TGen-created Valley Fever test approved by the FDA

- Valley Fever, sometimes known as Arizona's disease, typically strikes around the end of summer and beginning of fall. Now, the FDA has cleared a new test that can detect if a person has Valley Fever, in less than two hours.

Valley Fever is a microscopic fungus that lives in the soil. If it gets disturbed, it can break off and you can breathe it in. TGen, also known as the Translational Genomics Research Institute, has created a test that can find out of you have Valley Fever, by taking a respiratory specimen.

"This is a molecular test, so it looks for the DNA, looks directly at patient samples, to see if Valley Fever fungus is in the sample, whether or not the patient is affected," said David Engelthaler, a scientist in Flagstaff who helped develop the test.

Engelthaler said TGen has been working on this test for the better part of a decade. They licensed it out to DxNA, who conducted clinical trials to get the test approved by the FDA.    

"This is really exciting," said Engelthaler. "TGen is really focused. Very excited we can take a lot of our understanding and power of DNA testing to be able to impact something like Valley Fever." 

The next step is for the test to appear in hospitals and doctors offices within the next year, in order to help diagnose the thousands of people who get Valley Fever much faster.

The test takes about 1.5 hours for the diagnoses.

"It's pretty rapid, which gives physician time to decide how to best treat the patient before they go home," said Engelthaler. "Otherwise, other tests take days to weeks."

According to the CDC, about 6,000 people had Valley Fever in 2016.

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