FDA Grants Emergency Use Authorization to Corgenix for Ebola Test

Broomfield, Colo.-based 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 (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.)

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, non-profits 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.”

Ebola is indigenous to Africa and is one of the deadliest viruses in the world, with mortality rates of between 30 and 90 percent. Ebola and other viral hemorrhagic fevers are difficult to discriminate because many of the early signs and symptoms are nonspecific and common to other infectious diseases such as Dengue fever, Lassa fever, typhoid and malaria.

“Corgenix’s work is crucial to addressing the Ebola outbreak in West Africa,” said Sen. Michael Bennet (D-Colo.). “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.”

Corgenix makes specialized diagnostic kits for immunology disorders, vascular diseases, bone and joint disorders and viral hemorrhagic disease.