ITAP Multiplex Point-of-Care (POC) Diagnostic Tests
Overview:
In collaboration 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, regulatory authorization and commercialization of innovative point-of-care (POC) tests that can detect a combination of COVID and Flu A/B (including pan A/B). Additionally, combination POC tests may include RSV, but this is not required.
NIBIB is mobilizing and expanding the focus of the RADx Independent Test Assessment Program (ITAP) to increase availability of high-quality, accurate, and reliable COVID-Flu A/B POC tests. NIBIB plans to provide support required to accelerate test validation and regulatory review of molecular and antigen-based POC tests. These efforts will facilitate rapid production and commercialization of COVID-Flu A/B POC tests in the US.
NIBIB will consider applications from test manufacturers with existing technologies that can quickly scale production and can meet the FDA’s performance standards for authorization.
NIBIB will not consider applications for tests of past COVID, Flu A/B or RSV infection or immunity (e.g. COVID, Flu A/B or RSV antibodies).
Evaluation Criteria:
Organizations applying to ITAP will be evaluated for participation based on several criteria, including but not strictly limited to:
- Demonstrated capacity for manufacturing and distributing high-quality in-vitro diagnostics, AND at least one of the following:
- An existing technology adapted for POC detection of combined COVID and Flu A/B, with or without RSV virus, at design lock, with analytical and clinical performance data available
- An existing combination COVID/Flu A/B virus test kit, with or without RSV, available for POC diagnostic use in international markets
The application period for this program has passed.
Questions? Please visit our FAQs page or send inquiries to itapnibib@mail.nih.gov.
Overview:
In collaboration 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, regulatory authorization and commercialization of innovative point-of-care (POC) tests that can detect a combination of COVID and Flu A/B (including pan A/B). Additionally, combination POC tests may include RSV, but this is not required.
NIBIB is mobilizing and expanding the focus of the RADx Independent Test Assessment Program (ITAP) to increase availability of high-quality, accurate, and reliable COVID-Flu A/B POC tests. NIBIB plans to provide support required to accelerate test validation and regulatory review of molecular and antigen-based POC tests. These efforts will facilitate rapid production and commercialization of COVID-Flu A/B POC tests in the US.
NIBIB will consider applications from test manufacturers with existing technologies that can quickly scale production and can meet the FDA’s performance standards for authorization.
NIBIB will not consider applications for tests of past COVID, Flu A/B or RSV infection or immunity (e.g. COVID, Flu A/B or RSV antibodies).
Evaluation Criteria:
Organizations applying to ITAP will be evaluated for participation based on several criteria, including but not strictly limited to:
- Demonstrated capacity for manufacturing and distributing high-quality in-vitro diagnostics, AND at least one of the following:
- An existing technology adapted for POC detection of combined COVID and Flu A/B, with or without RSV virus, at design lock, with analytical and clinical performance data available
- An existing combination COVID/Flu A/B virus test kit, with or without RSV, available for POC diagnostic use in international markets
The application period for this program has passed.
Questions? Please visit our FAQs page or send inquiries to itapnibib@mail.nih.gov.