On August 12, 2014, the Food and Drug Administration approved a diagnostic device called Cologuard, which is a stool-based colorectal cancer (CRC) detection method manufactured by Exact Sciences Corporation. Cologuard analyzes stool specimens to detect hemoglobin, multiple DNA methylation and mutational markers, and the total amount of human DNA contained in cells that are shed into the colon by CRC or advanced adenomas.
A positive result may indicate the presence of CRC or advanced adenoma and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen adult men and women aged 50 years or older who are at typical average-risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. Stool or fecal DNA testing is not currently recommended as a method to screen for colorectal cancer by the United States Preventive Services Task Force, which recommends that adults aged 50-75 at average risk for colon cancer are screened using fecal occult blood testing, sigmoidoscopy, or colonoscopy.
The safety and effectiveness of Cologuard was established in a large clinical trial that screened 10,023 men and women and compared Cologuard to the fecal immunochemical test (FIT) that detects blood in the stool. Cologuard detected 92% of colorectal cancers and 42% of advanced adenomas. FIT screening that detected 74% of cancers and 24% of advanced adenomas. Proposed CMS coverage for the Cologuard test would be once every 3 years for Medicare beneficiaries aged 50-85 years who are asymptomatic and at average risk of developing colorectal cancer.