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 over-the-counter COVID-19 tests to the public. 

NIH RADx will provide dedicated ITAP resources for independent laboratory validation, clinical studies, and streamlined data collection in support of FDA emergency use authorization (EUA) applications.  For test manufacturers that can scale up quickly and meet the FDA’s performance and quality standards, the FDA will use the information from ITAP to accelerate the EUA review process.  Upon successful completion of ITAP, test manufacturers will be responsible for manufacturing, distribution, and sales into the U.S. market.

Organizations applying to ITAP will be evaluated for participation based on several criteria, including:

  1. A COVID-19 test that has an EUA for point-of-care (CLIA-Waived) use or a similar COVID-19 test that is authorized for self-testing use in major international markets,
  2. Demonstrated high volume test kit manufacturing, and
  3. Demonstrated capability for reproducibly manufacturing and distributing high quality products

If you are interested in this opportunity, please complete and submit the ITAP Basic Company Information Form found at the link below.

Important Links

ITAP Basic Company Information Form

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