OraSure Technologies, Inc. (NASDAQ:OSUR) announced today that it has received approval to affix the CE mark to its OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test, which is required to sell this product in the 27 countries that currently make up the European Union. The OraQuick ADVANCE® HIV test is the first and only rapid HIV test bearing a CE mark that can be used with oral fluid, in addition to blood.
The European Union requires companies to comply with a Medical Devices Directive (”MDD”) and an In Vitro Diagnostics Directive (“IVDD”) in order to sell medical devices in Europe. The CE mark is evidence that OraSure and its OraQuick ADVANCE® test meet the quality and other requirements of directives in effect in Europe, including the MDD and IVDD.
“The receipt of CE mark approval for our OraQuick ADVANCE® HIV test is a major milestone and the result of a lot of hard work by our Regulatory Department,” said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. “One of our key strategic objectives is to expand our business internationally, and the CE mark is a necessary approval in order to begin selling our OraQuick ADVANCE® test in the European Union. We have already engaged a distributor in the United Kingdom and intend to sign agreements with distributors for several other European countries in the next few months as we concurrently pursue the required individual country registrations.”
The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test, manufactured and sold by OraSure Technologies, is the first and only U.S. Food and Drug Administration approved and CLIA (Clinical Laboratory Improvements Amendments Act of 1988) waived rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in approximately 20 minutes, using oral fluid, fingerstick or venipuncture whole blood and plasma specimens. The Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration have deployed over one million OraQuick® tests in various public health, drug treatment and outreach settings throughout the United States. The OraQuick® test is also used by hospitals, state departments of health, clinics, community-based organizations, physician offices, and college/university health centers throughout the country.
About OraSure Technologies
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. These products are sold in the United States as well as 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.
OraSure Technologies is the leading supplier of oral-fluid collection devices and in vitro diagnostic assays to the employment, criminal justice, drug treatment, life insurance and public health markets for the detection of abused drugs and the antibodies to HIV. Based in Bethlehem, Pa., the company develops, manufactures and markets oral specimen collection devices, in vitro diagnostic tests, and other medical devices. For more information on the Company, please go to www.orasure.com.
