Exact Sciences says Cologuard Plus test results published in NEJM

Exact Sciences Corp. announced online publication of the BLUE-C study results in The New England Journal of Medicine. The peer-reviewed study, “Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening”, will also appear in the journal’s March 14, 2024 print issue. The 20,000-participant BLUE-C study was designed to determine the performance characteristics of Exact Sciences’ next-generation multitarget stool DNA test, Cologuard Plus, for colorectal cancer and to compare that performance to the fecal immunochemical test, a commonly used noninvasive CRC screening test. Exact Sciences submitted to the U.S. Food and Drug Administration its pre-market approval application for Cologuard Plus in December 2023, including complete results from BLUE-C, and plans to make the test available in 2025, pending approval. Cologuard Plus met all BLUE-C study endpoints, demonstrating 94% sensitivity for CRC at 91% specificity including non-advanced findings, and 93% specificity including no findings. Specificity was even better in younger age groups, at 96% in 45-54 year olds. Cologuard Plus will minimize unnecessary follow-up colonoscopies by reducing the likelihood of a false-positive screening test. Results from BLUE-C also show Cologuard Plus significantly outperformed an independent FIT for overall CRC sensitivity, treatable-stage CRC sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity.