Exact Sciences Corp. (EXAS) Monday has introduced Cologuard Plus, an FDA-approved noninvasive colorectal cancer - CRC screening test for average-risk adults aged 45 and older.
It offers 95 percent cancer detection sensitivity with 94 percent specificity, significantly reducing unnecessary colonoscopies compared to the original Cologuard test. Covered by Medicare and endorsed by the U.S. Preventive Services Task Force - USPSTF, the test enhances accuracy while maintaining the convenience of at-home sample collection.
Cologuard Plus offers significant performance enhancements, detecting 95 percent of colorectal cancers, outperforming fecal immunochemical tests - FIT. It also reduces unnecessary follow-ups by 40, minimizing false positives compared to the original Cologuard test.
Additionally, it identifies 43 percent of advanced precancerous lesions and 74 percent of high-grade dysplasia, improving early detection. With a 99.98 percent probability that a negative result means no colorectal cancer, the test provides greater confidence in screening accuracy.
Cologuard Plus is backed by data from the 20,000+ person BLUE-C study, published in the New England Journal of Medicine. Jake Orville, EVP and GM of Screening at Exact Sciences, highlighted its role in driving higher screening rates and enhancing early detection efforts.
Colorectal cancer is highly treatable when detected early, yet 48 million Americans remain unscreened. Routine screening helps identify precancerous growths for removal, preventing cancer development.
The ExactNexus technology platform supports ordering, results, and patient navigation, streamlining the process. While Cologuard Plus expands screening options, the original Cologuard test remains available, with 96 percent of patients aged 45+ facing no out-of-pocket costs.
Developed with the Mayo Clinic, Cologuard Plus builds on Exact Sciences' commitment to improving CRC screening access and outcomes through enhanced biomarkers, better sample stability, and refined lab processes.
EXAS is currently trading at $43.58 or 0.19% lower on the NasdaqCM (Nasdaq Capital Market.
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