Cologuard was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society's (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.
The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. False positives and false negative results can occur. In a clinical study, 13% of people without cancer or precancer received a positive result (false positive) and 8% of people with cancer received a negative result (false negative).
Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.
About Exact Sciences Corporation
Exact Sciences Corp. (NASDAQ: EXAS) is committed to playing a role in the eradication of colorectal cancer. As part of this mission we are proud to introduce Cologuard, which is described above and throughout this website. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of diseases of the GI tract. For more information, please visit the company's website at ExactSciences.com.
About Exact Sciences Laboratories, LLC
All Cologuard tests are processed and completed by Exact Sciences Laboratories at its state-of-the-art, CLIA (Clinical Laboratory Improvement Amendments) registered and CAP (College of American Pathologists) accredited lab in Madison, Wis. For more information about Exact Sciences Laboratories, visit ExactLabs.com. Rx Only.