Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening

This document is a technical report detailing the performance characteristics of the next-generation multitarget stool DNA (mt-sDNA) test compared to the fecal immunochemical test (FIT) for colorectal cancer (CRC) screening. The study, known as BLUE-C, was a prospective, cross-sectional assessment involving over 26,000 adults aged 40 years and older across more than 180 clinical sites. It was conducted from November 15, 2019, to January 5, 2023. The primary outcomes of the study included the sensitivity of the mt-sDNA test for CRC and its specificity for advanced neoplasia. Results indicated that the mt-sDNA test had a sensitivity of 93.9% for overall CRC, significantly higher than the 67.3% sensitivity of the FIT. The specificity for advanced neoplasia was also noted, with the mt-sDNA test showing a specificity of 90.6% compared to 94.8% for the FIT. The report also discusses study limitations and secondary outcomes related to advanced precancerous lesions and nonneoplastic findings.