OraSure Technologies, an IVD company, has submitted an application for a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to the US Food and Drug Administration (FDA) 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 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.
OraSure Technologies president and CEO Douglas Michels said 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.
"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," Michels said.