Exact Sciences’ Cologuard colorectal cancer screening test met or exceeded all primary and secondary endpoints of its recently-completed Phase III DeeP-C clinical trial, the company said.
The clinical trial evaluated Cologuard’s use for detection of colorectal cancer and pre-cancerous polyps. According to preliminary top-line data released by the company yesterday, the test correctly identified positive results for detection of colorectal in 92% of patients determined by colonoscopy to have pre-cancerous polyps or cancer.
But the test also showed 42% sensitivity for detection of pre-cancerous polyps – including 66% sensitivity for polyps equal to or greater than 2 cm. The test achieved a specificity, or ability to correctly identify negative results, of 87% during the trial.
DeeP-C’s co-primary endpoints were sensitivity and specificity of the Cologuard screening test for colorectal cancer. The trial’s two sets of co-secondary endpoints were sensitivity and specificity of the test for advanced adenomas; and non-inferiority of Cologuard to fecal immunochemical testing (FIT) for cancer sensitivity, and superiority to FIT for advanced adenoma sensitivity.
“There is a significant unmet clinical need for an accurate, convenient, non-invasive colorectal cancer screening test. The data from the DeeP-C trial are very promising,” Kevin T. Conroy, Exact Sciences’ president and CEO, said in a statement. “Cologuard may well be a future solution for identifying slow growing polyps much before they develop into cancer.”
DeeP-C was one of the most extensive colorectal cancer screening studies ever conducted in the U.S., having included 10,000 patients between ages 50 and 84 who were deemed to be at average risk for colorectal cancer. The study compared the performance of the Cologuard test to colonoscopy and FIT. Enrollment was conducted at 90 sites, with the goal of gaining a broad demographic sampling of patients.
Acording to the company, Cologuard is designed to detect specific changes in a patient’s DNA that appear in the stool and often indicate the presence of colorectal cancer or the pre-cancerous polyps most likely to develop into it. The test also identifies the presence of blood in the stool, another indicator of possible colorectal cancer.
Exact Sciences said it will submit data from DeeP-C to the FDA as part of its pre-market approval submission, though the company’s announcement gave no hint of when that might occur. The company also said it will submit later this year the study’s complete data set for publication in a peer-reviewed journal, presentation at a major medical meeting or both.
The study population included 64 cancer patients and 752 patients with pre-cancerous polyps. Patient results from Cologuard were compared to their colonoscopy result, as well as the histopathologic diagnosis of any lesions discovered during colonoscopy and biopsied.