The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program has established the Independent Test Assessment Program (ITAP) in order to accelerate regulatory review and availability of high-quality, accurate, and reliable diagnostic tests.
See a list of RADx Tech Innovation Funnel projects that address health topics beyond COVID-19.
Emergency Use Authorization
COVID-19 Tests with Emergency Use Authorization
ITAP COVID-19 Tests Produced Per Month
Data Updated: 04/28/2023
Description: Number of tests produced per month are manufacturing capability and includes over the counter (OTC) tests for COVID-19 in the Independent Test Assessment Program (ITAP). Note: this data will no longer be updated as of March 2023.
Closed Funding Opportunities
Point-of-Care Lesion Panel Tests
The application period for proposals to address the diagnostic needs for point-of-care (POC) lesion panel tests has closed. A description of this program can be found on the application portal.
Multiplex Over-the-Counter (OTC) Diagnostic Tests
ITAP is not presently accepting applications for over-the-counter (OTC) tests that can detect a combination of COVID-19, Flu A, and/or Flu B virus. Applications that were submitted prior to May 3, 2023 that meet all the previous eligibility criteria will be reviewed. Any future opportunities will be announced on the NIBIB website.
Hepatitis C Virus (HCV) RNA Point-of-Care (POC) Diagnostics
ITAP is not presently accepting applications for Hepatitis C Virus (HCV) RNA point-of-care diagnostic tests. Applications that were submitted prior to March 12, 2023 that meet all the previous eligibility criteria will be reviewed. Any future opportunities will be announced on the NIBIB website.
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. ITAP is not presently accepting new applications for COVID-19 tests.
Multiplex Point-of-Care (POC) Diagnostic Tests
ITAP is not presently accepting new applications for multiplex point-of-care diagnostic tests. Applications that were submitted by December 16, 2022 that meet all the previous eligibility criteria will be reviewed.
Mpox Virus Tests
ITAP is not presently accepting new applications for mpox (formerly 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 the NIBIB website.
Related News
To date, nine medical device developers participating in the RADx® Tech Independent Test Assessment Program have received emergency use authorization for at-home and point-of care test products that simultaneously detect COVID-19 and flu A/B.
Some people using antigen tests have experienced a negative test result only to find out that they have the virus. New research shows that repeat testing every other day increases the detection of the SARS-CoV-2 virus.
New recommendations from the NIH Rapid Acceleration of Diagnostics (RADx®) Tech Program provide a blueprint for the design and manufacture of more accessible diagnostic tests.