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Updated: Sep 16, 2025
Evaluation of Colorectal Cancer Risk and Prevalence by Stool DNA Integrity Detection
Published on: June 8, 2020
Integrating fecal immunochemical testing and methylated SEPT9 for enhanced colorectal cancer Screening: A
Jonas Dohmen1, Stefanie Rohrbach2, Tim Vilz1
1Department of Surgery, University of Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.
Introduction:
Colorectal cancer (CRC) remains a leading cause of cancer-related mortality, with an increasing incidence in individuals younger than 50 years old. Early detection through screening significantly improves outcomes, with non-invasive methods such as the fecal immunochemical test (FIT) providing a viable addition to colonoscopy. However, sensitivity limitations of FIT have prompted the exploration of additional biomarkers, including methylated SEPT9 (mSEPT9), a blood-based assay approved for CRC screening. The aim of this study was to directly compare the diagnostic performance of FIT and mSEPT9 and to assess the potential benefit of a combined FIT/mSEPT9 test.
Methods:
A multi-center case-control study was conducted with 100 CRC patients and 100 matched controls. FIT was performed using the OC-Sensor Test Kit, while mSEPT9 was detected by quasi-digital real-time PCR. Test performance was evaluated using sensitivity, specificity, and receiver operating characteristic (ROC) analysis. A combined FIT/mSEPT9 score was developed and evaluated for its diagnostic performance.
Results:
The FIT test demonstrated a sensitivity of 85% and a specificity of 78% (AUC: 0.88), while mSEPT9 achieved a sensitivity of 78% and a specificity of 75% (AUC: 0.82). The combination of FIT and mSEPT9 improved diagnostic performance, yielding an AUC of 0.92. With a specificity of 94%, the combined test detected 75% of CRC cases.
Conclusions:
The combined FIT/mSEPT9 test improves CRC detection compared to individual tests, demonstrating potential as an advanced non-invasive screening strategy. It meets established criteria for blood-based biomarkers, further supporting the integration of molecular biomarkers with conventional screening methods to enhance CRC screening efficiency and patient outcomes.
