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.

ITAP is not presently accepting new applications for COVID-19 tests. Applications that were submitted prior to August 5, 2022, that meet all the previous eligibility criteria will be reviewed. As the COVID-19 pandemic remains a dynamic situation, ITAP may accept new submissions in the future. In the meantime, those interested in submitting applications for COVID-19 technologies are encouraged to pursue other NIH funding opportunities.

Any future opportunities offered by the Rapid Acceleration of Diagnostics (RADx®) Tech program will be announced here on this website when available.