FDA EUA and WHO Listing for Corgenix POC Ebola Test
Corgenix Medical Corporation has received FDA emergency use authorization (EUA) of its ReEBOVTM Antigen Rapid Test.
The Corgenix Ebola rapid test is the first rapid diagnostic test and the first immunoassay authorized for emergency use by the FDA for the presumptive detection of Ebola virus. The EUA allows the use of the ReEBOVTM Antigen Rapid Test in circumstances when use of a rapid Ebola test is determined to be more appropriate than use of an authorized Ebola nucleic acid (molecular) test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus. The authorized ReEBOVTM Antigen Rapid Test is not intended for use for general Ebola virus infection screening, such as airport screening or contact tracing.
Unlike molecular testing, which in West Africa can still take days to return results from central testing laboratories, the Corgenix RDT is a point-of-care test that can be used in any clinical facility adequately equipped, trained and capable of such testing, or in any field laboratory with trained personnel capable of such testing, to diagnose suspected Ebola cases in 15-25 minutes. The U.S. regulatory authorization follows last week’s World Health Organization (WHO) listing for procurement for the Corgenix Ebola RDT, making this test available to the health care community worldwide.
The ReEBOVTM Antigen Rapid Test was developed by Corgenix in cooperation with additional members of the Viral Hemorrhagic Fever Consortium (VHFC), a collaboration of academic and industry members headed by Tulane University, including Autoimmune Technologies LLC, Zalgen Labs LLC, The Scripps Research Institute and the University of Texas Medical Branch at Galveston, as well as other collaborators in West Africa.
“This has the potential to be a game-changer in stopping the spread of the epidemic,” said Dr. Robert Garry, Professor of Microbiology and Immunology at Tulane, and Principal Investigator of the VHFC. “Instead of taking days for lab results, the Ebola RDT uses a drop of blood from a finger prick to deliver a diagnosis in as little as 15 – 25 minutes, potentially allowing trained public health workers to isolate and treat patients immediately. Medical personnel will be able to quickly identify hotspots and may prevent resurgence of cases in the current outbreak.”
The FDA’s emergency use authorization of the ReEBOVTM Antigen Rapid Test is for the presumptive detection of Ebola viruses (including Ebola Zaire virus detected in the West Africa outbreak in 2014) in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors, including geographic location with high prevalence of Ebola infection. The test was also evaluated under WHO’s Emergency Use Assessment and Listing procedure, which provides independent technical information on safety, quality and performance of in vitro diagnostics, principally to other United Nations (UN) agencies but also to WHO Member States and other interested organizations in the context of the Ebola emergency.
Tags: Ebola virus
Date Published: March 2, 2015
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