Exact Sciences Corp. said its 10,000-patient DeeP-C pivotal clinical study was designed to determine the performance characteristics of its multitarget stool DNA-based screening test Cologuard for colorectal cancer and to compare that performance to the fecal immunochemical test, a commonly used non-invasive colorectal cancer screening test.
The DeeP-C study took place at 90 centers throughout the United States and Canada.
The DeeP-C findings, published in the New England Journal of Medicine, included:
-- Sensitivity of Cologuard in detecting patients with colorectal cancer was 92 percent versus 74 percent for FIT.
-- Sensitivity in detecting patients with colorectal cancers in Stages I-III was 93 percent for Cologuard versus 73 percent for FIT.
-- Sensitivity for patients with advanced pre-cancerous lesions was 42 percent for Cologuard versus 24 percent for FIT.
-- Cologuard detected 69 percent of patients with polyps with high-grade dysplasia, or abnormality, versus 46 percent for FIT.
-- Cologuard achieved a specificity of 87 percent versus FIT specificity of 95 percent.
One-of-three U.S. adults age 50 and older has not been screened for colorectal cancer.
"We know colorectal cancer can be prevented and can be highly treatable if found early through screening," lead author Dr. Thomas F. Imperiale of the Indiana University School of Medicine and Regenstrief Institute Inc. said in statement.
"Sensitivity is the most important characteristic for screening tests because the primary role of such testing is to rule out diseases such as cancer. In our clinical study, the data showed Cologuard, the multitarget stool-based DNA test, is highly sensitive in detecting colorectal cancer and higher risk pre-cancerous polyps in a large, diverse average-risk patient population and has the potential to be an important screening tool."