DxNA LLC, a molecular diagnostics company, today announced the regulatory clearance by the U.S. Food and Drug Administration (FDA) to market its molecular test for rapid detection of Coccidioidomycosis (Valley Fever) using DxNA’s GeneSTAT.MDx Coccidioides test and proprietary GeneSTAT System.
The GeneSTAT.MDx Coccidioides test on the GeneSTAT System is intended to provide a definitive diagnosis for both Coccidioides strains that cause Coccidioidomycosis (Valley Fever). The DxNA test significantly improves the time to results over current diagnostic methods. The cleared test provides for the availability of molecular testing for the disease at clinical laboratories and healthcare facilities where patients with the disease are primarily seen rather than requiring specimens to be sent to reference laboratories.
The high performance Valley Fever test on the GeneSTAT System was developed based on intellectual property exclusively licensed from the Translational Genomics Research Institute (TGen) and Northern Arizona University (NAU) in Flagstaff, Arizona.
Currently, definitive testing is done by culture to grow the fungus in a Biosafety Level 3 laboratory, which is time consuming, up to 21 days, and exposes laboratory personnel to the highly infective fungus. The highly sensitive and reproducible GeneSTAT test (Sensitivity 100%, Specificity 99.6%, Reproducibility 100%) is performed directly on the patient specimen, providing a same-day result and significantly reducing the time to a definitive diagnosis and appropriate care.
“We are very pleased to announce the FDA clearance of our novel GeneSTAT.MDx Coccidioides test on our GeneSTAT system,” said David Taus, CEO of DxNA LLC. “We appreciate the contributions from our development partners, clinical sites, and the FDA review team to move this important diagnostic test forward. We now look forward to bringing our unique Valley Fever test to the market in order to provide patients and their health care providers the potential for a much earlier and more definitive Valley Fever diagnosis.
“This significant achievement for DxNA also facilitates development of other high value molecular diagnostic tests on our FDA-cleared and CE-marked GeneSTAT platform,” Taus said.
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.
“Valley Fever is such an important disease for those who live in or visit the Grand Canyon state or many other places in the southwest. We certainly can use better tools to help doctors diagnose it,” said Dr. Galgiani.
Dr. Paul Keim, Regents’ Professor in Biology and Cowden Endowed Chair in Microbiology, and Executive Director, The Pathogen and Microbiome Institute at NAU; and Professor, TGen Pathogen and Microbiome Division, said: “This is a milestone in our efforts to battle this devastating disease and to improve the health of our citizens. It has been a long journey that started with an idea of how to design a better diagnostics assay and is now ready for physicians to use.”
Dr. David Engelthaler, Co-Director and Associate Professor, TGen Pathogen and Microbiome 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.”
DxNA’s clearance follows the successful completion of a multi-center clinical study that focused on comparing the GeneSTAT Valley Fever assay to the current gold standard for diagnosing Valley Fever. The clinical study was carried out at three centers in Arizona and New Mexico, and included California samples: