Exact Sciences Corp. (Nasdaq: EXAS) today announced it has completed patient enrollment in its DeeP-C pivotal trial for colorectal cancer screening. The study enrolled more than 12,700 patients at sites in the United States and Canada.
Senior Research Associate II Tanya Quint at work in the Exact Sciences' lab in Madison, Wis. (Photo: Business Wire)
The DeeP-C study, one of the largest of its kind, is evaluating the accuracy of the company’s stool DNA colorectal cancer screening test, comparing it to traditional screening methods. It is being conducted among a population of patients between the ages of 50 and 84 at average risk of colorectal cancer. The results of the DeeP-C trial are expected to form the basis for submitting the non-invasive test for Pre-Market Approval with the U.S. Food and Drug Administration.
“We are pleased to have completed enrollment for one of the largest and most scientifically rigorous colorectal cancer screening trials ever implemented,” said principal study investigator Thomas Imperiale, M.D., professor of medicine and associate director for research for the division of gastroenterology at Indiana University School of Medicine. “A patient-friendly test that detects cancer and advanced polyps early may well have a significant impact in the fight against colorectal cancer.”
“This is a major milestone for Exact Sciences and a significant step forward in the early detection of colorectal cancer,” said Kevin T. Conroy, president and chief executive of Exact Sciences. “Colorectal cancer is often considered the most preventable, yet least prevented cancer. It is highly treatable if found early, but 40 percent of adults age 50 and older have not been screened as recommended. Closing enrollment in our DeeP-C study draws Exact Sciences one step closer to bringing a potentially life-saving test to market, something the entire company remains passionate about.”