WHO, FDA Give Authorization for Corgenix Ebola Diagnostic

Corgenix Medical Corporation 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.

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 test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus.

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 clinical or field laboratories 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.

“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,” said Douglass Simpson, Corgenix President and CEO. “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.”

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.

“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.”

Development of the Corgenix ReEBOV Antigen Rapid Test was supported by the National Institute of Allergy and Infectious Diseases (NIAID), the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation.