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Grail Stock Rockets 34%—But Can Its Cancer Test Live Up To The Hype?

GRAIL suddenly became one of healthcare’s most closely watched stocks after its shares surged nearly 34% to $107.97 on September 21, following FDA briefing documents that raised investor expectations ahead of a September 23 advisory committee review of Galleri. The blood test searches for cancer-associated DNA methylation patterns and is designed to detect signals from more than 50 types of cancer using a single blood draw, while also predicting where a detected signal may have originated. FDA reviewers reportedly raised no major outstanding concerns around analytical performance, study design, or primary safety, although the agency is asking outside experts to consider whether Galleri’s performance supports calling it an “early detection” test. The excitement is understandable, but the story is more complicated: Galleri’s largest U.K. study missed its primary endpoint, GRAIL remains deeply loss-making, and broad insurance reimbursement has yet to arrive. Here are the four factors shaping the debate.