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.  

The U.S. Department of Health and Human Services will prioritize new over-the-counter test applications that have the potential for manufacturing at significant scale. The goal is to accelerate the availability of high-quality, accurate, and reliable over-the-counter tests to the public as quickly as possible. 

For more information about this opportunity, please see the Point-of-Care Technology Research Network (POCTRN) website


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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.

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