FDA Approves Molecular Test for Valley Fever

The US Food and Drug Administration (FDA) announced that it has approved the molecular GeneSTAT.MDx Coccidioidomycosis test, as well as the proprietary GeneSTAT System.

Coccidioidomycosis, colloquially known as Valley Fever, can cause serious or long-term issues in the lungs for an estimated 5% to 10% of patients, according to the Centers for Disease Control and Prevention (CDC). In total, there were more than 11,000 cases in the United States in 2016.

The test, developed by DxNA LLC, will aid in providing physicians a more definitive diagnosis for both strains of Coccidioidomycosis, additionally improving the time to test result compared to the current diagnostic methods. The current testing method can take up to 21 days and requires a culture to be grown. The GeneSTAT.MDx test provides same-day results.

“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,” John Galgiani, MD, the director of the Valley Fever Center for Excellence at the University of Arizona College of Medicine, said in a statement.

The infectious boasts serious consequences, making the test’s speedy time to results important in the diagnostic process. According to DxNA LLC, the test is “performed directly on the patient specimen” which allows for a significantly reduced diagnosis time and improves the time to start with appropriate care.

“Sample handling and processing using the GeneSTAT Coccidioides assay is straightforward and well-controlled,” Anne Wertheimer, PhD, an assistant professor of applied biosciences at the University of Arizona’s College of Medicine, said. The self-contained assay in the cartridge format gave us confidence in the assay’s performance and validity. It was very robust for use by both entry level as well as highly skilled technicians and eliminates exposure of lab personnel to highly infectious culture.”

The test was developed based on intellectual property that is exclusively licensed from the Translational Genomics Research Institute and Northern Arizona University in Flagstaff, Arizona.

A press release was made available.