Corgenix Announces Initial Phase Completion of Multi-Year Pivotal Clinical Trial of Rapid Test for Lassa Fever

Corgenix Medical Corporation, a worldwide developer and marketer of diagnostic test kits for important cardiovascular and liver biomarkers as well as innovative products for emerging pathogens and lethal viruses, today announced completion of a major phase of the collaborative effort to combat important viral diseases.

The multi-year study, conducted primarily at the Kenema Government Hospital in Kenema, Sierra Leone, is investigating the clinical utility of several diagnostic products developed by Corgenix and other members of the Viral Hemorrhagic Fever Consortium (VHFC), a collaboration of academic and industry members headed by Tulane University. In this major study, scientists are using Consortium-developed recombinant antigen-based tests to evaluate patients presenting with clinical symptoms of Lassa hemorrhagic fever. Lassa fever is a dangerous, often fatal disease common to much of West Africa and is considered to be a bio-terror threat throughout the world.

“We are very pleased to successfully complete the initial clinical testing phase of our Lassa product development program,” said Douglass Simpson, Corgenix President and CEO. “The first product, a rapid 15-minute test that detects Lassa virus antigen in blood, demonstrated outstanding clinical performance in our studies. It showed its potential to dramatically change the way this disease is detected and treated, with healthcare workers now able to diagnose Lassa infections in the early acute stage, leading to earlier treatment and potentially saving many lives.”

Corgenix said that the first of the products used in the studies, the ReLASV™ Antigen Rapid Test, will be advanced into full commercialization this year. Corgenix has submitted the study results to secure CE Marking, a regulatory requirement in Europe and many other countries.

Lassa virus is a category-A select agent, requiring biosafety level 4 (BSL-4) laboratories. It poses a high individual risk of aerosol-transmitted laboratory infections that cause severe to fatal disease in humans for which vaccines or other treatments are not available. Lassa virus causes Lassa hemorrhagic fever characterized by bleeding and coagulation abnormalities, with mortality rates reported exceeding 25 percent, with children and pregnant women being the highest risk groups. This new rapid test serves the urgent need for screening of suspected Lassa fever cases in the early stages of infection when patients exhibit milder symptoms that can lead to misdiagnosis.
Robert Garry, Ph.D., Professor of Microbiology and Immunology at the Tulane University School of Medicine and Principal Investigator of the Consortium added, “We have been very pleased with the results of our collaborative effort over the past years. The diagnostic products for Lassa have shown to be remarkably effective in clinical settings in Africa and will have a meaningful impact on the health care in that part of the world, and will also fill a critical gap in bioterrorism defense.”

The Consortium will continue its research activities in Sierra Leone, Nigeria and other West African countries advancing other laboratory tests for Lassa and other tropical viral diseases. The research will also assess the potential impact these new generation diagnostic products have on significantly reducing mortality rates through earlier treatment.

The Consortium Lassa products have not yet been cleared for use in the United States by the U.S. Food and Drug Administration (FDA).