Doctors who need to test their patients for the potentially fatal Valley Fever disease will no longer have to rely on blood tests that take weeks to process and have questionable accuracy.
The Flagstaff branch of the Translational Genomics Research Institute and Northern Arizona University have developed a new genetic-based test that takes just an hour and, so far in tests and trials, has been accurate every time, said Dave Engelthaler director of programs and operations for TGen North.
The research institute announced last week that it had received a patent for the test and licensed the technology to St. George, Utah-based DxNA LLC. The company is in the final stages of FDA approval, so it hopes to make a test available to doctors and clinics by next year, Engelthaler said.
It’s an especially important advancement in Arizona, which sees thousands of Valley Fever cases each year.
This is one of several diagnostic tests TGen has developed for pathogens like influenza, MRSA, or antibiotic resistant staph, and general fungal infections, Engelthaler said. The tests are generally similar and involve isolating and amplifying segments of DNA that uniquely identify a pathogen, then testing samples for those genetic markers.
For Valley Fever, the test picks out the DNA fingerprints of the microscopic fungus Coccidioides, which causes the infection. The fungus is endemic to hot soils of the desert Southwest and typically enters the body through the lungs. For that reason, the TGen test uses a respiratory sample to run its analysis.
The Valley Fever test currently on the market, on the other hand, is immune-based and scans the blood for antibodies triggered by the fungus. Because people have different immune responses though, the test can often be inaccurate, Engelthaler said.
Engelthaler said he hopes doctors will test for Valley Fever more often if they have access to a more accurate test. TGen and the Centers for Disease Control and Prevention helped conduct a study that showed in areas that experience high levels of Valley Fever, sometimes less than 10 percent of people with pneumonia symptoms, which are similar to symptoms for a Valley Fever infection, are tested for the fungal disease.
Because the symptoms for both diseases are similar, many doctors also will initially prescribe pneumonia-targeted antibiotics to a patient, without waiting for the results of the pneumonia test to come in. It may take five to six times of the patient returning to the doctor without improvement for the physician to test for Valley Fever, Engelthaler said.
Five months is the average time to diagnose the infection from the time that a patient first seeks care, David Taus, CEO of DxNA LLC, said in a press release about the test.
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. So far in 2016, Arizona has seen 3,159 cases of the infection and while most of those occur in the southern part of the state, Coconino County sees a small number of cases each year, according to the public health services district. The county has seen 78 cases since 2014, with the most recent case logged on July 12.
“The Coconino County Public Health Services District continues to monitor coccidioidomycosis, however due to lower risks in Northern Arizona, coccidioidomycosis is not a major area of focus for the Health District,” spokesperson Trish Lees wrote in an email.
Nearly 60 percent of those infected, including dogs and other vertibrates, develop no significant symptoms but many others experience severe symptoms such as cough, fever and fatigue and as many as 500 people die each year from the disease.