On March 31, 2025 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported the launch of Cologuard Plus, the most accurate noninvasive colorectal cancer screening (CRC) test reported in studies to date.* FDA-approved for average-risk patients 45+ and covered by Medicare, the Cologuard Plus test detects 95% of colorectal cancers at 94% specificity in the U.S. screening population (Press release, Exact Sciences, MAR 31, 2025, View Source [SID1234651669]). This performance means fewer unnecessary follow-up colonoscopies—up to a 40% reduction compared to the original Cologuard test2—and greater confidence in results.

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Building on the trust and success of Cologuard—used for more than 19 million screenings over the past decade—Cologuard Plus delivers even greater performance while maintaining the convenience of at-home collection. Backed by pivotal data from the 20,000+ person BLUE-C study published in the New England Journal of Medicine, the Cologuard Plus test sets a new standard for noninvasive CRC screening:

Unmatched Noninvasive CRC Accuracy*:95% sensitivity for CRC detection, versus 71% sensitivity with fecal immunochemical test (FIT).1
Fewer False Positives: 40% reduction compared to the original Cologuard test.2
High Precancerous Lesion Detection:43% sensitivity for advanced precancerous lesions and 74% sensitivity for high-grade dysplasia—the type of precancerous growths most likely to become cancer.1
Greater Confidence in Negative Results: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.1
Access & Coverage:Covered by Medicare and included in the U.S. Preventive Services Taskforce (USPSTF) guidelines as a recommended stool-based screening option.
Recognized for Quality Care:Satisfies three years of colorectal cancer screening quality measure credit, helping health care professionals meet screening goals while improving patient outcomes.
"Cologuard Plus builds on the proven performance of Cologuard," said Jake Orville, Executive Vice President and General Manager, Screening. "Cologuard transformed colorectal cancer screening—driving an estimated 77% of the nationwide increase in CRC screening participation from 2018 to 20213 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."

Driving Better Outcomes Through Early Detection and Adherence

Colorectal cancer is highly treatable when caught early—survivable in about 90% of cases.‡ Yet, nearly 48 million Americans remain unscreened.4 Routine screening not only detects colorectal cancer when it’s most treatable but also prevents it by identifying precancerous growths so they can be removed.5

"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."

Effective screening depends on patient adherence, and Cologuard Plus is designed to remove barriers to testing. A large national sample of Cologuard orders shows that 71% of patients complete their test within an average of 28 days,6 significantly outperforming adherence rates seen in separate meta-analyses for FIT (42%) or colonoscopy referrals (38%).7

Follow-up adherence is also strong—79% of patients who receive a positive Cologuard result complete a colonoscopy, and 83% of patients complete repeat screening three years later.8,9 These adherence rates are critical in detecting cancer early and ensuring patients get the care they need.

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.10 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.11§

* Based on relative comparison to published reports; not direct evidence from head-to-head comparisons with all other screening tests.
† 94% specificity was determined for adults with no colorectal neoplasia age-weighted to the U.S. population
‡ Based on 5-year survival.
§ Exact Sciences estimate based on historical patient billing as of November 2024. Exceptions for coverage may apply; only patients’ insurers can confirm how the Cologuard test would be covered.