DENEB Blood Test Detects Both Colorectal Cancer and Advanced Adenomas—But Is Not Screening-Ready: The Lancet Gastroenterology & Hepatology | October 2026
What Did the Study Find?
DENEB developed a blood assay combining 19 cell-free and 20 exosomal microRNAs, measured by RT-qPCR and interpreted using locked machine-learning models. Biomarkers were identified in discovery cohorts, trained in 535 participants and independently tested in 230 participants with colonoscopy-defined outcomes.
In the testing cohort, the assay achieved an AUROC of 0.95 for advanced neoplasia. Sensitivity was 91% for colorectal cancer overall, 92% for stages I–III disease, and—most importantly—81% for advanced adenomas. Specificity was 85% for advanced neoplasia and 83% among participants with a negative colonoscopy. These results exceed the advanced-adenoma sensitivity reported for several existing blood-based approaches. However, DENEB was evaluated in an outcome-enriched case-control population containing known cancers rather than prospectively in an unselected screening cohort. PubMed
Why Does It Matter?
Detecting cancer alone can reduce mortality, but detecting advanced adenomas offers genuine cancer-prevention potential. The design may nevertheless overestimate real-world performance, predictive values and clinical utility.
GastroAGI Takeaway: DENEB is an unusually promising blood-based prevention test, but it should not replace FIT or colonoscopy until validated prospectively in average-risk screening populations.