Corgenix Receives FDA Authorization and WHO Listing for Emergency Use of Ebola Rapid Diagnostic Test

Corgenix Medical Corporation, a worldwide developer and marketer of diagnostic test kits, announced it has received U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) of its ReEBOV™ Antigen Rapid Test. The test is to be used for the presumptive detection of 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 location with high prevalence of Ebola infection.)

The Corgenix Ebola rapid test is the first rapid diagnostic test (RDT) 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 ReEBOV™ 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 ReEBOV™ 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 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,” said Douglass Simpson, Corgenix President and CEO. “Completing this product development in less than a year demonstrates how governmental agencies, regulatory bodies, industry, nonprofits and others can work together to find solutions to catastrophic events such as the Ebola virus outbreak. This collaboration has enabled us to quickly deliver this critically important point-of-care test and potential breakthrough in the fight against Ebola in the current outbreak in West Africa.”

“Corgenix’s work is crucial to addressing the Ebola outbreak in West Africa,” said United States Senator from Colorado Michael Bennet. “This new test has the potential to help medical officials in the field diagnose Ebola virus disease quicker than before to help control the spread of this vicious disease. We're extremely grateful that this Colorado-based company has invested its resources and completed this research to develop such a valuable tool.”

The ReEBOV™ 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. Mr. Simpson noted, "We are pleased to be part of the VHFC. This is a remarkable group of scientists who have been in the forefront of research in Ebola, Lassa fever and other dangerous viral diseases in Africa for many years. A key component of our success is a result of the commitment and participation of the Ministry of Sanitation and Public Health of the Republic of Sierra Leone and the dedicated medical personnel of the Kenema Government Hospital in Kenema, Sierra Leone, a number of whom have died fighting the current Ebola outbreak.”

“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 ReEBOV™ 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.

Mr. Simpson stated that the VHFC will remain actively engaged in efforts to advance additional diagnostic products, some already under development for viral and parasitic diseases, and to expand collaborations with global health care partners, including providers in West Africa. The consortium has already developed a suite of additional laboratory assays to complement its RDTs. These additional assays are being developed to permit confirmation of point-of-care test results and augment much needed serosurveillance capabilities via ongoing and future seroprevalence studies on both Ebola and Lassa fever.