MADISON, Wis., March 3, 2016 -- Exact Sciences Corp. (Nasdaq: EXAS) announced today that AMITA Health of the Chicago area has adopted Cologuard, the first and only FDA approved noninvasive stool DNA screening test for colorectal cancer.
“AMITA Health is determined to engage patients at a higher level in the quest to reduce the incidence of colon cancer. Cologuard offers us another solid screening option that is easy to administer and reliably adds to the arsenal physicians can offer patients in the fight against colon cancer,” said Dr. Reinhold Llerena, primary care physician with the AMITA Health Medical Group.
Cologuard analyzes a person’s stool to detect both altered DNA and blood known to be associated with colorectal cancer and precancer. Cologuard was shown to identify 92 percent of colorectal cancers in average risk patients with 87 percent specificity. Unlike some screening options, Cologuard does not require medication, dietary restrictions or bowel preparation prior to taking the test. Cologuard makes it easy for patients to take the test at their convenience and in the privacy and comfort of their own home.
"AMITA Health’s adoption of Cologuard provides more patients in the Chicagoland area access to an innovative screening tool for colorectal cancer," said Kevin Conroy, Chairman and CEO of Exact Sciences. “We are proud to work with their healthcare providers to get more people screened.”
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 colorectal cancer screening guidelines of the American Cancer Society and stool DNA is listed in the screening guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer. Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal 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.