RADx® Tech Independent Test Assessment Program for Hepatitis C Virus RNA Near-patient* Diagnostics (2026)

New Opportunity: Hepatitis C Virus Near-patient Diagnostics

As of July 29, 2026, the RADx^® Tech Independent Test Assessment Program (ITAP) is accepting proposals on a rolling basis for near-patient tests for the detection of the hepatitis C virus (HCV) RNA in fingerstick and venous whole blood. Test manufacturers with existing technologies for HCV RNA detection that can quickly enter production and meet the U.S. Food and Drug Administration’s (FDA’s) performance/quality standards are encouraged to apply. The technology should be suitable for CLIA Waived settings, with performance substantially equivalent to the current FDA cleared HCV RNA tests. ITAP will help accelerate the validation, regulatory authorization, and commercialization of select HCV RNA near-patient diagnostics. More information is available on the submission portal. Proposals may be submitted until September 27, 2026, at 11:59 PM ET.

Overview

In collaboration with the U.S. Centers for Disease Control and Prevention (CDC) and 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 near-patient tests for hepatitis C virus (HCV) RNA detection.

The intended use for HCV RNA near-patient tests would be qualitative detection of HCV RNA in human fingerstick and venous whole blood from adult individuals at risk and/or with signs and symptoms of HCV infection with or without antibody evidence of HCV infection.

The NIH is mobilizing and expanding the focus of the RADx Tech ITAP to increase availability of high-quality, accurate, and reliable HCV RNA tests. HCV RNA tests with rapid turnaround time and low cost will be prioritized. Tests must be compatible with fingerstick and venous whole blood. ITAP plans to provide support required to accelerate test validation and regulatory review of near-patient tests. These efforts will facilitate rapid production and commercialization of HCV RNA near-patient 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.

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 near-patient detection of HCV RNA at design lock, with analytical and clinical performance data available.
2. An existing HCV RNA test kit available for near-patient diagnostic use in international markets.

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

*Also termed, “point-of-care” (POC), near-patient 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. Near-patient 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).