ITAP for Diagnostic Mpox Lesion Panel - POCTRN


Independent Test Assessment Program (ITAP) for Diagnostic Mpox Lesion Panel Test Validation and Regulatory Authorization


In partnership with the FDA, the National Institute of Biomedical Imaging and Bioengineering (NIBIB) Rapid Acceleration of Diagnostics (RADx®) is soliciting proposals to accelerate the validation, regulatory authorization, and commercialization of innovative point-of-care (POC) lesion panel tests. This includes tests intended for the direct detection and differentiation of mpox virus (MPXV), herpes simplex virus types 1 and 2 (HSV1/2), Treponema pallidum (Syphilis), and varicella-zoster virus (VZV) in lesion swab specimens (“lesion panel”). 

NIBIB is mobilizing and expanding the focus of the RADx Tech Independent Test Assessment Program (ITAP) to increase availability of high-quality, accurate, and reliable POC mpox lesion panel diagnostics. NIBIB plans to support analytical and clinical testing to accelerate test validation and regulatory review of POC tests. These efforts will facilitate rapid production and commercialization of mpox lesion panel tests in the US.

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 can demonstrate performance to support authorization.

NIBIB will not consider applications for tests of prior MPXV, HSV1/2, VZV, and/or Syphilis infection or immunity (e.g. anti-MPXV antibodies). 

Evaluation Criteria

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, Syphillis
    • MPXV, HSV1/2, VZV, Syphillis 
  2. Technology appropriate for use in POC setting
  3. Demonstrated capacity for manufacturing and distributing high-quality in vitro diagnostic tests

The deadline for this opportunity has passed.


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