Army Announces FDA Marketing Approval for Next Generation Diagnostics System Global Fever Panel
Press Release — FOR IMMEDIATE RELEASE
FORT DETRICK, Md. – The U.S. Army Medical Materiel Development Activity, in partnership with BioFire Defense LLC, announced U.S. Food and Drug Administration marketing approvals for the Next Generation Diagnostics System Increment 1 Infectious Disease Panel, also known as the Global Fever Panel, and the associated External Control Kit.
The FilmArray® Global Fever Panel is a commercially available single-use, fully enclosed test for use with the BioFire® FilmArray 2.0 instrument to aid in the diagnosis of malaria, dengue fever, chikungunya fever and leptospirosis.
Although these diseases are rare in the United States, they are common in other parts of the world where U.S. Service Members are or may be deployed.
"Each year, Army and other Service physicians request thousands of tests for malaria, dengue fever, chikungunya fever and leptospirosis. To deployed Warfighters, and the people who care for their health, these diseases are not theoretical. Diagnostic testing for these diseases has been challenging because there is no single testing solution that can provide answers quickly. The Global Fever Panel meets these challenges; it will help physicians make diagnoses and provide information about medical readiness to unit commanders," said Dr. Clifford Snyder, product manager for USAMMDA's Warfighter Protection and Acute Care Project Management Office.
A blood sample is taken from the patient, loaded onto the Global Fever Panel, and analyzed in the Next Generation Diagnostics System Increment 1 device, BioFire's FilmArray 2.0. Within 50 minutes, the device reports either "Detected" or "Not Detected" for the nucleic acids of the organisms that cause these diseases.
Tests will be conducted by medical laboratory personnel in fixed facilities ("brick and mortar") and in facilities used by deployable units (e.g., field hospitals). The Department of Defense owns hundreds of FilmArray instruments and each of them can run the Global Fever Panel.
Physicians will use the testing results, along with other information, to prescribe treatment and document medical condition, in accordance with the indications for use, which say, "Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities."
The evaluation of the Global Fever Panel included the analysis of over 1,500 blood samples obtained by Army and Navy researchers in the United States, Central and South America, Africa and Asia. The Defense Health Agency funded product development.
This accomplishment is the result of the combined efforts of the U.S. Army Medical Research and Development Command; USAMMDA product development; the Armed Forces Research Institute of Medical Sciences; the U.S. Army Medical Research Directorate — Africa; the U.S. Army Medical Research Institute of Infectious Diseases; the U.S. Army Combat Capabilities Development Command Chemical Biological Center; the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense medical product development; the Naval Medical Research Unit — 2; the Naval Medical Research Unit — 6; Naval Health Research Center; the Health and Human Services/National Institute of Allergy and Infectious Diseases; the Next Generation Diagnostics System Increment 1 Infectious Disease Panel Integrated Product Team; and BioFire Defense, LLC.
Production and deployment of the Global Fever Panel to military users will begin in 2021.
About US Army Medical Materiel Development Activity:
USAMMDA is a subordinate command of the U.S. Army Medical Research and Development Command, under the Army Futures Command. As the premier developer of world-class military medical capabilities, USAMMDA is responsible for developing and delivering critical products designed to protect and preserve the lives of Warfighters across the globe. These products include drugs, vaccines, biologics, devices and medical support equipment intended to maximize survival of casualties on the battlefield.
About Army Futures Command:
Army Futures Command (AFC) leads the persistent modernization of the Army in order to provide future warfighters with the concepts, capabilities, and organizational designs needed to dominate a future battlefield. Headquartered in Austin, Texas, AFC has more than 26,000 people worldwide. The Army's six modernization priorities are the focus of our eight Cross Functional Teams: Long Range Precision Fires; Next Generation Combat Vehicle; Future Vertical Lift; Army Network; Air and Missile Defense; Soldier Lethality; Assured Positioning Navigation Timing; and, Synthetic Training Environment. The Artificial Intelligence Task Force and Army Applications Lab also support our efforts. Collaborating with entrepreneurs, scientists, industry, and academia, AFC strives to create the best solutions to keep Soldiers safe and America strong. For more information, visit https://www.army.mil/futures/.