December 16, 2009 (FinancialWire) — OraSure Technologies, Inc. (NASDAQ: OSUR) has received approval to affix the CE mark to its OraQuick(R) Rapid HCV Antibody Test. A CE mark is required to sell this test in the 27 countries that currently make up the European Union. The OraQuick(R) Rapid HCV Antibody Test is the first and only rapid Hepatitis C test bearing a CE mark that can be used with oral fluid.

The European Union requires companies to comply with the Medical Devices Directive (MDD) and In Vitro Diagnostics Directive (IVDD) in order to sell medical devices in Europe. The CE mark is evidence that OraSure and its OraQuick(R) Rapid HCV Antibody Test meet the quality and other requirements of these directives. The company is currently pursuing the required individual country registrations and expects to begin selling the test in Europe during the first quarter of 2010.

On a world-wide basis, there are an estimated 180 million people who are chronically infected with HCV, with an estimated three to four million individuals newly infected each year. According to the World Health Organization, most HCV infection is currently undiagnosed and up to 80 percent who have HCV show no signs or symptoms.

According to a new report issued by the UK Health Protection Agency on December 11, 2009, entitled “Hepatitis C in the UK — The Health Protection Agency Annual Report 2009,” it is currently estimated that approximately 185,000 individuals in the UK are chronically infected with Hepatitis C, including more than 8,000 people who were diagnosed in 2008 in England.

With the CE mark, the OraQuick(R) Rapid HCV Antibody Test is the second rapid test manufactured by OraSure to receive such approval. In June 2007, OraSure received approval to affix the CE mark to its OraQuick ADVANCE(R) Rapid HIV-1/2 Antibody Test which is currently being sold widely in the European Union. OraSure is also actively seeking approval of its OraQuick(R) Rapid HCV Antibody Test by the U.S. Food and Drug Administration .

OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices.

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