Independent Test Assessment Program (ITAP) for Monkeypox Virus Test Validation and Regulatory Authorization

Overview:

In partnership with the FDA, the National Institute of Biomedical Imaging and Bioengineering (NIBIB) Rapid Acceleration of Diagnostics (RADx) initiative is soliciting proposals to accelerate the validation, regulatory authorization and commercialization of innovative point-of-care (POC) or home tests that can directly detect Monkeypox Virus and home collection tests for Monkeypox Virus testing.

NIBIB is mobilizing and expanding the focus of the RADx Independent Test Assessment Program (ITAP) to increase availability of high-quality, accurate, and reliable Monkeypox Virus diagnostic tests. NIBIB plans to provide in-kind analytical and clinical testing required by the FDA to accelerate test validation and regulatory review of molecular and antigen-based POC or home diagnostic tests and home collection tests. These efforts will facilitate rapid production and commercialization of Monkeypox Virus tests in the US. 

NIBIB will consider applications from test manufacturers with existing technologies for Monkeypox Virus detection that can quickly scale production and can meet the FDA’s performance standards for authorization .

NIBIB will not consider applications for tests of past Monkeypox Virus infection or immunity (e.g. anti-Monkeypox antibodies).

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.