Core Viewpoint - Grail's shares dropped nearly 50% after its three-year cancer screening trial failed to meet its primary goal, significantly impacting the company [1] Company Summary - Grail's three-year cancer screening trial aimed to demonstrate a reduction in late-stage cancer diagnoses and improve early detection within the National Health Service (NHS) [1] - The trial involved over 142,000 participants aged 50 to 77 years, but the main goal of achieving a statistically significant reduction was not met, although a favorable trend was noted over time [1] - Grail had previously filed for U.S. regulatory approval of its Galleri test based on data from a smaller U.S. trial and the first-year data from the larger trial [1] Industry Summary - The Galleri multi-cancer early detection test is recommended for adults aged 50 and older with an elevated risk for cancer [1] - The approval of Galleri by the FDA does not appear to be at material risk, but the consideration of NHS data by the Centers for Medicare and Medicaid Services (CMS) for coverage policy remains uncertain [1] - Recent legislation allows for insurance coverage of multi-cancer early detection tests under Medicare plans for older adults starting in 2028, depending on age [1]
Grail shares plunge after major cancer screening trial misses main goal