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OraSure Technologies Submits CLIA
Waiver Application for OraQuick(R) HCV Rapid Test
  Date: 23 March 2011
Source: OraSure Technologies, Inc. OraSure Technologies Submits CLIA Waiver Application for OraQuick(R) HCV Rapid Test
BETHLEHEM, Pa., March 23, 2011 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that it has submitted to the U.S. Food and Drug Administration ("FDA") an application for a waiver under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") for its OraQuick® HCV Rapid Antibody Test for use with venous whole blood and fingerstick whole blood specimens.
The OraQuick® HCV Rapid Antibody Test is the first and only FDA-approved rapid test for the detection of antibodies to the hepatitis C virus and is currently classified as a moderately complex test which can be used by approximately 40,000 laboratories certified as meeting certain quality and training requirements under CLIA. According to the Centers for Medicaid and Medicare Services, if the CLIA waiver application is approved, the OraQuick® HCV test could then be available for use by more than 180,000 sites nationwide, including those that can perform CLIA-waived tests such as outreach clinics, community-based organizations and physician offices.
"If approved, a CLIA waiver would enable greater access to a test that could play a vital role in identifying HCV infection in the United States," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "Most importantly, the CLIA waiver will enable healthcare providers, those on the front lines of fighting this disease, to identify more individuals infected with hepatitis C and connect them to care and treatment."
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.
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