Independent Test Assessment Program (ITAP)

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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.

See a list of RADx Tech Innovation Funnel projects that address health topics beyond COVID-19.

    Emergency Use Authorization

    ITAP COVID-19 Tests Produced Per Month

    Data Updated: 04/28/2023

     

    Description: Number of tests produced per month are manufacturing capability and includes over the counter (OTC) tests for COVID-19 in the Independent Test Assessment Program (ITAP). Note: this data will no longer be updated as of March 2023.

    Multiplex Tests with Emergency Use Authorization

    Mpox Tests with Emergency Use Authorization

    Closed Funding Opportunities

    Point-of-Care Lesion Panel Tests

    The application period for proposals to address the diagnostic needs for point-of-care (POC) lesion panel tests has closed. A description of this program can be found on the application portal

    Multiplex Over-the-Counter (OTC) Diagnostic Tests

    ITAP is not presently accepting applications for over-the-counter (OTC) tests that can detect a combination of COVID-19, Flu A, and/or Flu B virus. Applications that were submitted prior to May 3, 2023 that meet all the previous eligibility criteria will be reviewed. Any future opportunities will be announced on the NIBIB website. 

    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.  

    Inquiries

    Send inquiries to itapnibib@mail.nih.gov

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