Corgenix expanding hemorrhagic fever virus product program

Published 11 July 2008

Recent outbreaks of the Lassa Hemorrhagic Fever in Africa show urgent need for new products that can be processed in any clinical or field lab

Denver, Colorado-based Corgenix Medical Corporation, a developer and marketer of diagnostic test kits, is expanding its collaborative effort for developing test kits for viral hemorrhagic fever (VHF) detection. The viral products are being produced under a grant awarded by the National Institutes of Health (NIH) and were developed by Corgenix in collaboration with Tulane University, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), BioFactura, Autoimmune Technologies, and various partners in West Africa. Joining the collaboration is Vybion, an Ithaca, New York-based biotechnology company. Vybion CEO Lee Henderson, Ph.D., stated, “We are pleased to be able to work with Corgenix, Tulane and the other partners. With our deep experience in protein expression from bacterial and mammalian cells and our extensive technology portfolio, we will be able to provide the commercial scale-up for the recombinant protein efforts.” Douglass Simpson, Corgenix President and CEO, said that “The addition of Vybion to our group is an important step in achieving full commercialization of the products developed under this collaboration. We already have products in the field in Africa, and with Vybion’s capabilities in producing large quantities of the critical reagents, we have the supply chain necessary for full scale production of these critically important detection products.”

Corgenix and the other partners have developed and applied for a patent for new recombinant proteins for Lassa virus. Lassa fever, a serious viral infection spread by contact with infected rodents, is estimated to infect 300,000 to 500,000 people per year across West Africa, with approximately 5,000 deaths. Current tests are expensive, not commercially available, can take days to return results, and usually require the culture of live Lassa virus in a high-containment laboratory to produce reagents. In some areas of Sierra Leone and Liberia, up to 16 percent of people admitted to hospitals have Lassa fever. Lassa fever is also associated with occasional epidemics, during which the case-fatality rate can reach 50 percent. New outbreaks of the Lassa hemorrhagic fever have been reported recently. Daniel Bausch, MD, director of the Mano River Union Lassa Fever Network and Tulane’s Program in West Africa, observed, “We are now seeing a much broader presence of this disease in Africa. Within the past two months alone we have seen an increase in the number of cases in Nigeria, with increased fatalities. It is critical that the assays we have already developed and are using in Africa, as well as others still in our development pipeline, become fully deployed to aid in this vital effort.”

Corgenix said the new tests already developed by the group can be run in just ninety minutes, and unlike other virus tests, do not require specially designed and engineered Biosafety Level 4 (BSL-4) laboratories operated by specially trained personnel. This makes the products ideal for important clinical areas such as Africa, as well as the bioterrorism concern. Under the NIH grant, Tulane has been leading a three-year study designed to develop better tests for VHFs, some of which are potential bioterrorism agents due to their high fatality rate and ease of transmission from person to person. Robert Garry, Ph.D., professor of microbiology and immunology at the Tulane University School of Medicine and Principle Investigator of the program, added, “We have been very pleased with the results of our development effort. The products have shown to be remarkably effective in clinical settings in Africa and will have a meaningful impact on the healthcare in that part of the world, but will also fill a critical gap in bioterrorism defense. Now with the addition of Vybion, Corgenix can successfully scale-up the production to address both needs.” Garry stated that the group intends to expand this program to address other important infectious agents-such as Ebola, Marburg and other hemorrhagic fever viruses-that are of concern to the public health and bioterrorism preparedness communities.