“Colorectal cancer is highly preventable and following the recommended screening guidelines can lead to life–saving early detection,” said Eric Hargis, CEO, Colon Cancer Alliance. “In more than 60 percent of all cases, colorectal cancer is not detected until its late stages, making treatment more challenging. New, patient–friendly screening options are desperately needed to prevent colorectal cancer or help identify it early, when it is most treatable. Given that more than half of colorectal cancer–related deaths could be avoided with regular screenings, having Cologuard as another option for people who have resisted getting a colonoscopy could result in many lives being saved and screening compliance rates to increase.”
Cologuard is designed to detect biomarkers from DNA in cancer that is shed from the colon as part of the digestive process and blood released in the stool. After the physician orders Cologuard, the kit is mailed directly to the patient’s home. The patient then collects a stool sample in the Cologuard Collection Kit and sends the kit back to the Exact Sciences lab for testing through a pre–paid mailer.
At the lab, the stool sample is analyzed in an automated system to yield a single test result—positive or negative for the presence of precancerous polyps or cancer. Results from the Cologuard test are turned around in as little as two weeks, and patients learn their results directly from their prescribing physician. Unlike many other screening options, Cologuard does not require medication or dietary restrictions, or bowel preparation prior to taking the test.
“The robustly conducted research as part of this FDA approval process has proven that this noninvasive test is highly sensitive in detecting both early stage colorectal cancer and the most advanced precancerous polyps most likely to develop into cancer,” said David Ahlquist, M.D., a Mayo Clinic gastroenterologist and co-inventor of the test. “The test is designed for high accuracy, ease of patient use, and wide accessibility. We hope that it will make a difference and save many lives.”
“The FDA approval of Cologuard represents a major achievement in Exact Sciences’ mission to make a noninvasive, patient-friendly screening test for colorectal cancer available,” said Kevin Conroy, President, CEO and Chairman of Exact Sciences. “Cologuard addresses a critical need for a more convenient screening option for patients to aid in prevention and early detection. Exact Sciences is committed to making Cologuard available and accessible to patients and looks forward to advancing cancer detection in other gastrointestinal cancers. On behalf of the Exact Sciences team, I would like to thank the FDA and CMS for allowing us to go through the parallel review process.”
Results from the company’s DeeP–C Study, prospective, 90–site, 10,000–patient pivotal study—one of the most extensive colorectal cancer screening studies ever conducted in the U.S.—were published in April 2014 in the New England Journal of Medicine’s, “Multi-target Stool DNA Testing for Colorectal-Cancer Screening”.