ITAP for Multiplex POC and OTC Diagnostics for COVID-19 and Flu Frequently Asked Questions
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)
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
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.
Can diagnostic test components be manufactured outside the U.S.?
Yes. At this time there are no requirements that test supplies and components be manufactured exclusively within the U.S.
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 April 17, 2025. The current solicitation can be found at this link here.
Will NIH provide summary feedback as to why a submission was not selected?
No, NIH does not intend to provide innovators with individual reviews or summaries of reviewer feedback in any phases of the program. This is due to the sheer number of anticipated submissions and the urgent need for NIH to focus its efforts on advancing selected proposals. Innovators who were not selected for ITAP support are encouraged to consider other NIH funding opportunities.
Where can I get more information?
Information about this project and how to submit a proposal can be found on the Cimit website.
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)
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
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.
Can diagnostic test components be manufactured outside the U.S.?
Yes. At this time there are no requirements that test supplies and components be manufactured exclusively within the U.S.
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 April 17, 2025. The current solicitation can be found at this link here.
Will NIH provide summary feedback as to why a submission was not selected?
No, NIH does not intend to provide innovators with individual reviews or summaries of reviewer feedback in any phases of the program. This is due to the sheer number of anticipated submissions and the urgent need for NIH to focus its efforts on advancing selected proposals. Innovators who were not selected for ITAP support are encouraged to consider other NIH funding opportunities.
Where can I get more information?
Information about this project and how to submit a proposal can be found on the Cimit website.