Valley Fever Rapid Diagnostic Test Approved by FDA


The US Food and Drug Administration (FDA) has approved a rapid diagnostic test for Valley Fever.

The US Food and Drug Administration (FDA) has approved a rapid test for Valley Fever which was developed based on intellectual property exclusively licensed from the Translational Genomics Research Institute and Northern Arizona University in Flagstaff, Arizona.

Valley Fever, or Coccidioidomycosis, is a fungal disease that can cause fatigue, cough, fever, shortness of breath, headache, night sweats, muscle aches or joint pain, and a rash on upper body or legs in those who are infected. Often times infections are asymptomatic; however, if symptoms do appear, they manifest between 1 and 3 weeks after a person breathes in the fungal spores. According to the Centers for Disease Control and Prevention (CDC), “approximately 5% to 10% of people who get Valley fever will develop serious or long-term problems in their lungs.”

A total of 11,829 cases were reported in 2016 in the 5 US states where the disease endemic, Arizona, California, Nevada, New Mexico, and Utah.

Because of the potentially serious consequences of the infection, rapid diagnostics are key. That hasn’t been the case with the currently available testing, which “is done by growing the fungus in a biosafety level 3 laboratory, a method that can take as many as 21 days to get results and expose laboratory personnel to the highly infective fungus,” according to the popular news outlet, GenomeWeb. The new “GeneSTAT test (Sensitivity 100%, Specificity 99.6%, Reproducibility 100%) is performed directly on the patient specimen, providing a same-day result and significantly reducing the time to a definitive diagnosis and appropriate care,” according to a press release put out by DxNA LLC.

The GeneSTAT.MDx Coccidioides test, which will run on the GeneSTAT System is expected to provide a diagnosis for both of the Coccidioides strains that cause Valley Fever. According to the press release, “The cleared test provides for the availability of molecular testing for the disease at clinical laboratories and healthcare facilities where patients with the disease are primarily seen rather than requiring specimens to be sent to reference laboratories.”

When speaking on the implications of this approval in the press release, John Galgiani, MD, director of the University of Arizona College of Medicine Valley Fever Center for Excellence said, “Valley Fever is such an important disease for those who live in or visit the Grand Canyon state or many other places in the southwest. We certainly can use better tools to help doctors diagnose it.”

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