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TMCNet:  Corgenix and Research Partners to Expand Ebola Virus Testing Capabilities in Sierra Leone

[March 27, 2014]

Corgenix and Research Partners to Expand Ebola Virus Testing Capabilities in Sierra Leone

DENVER --(Business Wire)--

An outbreak of the deadly Ebola virus in West Africa has prompted Corgenix Medical Corporation (OTCBB:CONX) to extend its existing viral hemorrhagic fever (VHF) rapid test 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), 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' recently CE marked ReLASV® Antigen Rapid Test for Lassa virus. The VHFC is a collaboration of academic and industry members headed by Tulane University and partially funded with support from the National Institutes of Health (NIH).

"This outbreak reinforces the importance of developing and testing a rapid Ebola test," said Robert Garry, Ph.D., Professor of Microbiology and Immunology at the Tulane University School of Medicine and Principal Investigator of the Consortium. "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."

The March 2014 Ebola outbreak originated in Guinea, with suspected cases in neighboring Sierra Leone and Liberia. This event has the added 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. "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 rapid, highly accurate, 15-minute test that 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 testin and diagnosis.

"We are expanding our rapid testing platform to Ebola with the intention of extending screening to patients using these advanced diagnostics," said Simpson. "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."

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. 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.

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 that includes Tulane University, Corgenix and its partners 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.

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.

Statements in this press release that are not strictly historical facts are "forward-looking" statements (identified by the words "believe," "estimate," "project," "expect" or similar expressions) within the meaning of the Private Securities Litigation Reform Act of 1995. These statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance of the Company's products and services in the marketplace, competitive factors, changes in the regulatory environment, and other risks detailed in the Company's periodic report filings with the Securities and Exchange Commission. The statements in this press release are made as of today, based upon information currently known to management, and the Company does not undertake any obligation to publicly update or revise any forward-looking statements.


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