Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2026
Performance of a multi-biomarker class, multi-cancer early detection (MCED) blood test in a prospectively collected cohort.
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Gainullin Vladimir G, Manesse Mael, Zhuang Fanglei, Gray Melissa, Hwang Hee Jung, Cerqueira Gustavo C, Nobles Christopher L, Kumar Madhav, Arvai Kevin, Chen Xi, Tyson Christopher, Ji Chen, Bae Jin H, Beleva Guthrie Violeta, Kaur Jaspreet, Katerov Viatcheslav E, Hogstrom Larson, Hagmann Leonardo N, Uren Philip J, Garces Jorge, Allawi Hatim T, Fa Vuna S, McElhinny Abigail, Silvestri Gerard A, Chesla David, Given Robert W, Beer Tomasz M, Diehl Frank
Аннотация
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: MP biomarkers detected all solid cancers analyzed, including those without recommended screening and aggressive cancers with poor 5-year survival.
IMPACT: These results demonstrate the potential clinical validity of multi-biomarker testing for the detection of several cancer types.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: MP biomarkers detected all solid cancers analyzed, including those without recommended screening and aggressive cancers with poor 5-year survival.
IMPACT: These results demonstrate the potential clinical validity of multi-biomarker testing for the detection of several cancer types.