Cologuard Plus Delivers Unmatched Accuracy in Noninvasive Cancer Screening

Credit: Adobe Stock/LIGHTFIELD STUDIOS

Exact Sciences has launched Cologuard Plus, a breakthrough in noninvasive colorectal cancer (CRC) screening. This U.S. Food and Drug Administration (FDA)-approved test for average-risk individuals aged 45 or older boasts 95% sensitivity for CRC detection at 94% specificity, making it the most accurate noninvasive CRC screening test reported in studies to date.

Results translate to fewer unnecessary colonoscopies — up to 40% fewer false positives compared with the original Cologuard test — offering patients and health care providers greater confidence in screening results.

“Cologuard Plus builds on the proven performance of Cologuard,” said Jake Orville, executive vice president and general manager for screening. “Cologuard transformed colorectal cancer screening — driving an estimated 77% of the nationwide increase in CRC screening participation from 2018 to 2021 and enabling more than 19 million screenings to date. Cologuard Plus delivers key enhancements to help improve patient care and streamline health care delivery, bringing us closer to eradicating this highly preventable and treatable disease.”

Cologuard Plus builds on the success of the original Cologuard test, which has been used in over 19 million screenings since its launch. The new version is backed by data from the 20,000-plus patient BLUE-C study, published in the New England Journal of Medicine. It demonstrates higher detection rates for precancerous lesions (43% sensitivity) and high-grade dysplasia (74% sensitivity), ensuring earlier intervention and prevention of CRC.

Access and convenience remain key priorities. Cologuard Plus is covered by Medicare and recommended by the U.S. Preventive Services Task Force (USPSTF). Patients can complete the test at home, with 71% adhering within an average of 28 days — a significantly higher completion rate than traditional stool-based tests or colonoscopy referrals.

Exact Sciences continues to expand patient access, with 96% of individuals aged 45-plus facing no out-of-pocket costs for screening. While Cologuard Plus enhances performance, the original Cologuard test remains available to ensure broader accessibility.

“Early detection helps save lives, and clinicians need highly accurate tests that their patients will complete,” concluded Paul Limburg, M.D., chief medical officer of screening. “Cologuard Plus delivers unprecedented performance in a noninvasive test — detecting more cancers while significantly reducing false positives. Combined with strong patient adherence, it gives health care providers confidence that more patients will get screened and receive accurate results to drive better outcomes.”