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Santa Maria Sun / News

The following article was posted on December 13th, 2017, in the Santa Maria Sun - Volume 18, Issue 41 [ Submit a Story ]
The following articles were printed from Santa Maria Sun [santamariasun.com] - Volume 18, Issue 41

FDA clears new valley fever diagnosis process

By KASEY BUBNASH

A Utah-based molecular diagnostics company, DxNA, began the process of manufacturing equipment for its new testing process for rapid detection of valley fever after the company announced on Dec. 6 that the U.S. Food and Drug Administration (FDA) cleared the test for marketing.

The test, according to DxNA Vice President of Marketing and Sales Lori Christiansen, would significantly improve the somewhat unreliable diagnosis processes currently used for valley fever, a disease commonly found on California’s Central Coast that can lead to chest pain, tiredness, fever, respiratory issues, and muscle and joint aches—all symptoms that can last more than a month.

Although nearly 60 percent of individuals infected with valley fever never get sick, it can cause serious, sometimes fatal, illnesses if left untreated. Reported cases of the illness are on the rise in the state and the county.

From Jan. 1 to Oct. 31 in 2017, Californians reported 5,121 total cases of valley fever, according to data collected by the California Department of Public Health (CDPH), a 25 percent increase from the 3,827 cases reported in the same time period in 2016. The trend holds true for Santa Barbara County as well, which saw a 60 percent increase in valley fever cases from 2015 to 2016, according to data collected by the Santa Barbary County Health Department.

Valley fever, which is caused by breathing in the spores of a fungus present in much of California’s soil, is notoriously difficult to diagnose, and the current processes can take weeks to produce results and frequently leads to false negatives.

“It is often misdiagnosed,” Christiansen said. “The symptoms of valley fever someone might have can look like the flu or pneumonia. There are also tests that sometimes don’t detect valley fever. If it’s missed or misdiagnosed, people are sometimes prescribed antibiotics that are inappropriate to treat valley fever.”

There are really only two ways currently to test for valley fever and neither are ideal, according to David Engelthaler, director of TGen North, an Arizona-based genomics research institute that developed the new valley fever test and licensed the technology to DxNA for marketing.

The most commonly used process is a blood test, Engelthaler said, which often takes weeks to order, several attempts, and frequently produces false results. Another way is to culture a sample from the patient’s respiratory system, which is time consuming and exposes laboratory personnel to the dangerous fungus.

TGen and DxNA’s newly cleared test can be performed directly on the patient’s specimen, providing a same-day result, improving accuracy, and significantly reducing the time between testing, diagnosis, and treatment. It tests DNA directly, Engelthaler said, and can pinpoint the valley fever fungal genome.

Test equipment is currently being manufactured, and Christiansen, of DxNA, said the test should be released to hospitals and labs in California and Arizona sometime in January.




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