Corgenix announces CE Mark notification for Lassa fever diagnostic test

By: Steve Tuesday May 14, 2013 0 comments Tags: CE Mark, Corgenix, Denver, Douglass Simpson, Lassa fever

Corgenix logoDENVER--Corgenix Medical Corporation (OTC BB: CONX), a global developer and marketer of diagnostic tests for cardiovascular disease, liver biomarkers and emerging pathogens and lethal viruses, announced it has received notification of CE Mark 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 and partially funded by a the National Institutes of Health.

The new test kit enables rapid diagnosis of Lassa viral hemorrhagic fever, a highly infectious virus responsible for thousands of deaths each year in West Africa.

"This 15-minute test has the potential to completely change the way Lassa fever is detected and treated," said Douglass Simpson, Congenix 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."

The disease is spread by infected rodents and is estimated to infect 300,000 to 500,000 people each year with at least 5,000 deaths reported annually.

The CE Mark notification was achieved after the successful completion of a multi-year study of the clinical utility of the test to evaluate patients presenting with clinical symptoms of Lassa fever, Corgenix said.

The company said it expects to move the test into full commercialization this year. VHFC Lassa products have not yet been cleared by the FDA for use in the United States.

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