BioFactura develops diagnostic kit for viral hemorrhagic fever infections

Published 2 November 2007

BioFactura and its partners conduct clinical tests in West Africa of test kits for viral hemorrhagic fever diagnosis; kits will be useful diagnostic tools in the event of bioterror attacks — but also for viral hemorrhagic fever infections common in Africa

Rockville, Maryland-based BioFactura says that the first test kits for viral hemorrhagic fever diagnosis have completed initial clinical testing in West Africa. The clinical test kits were developed under a $3.8 million grant awarded by the National Institutes of Health (NIH) and were developed by BioFactura in collaboration with Tulane University, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Corgenix Medical Corp., Autoimmune Technologies, and partners in West Africa. Under the NIH grant, Tulane is leading a three-year study designed to develop diagnostic tools for viral hemorrhagic fevers, some of which are caused by arenaviruses that are potential bioterrorism agents due to their high fatality rate and ease of transmission. Luis Branco, chief scientific officer of BioFactura, said, “These significant achievements are the culmination of two years of highly productive collaboration within the Lassa Fever Consortium. The extensive panel of reagents constitutes a unique and highly valuable set of tools for the continuing development of multifaceted approaches to diagnose, prevent, and potentially treat viral hemorrhagic fevers.”

Biosafety Level-4 studies related to this endeavor and subsequent field implementation of the diagnostic platform were performed by Joseph Fair, MPH, a predoctoral fellow at USAMRIID, under the supervision of Mary Guttieri, Ph.D., a USAMRIID Biodefense Research Microbiologist. According to USAMRIID commander Colonel George Korch, initial field testing has been met with great success. “The recombinant protein diagnostic platform will permit the valuable and very necessary means by which to examine the prevalence of this deadly pathogen,” Colonel Korch commented. “In addition to engineering effective and feasible diagnostic kits, this collaborative effort will provide an important gateway for future development of countermeasures to mitigate the threat of Lassa fever.”

The clinical studies are being conducted through the Mano River Union Lassa Fever Network in Sierra Leone in conjunction with the World Health Organization and Tulane. “Clinical reports from Sierra Leone continue to show amazing results” said Robert Garry, Ph.D., Professor of Microbiology and Immunology at Tulane, and Principle Investigator of the NIH grant. “We believe this remarkable collaboration will result in diagnostic and detection products that will truly have a meaningful impact on healthcare in West Africa and fill a critical gap in bioterrorism defense.”