DxNA LLC announces 510(K) submission of GeneSTAT analyzer and GeneSTAT coccidioides assay
St. George, Utah — July 10, 2017 — DxNA LLC, a molecular diagnostics company, today announced the 510(k) submission to the U.S. Food and Drug Administration (FDA) of its molecular diagnostics assay using its proprietary GeneSTAT System and GeneSTAT Coccidiodes molecular test for rapid detection of Coccidiomycosis (Valley Fever).
The Valley Fever assay on the GeneSTAT System, upon clearance by the FDA, provides for a more definitive diagnosis and will significantly improve the time to results over current diagnostic methods. The assay will also provide for the availability of molecular testing for the disease at clinical laboratories and healthcare facilities in the endemic regions where patients with the disease are primarily seen rather than requiring specimens to be sent to reference laboratories.
The Valley Fever assay on the GeneSTAT System has been developed based on intellectual property exclusively licensed from the Translational Genomics Research Institute (TGen) in Flagstaff, Arizona. 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 GeneSTAT test is performed directly on the patient specimen, providing a same-day result and significantly reducing the time to a definitive diagnosis and appropriate care.
DxNA's submission follows the successful completion of a multi-center clinical study. The clinical 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 510(k) regulatory submission of the GeneSTAT system and the Coccidiomycosis (Valley Fever) Assay to the FDA. We now look forward to concluding the regulatory process in order to bring our unique Valley Fever test to market once we receive FDA clearance. This is an important milestone for DxNA and our partners to bring to market a test that provides patients and their health care providers the potential for a much earlier and more definitive Valley Fever diagnosis. This is also a critical milestone for DxNA to transition as a company from development to commercial stage" said David Taus, CEO of DxNA LLC.
"I am very glad that DxNA is working to improve accurate diagnosis of Valley Fever," said Dr. Galgiani, Director of the Valley Fever Center for Excellence. "We very much need more of this to help physicians provide the best care for their patients."
Dr. Engelthaler, Co-Director of TGen's Pathogen Genomics Division, said: "TGen has been working on Valley Fever for more than 10 years, and we are glad to see commercial partners like DxNA are able to translate our research into new medical tools to help doctors better identify the Valley Fever fungus in their patients."
About DxNA LLC
DxNA LLC is a molecular diagnostics company that develops and distributes portable, 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 LLC is a privately held company located in St. George Utah.
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.
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 neurological disorders, cancer, diabetes, and infectious diseases, 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. TGen is allied with City of Hope, a world-renowned independent research and cancer and diabetes treatment center. This precision medicine alliance enables both institutes to complement each other in research and patient care, with City of Hope providing a significant clinical setting to advance scientific discoveries made by TGen. For more information, visit: http://www.tgen.org. Follow TGen on Facebook, LinkedIn and Twitter @TGen.
About Valley Fever
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.
DxNA Vice President Marketing & Sales
TGen Senior Science Writer