CE Mark for ReLASV® Antigen Rapid Test for Diagnosis of Lassa Fever
Corgenix Medical Corporation has received CE Marking for its ReLASV® Antigen Rapid Test for Lassa Fever diagnosis.
ReLASV is the first commercialized diagnostic test developed by Corgenix and other 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 new test kit enables rapid diagnosis of Lassa viral hemorrhagic fever, a highly infectious virus responsible for thousands of deaths each year across West Africa. The Lassa virus is considered a Category A (highest risk) pathogen and potential biowarfare agent by the National Institute of Allergy and Infectious Diseases (NIAID).
This 15-minute test has the potential to completely change the way Lassa fever is detected and treated, said Douglass Simpson, Corgenix President and CEO. 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.
CE Mark notification was achieved following 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. Corgenix will advance the ReLASV Antigen Rapid Test into full commercialization this year.
VHFC Lassa products have not yet been cleared for use in the United States by the U.S. Food and Drug Administration (FDA).
Date Published: May 13, 2013
Source article link: Corgenix » company contact details
GC and CFU Correlation Of 9 Mycoplasma spp Examined With Sartorius' Microsart® Range
Why Bio-Rad? Learn More Here!
Mérieux NutriSciences - European Food Safety Trends, Key Issues & Perspectives
How to Prevent False-Positive Results in Pathogen Testing
The BAX® System X5 for Pathogen Detection. Simple, Accurate, Validated