FDA completes transfer of emergency use authorization for ReEBOV Ebola antigen rapid test to Zalgen Labs.
Zalgen Labs LLC, a biotechnology and diagnostics company focused on high-impact neglected infectious diseases, announced Monday that its ReEBOV antigen rapid test received U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) on November 3, 2016. This marks the successful transfer of FDA EUA from Corgenix Medical to Zalgen.
The test is to be used for the presumptive detection of Ebola viruses (detected in the 2014 – 2016 West Africa outbreak) in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors (including geographic locations with high prevalence of Ebola infection). The authorized ReEBOV Antigen Rapid Test is intended for circumstances when the use of a rapid Ebola virus test is determined to be more appropriate than use of an authorized Ebola virus nucleic acid test.
Ebola virus is indigenous to western and central Africa and is one of the deadliest viruses in the world, with mortality rates of between 30 and 90 percent. The ReEBOV Antigen Rapid Test for Ebola was the first rapid diagnostic test (RDT) and the first immunoassay authorized for emergency use by the FDA for the presumptive detection of Ebola virus, and also the first listed for procurement by the World Health Organization (WHO) under the Emergency Use Assessment and Listing procedure. Under the terms of a previously announced collaboration agreement, NOWDiagnostics Inc. (NOWDx) will manufacture the ReEBOV Antigen Rapid Test for Ebola virus as well as other Zalgen diagnostic products.
Unlike molecular testing, which in West Africa can still take days to return results from central testing laboratories, the Zalgen ReEBOV RDT is a point-of-care test that can be used in laboratories or facilities adequately equipped, trained and capable of such testing. That includes testing in treatment centers and public health clinics or in field laboratories with trained personnel capable of such testing. Instead of taking days for lab results, the ReEBOV RDT uses a drop of blood from a finger prick to deliver a presumptive detection of Ebola virus antigen in as little as 15 – 25 minutes, potentially allowing trained public health workers to rapidly screen, isolate and initiate care of suspect Ebola patients. Medical personnel will be able to quickly identify hotspots and may prevent resurgence of cases in future outbreaks.
The ReEBOV Antigen Rapid Test was developed 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, The Scripps Research Institute and the University of Texas Medical Branch at Galveston, as well as other collaborators in West Africa, particularly the Ministry of Health and Sanitation (MOHS) of the Republic of Sierra Leone and the medical personnel of the Kenema Government Hospital in Kenema, Sierra Leone, a number of whom died fighting the 2014-16 Ebola outbreak.
“This emergency use authorization from the FDA enables Zalgen and our distribution partners to continue providing this remarkable product worldwide to test suspected Ebola cases,” said Zalgen managing director, Luis Branco, Ph.D. “Zalgen and the VHFC are already working with NOWDx to develop next generation diagnostic tests for Ebola, Lassa and other hemorrhagic fevers as well as other tropical diseases.”
Development of the ReEBOV antigen rapid test for Ebola was supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) (grants 1R43AI088843 and 2R44AI088843). Additional support was provided by The Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation.
(Source: Business Wire)