Independent Test Assessment Program (ITAP)

The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program 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

    Hepatitis C Virus (HCV) RNA Point-of-Care (POC) Diagnostics

    ITAP is not presently accepting applications for Hepatitis C Virus (HCV) RNA point-of-care diagnostic tests. Applications that were submitted prior to March 12, 2023 that meet all the previous eligibility criteria will be reviewed. Any future opportunities will be announced on the NIBIB website. 

    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 not presently accepting new applications for multiplex point-of-care diagnostic tests. Applications that were submitted by December 16, 2022 that meet all the previous eligibility criteria will be reviewed. 

    Solicitation can be viewed here. 

    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: 03/01/23

     

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

    Mpox Tests with Emergency Use Authorization

    Inquiries

    Send inquiries to itapnibib@mail.nih.gov

    Related News

    December 29, 2021
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    NIH RADx Tech Independent Test Assessment Program provides support for FDA authorization of two rapid at-home COVID-19 tests.
    October 25, 2021
    hands holding COVID test
    NIH is investing $70 million from the American Rescue Plan to help bring more high-quality, at-home tests onto the market in the U.S. in coordination with the FDA. NIH’s new Independent Test Assessment Program (ITAP) will establish an accelerated pathway to support FDA evaluation of tests with potential for large-scale manufacturing.