TEST:

Galleri Test

Analysis of these new data showed that the primary endpoint of the trial, aiming to reduce the incidence of stage III-IV cancer by at least 20 %, was missed. The trial is still ongoing.

''GRAIL, Inc...will present additional data from both the NHS-Galleri trial and the PATHFINDER 2 study further evaluating the Galleri® multi-cancer early detection (MCED) test at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 29-June 2, 2026.''

''GRAIL, Inc...today announced a collaboration with Epic to bring the Galleri® multi-cancer early detection test into one of the nation’s most widely used electronic health record (EHR) platforms, supporting broader adoption across health systems in the United States.''

Most patients with a cancer signal detected on a MCED test were true positives with a cancer consistent with the CSO reported. Patients had their MCED test results quickly adjudicated when presenting to a dedicated clinical program supporting a role for cancer diagnostic expertise in evaluating MCED tests.

''GRAIL, Inc...today announced topline results from the landmark, randomized, controlled NHS-Galleri trial, which evaluated annual multi-cancer screening with the Galleri® test in England’s National Health Service (NHS) over three years in 142,000 demographically representative participants aged 50 to 77. ''

Clinical utility of MCD testing for symptomatic patients in the United Kingdom varies substantially across referral pathways but is favorable for gynecologic and GI cancers. Future pathway-specific optimization of MCD tests must consider clinical utility explicitly and does not require retraining the underlying machine learning classifiers.

The MCED test correctly predicted the CSO in 87% of cases with a reported cancer type, consistent with previous clinical studies. CSO enabled efficient workup in most patients, with a median 39.5 days from result receipt to cancer diagnosis.

Additional prospective randomized clinical trials are needed before widespread adoption. The information and data included in this manuscript was previously presented as a poster (e612 Poster Q&A Sessions) at the 2024 American Society for Radiation Oncology Annual Meeting.

This study compares how MCED testing strategies affect CE and population health benefits.

NHS-Galleri is the first double-blind cancer screening RCT. It also, unusually, uses late-stage cancer incidence (rather than cancer mortality) as its primary outcome.

"GRAIL, Inc...today announced positive top-line performance and safety results from the pre-specified analysis of the first 25,578 participants in GRAIL’s registrational PATHFINDER 2 study. PATHFINDER 2 was initiated in 2021 to evaluate the safety and performance of the Galleri® multi-cancer early detection (MCED) test when added to standard of care single cancer screening in 35,878 adults over 50 years of age with no clinical suspicion of cancer. "

"GRAIL, Inc...will present new data highlighting the latest real-world evidence with the Galleri® multi-cancer early detection (MCED) test and additional data from GRAIL’s circulating tumor DNA (ctDNA)-based targeted methylation platform at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, April 25-30, 2025."