CLIA Waiver Enables HCV Rapid Testing in Point-of-Care Locations

OraSure Technologies, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for its OraQuick® HCV Rapid Antibody Test.

The OraQuick® HCV Test is the first and only FDA approved rapid test for the detection of antibodies to hepatitis C virus (HCV). The test can be carried out on fingerprick or venous whole blood samples and can provide a result in 20 minutes. The test is capable of detecting multiple HCV genotypes and has an accuracy of greater than 98%.

The CLIA waiver means that the OraQuick® HCV Test can now be used by more than 180,000 sites in the US to test people who are at risk for hepatitis C or have signs or symptoms of hepatitis. These sites now include point-of-care 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," said 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."

"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.," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "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."