Purpose of the Independent Test Assessment Program (ITAP) for Multiplex Over-the-Counter (OTC) Diagnostic Tests for COVID-19 and Flu

What is the Independent Test Assessment Program (ITAP) for Multiplex Over-the-Counter (OTC) Diagnostic Tests?

The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative established the Independent Test Assessment Program (ITAP) in order to accelerate regulatory review and availability of high-quality, accurate, and reliable over-the-counter COVID-19 tests to the public.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is mobilizing and expanding the focus of ITAP to increase availability of high-quality, accurate, and reliable COVID 19, Flu A, and/or Flu B over-the-counter tests. Assays that do not differentiate between Flu A and Flu B viruses may be considered.

What technologies will be considered?

NIBIB will consider applications from test manufacturers with existing OTC or point-of-care (POC) technologies that can quickly scale production and can meet the FDA’s performance standards for authorization. NIBIB will not consider applications for tests that require more than a single sample input. NIBIB will not consider applications for tests of past COVID-19, Flu A, or Flu B infection or immunity (e.g. COVID-19, Flu A, or Flu B antibodies).

How will these technologies be assessed?

Organizations applying to ITAP will be evaluated for participation 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 OTC detection of combined COVID-19, Flu A, and/or Flu B virus, at design lock, with analytical and clinical performance data available
2. An existing combination COVID-19, Flu A, and/or Flu B virus test kit, available for OTC diagnostic use in international markets, with analytical and clinical performance data available
3. An existing combination COVID-19, Flu A, and/or Flu B virus test kit available for POC use in the US

Can applicants from outside the United States apply?

Applicant companies must be incorporated in and maintain a primary place of business in the United States.

Do plans for marketing have to include the United States?

Yes, project teams must plan to market and deploy the test within the United States.

How will the submission process be administered?

The registration and submission portal is administered by the CIMIT serving as the RADx Coordination Center and operating under a contract with the NIH.

When can proposals be submitted?

Proposals may be submitted until May 3, 2023 at 11:59PM ET. 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 POCTRN website.