A rapid-diagnostic test for cryptococcal meningitis developed in collaboration between Thomas Kozel, foundation professor of microbiology with the University of Nevada, Reno School of Medicine, and IMMY, Inc., a biotechnology company based in Oklahoma, has been included in the first-ever World Health Organization Model List of Essential In Vitro Diagnostics.

In vitro diagnostics are devices that use samples from within the body, such as blood or tissue, to detect, diagnose or monitor health conditions. As the WHO report notes, health providers must have access to IVDs to diagnose patients effectively and promptly, or provide appropriate treatments. The newly published list of essential IVDs complements the WHO Model List of Essential Medicines, and together these significant lists help guide the development of effective, safe and cost-effective healthcare systems worldwide.

"The work by Dr. Kozel is a beautiful demonstration of how a long-term commitment to high-quality basic biomedical research can find its way to having actual positive impact on the health and well-being of literally hundreds of thousands of patients around the globe," said Thomas Schwenk, dean of UNR Med.

Disrupting disease through rapid diagnosis

Kozel was driving when a recent NPR story about work by the Centers for Disease Control to diagnose infectious diseases caught his attention. A rapid-diagnostic test to diagnose anthrax in hippos and Cape buffalo in Namibia, Africa was referenced and, because this relates to his research interest, Kozel sought to learn more. It turns out the test is, indeed, another example of his own work that has been licensed by the University to the private sector for commercialization.

The Kozel laboratory focuses on development of rapid, inexpensive, point-of-care diagnostics for infectious disease. Today, this research is conducted in collaboration with Kozel's microbiology collaborator Professor David Aucoin in the University's Center for Molecular Medicine.

Anthrax, ebola, zika, and several types of fungal infection are among the many serious diseases being disrupted by their research and discoveries. In some instances, diagnoses that once took days or weeks can now be accomplished in minutes.

Faster diagnosis means earlier administration of appropriate antimicrobial therapy, and reducing the cost of these diagnostics means they can be made more widely available, especially in third-world nations. As a result, this research is improving healthcare, saving lives and potentially curbing antibiotic resistance.

In the case of cryptococcal meningitis, this life-threatening fungal infection affects hundreds of thousands of people each year, primarily AIDS patients in sub-Saharan Africa. The cryptococcal rapid-diagnostic test is the result of decades of research by Kozel that was supported by the National Institutes of Health. Technology for the test was licensed by the University to IMMY in 2010.

"Studies have shown early identification and treatment are 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," Kozel said.

Commercialization benefits public health, society

In 2013, with the support of a Small (business) and Technology Transfer Research grant (STTR) from the National Institutes of Health's Small Business Technology Transfer program, Kozel and AuCoin launched DxDiscovery, Inc. Based in the Applied Research Facility on the University of Nevada, Reno campus, DxDiscovery licenses technologies to partner companies that manufacture and distribute the diagnostic tests.

DxDiscovery's work has been funded by highly competitive grants from the NIH and the Department of Defense. The test platform being advanced by DxDiscovery is an immunoassay in which antibodies are used for biomarker detection. Familiar examples of this platform, noted on the company's website, are the PSA test for prostate cancer, the "quick Strep" test for strep throat or the home pregnancy test.

Kozel and AuCoin's commercialized discoveries, licensed technologies and the development of DxDiscovery exemplify the role of commercialization in the research enterprise. In fact, Kozel's work with IMMY on the rapid-diagnostic test for cryptococcal meningitis was featured in the "Better World Report," published by the Association of University Technology Managers, as a university-research-driven technology that directly impacts the health and well-being of people around the globe.

As Ellen Purpus, the University's assistant vice president for Enterprise & Innovation, said, "Bringing discoveries into the marketplace is the way that University discoveries benefit society."

Enterprise & Innovation - part of the University's division of Research & Innovation - works with faculty members looking to develop spinout companies, commercialize or protect new technologies or discoveries, or seek entrepreneurial partners in the private sector.