Summary:
The results of this prospective multicenter study, conducted on 949 patients, confirm the efficacy of the FOB Gold® fecal immunochemical test (Sentinel Diagnostics) as a pivotal tool for optimizing diagnostic pathways in symptomatic patients. The study demonstrates that performing two FIT tests on distinct fecal samples, using the lowest hemoglobin limit of quantification, achieves a Negative Predictive Value (NPV) of 95.6% for advanced neoplasia and 99.7% for colorectal cancer (CRC). This approach has the potential to safely avert up to 71.1% of unnecessary colonoscopies in patients presenting with suspicious symptoms.
Key Highlights:
- Maximum Accuracy: Utilizing two samples increases sensitivity for CRC to 93.9% compared to a single-test approach.
- Healthcare System Efficiency: 71% of patients showed concordant negative results, suggesting that invasive procedures can be safely avoided in these cases.
- Focus on Alarm Symptoms: Sensitivity for advanced neoplasia significantly increases (up to 84.6%) in the presence of alarm symptoms such as rectal bleeding or anemia.
Scientific Reference:
Moen, S., et al. (2025). Two-sample fecal immunochemical testing as a tool to avert colonoscopy in symptomatic patients: a prospective multicenter cohort study. Endoscopy. DOI: 10.1055/a-2650-0664