DxNA LLC Announces Commencement of GeneSTAT® and Valley Fever Assay Multicenter Clinical Trial
St. George, Utah, August 11, 2015 - DxNA LLC today announced the commencement of a multi-center clinical study of DxNA’s molecular diagnostic test for the detection of Valley Fever (coccidioidomycosis) utilizing its proprietary diagnostic platform, The GeneSTAT® System. The implementation of the Valley Fever assay on the GeneSTAT System once cleared by the FDA will provide for more rapid test results than current test methods and the availability of molecular testing for the disease at clinical laboratories in the regions and healthcare facilities where cases are primarily seen. DxNA intends to submit its 510(k) application to the U.S. Food and Drug Administration for clearance of the assay and the GeneSTAT System in 2015. Valley Fever is a fungal infection caused by Coccidioides organisms that typically enter the body through the lungs. While the majority of people who are infected do not develop significant symptoms, a portion or infected patients develop symptoms that can be highly debilitating such as cough, fever and fatigue. Given that these symptoms are similar to other respiratory disease that are caused by bacteria or virus’, Valley Fever is often misdiagnosed and mistreated. As such an early definitive diagnostic is critical to optimal patient care.
The Valley Fever assay on the GeneSTAT System has been developed based on intellectual property exclusively licensed from The Translational Genetics Research Institute (TGen) in Flagstaff, Arizona and will provide for the rapid detection of the fungus in 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 3 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.
“We are pleased to announce the commencement of this trial of the Valley Fever Assay as the first step of bringing an expanding menu of unique tests on the GeneSTAT for infectious diseases to market,” said David Taus, CEO of DxNA LLC.
About DxNA LLC
DxNA LLC www.dxna.com is a privately held company located in St. George Utah. It is a molecular diagnostics company that develops and distributes portable, fully-integrated systems and tests for infectious disease in the medical, agricultural, food safety, and biosecurity markets. The Company's systems and technologies enable rapid and precise molecular testing to take place on-site by allowing for otherwise complex laboratory procedures to be performed almost anywhere.
DxNA’s patented GeneSTAT® portable Real Time PCR molecular diagnostic testing system will allow individuals with minimal training to conduct accurate real-time diagnostic testing in virtually any location including laboratories, clinics, physician offices, emergency rooms or field settings. Designed with economy in mind, GeneSTAT is inherently less costly than the real time PCR systems typical of clinical laboratories.
About Valley Fever Center for ExcellenceThe University of Arizona Valley Fever Center for Excellence was established in 1996 by the Arizona Board of Regents for the benefit of the entire state. Based at the University of Arizona College of Medicine – Tucson, the center has developed a research base, including all three of the state’s universities and an information program for both the scientific community and the general public. Much of the center’s research is conducted at the University of Arizona BIO5 Institute.