A recent multicenter study conducted on 6,600 participants has confirmed the efficacy of the FOB Gold® assay in colorectal cancer screening programs, demonstrating how the harmonization of analytical thresholds (cut-offs) ensures top-tier clinical results.
Clinical Results with the Sentinel Assay:
The study demonstrates that, through proper parameter calibration, the FOB Gold® assay achieves excellent performance, perfectly comparable to other leading providers in the sector:
- Maximum Clinical Sensitivity: The assay showed a sensitivity of 59.42% in detecting Advanced Neoplasia (AN), ensuring the necessary efficacy to identify significant lesions at an early stage on a large scale.
- High Predictive Value: The Positive Predictive Value (PPV) of 26.97% confirms the accuracy of the Sentinel test in correctly identifying patients who require endoscopic follow-up, with results statistically equivalent to major competitors.
- Healthcare System Efficiency: Thanks to result stability and the alignment of positivity rates, FOB Gold® allows for the optimization of hospital resources, reducing the burden of unnecessary colonoscopies.
Conclusions
The data published in Clin Chem Lab Med confirm that FOB Gold® is a robust and reliable solution. Its adoption allows laboratories to operate with the highest standards of clinical safety, while offering the necessary flexibility to adapt to specific local endoscopic capacities.
Scientific Reference: Dubé J, Plantefève R, Bonin M, Galarneau L, Rousseau JD, Corbin F, Ménard C, Çaku A. Thresholds adjustments and impact on clinical performance of three FIT assays in a colorectal cancer screening program. Clin Chem Lab Med. 2025 Nov 10;64(3):706-716. doi: 10.1515/cclm-2025-0546.