ST. GEORGE, Utah -- Aug. 13, 2015 -- DxNA LLC today announced the start of 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.
"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 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 UA 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 UA BIO5 Institute.
Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life changing results. TGen is focused on helping patients with cancer, neurological disorders and diabetes, through cutting edge translational research (the process of rapidly moving research towards patient benefit). TGen physicians and scientists work to unravel the genetic components of both common and rare complex diseases in adults and children. Working with collaborators in the scientific and medical communities literally worldwide, TGen makes a substantial contribution to help our patients through efficiency and effectiveness of the translational process. For more information, visit: http://www.
TGen Senior Science Writer