Product from UNR labs wins FDA's OK

The Food and Drug Administration has cleared a new diagnostic test developed in Reno 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 Thomas Kozel, professor of microbiology of the University of Nevada School of Medicine, and Sean Bauman, president and chief executive officer of Immuno-Mycologics Inc. of Norman, Okla.

Immuno-Mycologics licensed the intellectual property underlying the test from the university, which will share in the revenues.

The new 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.

Kozel, who has been conducting AIDS research for more than 25 years, said studies have shown that early identification and treatment is essential to beat the disease; a late diagnosis means antifungal therapy will likely fail in resource-limited countries. Most patients in that setting are not diagnosed until they are very sick, and then it's too late.

The antibody used for the Cryptococcus test was developed in the lab at the Reno campus with grants from the National Institutes of Health.

Bauman commercialized the technology to make it available at low cost to patients in developing countries with the agreement established through the UNR Technology Transfer Office.

The IMMY product is available in South Africa, Kenya and Uganda, and this FDA approval makes it available globally.