OraSure Technologies Inc was formed in May 2000 under Delaware law solely for the purposes of combining two companies, STC Technologies, Inc. and Epitope, Inc. and changing the state of incorporation of Epitope from Oregon to Delawar...e. The Company is engaged in development, manufacture, marketing and sale of oral fluid diagnostic products and specimen collection devices using its proprietary oral fluid technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types. It also manufactures and sells medical devices used for the removal of benign skin lesions by cryosurgery or freezing. Its diagnostic products include tests that are performed at the point of care and tests that are processed in a laboratory. These produc...ts are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities. One of its diagnostic products, the OraQuick In-Home HIV Test got approved by the U.S. FDA for sale in the over-the-counter or consumer retail markets in the United States. Its in vitro diagnostic testing is the process of analyzing oral fluid, blood, urine and other bodily fluids or tissue for the presence of specific substances or markers. Through its subsidiary, DNAG, the Company manufacture and sell kits that are used to collect, stabilize, and store samples of genetic material for molecular testing in the consumer genetics, clinical genetic testing, academic research, pharmacogenomics, personalized medicine, and animal genetics markets. The Company owns rights to trademarks and service marks that are necessary to conduct its business as currently operated. In the United States, it owns the OraSure, Intercept, OraQuick, OraQuick ADVANCE, Histofreezer, OraSure QuickFlu, Q.E.D., Oragene, ORAcollect, OMNIgene, Performagene, PrepIT, HEMAgene, and AUTO-LYTE. The competitors include medical diagnostic companies and specialized biotechnology firms, as well as pharmaceutical companies with biotechnology divisions The Company is subject to other federal and state laws targeting fraud and abuse in the healthcare industry, including false claims laws, marketing conduct laws and laws constraining the sales, marketing and other promotional activities of manufacturers of medical devices by limiting the kinds of financial arrangements, including sales programs, with physicians, hospitals, laboratories and other potential purchasers of medical devices.