The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Corgenix Medical’s ReEBOVAntigen Rapid Test, which is designed for presumptive detection of Ebola Zaire virus.
The test is being used to detect Ebola Zaire virus (detected in the West Africa outbreak in 2014) in individuals with signs and symptoms of Ebola virus infection in conjunction and with epidemiological risk factors, including geographic locations with high prevalence of Ebola infection.
Corgenix Medical president and CEO Douglass Simpson said: "The FDA and WHO have been working closely with us throughout this process to get this new test in the hands of those battling on the front lines of the Ebola outbreak as quickly as possible.
"Completing this product development in less than a year demonstrates how governmental agencies, regulatory bodies, industry, non-profits and others can work together to find solutions to catastrophic events such as the Ebola virus outbreak."
Corgenix has developed this test, with the help of Viral Hemorrhagic Fever Consortium (VHFC), a collaboration of academic and industry members headed by Tulane University, comprising Autoimmune Technologies, Zalgen Labs, The Scripps Research Institute and the University of Texas Medical Branch at Galveston and other collaborators in West Africa.
The authorized ReEBOV Antigen Rapid Test will not be used for general Ebola virus infection screening such as airport screening or contact tracing.
In addition, the test was assessed under World Health Organization’s (WHO) Emergency Use Assessment and Listing procedure, which offers independent technical information on safety, quality and performance of in vitro diagnostics.
Image: Electron micrograph of an Ebola virus virion. Photo: courtesy of CDC/Cynthia Goldsmith.