For Innovators
ITAP for Multiplex POC and OTC Diagnostics for COVID-19 and Flu
Overview
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.
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 POC and OTC tests. NIBIB plans to provide support required to accelerate test validation and regulatory review of molecular and antigen-based POC and OTC tests.
Applicants are expected to self-fund all 510(k) analytical and clinical studies.
NIBIB will not consider applications for tests of past infection or immunity (e.g., antibody tests).
Evaluation Criteria
Organizations applying to ITAP will be evaluated for participation based on several criteria, including but not strictly limited to:
- Product must be design locked
- Preliminary analytical and clinical performance data indicates a high likelihood to meet
- FDA 510(k) acceptance criteria
- Applicant has an established quality management system (QMS)
- Demonstrated capacity for high volume manufacturing scale-up and distribution
- Robust commercialization strategy
- Reportable results (e.g., compliance and implementation of MARS standards)
- Products must be manufactured domestically
Other factors considered for selection:
- <30 minutes time to result
- <$10 COGS per test or product suited for broad implementation in low-resource settings
- Improved usability / accessibility (e.g. reduced number of steps & components,
- Minimal/no fluid transfer, use of recognizable tactile features, multi-modal results output,etc.)
- Path to ≥2-year shelf life
- Novel targets (e.g., H5N1)
- Compatibility with multiple sample types
- Shipping does not require controlled temperature
FAQ
What is the ITAP for Multiplex POC and OTC Diagnostics for COVID-19 and Flu Program?
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.
How will these technologies be assessed?
Organizations applying to ITAP will be evaluated for participation based on several criteria, including but not strictly limited to:
- Product must be design locked
- Preliminary analytical and clinical performance data indicates a high likelihood to meet FDA 510(k) acceptance criteria
- Applicant has an established quality management system (QMS)
- Demonstrated capacity for high volume manufacturing scale-up and distribution
- Robust commercialization strategy
- Reportable results (e.g., compliance and implementation of MARS standards)
- Products must be manufactured domestically
Can applicants from outside the U.S. apply?
NIBIB will consider applications from test manufacturers who are incorporated in and maintain a primary place of business in the United States.
Do plans for marketing have to include the U.S.?
Yes, project teams must plan to market and deploy the test within the U.S.
How will the submission process be administered?
The registration and submission portals are administered by Cimit, serving as the RADx Coordination Center and operating under a contract with the NIH.
When can proposals be submitted?
Proposals may be submitted until June 17, 2025. The current solicitation can be found at this link here.