First-to-market, point-of-care rapid diagnostic test based on recombinant antigen technology for the detection of Lassa viral hemorrhagic fever filed for CE Marking.
DENVER — April 22, 2013 — Corgenix Medical Corporation (OTC BB: CONX), a worldwide developer and marketer of diagnostic test kits for important cardiovascular and liver biomarkers as well as innovative products for emerging pathogens and lethal viruses, today announced completion of a major phase of the collaborative effort to combat important viral diseases.
The multi-year study, conducted primarily at the Kenema Government Hospital in Kenema, Sierra Leone, is investigating the clinical utility of several diagnostic products developed by Corgenix and other members of the Viral Hemorrhagic Fever Consortium (VHFC), a collaboration of academic and industry members headed by Tulane University. In this major study, scientists are using Consortium-developed recombinant antigen-based tests to evaluate patients presenting with clinical symptoms of Lassa hemorrhagic fever. Lassa fever is a dangerous, often fatal disease common to much of West Africa and is considered to be a bio-terror threat throughout the world.
“We are very pleased to successfully complete the initial clinical testing phase of our Lassa product development program,” said Douglass Simpson, Corgenix President and CEO. “The first product, a rapid 15-minute test that detects Lassa virus antigen in blood, demonstrated outstanding clinical performance in our studies. It showed its potential to dramatically change the way this disease is detected and treated, with healthcare workers now able to diagnose Lassa infections in the early acute stage, leading to earlier treatment and potentially saving many lives.”
Corgenix said that the first of the products used in the studies, the ReLASVTM Antigen Rapid Test, will be advanced into full commercialization this year. Corgenix has submitted the study results to secure CE Marking, a regulatory requirement in Europe and many other countries.
Lassa virus is a category-A select agent, requiring biosafety level 4 (BSL-4) laboratories. It poses a high individual risk of aerosol-transmitted laboratory infections that cause severe to fatal disease in humans for which vaccines or other treatments are not available. Lassa virus causes Lassa hemorrhagic fever characterized by bleeding and coagulation abnormalities, with mortality rates reported exceeding 25 percent, with children and pregnant women being the highest risk groups. This new rapid test serves the urgent need for screening of suspected Lassa fever cases in the early stages of infection when patients exhibit milder symptoms that can lead to misdiagnosis.
Robert Garry, Ph.D., Professor of Microbiology and Immunology at the Tulane University School of Medicine and Principal Investigator of the Consortium added, “We have been very pleased with the results of our collaborative effort over the past years. The diagnostic products for Lassa have shown to be remarkably effective in clinical settings in Africa and will have a meaningful impact on the health care in that part of the world, and will also fill a critical gap in bioterrorism defense.”
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.
The Consortium 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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