In the U.S. Valley fever is prevalent in the Southwest where temperatures are high and the soils are dry. Valley Fever is a lung infection. A fungus becomes airborne when dust around construction areas and agricultural areas is transported by the wind. When spores are inhaled, Valley Fever can result.

The number of reported Valley Fever cases in Arizona hit a record high in 2006, with 5,535 cases. “In the last decade, the incidence of reported valley fever in Arizona has increased from 58.1 per 100,000 persons in 2005 to 84.4 per 100,000 persons in 2014.”

It is an infection caused by the microscopic fungus Coccidioides, a pathogen that lives in desert soils and typically enters the body through the lungs. An estimated 150,000 Americans are infected annually by Valley Fever, and as many as 500 die each year. Phoenix and Tucson are endemic to Valley Fever. Also is spreading throughout the arid regions of North and South America. “Currently, there is no definitive test for Valley Fever.

Valley Fever most commonly causes a progressive lung infection, but can also spread to other parts of the body, including the skin, bone, brain and the rest of the nervous system.

Nearly 60 percent of those infected by Valley Fever — including other vertebrates, and especially dogs — develop no significant symptoms. However, some patients develop highly debilitating symptoms, such as cough, fever and fatigue. These symptoms are similar to other respiratory diseases caused by bacteria or virus, and often lead to delayed diagnoses and inappropriate treatment. Very severe Valley Fever can require lifelong treatment with antifungal drugs, and even result in death.

People suffer without understanding of what they are going through, it was lacking a diagnosis and now a testing technology developed by the Translational Genomics Research Institute (TGen) and Northern Arizona University (NAU),  are protected by a patent issued by the U.S. Patent and Trademark Office.

To make it  commercially available to hospitals and clinics TGen and NAU have exclusively licensed this technology to DxNA LLC, a company based in St. George, Utah, which plans to make this Valley Fever Test upon completion of FDA clinical trials and a subsequent FDA 510(k) submission for review and clearance later this year.

Now the new rapid, 1-hour, genetic-based test will provide physicians and patients with a precise diagnosis, enabling prompt treatment and preventing this disease from becoming more serious,” said Dr. Paul Keim, Director of TGen’s Pathogen Genomics Division, or TGen North, based in Flagstaff.

DxNA’s primary focus is on bringing the benefits of infectious disease molecular testing to underserved community hospitals and clinics so that critical diagnostic information is more readily and quickly available. Using this information in a timelier manner has been shown to impact clinical decision making, improve patient outcomes and lower treatment costs.

Dr. Keim who also is the Cowden Endowed Chair of Microbiology at NAU, and Director of NAU’s Center for Microbial Genetics and Genomics (MGGen) said, “For the past decade, TGen has worked to develop better tools and technology to address Valley Fever, and we think it is critical to be able to apply our cutting-edge science to problems in our own backyard,”

This new genetic-based test can precisely identify both strains of Valley Fever: Coccidioides posadasii, found in Arizona, New Mexico, Texas and much of Latin America, and Coccidioides immitus, which is found in California, Washington and Baja Mexico.

Most infections occur in central and southern Arizona. Each year on average, there are an estimated 150,000 cases in Arizona, resulting in more than 1,700 hospitalizations at a cost of more than $86 million.

“These high costs are driven to a significant degree by the high level of misdiagnosis, resulting in an average time to diagnosis of 5 months from when a patient first seeks care,” said David Taus, CEO of DxNA LLC. “The Patented test provides definitive results in 60 minutes, dramatically improving the diagnosis of the disease over current methodologies, both in terms of time and accuracy.”

This is what Taus have to say is, The intellectual property used in DxNA’s Valley Fever Test is exclusive to DxNA LLC, and covers both human and veterinary applications.

Keywords: Valley fever, patent, diagnosing technology, TGen and NAU