July 1, 2024- Cepheid announced that it has received FDA De Novo marketing authorization and Clinical Laboratory Improvement Amendments (CLIA) Waiver approval for Xpert® HCV, the only molecular test in the US to detect hepatitis C virus RNA directly from a human capillary whole blood (fingerstick) sample. The Xpert HCV test is performed on the GeneXpert Xpress System.
In the United States, 2.4 million people are estimated to be living with hepatitis C and more than half of the people with HCV do not know that they have the virus. An HCV RNA test at the point of care can simplify testing algorithms, increase diagnosis rates, and support timely linkage to care and treatment.
The Viral Hepatitis National Strategic Plan for the United States calls for greater than 80% of people with hepatitis C to achieve viral clearance by 2030. Currently, the clinical care pathway for detection of hepatitis C faces many barriers, including complicated multi-step diagnostic algorithms based on antibody screening and RNA confirmation3. These algorithms require centralized testing technologies that may result in treatment delays and loss-to-follow up and could discourage at-risk populations from accessing testing and receiving care. Xpert® HCV can accurately detect active HCV infection from individuals at risk and/or with signs and symptoms of HCV infection with or without antibodies to HCV from a capillary blood sample.