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 April 2014. Cologuard is included in the American Cancer Society's (2014) colon 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 of either sex, 50 years or older, who are at average risk for colon cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established.
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.