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Corgenix to Expand Ebola Virus Rapid Testing Capabilities in Sierra Leone

An outbreak of the deadly Ebola virus in West Africa has prompted Corgenix Medical Corporation 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(R) 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 testing 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.

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