FDA authorizes marketing of first point-of-care hepatitis C RNA test

FDA granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test that allows for a more rapid test-and-treat approach compared with the standard multi-step testing approach. The test may be performed in CLIA-approved settings, such as certain substance use disorder treatment facilities, doctor’s offices, EDs, and urgent care clinics. Rather than requiring a sample to be sent to a central lab for testing, the test detects HCV RNA and delivers results in about an hour using a blood sample from the fingertip.