Performance of a cell-free DNA blood-based test for colorectal cancer screening

Early detection of colorectal cancer (CRC) could prevent a substantial proportion of CRC associated deaths, yet in the USA more than one third of the screening-eligible population is not up to date with screening. A blood-based test has the potential to improve screening adherence. The ECLIPSE clinical trial in the USA and Canada evaluated a cell-free DNA (cfDNA) blood-based test in a population eligible for colorectal cancer screening. A total of 83.1% of the participants with CRC detected by colonoscopy had a positive cfDNA test, while 16.9% had a negative test, indicating a sensitivity of the test for detection of CRC of 83.1% (95% CI 72.2-90.3). Sensitivity for stage I, II, or III CRC was 87.5% (95% CI 75.3-94.1), and sensitivity for advanced precancerous lesions was 13.2% (11.3-15.3). Among participants without any advanced colorectal neoplasia identified on colonoscopy, 89.6% had a negative cfDNA test, whereas 10.4% had a positive cfDNA test, which indicates a specificity for any advanced neoplasia of 89.6% (95% CI 88.8-90.3).