Corgenix Gains CE Mark for ReLASV® Antigen Rapid Test for Diagnosis of Lassa Fever

Corgenix Medical Corporation, a worldwide developer and marketer of diagnostic tests for cardiovascular disease, liver biomarkers and emerging pathogens and lethal viruses, today announced that notification of CE Mark was received 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.”

Lassa fever is a dangerous, often fatal disease common to much of West Africa with children and pregnant women being the highest risk groups; early stages of the disease are difficult to distinguish from other diseases. Lassa fever is spread by contact with infected rodents and is estimated to infect 300,000 to 500,000 people per year across the region, with at least 5,000 deaths reported annually. The illness is characterized by bleeding and coagulation abnormalities, with mortality rates reported exceeding 25 percent and reaching 50 percent during epidemics.

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.

Under grants or contracts awarded in the past five years, the VHFC has developed and patented new recombinant proteins for Lassa virus and developed several viral detection products. The Consortium will continue its research activities in Sierra Leone, Nigeria, and other West African countries, advancing other laboratory tests for Lassa and other tropical viral diseases. The research will also assess the potential impact these new generation diagnostic products have on significantly reducing mortality rates through earlier treatment.

VHFC Lassa products have not yet been cleared for use in the United States by the U.S. Food and Drug Administration (FDA).