Diagnostic Accuracy of a Blood-Based Biomarker Panel for Colorectal Cancer Detection: A Pilot Study

Colorectal cancer (CRC) is a leading cause of death worldwide. Despite its preventability through screening, compliance still needs to improve due to the invasiveness of current tools. There is a growing demand for validated molecular biomarker panels for minimally invasive blood-based CRC screening. This study assessed the diagnostic accuracy of four promising blood-based CRC biomarkers, individually and in combination. This case-control study involved plasma samples from 124 CRC cases and 124 age- and sex-matched controls. Biomarkers tested included methylated DNA encoding the Septin-9 gene () using Epi proColon 2.0 CE, insulin-like growth factor binding protein 2 (IGFBP2), dickkopf-3 (DKK3), and pyruvate kinase M2 (PKM2) by ELISA. Diagnostic accuracy was measured using the receiver operating characteristic (ROC), area under the curve (AUC), as well as sensitivity and specificity. Diagnostic accuracy for , IGFBP2, DKK3, and PKM2 was 62.9% (95% CI: 56.8-62.9%), 69.7% (95% CI: 63.1-69.7%), 61.6% (95% CI: 54.6-61.6%), and 50.8% (95% CI: 43.4-50.8%), respectively. The combined biomarkers yielded an AUC of 74.4% (95% CI: 68.1-80.6%), outperforming all biomarkers except IGFBP2. These biomarkers show potential for developing a minimally invasive CRC detection tool as an alternative to existing approaches, potentially increasing adherence, early detection, and survivorship.