Corgenix Medical has received the notification of CE Mark for its Relasv antigen rapid test for Lassa fever diagnosis.
Relasv is the diagnostic test developed by Corgenix and members of the Viral Hemorrhagic Fever Consortium (VHFC), a collaboration of academic and industry members headed by Tulane University partially funded with support from the National Institutes of Health (NIH).
The Lassa virus is considered as Category A (highest risk) pathogen and potential biowarfare agent by the National Institute of Allergy and Infectious Diseases (NIAID).
Corgenix president and CEO Douglass Simpson said that the 15-minute test has the potential to completely change the way Lassa fever is detected and treated.
"Instead of having to wait days to find out if a patient has Lassa fever, health care workers are now able to diagnose and treat Lassa infections in the early acute stage, potentially saving many lives," Simpson added.
CE Mark notification follows the successful completion of a multi-year study of the clinical utility of the test to evaluate patients presenting with clinical symptoms of Lassa hemorrhagic fever.
