We’re excited to share the long-awaited announcement that the FDA has reclassified HCV RNA tests and certain antibody tests from class III to II. This simplifies the process for regulatory approval and is a hopeful step towards manufacturers bringing HCV point of care diagnostics to market in the U.S. Now the real work begins – engaging manufacturers like Cepheid to seek FDA approval – and we need your help.

In reviving the Hepatitis Diagnostics Work Group, NVHR will co-facilitate future meetings with the Treatment Action Group (TAG), a longtime expert in HCV diagnostics. We’ll be in touch about reconvening the work group in the New Year to discuss plans to develop a sign-on letter to Cepheid and additional next steps.

In the meantime, we invite you to join NVHR and TAG on December 16th at 3 pm ET for a discussion on what it will take to make HCV point of care diagnostics a reality in the United States. Dr. Anne Gaynor from the Association of Public Health Laboratories (APHL) will walk us through what reclassification means and answer any questions you may have. If you are not already registered for the NVHR Grassroots Advocacy Call, please sign-up here