RADx® Tech Independent Test Assessment Program (ITAP) for Hepatitis C Virus (HCV) RNA Point-of-Care (POC)* Diagnostics

Overview

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 RNA (HCV RNA) detection and quantitation. 

Prior to initiating hepatitis C treatment, it is important to know if a patient has evidence of HBV or HIV, and if the patient is pregnant. While there are already POC tests for HIV and pregnancy, there are none for HBV. Therefore, in addition to POC tests for HCV RNA, ITAP will also consider applications that include POC tests for the detection of HBV DNA for individuals undergoing hepatitis C treatment. The intended use for HCV RNA tests would be: 1) diagnosis of HCV infection, and 2) management of individuals undergoing therapy. The intended use for HBV tests would be diagnosis for individuals undergoing hepatitis C treatment. 

NIH is mobilizing and expanding the focus of the RADx Tech Independent Test Assessment Program (ITAP) to increase availability of high-quality, accurate, and reliable HCV RNA tests and HBV DNA tests. HCV RNA tests will be prioritized. ITAP plans to provide support required to accelerate test validation and regulatory review of POC tests, with a preference for fingerstick blood samples. These efforts will facilitate rapid production and commercialization of HCV RNA POC tests in the US.   

ITAP will consider applications from test manufacturers with existing technologies that can quickly enter production and can meet the FDA’s performance/quality standards for authorization.  

ITAP will not consider applications for tests for HCV antibodies. 

Evaluation Criteria

Organizations applying to ITAP will be evaluated based on several criteria, including but not strictly limited to: 

Demonstrated capacity for manufacturing and distributing high-quality in-vitro diagnostics, AND at least one of the following:

1. An existing technology adapted for POC detection and quantitation of HCV RNA, at design lock, with analytical and clinical performance data available
   • May include detection of HBV DNA for diagnosis of individuals undergoing HCV therapy
2. An existing HCV RNA test kit, available for POC diagnostic use in international markets
   • May include detection of HBV DNA for diagnosis of individuals undergoing HCV therapy
3.  An existing HBV DNA test kit, available for POC diagnostic use in international markets

The deadline for this opportunity has passed.

Questions? Please visit our FAQs page or send inquiries to itapnibib@mail.nih.gov.

*Point-of-care (POC) typically refers to patient care settings where testing can be completed near the patient, such as at the bedside in a hospital or at a health clinic, physician office, or pharmacy. POC settings performing clinical testing must be certified as a laboratory under the Clinical Laboratory Improvement Amendments, or CLIA, which is administered by the Centers for Medicare & Medicaid Services (CMS).