Results of the population-based PREEMPT-CRC study

An original investigational paper published in JAMA 2025 reports the clinical validation of an investigational, blood-based circulating tumor DNA (ctDNA) test for the early detection of colorectal cancer at average risk. In a prospective, multicenter, population-based diagnostic accuracy design, the test performance was evaluated against screening colonoscopy with histopathological reference standard; in the evaluable population, the test showed a sensitivity of 79.2% for colorectal cancer and a specificity of 91.5% for advanced colorectal neoplasia, while the detection of advanced precancerous lesions did not reach a predefined acceptance criterion with 12.5% sensitivity.