Rapid diagnostic test shown to significantly reduce time-to-diagnosis of Lassa fever patients
DENVER — April 1, 2014 — A Corgenix Medical (OTC BB: CONX.OB) rapid diagnostic test (RDT) for the dangerous Lassa fever virus has demonstrated the ability to quickly detect the virus, responsible for the deaths of thousands and infection of hundreds of thousands in West Africa each year. That’s according to the results of the five-year trial Lassa Fever in Post-Conflict Sierra Leone published in the PLOS Neglected Tropical Diseases Journal.
The trial, conducted primarily at the Kenema Government Hospital in Kenema, Sierra Leone, investigated 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.
“This major trial validates the ability of rapid Lassa fever testing to quickly identify cases for immediate treatment,” said Douglass Simpson, Corgenix President and CEO. “The trial also established new standards for rapid field and laboratory identification of Lassa fever and other viral hemorrhagic fevers, which include the Ebola virus. This type of investigation is critical in resource limited laboratory and clinical settings.”
Researchers working in Sierra Leone with Recombinant Lassa Virus (ReLASV) Diagnostic products were able to diagnose and treat patients earlier, which may reduce the fatality rate for Lassa fever cases. The ReLASV® Antigen Rapid Test for Lassa Fever is the first commercialized diagnostic test developed by Corgenix and other VHFC members, including Tulane University.
“Getting to the patients early is critical,” said Matt Boisen, trial co-author and Corgenix Medical Project Director – Infectious Diseases. “The data indicates that if the patient is diagnosed early enough, the potential for successful treatment is improved, and point-of-care testing with RDTs is the ideal method for rapid diagnosis.”
Lassa fever is characterized by bleeding and coagulation abnormalities, with mortality rates as high as 70 percent, with children and pregnant women being the highest risk groups. The Lassa virus is considered a Category A (highest risk) pathogen and potential bioterrorism agent by the National Institute of Allergy and Infectious Diseases (NIAID).
Conventional Lassa virus testing is costly, time-consuming and requires specialized handling in high-level biohazard laboratories. This can result in delays of up to several days before diagnosis can be confirmed and treatment started. ReLASV Antigen Rapid Test is a highly accurate, 15-minute test that detects Lassa virus antigen in serum, plasma or blood, leading to early acute-stage treatment. Patients with a definitive Lassa fever virus diagnosis are treated with the anti-viral drug ribavirin.
Robert Garry, Ph.D., Professor of Microbiology and Immunology at the Tulane University School of Medicine and Principal Investigator of the VHFC, said the trial conducted at the Kenema Government Hospital demonstrates how important it is for the test to match the environment.
“In a difficult resource environment such as Sierra Leone, where the testing mechanisms are very different than in the U.S. or other developed countries, properly configured tests can be highly successful,” said Garry. “A testing program in coordination with a health care system aligned with local authorities, the federal government, and community outreach can provide an organized system that addresses these life-threatening diseases.”
The VHFC is continuing its Sierra Leone research to address Lassa fever, Ebola fever and other severe, high-mortality tropical diseases in West Africa.
The Corgenix ReLASV Antigen Test Kit is CE marked for diagnostic use in the EU and other international markets. It has not been cleared or approved for diagnostic use in the United States by the FDA. Corgenix Ebola products have not yet been cleared or approved for diagnostic use by any worldwide regulatory authority.
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.
About Corgenix Medical Corporation
Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases (including the world’s only non-blood-based test for aspirin effect), bone and joint disorders and a line of unique detection products for viral hemorrhagic disease. 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 .
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