Responding to the current outbreak of deadly Ebola virus in West Africa, Corgenix Medical Corporation has announced that it will extend its existing viral hemorrhagic fever (VHF) rapid test kit development to include the Ebola virus. Corgenix has already developed and CE marked a rapid test for the Lassa fever virus, another member of the VHF group of viruses.
In collaboration with its research partners from the Viral Hemorrhagic Fever Consortium (VHFC) , Broomfield, Colorado based Corgenix recently completed a multi-year study conducted at the Kenema Government Hospital (KGH) in Kenema, Sierra Leone. The clinical trial investigated the clinical utility of several VHFC diagnostic products, including Corgenix’s recently CE marked ReLASV Antigen Rapid Test for Lassa virus.
The The Viral Hemorrhagic Fever Consortium is a collaboration of academic research institutes and industry members headed by Tulane University in New Orleans, LA, and partially funded with support from the National Institutes of Health (NIH). Established in 2010 as a result of a five-year $15 million contract awarded to Tulane University by the National Institute of Allergy and Infectious Diseases (NIAID), a NIH agency, the VHFC’s mission is to promote global health and safety by creating new products to diagnose, treat and significantly reduce the incidence and mortality rate of viral hemorrhagic fevers.
The original NIAID contract was awarded for Tulane’s ongoing efforts to treat and prevent Lassa Fever, a disease that threatens hundreds of thousands of lives annually in West Africa and is classified as a potential bioterrorism threat. Lassa fever, Ebola fever, Marburg fever, and others, are severe, often fatal diseases common throughout much of West Africa. Children and pregnant women are the highest risk groups. VHF diseases, in their early stages, are difficult to distinguish from other, less serious diseases. Suspected cases of either Lassa or Ebola fevers can exhibit similar symptoms, including hemorrhage. Lassa hemorrhagic fever is spread through 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. 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)
Ebola hemorrhagic fever can be transmitted to humans through contact with several animal species and is spread among humans through close contact with other infected individuals. Ebola is one of the deadliest viruses on the planet, with mortality rates of between 50 and 90 percent, and it can kill within 10 days to two weeks.
The goal of the VHF Consortium is to undertand mechanisms related to the human immune response to Lassa virus infection and other VHF diseases — specifically, by understanding what parts of the virus are recognized by the immune system so that the mechanisms of antibody-mediated protection or pathogenesis in humans with can be better understood.
Tulane’s previous efforts focused on development of new recombinant proteins for Lassa virus and diagnostic products, which have shown to be extremely effective in clinical settings in Africa. The NIH award enabled research to move to the next level, allowing for focus to be shifted towards better treatment and ultimately prevention of Lassa fever altogether.
The Consortium is a collaboration between Tulane, Scripps Research Institute, Broad Institute, Harvard University, University of California at San Diego, University of Texas Medical Branch, Autoimmune Technologies LLC, Corgenix Medical Corporation, Kenema Government Hospital (Sierra Leone), Irrua Specialist Teaching Hospital (Nigeria) and various other partners in West Africa. Together the VHFC partners work on evaluating antibodies from patients who have been infected by Lassa virus and have subsequently recovered, to see if those antibodies might play a role in the development of a vaccine or treatment for the illness. The Consortium will now expand this program to include other important infectious agents such as Ebola, Marburg and other Arenaviruses that are of great concern to public health and bioterrorism.
Dr. James Robinson, professor of pediatrics at Tulane University School of Medicine, is the principal investigator of the program, and Dr. Robert F. Garry, Ph. D., a Professor of Microbiology and Immunology at the Tulane University School of Medicine provides both scientific (laboratory, clinical and international) resources and contract management. Their facilities include fully equipped immunology and virology laboratories run by Drs. Robinson, Garry, and their colleague Dr. Daniel Bausch, an Associate Professor in the Department of Tropical Medicine and Section of Infectious Diseases, Department of Internal Medicine, at the Tulane University Health Sciences Center. Formerly with the CDC Special Pathogens Branch, Dr. Bausch has extensive experience in sub-Saharan Africa, Latin America, and Asia combating pathogens such as Ebola and Lassa viruses, hantavirus, and SARS coronavirus. He serves as a frequent consultant for the World Health Organization, United Nations, and National Institutes of Health. Dr. Bausch places a strong emphasis on capacity building in all his research projects, which include epidemiology and control of viral hemorrhagic fevers and emerging pathogens; building research capacity in developing countries and he also has a keen interest in the role of the scientist in promoting health and human rights.
