Corgenix Medical Corporation, 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.
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.