Cepheid was incorporated in the State of California on March 4, 1996. The Company is a molecular diagnostics company that develops, manufactures and markets integrated systems for testing in the clinical market, as well as for application in its non-clinical markets. The Company's systems enable molecular testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. The Company's product portfolio consists of tests, reagents and systems for the clinical and non-clinical markets. The Company's two systems are the GeneXpert and SmartCycler. The GeneXpert system, offers services in the clinical market, integrates sample preparation in addition to DNA amplification and detection. The GeneXpert system is designed for user types ranging from reference laboratories and hospital central laboratories to satellite testing locations, such as emergency departments and intensive care units within hospitals and doctors' offices. The SmartCycler system integrates DNA amplification and detection to allow rapid analysis of a sample. Company faces competition from a number of companies that offer products to its target markets. Company has patents covering technologies of its own and has licensed technologies from others. In addition to patents, it rely on a combination of trade secrets, copyright and trademark laws, nondisclosure agreements, licenses and other contractual provisions and technical measures to maintain and develop its competitive position with respect to intellectual property. In the Clinical market, its products are regulated as medical device products by the FDA and comparable agencies in other countries. For the Non-Clinical market, all of its products are being produced under ISO 13485 and Quality System Regulations.
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