Miguel Bronchud, Co-Founder and Director of Clinical Research at BO REAL BioTech, shared on LinkedIn:
”Colorectal cancer is rather prevalent in both males and females and (combined) one of the deadliest cancers in the developed world- but cases and deaths are preventable through appropriate screening.
Blood-based screening tests hold promise for increasing participation in colorectal cancer screening; however, their preventive effect remains limited if premalignant lesions are missed.
Detection of advanced adenomas is essential to reduce both colorectal cancer incidence and mortality. The DENEB study aimed to develop and evaluate a novel blood-based assay for this purpose.
The blood-based test developed through discovery and training interrogated the transcriptional expression of 19 cell-free and 20 exosomal miRNAs using RT-qPCR. In the testing cohort (clinical cohort 2), the test showed an area under the receiver operating characteristic curve of 95% (95% CI 92–98) for distinguishing colorectal cancers and advanced adenomas from non-disease controls.
Sensitivity for colorectal cancer of any stage was 91% (95% CI 80–96; 89% [75–96] for males and 95% [75–99] for females), while sensitivity for stage I, II, or III colorectal cancers was 92% (80–97).
Sensitivity for advanced adenomas was 81% (69–89; 82% [67–91] for males and 79% [57–92] for females).
The specificity for advanced neoplasia was 85% (95% CI 77–90). Specificity for a negative colonoscopy was 83% (95% CI 72–91).
The DENEB study was an outcome-enriched case-controlled multicentre biomarker study, conducted according to the Early Detection Research Network phase I–III framework to discover circulating biomarkers associated with colorectal cancer and advanced adenomas (phase I) and then train (phase II) and test a blood-based assay (phase III) in non-overlapping cohorts.
These are highly promising results but of course large-scale prospective studies are needed to determine its performance, clinical utility, and potential role within population-based screening strategies.”
Title: A blood-based test for detection of advanced adenomas and colorectal cancer (DENEB): a multicentre diagnostic accuracy study
Authors: Alessandro Mannucci, Caiming Xu, Francesc Balaguer, Yoshinaga Okugawa, Yuji Toiyama, Miguel Pera, Jing Zhang, David L. Bartlett, Ali H. Zaidi, Christina Therkildsen, Giulia Martina Cavestro, Luis Bujanda, Ajay Goel
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