December 5, 2021

NIH RADx initiative expands COVID-19 testing innovation for additional types of rapid tests

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BD Veritor™ System for Rapid Detection of SARS CoV 2. The lateral flow immunoassay with a reader delivers electronic results intended to be used in point-of-care settings.BD Veritor™ System

The NIH Rapid Acceleration of Diagnostics (RADx) initiative announced today that it has issued contract awards totaling $77.7 million to develop and manufacture 12 new rapid diagnostic tests for SARS-CoV-2, the virus that causes COVID-19.

The home and point-of-care testing platforms target the need for high-performance, low-cost home tests and point-of-care tests that can potentially detect multiple respiratory infections. These projects are part of the RADx Tech program, which involves an intensive concept viability “shark-tank”-like assessment conducted by a panel of technical, regulatory and business experts. The awards support the development, validation, scale-up and manufacturing with the goal of bringing needed tests to the market as early as this year.

“These technologies represent important innovations to address the need for ready access to rapid, low-costs tests everywhere in the country, including in every home,” said Bruce J. Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and lead for RADx Tech. “The potential to test simultaneously for multiple types of infection at the point-of-care, is a new frontier that we hope to advance and could be a major step toward transforming U.S. healthcare.”

The new awards are in addition to 33 that NIH previously disbursed through its technology development program. The RADx Tech program has resulted in 32 U.S. Food and Drug Administration emergency use authorizations (EUAs), including supporting the first home test EUA. Companies supported by the RADx program that achieved an EUA have contributed over 840 million tests to the U.S. market since fall of 2020.

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