July 1, 2024 – The U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, making this the first hepatitis C virus test that can be used in point-of-care settings. Testing may be performed in settings such as substance use disorder treatment facilities, urgent care clinics, and emergency rooms under CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver. This test detects HCV RNA in about an hour, enabling a test-to-treat approach enabling the possibility of treating within a clinical encounter.
Validation of the Xpert HCV test was gathered through the Independent Test Assessment Program (ITAP), a National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program, in collaboration with the FDA. The Johns Hopkins University served as a clinical site to assist with this validation.
To read more: FDA news announcement and Cepheid announcement.
