TEST:

Galleri Test

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."

"GRAIL, Inc...and Quest Diagnostics (NYSE: DGX)...today announced the initial phase of a program to improve provider access to GRAIL's Galleri® multi-cancer early detection (MCED) test. Providers can now order the Galleri test directly from GRAIL through the Quest Diagnostics connectivity system. The Quest Diagnostics connectivity system enables providers in the United States to order and receive reports of laboratory tests electronically through Quest's Quanum laboratory portal and more than 900 electronic health record (EHR) systems. More than 500,000 providers used the Quest connectivity system last year."

P=N/A, N=1000, Recruiting, Dana-Farber Cancer Institute | Initiation date: Dec 2024 --> Mar 2025

P=NA | N=6,662 | PATHFINDER (NCT04241796) | Sponsor: GRAIL, Inc. | "PRO assessment was conducted for eligible PATHFINDER study participants with either a cancer signal detected (CSD) or no cancer signal detected (NCSD) over a 12-month follow-up period....Overall the study demonstrated minimal patient distress associated with MCED testing. Most participants with a NCSD result responded that they were 'relieved about my test result'. The negative patient-reported impacts associated with a CSD test result were small and returned to baseline within 12 months. High overall satisfaction with the MCED test was reported across participant groups regardless of signal detection status and eventual diagnosis. Most participants reported they were 'likely'/'very likely' to adhere to future guideline recommended screening tests as recommended by their healthcare provider."