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 manufacture Cologuard. Cologuard was approved by the FDA in August 2014, and results from Exact Sciences' prospective, 90-site, point-in-time, 10,000-patient pivotal study were published in the New England Journal of Medicine in April 2014. Cologuard is included in the American Cancer Society's (2014) 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 of either sex, 50 years or older, who are at average risk for colorectal cancer, 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.
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