Exact Sciences has completed enrolling patients in its DeeP-C pivotal trial, designed to compare the accuracy of the stool DNA test in screening colorectal cancer with traditional screening methods.
The test uses stool samples collected at home to isolate the human DNA and identify 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.
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 percent 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."
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.