Exact Sciences Launches Cologuard Plus™ Test for Colorectal Cancer Screening
Exact Sciences Corp. (Nasdaq: EXAS), a leader in cancer screening and diagnostic tests, has announced the launch of Cologuard Plus™, a groundbreaking noninvasive colorectal cancer (CRC) screening test. The Cologuard Plus test boasts the highest reported accuracy to date for CRC detection in studies, showing a remarkable 95% sensitivity and 94% specificity in the U.S. screening population. It is FDA-approved for use in average-risk individuals aged 45 and older, and it is also covered by Medicare.
This new test improves upon the original Cologuard® test by reducing the number of unnecessary follow-up colonoscopies. Cologuard Plus offers a 40% reduction in follow-up colonoscopies compared to its predecessor, providing greater confidence in results. This reduction is particularly important in a healthcare system that strives to minimize patient burden and healthcare costs while improving diagnostic accuracy.
The Cologuard Plus test, which builds on the success of the original Cologuard, detects 95% of colorectal cancers with 94% specificity, making it the most accurate noninvasive screening option available. Additionally, it shows a 40% reduction in false positives compared to the original test, thus minimizing unnecessary follow-ups. The test also demonstrates strong sensitivity for detecting advanced precancerous lesions, including 43% sensitivity for advanced precancerous lesions and 74% sensitivity for high-grade dysplasia—the types of precancerous growths most likely to progress to cancer.
Another key benefit of Cologuard Plus is its ability to provide greater confidence in negative results. A negative result from Cologuard Plus means a 99.98% chance that the patient does not have colorectal cancer, offering significant peace of mind to both patients and clinicians. Furthermore, Cologuard Plus is included in the U.S. Preventive Services Task Force (USPSTF) guidelines as a recommended stool-based screening option, making it accessible for a wide population.
Jake Orville, Executive Vice President and General Manager of Screening at Exact Sciences, stated, “Cologuard transformed colorectal cancer screening—driving a significant increase in CRC screening participation over the past few years. Cologuard Plus brings essential enhancements that will improve patient care, streamline healthcare delivery, and bring us closer to eradicating this highly preventable and treatable disease.”
Colorectal cancer is one of the leading causes of cancer-related deaths in the United States, but it is highly treatable when caught early. When detected early, the survival rate for colorectal cancer is around 90%. Yet, nearly 48 million Americans remain unscreened for the disease, underscoring the need for effective, accessible screening solutions. Cologuard Plus provides a means to detect colorectal cancer at its most treatable stage, while also identifying precancerous lesions that can be removed to prevent cancer from developing.
Dr. Paul Limburg, Chief Medical Officer of Screening at Exact Sciences, emphasized the importance of early detection and adherence, saying, “Early detection helps save lives, and clinicians need highly accurate tests that their patients will complete. Cologuard Plus delivers unprecedented performance in a noninvasive test—detecting more cancers while significantly reducing false positives. This test, combined with strong patient adherence, gives healthcare providers confidence that more patients will get screened and receive accurate results to drive better outcomes.”
Patient adherence is critical for effective screening, and Cologuard Plus is designed to make the process as convenient as possible. Unlike traditional methods like colonoscopy, Cologuard Plus is shipped directly to the patient’s home, where they can collect their sample at their convenience. Studies show that 71% of patients who are ordered Cologuard complete the test within an average of 28 days, far outperforming the completion rates of other screening options like the fecal immunochemical test (FIT) and colonoscopy referrals.
Moreover, follow-up adherence for Cologuard is also strong, with 79% of patients completing a colonoscopy after a positive result and 83% completing a repeat screening three years later. These high adherence rates are essential for ensuring that patients who need further care receive it promptly.
The Cologuard Plus test integrates with Exact Sciences’ ExactNexus™ technology platform, which simplifies ordering, result delivery, and patient navigation, further improving test completion rates. This platform is proven to enhance patient engagement and make the screening process smoother, improving overall screening outcomes.
Exact Sciences also notes that, in the U.S., more than 96% of patients aged 45 and older face no out-of-pocket costs for Cologuard screening. This affordability, coupled with the proven accuracy and convenience of Cologuard Plus, is expected to expand patient access and help close the gap in colorectal cancer screening rates.
With the launch of Cologuard Plus, Exact Sciences is making significant strides in improving the early detection of colorectal cancer, empowering both patients and healthcare providers with a powerful tool that saves lives and reduces unnecessary procedures. As Cologuard Plus sets a new standard for noninvasive CRC screening, Exact Sciences continues to work towards the goal of eradicating colorectal cancer and improving patient outcomes nationwide.
