RADx® Tech Independent Test Assessment Program for Hepatitis C Virus RNA Near-patient* Diagnostics (2026)
FAQs
What is the RADx® Tech Independent Test Assessment Program (ITAP) for Hepatitis C Virus (HCV) RNA Near-patient Diagnostics?
In collaboration with the U.S. Centers for Disease Control and Prevention (CDC) and FDA, the National Institute 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 HCV RNA detection.
Test manufacturers with existing technologies for HCV RNA detection that can quickly enter production and meet the FDA’s performance/quality standards are encouraged to apply. ITAP will help accelerate the validation, regulatory authorization, and commercialization of select HCV RNA near-patient diagnostics.
What technologies will be considered?
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.
How will these technologies be assessed?
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:
- An existing technology adapted for near-patient detection of HCV RNA at design lock, with analytical and clinical performance data available.
- An existing HCV RNA test kit, available for near-patient diagnostic use in international markets.
Can applicants from outside the U.S. apply?
Yes, applicants from all geographies are encouraged to apply. Preferably, test manufacturers will be incorporated in and maintain a primary place of business in the United States.
Can diagnostic test components be manufactured outside the U.S.?
Yes. At this time there are no requirements that test supplies and components be manufactured exclusively within the U.S.
Do plans for marketing have to include the U.S.?
Yes, project teams must plan to market and deploy the test within the U.S.
How will the submission process be administered?
The registration and submission portals are administered by Cimit serving as the RADx Tech Coordination Center and operating under a contract with the NIH.
When can proposals be submitted?
Proposals may be submitted until September 27, 2026, at 11:59 PM ET. The link to the submission portal can be found here.
Will NIH provide summary feedback as to why a submission was not selected?
No, NIH does not intend to provide innovators with individual reviews or summaries of reviewer feedback in any phases of the program. This is due to the sheer number of anticipated submissions and the urgent need for NIH to focus its efforts on advancing selected proposals. Innovators who were not selected for RADx Tech support are encouraged to consider other NIH funding opportunities.
Where can I get more information?
Information about this project and how to submit a proposal can be found on the Cimit website.
*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).
Deadline
September 27, 2026
Timeline
Submission Opens: July 29, 2026
Submission Deadline: September 27, 2026