RADx® Tech Independent Test Assessment Program (ITAP) for Hepatitis B Virus Surface Antigen (HBsAg) Point-of-Care (POC)* Diagnostics FAQs

What is the RADx ITAP for HBsAg POC Diagnostics Program?

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 B virus surface antigen (HBsAg) detection. 

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

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:

1. An existing technology adapted for POC detection of HBsAg, at or near design lock, with analytical and clinical performance data available
2. An existing HBsAg test kit, available for POC diagnostic use in international markets

Can applicants from outside the U.S. apply?

Yes, applicants from all geographies are encouraged to apply.

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 Coordination Center and operating under a contract with the NIH.

When can proposals be submitted?

Proposals may be submitted from September 23, 2024 until October 23, 2024. The link to the current solicitation 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.