COVID-19 RESPONSE: JPM CBRN Medical, in support of the Office of the Assistant Secretary of Defense for Health Affairs, rapidly delivered a new COVID-19 diagnostic test under the FDA’s Emergency Use Authorization. The test will be used with the Next Generation Diagnostics System 1, a diagnostic platform the JPEO-CBRND already fields and globally-distributes, made by industry partner BioFire Defense, LLC. The system is known commercially as the BioFire FilmArray. BioFire FilmArray systems have been deployed throughout the DOD’s healthcare system and hospitals and laboratories across the globe. The COVID-19 test is designed to be easy-to-use and allows for results within one hour. While the FilmArray was originally developed for the DOD, the diagnostic system and COVID-19 test could also strengthen public health response to the current coronavirus outbreak.
Army AL&T News
The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) collaborated with industry to develop diagnostic tests for the novel coronavirus (COVID-19).
Molecular diagnostics company Cepheid Inc. of Sunnyvale, California, created a rapid molecular diagnostic test to detect COVID-19, and was issued an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration on March 20, allowing for its immediate use. The test is designed for use on the company’s GeneXpert family of diagnostic systems. GeneXpert systems are deployed across numerous DOD medical treatment facilities, and are widely used in hospitals and health care facilities worldwide. The test’s development was funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services; the working relationship was facilitated by the JPEO-CBRND using an Other Transaction Authority (OTA) agreement. BARDA seeks to protect our nation from chemical, biological, radiological, and nuclear threats, as well as from pandemic influenza and emerging infectious diseases like coronavirus.
The JPEO-CBRND also partnered with BioFire Defense, LLC of Salt Lake City, Utah to develop a COVID-19 diagnostic test, which received an EUA from the FDA on March 23. The test is used with BioFire’s FilmArray and FilmArray Torch systems. The BioFire FilmArray 2.0G is the diagnostic system fielded by the JPEO-CBRND’s Next Generation Diagnostics System 1 (NGDS 1) program to the Joint Force, with the commercial 2.0L version already present in many of the DOD’s medical treatment facilities. This effort was supported by the Office of the Assistant Secretary of Defense for Health Affairs, using Defense Health Program funds. Both technologies provide a rapid point-of-care COVID-19 diagnostic capability for the Force and the civilian population.
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