Corgenix Announces Initial Results in Development of New Tests for Viral Infections and Bioterrorism Threats.

Inexpensive, Rapid Diagnostic Test Kits for Dangerous Hemorrhagic Viruses Can Be Run in Any Clinical or Field Lab

DENVER -- Corgenix Medical Corporation (OTCBB:CONX), a worldwide developer and marketer of diagnostic test kits, announced that the first test kits for viral hemorrhagic fever (VHF) detection have completed initial clinical testing in West Africa. The new kits could soon help diagnose and prevent the spread of dangerous VHFs such as Lassa fever.

Corgenix is part of a collaborative group that has developed and patented 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.

Corgenix' President and Chief Executive Officer Douglass Simpson said the new tests can be run in just 90 minutes and, unlike current tests, don't require specially designed and engineered Biosafety Level 4 (BSL-4) laboratories operated by specially trained personnel.

"These are the first test kits developed in a practical platform that can be used in any clinical laboratory, and you don't have to grow or transport the actual virus in order to run the tests," said Simpson. "We've succeeded in combining the skills of different parties, resulting in development of some remarkable test kits in a surprisingly short period of time. As a group we intend to expand this program to address other important infectious agents with both clinical health issues and threat of bioterrorism such as Ebola, Marburg and other hemorrhagic fever viruses."

The clinical test kits were developed under a $3.8 million 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, Inc., Autoimmune Technologies, LLC and various partners in West Africa.

Under the NIH grant, Tulane is leading a three-year study designed to develop better tests for VHFs, some of which are caused by arenaviruses, a family of viruses that are potential bioterrorism agents due to their high fatality rate and ease of transmission from person-to-person.

The clinical studies are being conducted through the Mano River Union Lassa Fever Network in Sierra Leone. Tulane University, under contract with the World Health Organization, implements the program in the Mano River Union countries (Sierra Leone, Liberia and Guinea) which aims to assist in the development of national and regional prevention and control strategies for Lassa fever and other important regional diseases, including the enhancement of laboratory diagnostic capacity, surveillance and training in laboratory diagnosis, clinical management, and infection and environmental control.

"The newly developed assays continue to show amazing results in Sierra Leone," said Joseph Fair, a Tulane graduate student, who is performing the field testing.

Robert Garry, Ph.D., Professor of Microbiology and Immunology at the Tulane University School of Medicine and Principle Investigator of the NIH grant, added, "We believe this remarkable collaboration will result in diagnostic and detection products that will truly have a meaningful impact on the healthcare in West Africa, but will also fill a critical gap in bioterrorism defense."

Daniel Bausch MD, MPH&TM, Director of the Mano River Union Lassa Fever Network and Tulane's Program in West Africa, observed, "These initial clinical test results have shown that it is possible to develop a detection system that will have a meaningful impact on the practice of medicine and quality of life in sub-Saharan Africa. In some areas of Sierra Leone and Liberia, up to 16 percent of people admitted to hospitals have Lassa fever. Thus the impact of this disease on the populations in this area of the world is serious. Furthermore, Lassa fever is also associated with occasional epidemics, during which the case-fatality rate can reach 50 percent."

The first patent application from the collaboration - Soluble and Membrane-Anchored Forms of Lassa Virus Subunit Proteins - has been submitted to the U.S. Patent and Trademark Office. It describes the production of full-length recombinant Lassa virus proteins, as well as diagnostic and preventative methods using novel forms of the proteins.

BioFactura CEO Darryl Sampey stated, "We expect this patent application is the first of many that will come from the collaboration with Corgenix and the other parties. This application discloses new tools and methods for the design, production, and use of soluble and membrane-anchored forms of the proteins, and additionally describes diagnostic and therapeutic antibodies used in assay development as well as for the prevention and treatment of infection by Lassa virus and other arenaviruses."

About Tulane University

Tulane University (New Orleans LA) was founded in 1834. Tulane is one of the most highly regarded and selective research universities in the United States, and is a member of the prestigious Association of American Universities. Tulane's schools and colleges offer undergraduate, graduate and professional degrees in the liberal arts, science and engineering, architecture, business, law, social work, medicine and public health and tropical medicine.

About USAMRIID

USAMRIID (U.S. Army Medical Research Institute of Infectious Diseases), located at Fort Detrick, Maryland, is the lead medical research laboratory for the U.S. Biological Defense Research Program, and plays a leading role in national defense and in infectious disease research. The Institute's mission is to conduct basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Material Command.

About Autoimmune Technologies, LLC

Autoimmune Technologies (New Orleans LA) is a privately held biomedical company. It has licensed several breakthrough research discoveries from Tulane University School of Medicine and has made exciting discoveries of its own. Autoimmune is working to offer new diagnostic tests and new anti-viral therapeutics to the medical community based on this proprietary research.

About BioFactura, Inc.

BioFactura (Rockville MD) is a biopharmaceutical development company focused on solving unmet medical and national security needs in the infectious disease arena. With a pipeline including therapeutics, vaccines, diagnostics, and bio-manufacturing technologies, BioFactura intends to bring critical products rapidly to market.

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. 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. More information is available at www.corgenix.com.

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