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

US Food and Drug Administration (FDA) emergency-use-authorization (EUA) allows the test to be used worldwide for the presumptive detection of Zaire ebolavirus (detected in the West Africa outbreak in 2014) in individuals with signs and symptoms of infection in conjunction with epidemiological risk factors, including geographic locations with high prevalence of infection. 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 Medical Corporation (Broomfield, CO, USA) received the EUA for its ReEBOV Antigen Rapid Test, the first rapid diagnostic test (RDT) and the first immunoassay with FDA EUA for the presumptive detection of Ebolavirus. The US regulatory authorization follows the World Health Organization (WHO)’s recent emergency-use listing of this test, making it available worldwide. The EUA allows for its use in circumstances when use of an Ebola RDT is determined more appropriate than use of an authorized Ebola nucleic acid (molecular) test, which has been demonstrated to be more sensitive in detecting the Zaire ebolavirus. Molecular testing in West Africa can still take days to return results from central testing laboratories, whereas ReEBOV is for rapidly diagnosing suspected Ebola cases at point-of-care in any clinical facility or field laboratory capable of such testing. ReEBOV is currently not authorized for Ebolavirus infection screening such as airport screening or contact tracing.

“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 Ebolavirus 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.”

The ReEBOV test was developed by Corgenix in cooperation with additional members of the Viral Hemorrhagic Fever Consortium (VHFC) and 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 Prof. Robert Garry, 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.”

Related Links:
Viral Hemorrhagic Fever Consortium
Corgenix Medical Corporation