzNA--/https://media.zenfs.com/en/prnewswire.com/df6f1c041e7249704f56bfd0aaad45cf","width":400,"height":76}},"href":"https://mma.prnewswire.com/media/2460831/Grail_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":""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. "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. Galleri has been rigorously studied in case-controlled and interventional studies. This FDA submission marks a critical step toward making Galleri available to more people and advancing early detection to provide a significant public health benefit."","length":831,"tagName":"p"},{"type":"text","cont...