A test developed by Flagstaff researchers to detect Valley Fever has been given approval by the U.S. Food and Drug Administration. The test is faster and more accurate than current means of detecting the fungus that causes Valley Fever, which rely on either culturing the fungus or testing a patient's blood for an antibody response.
Instead, the genetic-based test developed by Flagstaff's Translational Genomics Research Institute picks out the DNA fingerprints of the microscopic fungus Coccidioides, which causes the Valley Fever infection.
In clinical trials, the test was close to 100 percent in terms of sensitivity and specificity, said Dave Engelthaler, director of TGen North in Flagstaff. Another advantage is that it can be completed in a hospital lab in under two hours, Engelthaler said.
The research institute has developed similar diagnostic tests for pathogens like influenza, MRSA, or antibiotic resistant staph, and general fungal infections, but this was the first one to get FDA clearance, he said.
TGen patented and licensed the testing technology to St. George, Utah-based DxNA LLC, which developed an instrument to perform the test and is putting it on the market.
"Valley Fever is obviously a critical infection in the desert Southwest and therefore this became a really important thing for us to focus on at TGen," Engelthaler said.