FDA and WHO grant Corgenix emergency Ebola rapid diagnostic test use

FDA and WHO grant Corgenix emergency Ebola rapid diagnostic test use | Courtesy of nydailynews.com

Corginex Medical Corp., a company that develops and sells diagnostic test kits, recently received emergency use authorization from the Food and Drug Administration (FDA) to use its ReEBOV™ Antigen Rapid Test to detect the Ebola virus in West Africa. 

It is the first rapid diagnostic test (RDT) approved by the FDA and is also the first immunoassay that has gained approval. Because the RDT has also received approval from the World Health Organization (WHO), it is now available 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,” Corgenix President and CEO Douglass Simpson said. “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.”

Previously, the Antigen Rapid Test could be used only when it was more sensible than a traditional molecular test that has proved to be the most accurate and sensitive in identifying the Ebola Zaire virus. Molecular tests can require days to be run in West Africa, while in contrast Corgenix’s RDT detects Ebola in just 15-25 minutes. It can be administered in any facility or even in a field laboratory with trained staff and adequate equipment.