Independent Test Assessment Program (ITAP)

Announcement: See new opportunity for monkeypox virus diagnostics below

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. 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.

New Opportunity for Monkeypox Virus

ITAP is accepting new proposals on a rolling basis to address the diagnostic needs of the monkeypox outbreak. ITAP support will help accelerate the validation, regulatory authorization, and commercialization of point-of-care (POC) and home monkeypox virus tests. Proposals for POC and home tests that can directly detect the monkeypox virus and kits for at-home monkeypox virus self-collection are being accepted as of September 7, 2022.

NIBIB will consider applications only from test manufacturers with existing technologies for monkeypox virus that can quickly scale production and meet the U.S. Food and Drug Administration's performance/quality standards.

More information is available here.