Molecular diagnostics company Exact Sciences has completed enrolling patients in its DeeP-C pivotal trial, designed to compare the accuracy of stool DNA testing with traditional screening methods in colorectal cancer screening.
Using stool samples of the participants collected at home, the clinical laboratory isolates the human DNA and identifies specific altered and mutated DNA targets associated with degenerated colorectal cancer and pre-cancer cells.
The study has enrolled 12,700 patients between the ages of 50 and 84 who are at average risk of colorectal cancer, a second leading cause of cancer deaths in the US and the most deadly cancer among non-smokers.
Exact Sciences president and chief executive Kevin Conroy said colorectal cancer is often considered the most preventable, yet least prevented cancer.
"It is highly treatable if found early, but 40% of adults age 50 and older have not been screened as recommended," Conroy added.
"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."
Indiana University School of Medicine gastroenterology division associate research director and medicine professor and principal study investigator Thomas Imperiale said a patient-friendly test that detects cancer and advanced polyps early will have a significant impact in fighting colorectal cancer.
"We are pleased to have completed enrollment for one of the largest and most scientifically rigorous colorectal cancer screening trials ever implemented," Imperiale added.
The company is planning to use the DeeP-C trial data to submit a pre-market approval application to the US Food and Drug Administration.
The stool DNA test is an investigational device and is not available for sale in the US, according to the company.
Image: The stool DNA test isolates human DNA and identifies specific altered and mutated DNA targets associated with degenerated colorectal cancer and pre-cancer cells. Courtesy: Business Wire.