DxNA LLC has started a multi-center clinical study of DxNA’s molecular diagnostic test for the detection of Valley Fever (coccidioidomycosis), using its proprietary diagnostic platform, The GeneSTAT® System.
DxNA intends in 2015 to submit its 510(k) application to the U.S. Food and Drug Administration for clearance of the test and the GeneSTAT System.
Valley Fever is a fungal infection caused by Coccidioides organisms that typically enter the body through the lungs. While the most people who are infected do not develop significant symptoms, a portion of infected patients develop symptoms that can be highly debilitating, such as cough, fever and fatigue. Creating an early, definitive diagnostic is critical to patient health, since these symptoms are similar to other respiratory diseases caused by bacteria or virus. As a result, Valley Fever is often misdiagnosed and mistreated.
The Valley Fever assay on the GeneSTAT System has been developed based on intellectual property exclusively licensed from the Phoenix-based non-profit Translational Genetics Research Institute (TGen), and will provide for the rapid detection of the fungus in patients.
“Valley Fever is Arizona’s disease and therefore has always been a critical target for TGen,” said Dr. Paul Keim, Director of TGen’s Pathogen Genomics Division in Flagstaff, Ariz. — TGen North. “This is an exciting step towards the realization of our Valley Fever diagnostic test being able to help clinicians better diagnose and respond to patients.”
Currently definitive testing is done by culture to grow the fungus in a laboratory, which is time consuming, up to 21 days, and potentially exposes laboratory personnel to the highly infective fungus. The highly sensitive DxNA test is performed directly on the patient specimen, reducing the time to a definitive diagnosis and appropriate care.
The study will be carried out at three sites to encompass samples from the endemic regions for Valley Fever: central and southern Arizona, and the San Joaquin Valley in California. In addition to the these sites, The Valley Fever Center for Excellence, under the direction of Dr. John Galgiani, has been instrumental in working with DxNA in the process of developing the assay and in setting up the clinical trial.
