Independent Test Assessment Program (ITAP)
The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) 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.
Current Funding Opportunities
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Independent Test Assessment Program (ITAP) for Multiplex POC and OTC Diagnostics for COVID-19 and Flu
In partnership with the FDA, the National Institute of Biomedical Imaging and Bioengineering (NIBIB) Rapid Acceleration of Diagnostics (RADx®) Tech program is soliciting proposals to accelerate the validation, 510(k) submission, and commercialization of innovative point-of-care (POC) and over-the-counter (OTC) multiplex tests that can detect at-minimum COVID-19, Flu A and Flu B. Tests that include additional respiratory targets (e.g., H5N1, RSV) are encouraged.
Past Funding Opportunities
RADx® Tech Independent Test Assessment Program (ITAP) for Hepatitis B Virus Surface Antigen (HBsAg) Point-of-Care (POC)* Diagnostics
In collaboration with the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program sought proposals to accelerate the validation, regulatory authorization, and commercialization of innovative point-of-care (POC) tests for hepatitis B virus surface antigen (HBsAg) detection. ITAP is not presently accepting new applications for Hepatitus B Virus POC Diagnostics.
ITAP for Diagnostic Mpox Lesion Panel
ITAP is not presently accepting new applications for Mpox Lesion Panel. Applications that were submitted by the deadline that meet all the previous eligibility criteria will be reviewed.
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 diagnostics 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 monkeypox virus tests. Applications that were submitted prior to October 17, 2022 that meet all the previous eligibility criteria will be reviewed.
Hepatitis C Virus Point-Of-Care Diagnostics
ITAP is not presently accepting new applications for Hepatitis C diagnostics. Applications that were submitted prior to March 12, 2023 that meet all the previous eligibility criteria will be reviewed.
Multiplex Over-the-Counter (OTC) Diagnostic Tests for COVID-19 and Flu
ITAP is not presently accepting new applications for monkeypox virus tests. Applications that were submitted prior to May 3, 2023 that meet all the previous eligibility criteria will be reviewed.