“This outbreak reinforces the importance of developing and testing a rapid Ebola test,” says Dr. Garry. “In patients demonstrating fevers, we need the ability to not only screen for Lassa, but also Ebola. The VHFC is expanding on our existing diagnostic testing foundation to advance Ebola testing in the same way we’ve been successful with the development of the rapid test for the Lassa virus.”
Dr. Garry also serves in the Tulane University administration as Assistant Dean for Graduate Studies in Biomedical Sciences, directing a large multidisciplinary training program. Research in the Garry Laboratory focuses on a number of aspects of viral pathogenesis. He was involved in collaborative studies that lead to the determination that entry proteins of enveloped viruses form at least three distinct structural classes.
The March 2014 Ebola outbreak originated in the west African nation of Guinea, with suspected cases in neighboring Sierra Leone and Liberia. This event has the added the consequence of two high mortality VHFs in the same area of West Africa.
“This outbreak clearly demonstrates that Ebola, though rare, is still a major public health problem,” said Douglass Simpson, Corgenix President and CEO, who holds B.S. and M.S. degrees in Biology and Chemistry from Lamar University in Beaumont, Texas. – “When it does occur, it is deadly, and getting test results back quickly is the key to diagnosing and treating patients and saving lives.”
Current Ebola testing requires special biohazard handling, and samples are often sent out of West Africa for processing. This can result in delays of up to several days before diagnosis can be confirmed and treatment started. The Corgenix ReLASV test is a highly accurate, Antigen Rapid Test for Lassa Fever diagnosis. The 15-minute test detects Lassa virus antigen in blood, leading to early acute-stage treatment, which is key to survival. ReLASV is currently being used on-site at KGH in Sierra Leone for Lassa fever testing and diagnosis.
Last May, Corgenix announced that notification of CE Mark was received for ReLASV — the first commercialized diagnostic test developed by Corgenix and other VHFC members. The test kit enables rapid diagnosis of Lassa viral hemorrhagic fever, a highly infectious virus responsible for thousands of deaths each year across West Africa. .
“This 15-minute test has the potential to completely change the way Lassa fever is detected and treated,” says 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.”
“We are expanding our rapid testing platform to Ebola with the intention of extending screening to patients using these advanced diagnostics,” Mr. Simpson continues. “Due to the added risk to the population and health care workers, it will be important that health officials have the ability to screen not only for Lassa, but for Ebola, with a rapid test capable of being run in field hospitals in a format that works throughout West Africa.”
In 2010, Corgenix was awarded an NIH grant to work with Tulane University, The Scripps Research Institute and Autoimmune Technologies for the development of new, rapid diagnostic tests for the Ebola and Marburg viruses. Through this foundational grant and the VHFC partnership plan to continue to develop advanced testing products for Ebola, Marburg and other dangerous hemorrhagic fevers, which are also considered bioterrorism threats. The research includes the development of testing capabilities that would pair Lassa and Ebola rapid detection kits for use in Sierra Leone and other West Africa locations.
VHFC Lassa diagnostic (ReLASV Test Kit) is CE marked for diagnostic use in EU and other international markets. It has not been cleared or approved for diagnostic use in the United States by the FDA. VHFC Ebola products have not yet been cleared or approved for diagnostic use by any worldwide regulatory authority.
Corgenixdevelops and manufactures specialized diagnostic kits for various 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.
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The Viral Hemorrhagic Fever Consortium partners include the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) Tulane University, 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 in Edo State, Nigeria, Autoimmune Technologies, LLC in New Orleans, LA, Professor Michael Oldstone, whose lab is interested in understanding the molecular basis of how viruses infect cells, how the immune response aborts viruses, how viruses wrestle control away from the immune system to establish persistent infections, how persistent infection is initiated and maintained, and the mechanism of how such infections cause disease, the Institute of Microbiology of Université de Lausanne, Switzerland, Zalgen Labs, LLC at the Germantown Innovation Center in the state of Maryland, and various other partners in West Africa. More information is available at:
Corgenix Medical Corporation
The Viral Hemorrhagic Fever Consortium
Corgenix Medical Corporation
The Viral Hemorrhagic Fever Consortium