The approval marks the successful transfer of FDA EUA from Corgenix Medical to Zalgen.
ReEBOV antigen rapid test will 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.
The risk factors include geographic locations with high prevalence of Ebola infection.
The authorized ReEBOV Antigen Rapid Test is directed 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.
ReEBOV test is claimed to be 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.
As per terms of the earlier collaboration agreement, NOWDiagnostics(NOWDx) will produce ReEBOV antigen rapid test for Ebola virus and other Zalgen diagnostic products.
The test uses a drop of blood from a finger prick to deliver a presumptive detection of Ebola virus antigen in between 15 and 20 minutes.
ReEBOV test was developed in partnership with other members of the Viral Hemorrhagic Fever Consortium (VHFC) (VHFC), a collaboration of academic and industry members headed by Tulane University.
Zalgen managing director Dr Luis Branco said: “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.”
