Our Initiatives
ITAP: RADx® Tech Independent Test Assessment Program Initiative
About
Design and oversee innovation process to fast-track regulatory review and availability of high-quality, accurate, and reliable diagnostic tests for a range of conditions.
Overview
Core Leads
Michael Dempsey
Subprojects Core Lead for CINTA; Entrepreneur-in-Residence, Consultant Innovator, Cimit
Title or headline here
Description etc here
Penny Ford-Carleton, RN, MS, MPA, MSC
Description etc here
Title or headline here
Description etc here
CINTA Staff
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
During the COVID-19 pandemic, the National Institute of Biomedical Imaging and Bioengineering (NIBIB) created the RADx® Tech Independent Test Assessment Program (ITAP) to fast-track regulatory review and availability of diagnostic tests. A collaboration between NIBIB and the Food and Drug Administration, RADx® Tech ITAP facilitated new ways of the agencies working together to support improved health for all Americans.
Based on the success of RADx®Tech ITAP in helping fast track COVID-19 tests to market, NIBIB has expanded the program to advance commercialization of tests for a variety of health conditions. Cimit plays a leadership role in the program by helping to:
- design and manage the innovation process.
- solicit and oversee application reviews.
- make funding recommendations to NIBIB.
- engage experts to serve as mentors to awarded teams on product development, business, and regulatory processes.
- ensure that the overall process meets NIBIB goals.
This program is focused on validation, regulatory authorization, and commercialization. Applicants must have a well-defined product to be considered for funding.
Among the ITAP programs that Cimit has supported are:
- multiplex tests that detect SARS-CoV-2, influenza A/B, and RSV.
- mpox tests.
- lesion panels that test for the mpox virus, herpes simplex virus (types 1 and 2), Treponema Pallidum (syphilis), and varicella-zoster virus.
- hepatitis B and C virus tests.
Challenge
Accelerate regulatory review and availability of high-quality, accurate and reliable diagnostic tests to help advance treatment and improve outcomes for people with a range of conditions.
Rapid approval of accurate diagnostic tests has the potential to accelerate the eradication of curable diseases, such as hepatitis C, and improve treatment for other persistent problems, such as fetal health across the globe.
Impact
Mpox:
- In February 2023, the Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a test that detects DNA from monkeypox virus from individuals suspected of mpox2 by their healthcare provider.
- In March 2024, the FDA granted EUA for the collection of lesion swab specimens at home by individuals presenting with a rash suspected of mpox1.
Multiplex:
- More than a dozen flu and COVID-19 multiplex tests have received FDA EUA.
- In June 2024, the FDA granted EUA for a multiplex SARS-CoV-2, Influenza A/B, and RSV test that produces results in 20 minutes on a compact analyzer.
- In October 2024 — just 16 months from pre-clinical testing to approval — the FDA granted marketing authorization of a COVID-19/flu A and B antigen test.
Hepatitis C:
- In June 2024 — less than five months after the start of clinical trials — the FDA granted marketing authorization for the first hepatitis C virus test that can be used in certified point-of-care settings for individuals at risk for hepatitis C.
Activities
Visit the ITAP page on NIBIB’s website to read about all projects, funding opportunities, and results.