Exact Sciences Corporation, a molecular diagnostics company, focuses on the early detection and prevention of colorectal cancer. The company has developed a non-invasive, patient friendly screening test called Cologuard to meet its primary goal of becoming the market leader in non-invasive colorectal cancer screening products. The company’s Cologuard test is a non-invasive stool-based DNA screening test designed to detect DNA markers, which in published studies have been shown to be associated with colorectal cancer. In addition to DNA markers, its test includes a protein marker to detect blood in the stool, utilizing an antibody-based fecal immunochemical test (FIT). Cologuard is designed to detect pre-cancerous lesions or polyps, and each of the four stages of colorectal cancer and is a preventive tool. By detecting pre-cancers and cancers early with the company’s test, affected patients could be referred to colonoscopy, during which the polyps or lesions could be removed. Cologuard includes proprietary and patented methods that isolate and analyze the human DNA that are shed into stool every day from the exfoliation of cells that line the colon. The company’s test also detects blood in stool, utilizing an antibody-based FIT test. Strategy The company’s strategic roadmap includes various major components, such as commercializing the U.S. Food and Drug Administration (FDA)-approved product that detects colorectal pre-cancer and cancer; successfully operating a Federal Clinical Laboratory Improvement Amendments certified laboratory facility to process Cologuard tests and provide patient results; and securing favorable reimbursement for its laboratory services from payors. Research and Development The company’s research and development expenses were $28.7 million for the year ended December 31, 2014. Government Regulation Certain of the company’s activities are subject to regulatory oversight by the FDA under provisions of the Federal Food, Drug, and Cosmetic Act and regulations thereunder, including regulations governing the development, marketing, labeling, promotion, manufacturing and export of diagnostic products. The company’s commercialization activities for Cologuard subject the company to regulations of the Department of Transportation, the United States Postal Service, and the CDC that apply to the surface and air transportation of clinical laboratory specimens. Intellectual Property As of December 31, 2014, the company owned 12 issued patents and 30 pending patent applications in the United States, and 50 issued patents and 32 pending patent applications in foreign jurisdictions. In addition, as part of the company’s 2009 strategic transaction with Genzyme Corporation, the company received an exclusive license back from Genzyme Corporation in the fields of colorectal cancer screening and stool-based detection of any disease or condition to the 29 patents issued and 2 pending patent applications in the U.S., and 35 patents issued and 1 pending patent applications in foreign jurisdictions sold to Genzyme Corporation. Each of the company’s patents has a term of 20 years from its respective priority filing date. Consequently, its earliest patents are set to expire in 2016. History Exact Sciences Corporation was founded in 1995. The company was incorporated in the state of Delaware in 1995.
exact sciences corp (EXAS:NASDAQ CM)
441 Charmany Drive
Madison, WI 53719
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