Exact Sciences Corporation, a molecular diagnostics company, focuses on the early detection and prevention of colorectal cancer. The company has developed a non-invasive screening test to meet its primary goal of offering a diagnostic screening product for the early detection of colorectal pre-cancer and cancer. Cologuard test The company’s Cologuard test is a non-invasive stool-based DNA (sDNA) 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). The company’s Cologuard test is designed to detect pre-cancerous lesions or polyps, and each of the four stages of colorectal cancer. By detecting pre-cancers and cancers early with its test, affected patients can be referred to colonoscopy, during which the polyps or lesions can be removed. The company’s Cologuard test 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. Research and Development The company’s research and development expenses were $27.7 million, as of December 31, 2013. Regulations Certain of the company’s activities are subject to regulatory oversight by the U.S. Food and Drug Administration 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. Laboratory Certification, Accreditation and Licensing: The company is also subject to U.S. and state laws and regulations regarding the operation of clinical laboratories. Federal Clinical Laboratory Improvement Amendments (CLIA) requirements and laws of certain other states impose certification requirements for clinical laboratories, and establish standards for quality assurance and quality control, among other things. Intellectual Property As of December 31, 2013, the company owned 10 issued patents and 28 pending patent applications in the United States, and 62 issued patents and 26 pending patent applications in foreign jurisdictions. In addition, as part of its 2009 strategic transaction with Genzyme Corporation, the company received a license back from Genzyme Corporation in the fields of colorectal cancer screening and stool-based detection of any disease or condition to the 26 patents issued and 7 pending patent applications in the U.S., and 29 patents issued and 12 pending patent applications in foreign jurisdictions sold to Genzyme Corporation. History Exact Sciences Corporation was founded in 1995.
exact sciences corp (EXAS:NASDAQ CM)
441 Charmany Drive
Madison, WI 53719
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