JULY 5, 2024

FDA Clears First Point-of-Care HCV Test

By IDSE News Staff

The FDA granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus test that can be used at certified point-of-care settings for people at risk for HCV.

The test may be performed in settings operating under Clinical Laboratory Improvement Amendments Certificate of Waiver, such as certain substance use disorder treatment facilities, correctional facilities, syringe service programs, doctors’ offices, emergency