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Independent Test Assessment Program (ITAP)

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

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.

Multiplex Tests with Emergency Use Authorization

Mpox Tests with Emergency Use Authorization

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. 

Solicitation can be viewed here. 

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.  

Inquiries

Send inquiries to itapnibib@mail.nih.gov

Related News

Science Highlights
June 12, 2024

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.

Science Highlights
August 31, 2023

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.

Science Highlights
July 24, 2023

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.