IMMY, University of Nevada School of Medicine Receive FDA Clearance for Crag Lateral Flow Assay
Published: Aug 26, 2011
The Food and Drug Administration has cleared a new diagnostic test that will help save the lives of hundreds of thousands of AIDS patients stricken with cryptococcosis, a fungal meningitis. The test was developed through a collaboration between Tom Kozel, professor of microbiology of the University of Nevada School of Medicine, and Sean Bauman, president and CEO of IMMY (Immuno-Mycologics) of Oklahoma. The new, rapid blood test known as the CrAg Lateral Flow Assay leads to early diagnosis of cryptococcosis, a leading cause of AIDS-related deaths in developing countries, by detecting the cryptoccocal antigen. Using an antibody developed by Kozel, the point-of-care product is a simple dipstick test requiring no equipment.