Feb 20 (Reuters) – Grail shares plunged nearly 50% in premarket trading on Friday after its three-year cancer screening trial failed to meet its main goal, dealing a major blow to the blood test maker.
The setback comes just weeks after Grail filed for the U.S. regulatory approval of its Galleri test based on data from a smaller U.S. trial and first-year data from the much larger three-year trial.
The larger trial was designed to show whether using the test could reduce late-stage cancer diagnoses and increase early detection within the National Health Service to decide on a screening program in England.
Grail, after markets closed on Thursday, said the main goal of statistical significant reduction was not met, but “a favorable trend was observed over time” in the trial, which tested more than 142,000 people aged 50 to 77 years across the NHS.
The company had submitted its premarket approval application for Galleri to the U.S. Food and Drug Administration late last month using the data from a study of about 25,000 U.S. participants and the first year of the NHS-Galleri trial.
The Galleri multi-cancer early detection test is already recommended for adults, such as those aged 50 years or older, with an elevated risk for cancer.
Canaccord Genuity analyst Kyle Mikson said although the FDA approval of Galleri does not appear to be at material risk, it remains to be seen if the Centers for Medicare and Medicaid Services would consider the NHS data as it decides to establish the coverage policy.
Earlier this month, U.S. President Donald Trump signed into law a bill allowing insurance coverage of multi-cancer early detection tests under Medicare plans for older adults, starting in 2028 depending on age.
“We believe it is relatively likely that CMS will emphasize U.S.-based studies… rather than the specific endpoints that NHS established,” Mikson said.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Shilpi Majumdar)
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