DxNA LLC Announces the Successful Completion of the GeneSTAT® and Pathogene® Valley Fever Assay Multicenter Clinical Trial
St. George, Utah, August 13, 2016: DxNA LLC today announced the successful completion 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 endemic regions and healthcare facilities where cases are primarily seen. DxNA will now move forward on completing the 510(k) submission to the U.S. Food and Drug Administration for clearance of the assay and the GeneSTAT System with an expected submission date in the 4th QTR of 2016.
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 diseases that are caused by bacteria or viruses, Valley Fever is often misdiagnosed and mistreated as pneumonia or cancer. 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 providing a same day result, therefore significantly reducing the time to a definitive diagnosis and appropriate care..
The study was carried out at three centers in Arizona, New Mexico and California and focused on comparing the GeneSTAT Valley Fever assay to the current gold standard for diagnosing Valley Fever. In addition to the three trial centers, Banner Healthcare, Laboratory Sciences of Arizona, University of Arizona and Tricore Laboratories in New Mexico, The Valley Fever Center for Excellence, under the direction of Dr. John Galgiani, and TGen under the direction of Dr. Paul Keim and Dr. David Engelthaler have been instrumental in working with DxNA in the process of developing the assay, providing clinical perspective and assisting with the clinical trial..
“We are pleased to announce the successful completion of this trial of the Valley Fever Assay and are now looking forward to completing the regulatory process and bringing this and other infectious disease assays 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 Excellence.
The UA 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.