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OraSure Receives CLIA Waiver for OraQuick HCV Rapid Test
Posted on:
November 29, 2011
OraSure Technologies Inc. announces that the FDA has granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") for its OraQuick® HCV Rapid Antibody Test for use with fingerstick whole blood and venous whole blood specimens.
The test is the first and only FDA-approved rapid test for the detection of antibodies to the hepatitis C virus ("HCV"). It utilizes the OraQuick® technology platform, provides results in 20 minutes. With this waiver, the HCV test now can be used by more than 180,000 sites in the U.S. to test persons who are at risk for hepatitis C or have signs or symptoms of hepatitis. These sites now extend to facilities that can perform CLIA-waived tests, such as outreach clinics, community-based organizations and physician offices.
"Today, more than 4 million Americans are infected with hepatitis C and the vast majority do not know it," says Dr. Willis C. Maddrey, president of the Chronic Liver Disease Foundation. "Hepatitis C is a leading cause of chronic liver disease, cirrhosis and liver cancer. However, new therapies are now available that can effectively treat a high percentage of people with HCV infection, making expanded and accessible testing for HCV a critical step in fighting this epidemic."
Douglas A. Michels, president and CEO of OraSure Technologies, says "A CLIA waiver for our OraQuick HCV test represents a critical milestone in our quest to make the test available to the widest possible range of at risk individuals in the U.S. The CLIA waiver will enable healthcare providers, those on the front lines of fighting this devastating disease, to use this simple and accurate test in physician offices and outreach settings so more individuals infected with hepatitis C can be diagnosed and treated."
As previously announced, OraSure has entered into agreements with Merck & Co. to collaborate on the development and promotion of the HCV test. Under these agreements, Merck will provide detailing and other promotional support for the test in the physicians' office markets in the U.S. and internationally. The approval of the CLIA waiver enables physicians to utilize the test in their office settings.
The OraQuick® HCV Rapid Antibody Test is a single-use immunoassay for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in fingerstick whole-blood specimens and venipuncture whole blood specimens from individuals 15 years or older. The test results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with HCV in persons with signs or symptoms of hepatitis and in persons at risk for hepatitis C infection. This assay has not been FDA approved for use in patient populations without signs or symptoms of HCV, or not at risk for hepatitis C infection. It is not for use in screening whole blood, plasma or tissue donors. Performance characteristics have not been established for testing a pediatric population less than 15 years of age or for pregnant women.
www.orasure.com
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