Diagnostic performance of a 4-miRNA blood panel for colorectal cancer

Abstract

Abstract Early detection of colorectal cancer (CRC) significantly improves clinical outcomes; however, the widely used faecal immunochemical test (FIT) exhibits suboptimal sensitivity. We aimed to develop a blood-based diagnostic panel using high-mannose (HM)-associated miRNAs captured by recombinant Oscillatoria agardhii agglutinin (OAA1). Using a two-stage design, we analysed retrospective discovery ( n = 99) and prospective validation ( n = 21) cohorts. Serum HM-associated miRNAs were captured using OAA1-immobilised columns and quantified by reverse transcription-quantitative polymerase chain reaction. Multivariate logistic regression identified an optimised 4-miRNA panel (miR-122-5p, miR-130a-3p, miR-15b-5p, and miR-126-3p) with an area under the curve (AUC) of 0.886 in the discovery cohort. The panel score exhibited a significant stage-dependent increasing trend across the adenoma–carcinoma sequence ( P < 0.0001) and showed no significant association with tumour location, maximum tumour diameter, or conventional tumour markers. In the independent validation cohort, this panel achieved an AUC of 0.944, with 100% sensitivity and 83.33% specificity. These results suggest that the OAA1-captured 4-miRNA panel can serve as a non-invasive liquid biopsy tool for early CRC detection. This may help address the anatomical and tumour-burden limitations of the FIT, supporting the panel’s potential utility as a secondary screening strategy in clinical practice.