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IMMY, University of Nevada receive FDA clearance for CrAg Lateral Flow Assay

Published on August 25, 2011 at 12:33 AM · No Comments

New test hastens diagnosis of cryptococcal meningitis, top cause of HIV-related deaths in developing countries

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.

"Our goal is to save lives," said Bauman. "With the CrAg Lateral Flow Assay, a health-care provider can give the test, observe the results, and administer the first dose of oral medication, all within a few minutes-resulting in a life that has truly been changed for the better."

Current diagnostic tests for cryptococcosis are effective, but are not suitable for resource-limited settings. The tests require technical expertise, special laboratory equipment, and refrigeration for storage. All of these elements are difficult to come by for a rural clinic in a resource-limited country that lacks reliable electricity and proper infrastructure.

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