DENVER & GERMANTOWN, Md.--(BUSINESS WIRE)--Corgenix Medical Corporation (OTC BB: CONX), a worldwide developer and marketer of diagnostic test kits, announced today that it has entered into a collaboration agreement with Zalgen Labs, a biotechnology company dedicated to the development of multiple diagnostic testing platforms and immunotherapeutics for high impact neglected infectious diseases.
Both companies will work collaboratively to investigate the feasibility of developing a “next generation” rapid test kit for the early detection of active cytomegalovirus (CMV) infections, and previous exposure to the virus in women of childbearing age. Congenital birth defects and disabilities associated with active CMV infections are one of the most common causes of birth defects in the U.S. and worldwide.
“This exciting collaboration with Zalgen has great potential to impact health care in the U.S. and globally,” said Douglass Simpson, President and CEO of Corgenix. “Our work is focused on development of point-of-care diagnostic products with the ability to help millions, and it represents a huge market potential, with an estimated demand for four million tests per year in the United States alone.”
There are no FDA cleared point-of-care tests for CMV, and testing currently requires the drawing of fluid from the amniotic sac for CMV testing.
“Introduction of a rapid, point-of-care test for early assessment of CMV status in women of childbearing age is long overdue, and will greatly aid in reducing potentially devastating birth defects associated with active CMV infections during pregnancy,” said Luis M. Branco, Ph.D., Co-Founder of Zalgen Labs.
Corgenix’ role in the collaboration includes the design of rapid test prototypes for CMV detection based on its proprietary viral hemorrhagic disease detection technology. If successful, the tests would be further developed to prepare for clinical trials.
Both Corgenix and Zalgen are members of the Viral Hemorrhagic Fever Consortium, working to develop state-of-the-art diagnostic products for biothreat agents and emerging pathogens.
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 Zalgen Labs
Zalgen Labs is a biotechnology company, with headquarters in Germantown MD, 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, visit www.zalgenlabs.com.