Independent Test Assessment Program (ITAP)

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.

Multiplex Point-of-Care (POC) Diagnostic Tests

ITAP is now accepting applications for proposals to accelerate the validation, regulatory authorization and commercialization of innovative point-of-care (POC) tests that can detect a combination of COVID-19 and Flu A/B (including pan A/B). Proposals for combination POC tests may include respiratory syncytial virus (RSV) but is not required.

NIBIB plans to provide the support required to accelerate test validation and regulatory review of molecular and antigen-based POC tests to facilitate rapid production and commercialization of COVID-Flu A/B POC tests in the U.S.  Proposals will be considered from test manufacturers with existing technologies that can quickly scale production and meet the FDA’s performance standards for authorization.

More information and how to apply

Monkeypox Virus Tests

ITAP is not presently accepting new applications for 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 our website.