Multicenter diagnostic study shows DENEB blood test detects 81% of advanced adenomas and 92% of stage I-III colorectal cancers

The study enrolled participants already scheduled for colonoscopy and compared plasma methylation and protein markers in the DENEB panel against colonoscopy histology. Sensitivity reached 91% overall for cancer and remained high (92%) for stages I-III, while specificity for no advanced findings was 88%. These figures exceed the FDA-approved Shield test, which detects only 13% of advanced adenomas in published data. The design was retrospective case-control within a screening cohort rather than a prospective population-based trial.

Existing blood tests have performed well for invasive cancer but consistently underperformed on precancerous lesions that colonoscopy can remove. DENEB's polyp detection rate suggests a pathway to prevention rather than solely earlier diagnosis, potentially raising overall screening uptake among people who decline stool tests or endoscopy. However, the study population was enriched for higher-risk individuals and drawn from East Asian and Spanish centers, limiting immediate generalizability to average-risk US adults.

Next steps require prospective screening studies in unselected populations to measure interval cancer rates and determine whether a positive DENEB result increases colonoscopy completion without excessive false positives. Regulatory review will also need outcome data showing reduced colorectal cancer incidence or mortality before guideline endorsement.