Zalgen Labs Opens Advanced Product Development Center in Colorado

8/22/16

GERMANTOWN, Md. & DENVER--(BUSINESS WIRE)--Zalgen Labs, a biotechnology and diagnostics company focused on high-impact, neglected infectious diseases, announced that it has received via transfer the viral hemorrhagic fever diagnostics business from Corgenix Medical Corporation and opened an advanced product development center in the Fitzsimons Bioscience Park Center on the University of Colorado Anschutz Medical Campus in Aurora, Colo.

Zalgen is a member of the Viral Hemorrhagic Fever Consortium(VHFC), an academic and industry collaboration lead by Tulane University working to develop state-of-the-art diagnostic and immunotherapeutic products for biothreat agents and emerging pathogens.

The Corgenix products transferred to Zalgen include the ReEBOV®Antigen Rapid Test, the first rapid diagnostic test (RDT) and the first immunoassay authorized for emergency use by the FDA for the presumptive detection of Ebola virus, and also the first listed for procurement by the World Health Organization (WHO)under the Emergency Use Assessment and Listing procedure. Also transferred is the ReLASV® Antigen Rapid Test for Lassa fever diagnosis, the first RDT for Lassa virus to be CE Marked, and other products for research use only.

Concurrent with the product transfer from Corgenix, the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) transferred to Zalgen an existing Small Business Innovation Research (SBIR) grant for development of recombinant antigen diagnostics for filoviruses, which has already resulted in development of the ReEBOV® Ebola test, among others.

“We are excited to add these remarkable diagnostic products to Zalgen's business, and we look forward to adding them to our expanding global distribution network,” said Zalgen Co-Founder Luis Branco, Ph.D. “Zalgen has been active in the research and development of these products since our inception, and our new development site in Colorado will serve as the Company’s primary site for diagnostics, while our immunotherapeutics activities will remain centered in Maryland.”

“Bringing robust viral hemorrhagic fever diagnostics to point-of-care testing greatly improves patient management and will be critical for early detection of pathogens that can become a global threat,” noted Zalgen Co-Founder Robert Garry, Ph.D. “The new Colorado facility will focus on advancing field-deployable and laboratory-based tests to improve diagnostic and surveillance capabilities of neglected tropical diseases, including both Ebola and Lassa fever.”

About Zalgen Labs

Zalgen Labs is a biotechnology and diagnostics company specializing in the design and production of superior biological molecules critical for the development and commercialization of immunotherapeutics, novel vaccines, and reliable, rapid, and affordable diagnostic platforms targeting neglected and underrepresented human infectious diseases. The company makes use of its proprietary expression platforms, including its patented mammalian cell-based biomanufacturing system, CHOLCelect, to deliver next generation biologicals to world health and biodefense settings. For more information, visitwww.zalgenlabs.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, Scripps Research Institute, Harvard University/Broad Institute, University of Texas Medical Branch, Autoimmune Technologies LLC, Kenema Government Hospital (Sierra Leone), Redeemers University and the Irrua Specialist Teaching Hospital (Nigeria), Zalgen Labs, LLC, and various other partners in West Africa. More information is available at www.vhfc.org

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