On September 23, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported it will present new data highlighting the Galleri multi-cancer early detection (MCED) test performance and safety from its registrational PATHFINDER 2 study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 in Berlin, Oct. 17-21, 2025 (Press release, Grail, SEP 23, 2025, View Source;symplify-and-reflection-studies-at-esmo-congress-2025-and-edcc-302563434.html [SID1234656176]). The PATHFINDER 2 study, conducted under an FDA-approved investigational device exemption application, is the largest MCED interventional study conducted in the U.S. in an intended use population with no clinical suspicion of cancer.
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As previously reported, top-line results from evaluable PATHFINDER 2 study participants with 12 months of follow-up showed that adding the Galleri test to standard of care screening demonstrated substantially greater additional cancer detection, as well as a substantially higher positive predictive value (PPV), than observed in the first PATHFINDER study. Cancer signal of origin (CSO) accuracy and specificity were consistent with the PATHFINDER study.
In addition, the company will present new Galleri data from the follow-up of symptomatic participants enrolled in SYMPLIFY, a prospective observational study, and real world experience of veterans tested with Galleri from the REFLECTION study at the Early Detection of Cancer Conference (EDCC) 2025 in Portland, Ore., Oct. 21-23, 2025.
"Galleri is the only available MCED test with demonstrated performance in an intended use population being screened for cancer. These new data build on the results from our first clinical implementation study, PATHFINDER, which was published in the Lancet in 2023, and showed that Galleri approximately doubled the number of cancers identified when added to standard of care screening," said Josh Ofman, MD, MSHS, President of GRAIL. "We’re witnessing the beginning of a transformative era for cancer screening, with these results demonstrating Galleri’s ability to detect cancers earlier, when they can be easier to treat and are potentially curable."
ESMO Data Presentations
Title: Safety and Performance of a Multi-Cancer Early Detection (MCED) Test in an Intended-Use Population: Initial Results from the Registrational PATHFINDER 2 Study
Abstract Number: 7528
Session Title: Proffered Paper session 1: Basic science & Translational research
Date/Time: Saturday, Oct. 18, 2025 at 10:15-10:25 a.m. CEST
Location: Nuremberg Auditorium – Hall 5.2
Title: Clinical Performance of a Blood-only, Targeted Methylation Circulating Tumor DNA (ctDNA) Assay for Minimal Residual Disease (MRD) Detection in Colorectal Cancer (CRC)
Abstract Number: 6215
Presentation Type: e-Poster
EDCC Data Presentations
Title: Long-term cancer registry follow-up of false positive multi-cancer early detection (MCED) test results from the SYMPLIFY study.
Presentation Type: Poster
Title: REFLECTION: Real-World Evidence Study of Multi-Cancer Early Detection (MCED) Among Veterans in the Veterans Affairs Healthcare System (VA)
Presentation Type: Lightning Talk
Date/Time: Thursday, Oct. 23, 10:35-10:50 AM PT
Title: NHS-Galleri trial: approaches to retain a diverse participant cohort across multiple trial appointments
Presentation Type: Poster
Title: Baseline participant characteristics from PATHFINDER 2, a prospective interventional study of a multi-cancer early detection test in a population setting
Presentation Type: Poster
Title: Molecular Cancer Signal Localization in Multi-Cancer Early Detection (MCED) Testing Minimizes Radiation and Imaging Burden Compared to Whole Body Imaging Approaches
Presentation Type: Poster