Corgenix Gains CE Mark for ReLASV® Antigen Rapid Test for Diagnosis of Lassa Fever
Corgenix Gains CE Mark for ReLASV®Antigen Rapid Test for Diagnosis of Lassa Fever
Point-of-care diagnostic test enables rapid detection of deadly Lassa viral hemorrhagic fever and related bioterrorism threat
DENVER--(BUSINESS WIRE)-- Corgenix Medical Corporation (OTC BB: CONX), 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).
About Corgenix Medical Corporation
Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases and bone and joint disorders, including the world's only non-blood-based test for aspirin effect, and is active in the development of technology and products for emerging pathogens such as the viral hemorrhagic fevers. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 50 diagnostic products through a global distribution network and has significant experience in product submissions to the FDA and other worldwide regulatory authorities. Additionally Corgenix contract develops and manufactures products for key medical and life science companies in state-of-the-art facilities in Colorado. The company operates under a Quality Management System that is ISO 13485:2012 certified and compliant with FDA regulations. More information is available at www.corgenix.com.
About the Viral Hemorrhagic Fever Consortium
The Viral Hemorrhagic Fever Consortium was established in 2010 as a result of several multi-year grants and contracts awarded to Tulane University by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to support Tulane's ongoing efforts to treat and prevent Lassa fever. The goal of the Consortium is to understand mechanisms related to the human immune response to Lassa virus infection. Specifically, by understanding what parts of the virus are recognized by the immune system, scientists can better understand mechanisms of antibody-mediated protection or pathogenesis in humans with Lassa fever. Consortium efforts have focused on the development of new recombinant proteins for Lassa virus diagnostic products, which have shown to be extremely effective in clinical settings in Africa. This progress is allowing a transition of efforts towards instituting better treatment of affected individuals and ultimately prevention of Lassa fever altogether. The Consortium is a collaboration between Tulane, The Scripps Research Institute, Broad Institute, Harvard University, University of California at San Diego, University of Texas Medical Branch, Autoimmune Technologies LLC, Corgenix Medical Corporation, Vybion, Inc, the Kenema Government Hospital (Sierra Leone), the Irrua Specialist Teaching Hospital (Nigeria) and various other partners in West Africa. More information is available at www.vhfc.org.
The development and clinical testing of the Lassa products has been funded by NIAID to develop recombinant proteins for Lassa virus. The information contained in this press release does not necessarily reflect the position or the policy of the U.S. Government, and no official endorsement should be inferred.
Corgenix Medical Corp
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Senior VP Operations and Finance and CFO
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KEYWORDS: United States North America Nigeria Colorado Sierra Leone Africa
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