ITAP for Multiplex OTC Diagnostic Tests - POCTRN
Independent Test Assessment Program (ITAP) for Multiplex Over-the-Counter (OTC) Diagnostic Tests for COVID-19 and Flu
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 over-the-counter (OTC) tests that can detect a combination of COVID-19, Flu A, and/or Flu B virus. Assays that do not differentiate between Flu A and Flu B viruses may be considered.
NIBIB is mobilizing and expanding the focus of the RADx Independent Test Assessment Program (ITAP) to increase availability of high-quality, accurate, and reliable combination COVID-19, Flu A, and Flu B virus OTC tests. NIBIB plans to provide support required to accelerate test validation and regulatory review of molecular and antigen-based OTC tests. These efforts will facilitate rapid production and commercialization of combination COVID-19, Flu A, and/or Flu B virus OTC tests in the US.
NIBIB will consider applications from test manufacturers who are incorporated in and maintain a primary place of business in the United States and have 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-19, Flu A, or Flu B infection or immunity (e.g., COVID-19, Flu A, or Flu B antibodies).
Organizations applying to ITAP will be evaluated for participation based on several criteria, including but not strictly limited to the demonstrated capacity for manufacturing and distributing high-quality in-vitro diagnostics in the United States, AND at least one of the following:
- An existing technology adapted for OTC detection of combined COVID-19, Flu A, and/or Flu B virus, at design lock, with analytical and clinical performance data available
- An existing combination COVID-19, Flu A, and/or Flu B virus test kit, available for OTC diagnostic use in international markets, with analytical and clinical performance data available
- An existing combination COVID-19, Flu A, and/or Flu B virus test kit available for point-of-care use in the US
The deadline for this opportunity has passed.