Supports Manufacturers of SARS-CoV-2, Mpox, Flu, and Hepatitis Tests Seeking EUAs
The COVID-19 pandemic caught the world by surprise, and scientists worked collectively to develop new diagnostic tests, treatments, and vaccines. In response to the pandemic, the National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx®) initiative to hasten the development, commercialization, and implementation of novel diagnostic tests for SARS-CoV-2, the virus that causes COVID-19. New diagnostic tests must be accurate, fast, inexpensive, used in a wide variety of settings/locations, accessible, and sensitive.
In Fall 2020, MRIGlobal was contracted as part of the NIH RADx Tech program to perform analytical studies for companies seeking Emergency Use Authorization (EUA) of their COVID-19 at-home test devices. This work provided test manufacturers with the data needed to support their EUA submissions to the U.S. Food and Drug Administration or make improvements to their devices. When demand for these diagnostic tests rose in late 2021, our scientists completed studies for three device manufacturers in record time which enabled their tests to reach the market in time for the anticipated holiday surge. To date, MRIGlobal has performed analytical studies for more than 30 manufacturers that enabled many of these companies to receive an EUA.
The success of RADx Tech has led to an expansion of the program to assess new targets that include hepatitis C virus (HCV), mpox, and rapid tests to simultaneously detect SARS-CoV-2 and influenza A & B. MRIGlobal successfully completed analytical testing for an mpox test that went on to receive an EUA and is currently contracted to perform analytical studies for HCV and over-the-counter and point-of-care multiplex tests.
This project has been funded in part with Federal funds from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health, Department of Health and Human Services, under Contract Nos. 75N92022D00013, 75N92022C00027, 75N92022P00030, 75N92021P00129, and 75N92020P00171.
GETTING STARTED AT MRIGLOBAL
Contact MRIGlobal for further information about our work with infectious diseases. Through an interdisciplinary approach, we provide scientific and subject matter expertise for development of medical countermeasures research against specific threats, while expanding and accelerating the delivery of high quality clinical diagnostic products.
To discuss how we can help your project be successful, contact us today.
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