Performance of a multi-biomarker class, multi-cancer early detection (MCED) blood test in a prospectively collected cohort.

Authors

Vladimir G Gainullin, Mael Manesse, Fanglei Zhuang, Melissa Gray, Hee Jung Hwang, Gustavo C Cerqueira, Christopher L Nobles, Madhav Kumar, Kevin Arvai, Xi Chen, Christopher Tyson, Chen Ji, Jin H Bae, Violeta Beleva Guthrie, Jaspreet Kaur, Viatcheslav E Katerov, Larson Hogstrom, Leonardo N Hagmann, Philip J Uren, Jorge Garces, Hatim T Allawi, Vuna S Fa, Abigail McElhinny, Gerard A Silvestri, David Chesla, Robert W Given, Tomasz M Beer, Frank Diehl

Published in

Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology. Oct 02, 2026. Epub Oct 02, 2026.

Abstract

Multi-biomarker blood tests have the potential to detect a broad range of cancer types and stages. Herein, we assessed the performance of a methylation and protein (MP) classifier using samples from a large, multi-center, prospectively collected case-control study. As part of the assay development process, we performed an exploratory analysis investigating the addition of a somatic mutation reflex approach (MP-reflex) on samples with scores below the threshold for a positive MP call but above a clear negative MP call.
This study included 6,352 samples (1,438 cancer; 4,914 non-cancer) representing all stages among 21 tumor organ types divided approximately equally between a training and a test set. The sensitivity of the MP classifier was determined at a high specificity. The MP-reflex approach was investigated on MP samples at the same specificity threshold and detectable MP signals above pre-specified lower thresholds.
Overall sensitivity for MP biomarkers was 50.9% (98.5% specificity), with sensitivities of 15.4%, 26.1%, 38.0%, 67.8%, 85.5%, and 37.5% for stages I, I and II combined, II, III, IV, and unknown, respectively. With breast and prostate cancers excluded, overall test sensitivity was 56.8%, with sensitivities of 17.2%, 30.7%, 48.6%, 73.5%, 86.5%, and 40.0% for stages I, I and II combined, II, III, IV, and unknown, respectively.
MP biomarkers detected all solid cancers analyzed, including those without recommended screening and aggressive cancers with poor 5-year survival.
These results demonstrate the potential clinical validity of multi-biomarker testing for the detection of several cancer types.

PMID:
42826075
Bibliographic data and abstract were imported from PubMed on 03 Oct 2026.

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