ITAP - POCTRN

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.

New Opportunity: Hepatitis C Virus Point-Of-Care Diagnostics

As of January 26, 2023, the RADx Tech Independent Test Assessment Program (ITAP) is accepting proposals on a rolling basis for POC tests for the direct detection and quantitation of the hepatitis C virus RNA. Test manufacturers with existing technologies for HCV RNA detection and quantitation that can quickly enter production and meet the U.S. Food and Drug Administration's (FDA’s) performance/quality standards are encouraged to apply. ITAP will help accelerate the validation, regulatory authorization, and commercialization of select HCV RNA POC diagnostics. While priority will be given to HCV tests, proposals may also include hepatitis B virus (HBV) qualitative DNA POC tests given the importance of knowing the presence of detectable HBV DNA in a patient undergoing treatment for hepatitis C. Proposals may be submitted until February 26, 2023, 11:59 PM ET.

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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.

Any future opportunities will be announced on our website.