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Top-Line Data Show Exact Sciences’ Cologuard Test Demonstrates 92 Percent Sensitivity in the Detection of Colorectal Cancer
All endpoints achieved in 10,000-patient trial of non-invasive, convenient DNA-based screening test for colorectal cancer and pre-cancerous polyps
MADISON, Wis.–(BUSINESS WIRE)– Exact Sciences Corp. (NAS: EXAS) today announced that preliminary analysis shows that the company’s 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.
Senior Research Associate Tanya Quint loads one of the instruments used to run Exact Sciences’ Cologuard test at the company’s headquarters in Madison, Wis. (Photo: Business Wire)
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. It is the percentage of patients who were determined by colonoscopy not to have pre-cancerous polyps or cancer who had a negative Cologuard test result.
According to the Journal of the National Cancer Institute, colorectal cancer is often considered the most preventable, yet least prevented cancer. But nearly 50 percent of those age 50 and older have not been screened as recommended. As a result, colorectal cancer is the second leading cause of cancer death in the United States.
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. The study is one of the most extensive colorectal cancer screening studies ever conducted in the United States. It compared the performance of the Cologuard test to colonoscopy and fecal immunochemical testing or FIT.
“The DeeP-C trial evaluated Cologuard’s ability to detect both pre-cancerous polyps and cancer in a large, average-risk patient population,” said principal study