The DENEB study developed and validated a blood-based miRNA assay (39 cell-free and exosomal miRNAs measured by RT-qPCR, scored via XGBoost) to detect colorectal cancer and advanced adenomas in average-risk individuals aged 45+, tested in a multicentre case-control design across Spain and Japan (testing cohort n=230).
In the testing cohort, the assay achieved an AUC of 95% (95% CI 92–98); sensitivity for colorectal cancer was 91% (95% CI 80–96) and for advanced adenomas was 81% (95% CI 69–89); specificity for advanced neoplasia was 85% (95% CI 77–90) and for negative colonoscopy was 83% (95% CI 72–91).
- Outcome-enriched case-control design inflates apparent performance vs. real-world screening prevalence. - Testing cohort is relatively small (n=230), limiting precision of confidence intervals. - Cohorts drawn from only two countries (Spain, Japan), limiting generalizability to other populations.
This blood-based miRNA test shows high sensitivity for both colorectal cancer and advanced adenomas—the premalignant lesions most blood tests miss—but prospective large-scale trials in unselected screening populations are needed before clinical adoption.
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