Exact Sciences today announced the launch of Cologuard Plus, a more accurate non-invasive colorectal cancer screening (CRC) test. FDA-approved for average-risk patients 45+ and covered by Medicare, the company said the Cologuard Plus test detects 95% of colorectal cancers at 94% specificity in the U.S. screening population. This performance could mean fewer unnecessary follow-up colonoscopies—up to a 40% reduction compared to the original Cologuard test.
The Cologuard Plus test features:
- 95% sensitivity for CRC detection, versus 71% sensitivity with fecal immunochemical test (FIT)
- 40% reduction compared to the original Cologuard test.
- 43% sensitivity for advanced precancerous lesions and 74% sensitivity for high-grade dysplasia—the type of precancerous growths most likely to become cancer.
- A negative Cologuard Plus result means a 99.98% chance the patient does not have colorectal cancer—offering peace of mind to both patients and clinicians.
- Coverage by Medicare and included in the U.S. Preventive Services Taskforce (USPSTF) guidelines as a recommended stool-based screening option.
“Early detection helps save lives, and clinicians need highly accurate tests that their patients will complete,” said Dr. Paul Limburg, Chief Medical Officer, 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.”
Like the original Cologuard test, the Cologuard Plus test is shipped directly to a patient’s home and integrates with the ExactNexus technology platform. This platform simplifies ordering, result delivery, and patient navigation—a feature proven to improve test completion rates. As Exact Sciences works to expand patient access to the Cologuard Plus test, the original Cologuard test will remain available. Nationwide, more than 96% of patients aged 45 and older have no out-of-pocket costs for screening with the Cologuard test.
