ArticleClinical chemistry and laboratory medicine2026
Prospective evaluation of a multi-gene cfDNA methylation assay for CRC screening in a high-risk cohort.
Article in Clinical chemistry and laboratory medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectivesColorectal cancer (CRC) screening is crucial for early detection, yet the invasiveness of the gold-standard colonoscopy limits compliance. To address the limitation, this study proposes a novel multi-target free DNA methylation model and evaluated its risk stratification performance for CRC in high-risk populations.
methodsIn this prospective study, a cohort of 603 high-risk individuals was enrolled. Following exclusions, 570 participants who underwent successful colonoscopy were analyzed. Their plasma samples were assessed for the methylation status of a six-biomarker panel (Septin9 region 1, BCAT1, IKZF1, BCAN, VAV3, Septin9 region 2). The performance of a model integrating these markers was evaluated against colonoscopy.
resultsThe combined six-marker model demonstrated superior auxiliary screening performance compared to any single marker. It achieved a high sensitivity of 85.42 % and a negative predictive value (NPV) of 98.56 % for CRC, with a significantly larger AUC of 0.911.The model showed strong performance in early-stage cancers (85.71 % for stage I, 92.86 % for stage II) and for high-grade intraepithelial neoplasia (HGIN) (75.00 %). Specificity exceeded 94 % for distinguishing CRC from non-neoplastic conditions and normal tissue. Compared to conventional tumor markers, the six-marker model achieved significantly higher AUCs (0.911 vs. 0.599-0.711) and superior sensitivity at 90 % fixed specificity (87.5 % vs. 29.2-41.7 %). Multivariable analysis identified the model score as the sole independent predictor of CRC (OR=1.12, p<0.001).
conclusionsThe results demonstrate the clinical potential of a multi-gene cfDNA methylation-based approach to augment CRC screening strategies for high-risk individuals.
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