The Food and Drug Administration (FDA) recently approved the FilmArray® Respiratory Panel EZ detection and diagnosis device for use in non-laboratory environments. Cofunded by the Defense Threat Reduction Agency’s Joint Science and Technology Office and BioFire Diagnostics, this new device rapidly detects and diagnoses illnesses that threaten our warfighters and prevent the spread of disease.
The RP EZ diagnostic test requires only minutes for medical personnel to administer and can detect 11 viral and 3 bacterial pathogens associated with respiratory infections within an hour. To date, approximately 3,000 FilmArray RP EZ® units are in service globally.
Managed by DTRA’s Dr. Nathan Adams, this milestone marks the first time a highly multiplexed molecular diagnostic test was granted the FDA’s Clinical Laboratory Improvement Amendments (CLIA)-waiver. The CLIA waiver allows testing of the device by everyday users, such as doctor’s offices and clinics.
This milestone provides the Department of Defense and health workers with real-time force protection capabilities to detect and diagnose diseases that cause public health concerns such as influenza, the common cold or whooping cough.
“The FilmArray® RP EZ device is an important part of a suite of detection and diagnosis tools currently under development for the protection of our troops. The sure-fire device allows for quicker medical care for deployed warfighters, especially those on ships or in areas without access to more definitive care,” said Dr. Ronald Hann, director for DTRA’s Joint Science and Technology Office.
FilmArray® RP EZ clinical trials were supported by the U.S. Department of Defense Chemical and Biological Defense program through DTRA. Trial sites included primary care, pediatric, community, and family practice clinics. A mix of adult and pediatric subjects with signs or symptoms of respiratory infection were eligible to participate in the study. Operators in the CLIA-waived setting, comprised primarily of nurses and medical assistants, achieved highly accurate results with overall 96.8% positive agreement and 99.5% negative agreement with an FDA-cleared molecular comparative method.