In collaboration with the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program is soliciting proposals to accelerate the validation, regulatory authorization, and commercialization of innovative point-of-care (POC) tests for hepatitis C virus (HCV) RNA detection and quantitation. Test manufacturers with existing technologies for HCV RNA detection and quantitation that can quickly enter production and meet the FDA’s performance/quality standards are encouraged to apply. The Independent Test Assessment Program (ITAP) will help accelerate the validation, regulatory authorization, and commercialization of select HCV RNA POC diagnostics. While priority will be given to HCV tests, proposals may also include hepatitis B virus (HBV) qualitative DNA POC tests, given the importance of knowing the presence of detectable HBV DNA in a patient undergoing treatment for hepatitis C.
What is VentureWell’s role in the Hepatitis C Viral Load Testing at Point of Care Program?
VentureWell serves as a critical facilitator within the Hepatitis C program, leveraging its network and expertise to identify, assess, select, and contract vendors and professional service consultants.
VentureWell’s role includes providing vital infrastructure support and commercialization services for Hepatitis C diagnostic innovators, to help accelerate the validation, regulatory authorization, and commercialization of innovative POC viral load tests that can directly detect the Hepatitis C virus.