First POC Hepatitis C RNA Test Enables Single-Visit Testing and Treatment

While some individuals may experience a short-term illness, over half of those infected develop a chronic, long-term condition. In the United States, it is estimated that between 2.4 and 4 million people are living with hepatitis C. If untreated, the virus can lead to severe health issues, including liver cancer and liver failure. Until now, HCV testing has involved multiple steps, requiring patients to return for results and further tests, often resulting in missed diagnoses and treatment. Now, a breakthrough has been made with the introduction of the first point-of-care HCV test, which facilitates testing and treatment in a single visit for those at risk.

Developed by Cepheid (Sunnyvale, CA, USA), the Xpert HCV test eliminates the need to send samples to a central lab and can detect HCV RNA from a fingertip blood sample, delivering results within approximately one hour. The U.S. Food and Drug Administration has granted marketing authorization for the use of the Xpert HCV test alongside the GeneXpert Xpress System. This test is authorized for use in various settings under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, including substance use disorder treatment centers, correctional facilities, syringe service programs, physician's offices, emergency departments, and urgent care clinics. This significant development supports a test-and-treat approach, allowing individuals to be tested and, if they test positive for HCV RNA, to be connected to care and potentially begin treatment during the same healthcare visit.

"Despite the existence of a safe and highly effective oral cure for hepatitis C, many people do not know they have the disease due partly to the lack of availability of convenient, widespread testing options," said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "Equipping health care providers with tools to diagnose and treat patients in the same visit can result in hundreds of thousands more hepatitis C patients being diagnosed and treated, preventing individual disease progression and additional spread of the virus."