ITAP Multiplex Point-of-Care Diagnostic Tests FAQs
What is the Independent Test Assessment Program (ITAP) for Multiplex Point-of-Care Diagnostic Tests?
The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program established the Independent Test Assessment Program (ITAP) in order to accelerate regulatory review and availability of high-quality, accurate, and reliable over-the-counter COVID-19 tests to the public.
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is mobilizing and expanding the focus of ITAP to increase availability of high-quality, accurate, and reliable COVID19 plus Flu A/B with/without RSV point-of-care (POC) tests.
What technologies will be considered?
NIBIB will consider applications from test manufacturers with existing POC technologies that can quickly scale production and can meet U.S. Food and Drug Administration (FDA) performance standards for authorization.
NIBIB will not consider applications for tests of past COVID-19, Flu A/B or RSV infection or immunity (e.g., COVID-19, Flu A/B or RSV antibodies).
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:
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 COVID-19 plus Flu A/B with/without RSV at design lock, with analytical and clinical performance data available
- An existing COVID-19, plus Flu A/B with/without RSV virus test kit available for POC diagnostic use in international markets
Can applicants from outside the U.S. apply?
Yes, applicants from all locations are encouraged to apply.
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 the 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 December 16, 2022, 11:59PM ET. The link to the current solicitation can be found 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 RADx Tech 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 Point of Care Technologies Research Network (POCTRN) website.
What is the Independent Test Assessment Program (ITAP) for Multiplex Point-of-Care Diagnostic Tests?
The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program established the Independent Test Assessment Program (ITAP) in order to accelerate regulatory review and availability of high-quality, accurate, and reliable over-the-counter COVID-19 tests to the public.
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is mobilizing and expanding the focus of ITAP to increase availability of high-quality, accurate, and reliable COVID19 plus Flu A/B with/without RSV point-of-care (POC) tests.
What technologies will be considered?
NIBIB will consider applications from test manufacturers with existing POC technologies that can quickly scale production and can meet U.S. Food and Drug Administration (FDA) performance standards for authorization.
NIBIB will not consider applications for tests of past COVID-19, Flu A/B or RSV infection or immunity (e.g., COVID-19, Flu A/B or RSV antibodies).
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:
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 COVID-19 plus Flu A/B with/without RSV at design lock, with analytical and clinical performance data available
- An existing COVID-19, plus Flu A/B with/without RSV virus test kit available for POC diagnostic use in international markets
Can applicants from outside the U.S. apply?
Yes, applicants from all locations are encouraged to apply.
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 the 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 December 16, 2022, 11:59PM ET. The link to the current solicitation can be found 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 RADx Tech 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 Point of Care Technologies Research Network (POCTRN) website.