DOD-Funded Diagnostic Test for COVID-19 Granted Emergency Use Authorization

FORT DETRICK, Md. – The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for BioFire Defense, LLC’s diagnostic test to detect novel coronavirus (COVID-19) on March 23, 2020.

The EUA was granted five weeks after the Department of Defense (DOD) leveraged an existing contract agreement with BioFire Defense, LLC in support of the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) to develop the COVID-19 test. This created a new capability for rapid and widespread testing of COVID-19 on the BioFire® FilmArray® system. The FilmArray® is currently fielded throughout the DOD’s deployed health care system and is used to diagnose infectious diseases in order to aid in treatment of service members.

The EUA permits the use of COVID-19 diagnostic tests developed by laboratories and commercial manufacturers during this Department of Health and Human Services (HHS)-declared public health emergency. When no FDA-approved or cleared tests are available, and other criteria are met demonstrating safety and efficacy, the FDA can make tests available under this authorization. This EUA will remain in effect and the tests may be used for the duration of the COVID-19 declaration justifying emergency use of these diagnostics, unless terminated or revoked by the FDA.

The BioFire COVID-19 test is for use on respiratory specimens collected by their healthcare provider from individuals suspected of having COVID-19, to include DOD service members who may have been exposed to the virus. Testing is authorized for U.S. laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high or moderate complexity tests, or in similarly qualified non-U.S. laboratories. The test is intended for use by laboratory personnel who have received specific training on the use of the BioFire® FilmArray® 2.0 and/or the FilmArray® Torch Instrument Systems.

“Given the COVID-19 testing availability challenges we’re seeing, having this EUA means DOD can use the FilmArray, which is the Department’s biological diagnostic capability, to test service members across the globe,” said Dr. Jason Roos, Deputy Joint Program Executive Officer for Chemical, Biological, Radiological and Nuclear Defense. “The test will allow us to diagnose COVID-19 infections quickly and confidently and then work to get those Soldiers, Sailors, Airmen, and Marines healthy again as quickly as possible.”

Read more about the delivery order awarded to BioFire Defense, LLC, by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) here: https://www.jpeocbrnd.osd.mil/news/news-story/2020/03/11/dod-leveraging-diagnostic-platform-for-covid-19-rapid-response

About the JPEO-CBRND: The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense is the Joint Service’s lead for development, acquisition, fielding and life-cycle support of chemical, biological, radiological, and nuclear defense equipment and medical countermeasures. As an effective acquisition program, the JPEO-CBRND puts capable and supportable systems in the hands of the service members and first responders, when and where it is needed, at an affordable price. Our vision is a resilient Joint Force, enabled to fight and win unencumbered by a chemical, biological, radiological, or nuclear environment, championed by innovative and state-of-the-art solutions. The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) is a component of the JPEO-CBRND and facilitates the advanced development and acquisition of medical countermeasures and systems to enhance the nation’s biodefense response capability.

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DOD-Funded Diagnostic Test for COVID-19 Granted Emergency Use Authorization

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