(Released 11 March 2020) Fort Detrick, MD – In support of the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)), the Department of Defense (DOD) leveraged an existing contract agreement with BioFire Defense, LLC, to develop a rapid response diagnostic test capability to detect novel coronavirus (COVID-19).
The test will be developed for use on the BioFire® FilmArray® instrument, which is used to diagnose infectious diseases in order to aid in treatment of service members. The FilmArray® is currently fielded throughout the DOD’s deployed health care system. While the DOD’s primary goal is to protect the warfighter, making a DOD-developed FilmArray® COVID-19 test available within the civilian health care system could also ultimately strengthen public health response to the current outbreak.
The FilmArray® and existing respiratory panels can identify four common human coronaviruses (229E, NL63, OC43, HKU1), but the panels will not recognize COVID-19. Creation of a COVID-19 diagnostic test for this specific coronavirus variation addresses this capability gap. The test is designed to be easy-to-use and will typically be positioned within patient care facilities, allowing for results within one hour.
Once developed, the DOD will submit information about the COVID-19 diagnostic test on the FilmArray® to the U.S. Food and Drug Administration (FDA) for potential use under an Emergency Use Authorization (EUA), which would allow use of the test in response to the current outbreak.
The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological and Nuclear Medical (JPM CBRN Medical), through Army Contracting Command-Natick, awarded a delivery order to BioFire Defense, LLC, on February 15, 2020. Funding was requested and provided by the Deputy Assistant Secretary of Defense for Health Readiness Policy and Oversight.
BACKGROUND: In 2013, the JPEO-CBRND awarded a contract to BioFire Defense, LLC, to develop the Next Generation Diagnostic System 1 (NGDS 1); an innovative medical countermeasure system known commercially as the BioFire® FilmArray®. Commercially-available panels that work in conjunction with the BioFire® FilmArray® can diagnose respiratory diseases from nasopharyngeal swabs and aid in protecting and treating our nation’s warfighters from biological diseases they may encounter while operating in high-risk military environments.