By VETTAPHARMA reporter: Shares of Grail, Inc. (NASDAQ: GRAL) fell sharply — down nearly 50% in pre-market trading — after the company’s pivotal three-year cancer screening trial failed to meet its primary endpoint of a statistically significant reduction in late-stage (Stage III-IV) cancer diagnoses in participants aged 50 to 77 within the United Kingdom’s National Health Service (NHS).
The NHS-Galleri trial, which enrolled over 142,000 participants, was designed to evaluate whether annual screening with the Galleri multi-cancer early detection blood test could reduce late-stage cancer diagnoses and improve early detection across multiple cancer types. While a favorable trend toward fewer Stage III-IV cancers in a pre-specified group of 12 deadly cancers was observed, the results did not achieve the statistical significance required for the primary endpoint.
This setback comes shortly after Grail’s premarket approval submission to the U.S. Food and Drug Administration for the Galleri test, based on combined U.S. and NHS trial data. Although analysts suggest the FDA approval path remains intact, regulators such as the U.S. Centers for Medicare and Medicaid Services (CMS) may focus more heavily on U.S.-based data when setting future Medicare coverage policy for multi-cancer early detection tests.
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👉 NHS Galleri trial reveals clinically meaningful cancer detection improvements despite mixed primary results. Vettapharma.com discusses earlier NHS findings showing a clinically meaningful reduction in Stage IV cancer diagnoses and increased early stage detection rates when Galleri screening was added to standard care — despite the trial’s mixed primary outcome. (VETTAPHARMA)
