ITAP - POCTRN

Independent Test Assessment Program (ITAP)

The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) program has established the Independent Test Assessment Program (ITAP) in order to accelerate regulatory review and availability of high-quality, accurate, and reliable diagnostic tests.

Current Funding Opportunities

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Past Funding Opportunities

ITAP for Diagnostic Mpox Lesion Panel

NIBIB is soliciting proposals to address the diagnostic needs for 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 plans to support analytical and clinical testing to accelerate test validation and regulatory review of POC tests. These efforts will help 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:

  • MPXV and HSV1/2 only
  • 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).

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COVID-19 Tests

The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative has 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. ITAP is not presently accepting new applications for COVID-19 tests.

Multiplex Point-of-Care (POC) Diagnostic Tests

ITAP is not presently accepting new applications for multiplex point-of-care diagnostics tests. Applications that were submitted by December 16, 2022 that meet all the previous eligibility criteria will be reviewed.

MPox Virus Tests

ITAP is not presently accepting new applications for monkeypox virus tests. Applications that were submitted prior to October 17, 2022 that meet all the previous eligibility criteria will be reviewed.

Hepatitis C Virus Point-Of-Care Diagnostics

ITAP is not presently accepting new applications for Hepatitis C diagnostics. Applications that were submitted prior to March 12, 2023 that meet all the previous eligibility criteria will be reviewed.

Multiplex Over-the-Counter (OTC) Diagnostic Tests for COVID-19 and Flu

ITAP is not presently accepting new applications for monkeypox virus tests. Applications that were submitted prior to May 3, 2023 that meet all the previous eligibility criteria will be reviewed.

Any future opportunities will be announced on our website.