Grail reported that its large NHS-backed trial of the Galleri multicancer early detection (MCED) blood test failed to meet the study’s primary endpoint of a statistically significant reduction in stage III–IV cancer diagnoses. The company disclosed topline results from the 142,000‑participant trial alongside quarterly financials and said it will extend follow-up by up to a year to assess maturing effects. Grail highlighted a favorable trend in a prespecified subgroup of 12 deadly cancers and reported reductions in stage IV diagnoses and increases in stage I–II detections for that group. Regulators and payers, including the FDA and CMS, remain focal points; Grail said it expects the NHS result will not automatically rule out its U.S. premarket approval pathway. Market reaction was immediate: the company’s stock plunged roughly half its value in after‑hours trading. Analysts and independent experts called the topline outcome a major setback for the MCED field and flagged the need for more granular data on lead‑time bias, study design and long‑term clinical benefit. Next steps: Grail will publish more detailed analyses at ASCO and extend follow up; the industry now awaits the full dataset to judge whether Galleri can still support regulatory approvals and reimbursement strategies.
Get the Daily Brief