ITAP for Diagnostic Lesion Panels FAQs - POCTRN


ITAP for Diagnostic mpox Lesion Panel FAQs

What is the Independent Test Assessment Program (ITAP) for Diagnostic Mpox Lesion Panel Program?

The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) initiative 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 expanding the focus of ITAP to accelerate the validation, regulatory authorization/clearance, and commercialization of innovative point-of-care (POC) lesion panel tests. This includes tests intended for the direct detection of mpox virus (MPXV), herpes simplex virus types 1 and 2 (HSV1/2), Treponema pallidum (Syphilis), and varicella-zoster virus (VZV) in lesion specimens (“lesion panel”). 

When can proposals be submitted?

Deadline for proposal submission is January 22, 2024 at 11:59PM ET. The link to the current solicitation can be found here.

What technologies will be considered?

Point-of-care (POC) lesion panel tests intended for the direct detection of mpox Virus (MPXV), Herpes Simplex Viruses (HSV-1/2), Treponema pallidum (Syphilis), and Varicella zoster Virus (VZV) in lesion specimens. 

NIBIB will consider applications from test manufacturers with existing technologies for detection of a) MPXV and HSV1/2 only or b) MPXV and HSV1/2 in combination with VZV and/or Syphilis. NIBIB will only consider tests that can quickly reach design lock, scale production, and meet the FDA’s performance standards for authorization/clearance.

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: 

  1. An existing technology, at/near design lock, with performance data available for detection of: 
    • MPXV, HSV1/2 
    • MPXV, HSV1/2, VZV 
    •  MPXV, HSV1/2, Syphilis 
    •  MPXV, HSV1/2, VZV, Syphilis 
  2. Technology can be adapted for use in POC setting  
  3. Demonstrated capacity for manufacturing and distributing high-quality in vitro diagnostic tests

Can applicants from outside the U.S. apply?

Yes, at this time there are no requirements that applicant companies be 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 Tech Coordination Center and operating under a contract with the NIH.

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 this website.