At Exact Sciences we are developing a molecular diagnostic colorectal cancer screening test that detects both cancer and pre-cancer.
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., April 18, 2013 – Exact Sciences Corp. (Nasdaq: 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.
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.
Colorectal Cancer: Most preventable, yet least prevented cancer
According to the Journal of the National Cancer Institute, colorectal cancer is the most preventable, yet least prevented cancer. Last year 50,000 people died from colorectal cancer and approximately 140,000 people were diagnosed in the United States alone. This cancer is detected in late stages 60% of the time. It is this late detection that makes treatment difficult and expensive. Early detection is essential in fighting colorectal cancer- and it begins with screening. There are multiple screening methods endorsed by the American Cancer Society (ACS) including stool DNA testing. Exact Sciences is currently developing a test based on this technology; however, this test is not approved for sale and is for investigational use only. Studies have shown that when given an option, patients are twice as likely to comply. The higher the compliance rate, the lower the number of people negatively affected by colorectal cancer.