Exact Sciences Corp. (EXAS) announced that preliminary analysis shows that its Cologuard colorectal cancer screening test met or exceeded all primary and secondary endpoints of its recently completed DeeP-C pivotal clinical trial. The clinical trial evaluated the test's use for the detection of colorectal cancer and pre-cancerous polyps.
According to the company, preliminary, top-line data show that Cologuard demonstrated 92 percent sensitivity for the detection of colorectal cancer and 42 percent sensitivity for the detection of pre-cancerous polyps, including 66 percent sensitivity for polyps equal to or greater than 2 centimeters. The test achieved a specificity of 87 percent during the trial.
Sensitivity measures a test's ability to correctly identify positive results. It is the percentage of patients who were determined by colonoscopy to have pre-cancerous polyps or cancer who had a positive Cologuard test result. Specificity measures a test's ability to correctly identify negative results.
The company's pivotal DeeP-C trial included 10,000 patients between the ages of 50 and 84 who were at average risk for colorectal cancer. Enrollment was conducted at 90 sites to gain a broad demographic sampling of patients.
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