Independent Test Assessment Program (ITAP)

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

    Funding Opportunity Announcements

    COVID-19 Tests

    The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative has 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. ITAP is not presently accepting new applications for COVID-19 tests.

    Multiplex Point-of-Care (POC) Diagnostic Tests

    ITAP is now accepting applications for proposals to accelerate the validation, regulatory authorization and commercialization of innovative point-of-care (POC) tests that can detect a combination of COVID-19 and flu A/B (including pan A/B). Proposals for combination POC tests may include respiratory syncytial virus (RSV) but is not required.

    NIBIB plans to provide the support required to accelerate test validation and regulatory review of molecular and antigen-based POC tests to facilitate rapid production and commercialization of COVID-19, flu A/B, with/without RSV POC tests in the U.S. Proposals will be considered from test manufacturers with existing technologies that can quickly scale production and meet the FDA's performance standards for authorization.

    Click here for more information and to apply.

    Mpox Virus Tests

    ITAP is not presently accepting new applications for mpox (formerly monkeypox) virus tests. Applications that were submitted prior to October 17, 2022 that meet all the previous eligibility criteria will be reviewed. Any future opportunities will be announced on the NIBIB website.  

    Emergency Use Authorization

    ITAP COVID-19 Tests Produced Per Month

    Data Updated: 11/29/2022

     

    Description: Number of tests produced per month are manufacturing capability and includes over the counter (OTC) tests in the Independent Test Assessment Program (ITAP).

    Multiplex Tests with Emergency Use Authorization

    Inquiries

    Send inquiries to itapnibib@mail.nih.gov

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