TEST:

Galleri Test

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."

In addition, annual public funding of $100 billion for this test would be socially unaffordable; the opportunity costs would be unacceptable for both ethical and economic reasons. Further, the least well off with respect to cancer care would be made worse off if this test were publicly funded for everyone over the age of fifty.

"GRAIL, Inc...announced early results from the REFLECTION study, which aims to understand the real-world experience of the Galleri® multi-cancer early detection (MCED) test in routine clinical settings. The Galleri test is recommended for adults with an elevated risk for cancer, such as those age 50 or older. In this study, a diverse population of veterans from U.S. Department of Veterans Affairs (VA) sites with toxic exposure but with no symptoms suggestive of cancer were included in study enrollment. Initial results showed that among study participants, the veteran cohort had a cancer signal detection rate consistent with other populations that have received the MCED test. The findings were presented during a presentation at the 2024 Early Detection of Cancer Conference (EDCC)."

We previously expressed concerns about the sensitivity and specificity of the Galleri test. In this Perspective, we revisit the hyped technology, and we provide new suggestions on the use of this test.