The US Food and Drug Administration (FDA) has granted a clinical laboratory improvement amendments (CLIA) waiver for OraSure Technologies' OraQuick HCV Rapid Antibody test.
The OraQuick HCV Rapid Antibody detects antibodies to the hepatitis C virus (HCV) and by using OraQuick technology platform the test provides results just with in 20 minutes.
OraSure Technologies president and CEO Douglas Michels said a CLIA waiver for their OraQuick HCV test represents a critical milestone in their quest to make the test available to the widest possible range of at risk individuals in the US.
"The CLIA waiver will enable healthcare providers 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," Michels said.