GeneSTAT, LLC receives a de novo regulatory clearance by the FDA for the GeneSTAT.MDx™ Coccidioides Test on the GeneSTAT® Analyzer – the only FDA cleared molecular test for Valley Fever
With technology developed by TGen, the test allows for rapid definitive diagnosis of Valley Fever
St. George, Utah — Dec. 6, 2017 — GeneSTAT, 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 GeneSTAT’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, causing Coccidioidomycosis (Valley Fever). The GeneSTAT 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 at least 97.8%) 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 GeneSTAT 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 GeneSTAT 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 GeneSTAT 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 GeneSTAT are able to translate our research into new medical tools to help doctors better identify the Valley Fever fungus in their patients.”
GeneSTAT’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:
- Banner Healthcare and Laboratory Sciences of Arizona; University of Arizona, under the direction of Dr. Michael Saubolle, System Medical Director, Infectious Diseases Division, Laboratory Sciences of Arizona/Sonora Quest Laboratories, Banner Health, Banner-University Medical Center Phoenix;
- TriCore Reference Laboratories in New Mexico under direction of Dr. Stephen Young, Professor Emeritus of Pathology, University of New Mexico, and Director of Research & Clinical Trials, TriCore Reference Laboratories;
- The Infectious Disease Research Core (IDRC) at the Bio5 Institute under the direction of Dr. Anne Wertheimer, Assistant Professor, Associate Director of the IDRC, and Director of Diagnostic Laboratory Sciences within the Applied Biosciences Graduate Interdisciplinary Program University of Arizona.
Clinical Site Comments:
Dr. Michael Saubolle: “FDA clearance of the GeneSTAT® Coccidioides Assay which uses a 106-bp target sequence repeated multiple times, provides greater opportunity for clinical laboratories to implement broadly a test that is both sensitive and specific and can reduce time to diagnosis of coccidioidomycosis. Availability of this test allows more efficacious diagnosis of coccidioidomycosis in patients with negative early serologies or those with compromised immune responses.”
Dr. Stephen Young: “The FDA clearance of this test will significantly reduce the time required for laboratory diagnosis of Coccidioides and should result in significantly better outcomes for patients with this infectious disease.”
Dr Anne Wertheimer: “Sample handling and processing using the GeneSTAT Coccidioides assay is straightforward and well-controlled. The self-contained assay in the cartridge format gave us confidence in the assay’s performance and validity. It was very robust for use by both entry level as well as highly skilled technicians and eliminates exposure of lab personnel to highly infectious culture.”
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About GeneSTAT LLC
GeneSTAT LLC www.genestatdiagnostics.com 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. GeneSTAT LLC is a privately held company located in St. George, Utah.
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 affiliated with City of Hope, a world-renowned independent research and cancer and diabetes treatment center: www.cityofhope.org. This precision medicine affiliation 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: www.tgen.org. Follow TGen on Facebook, LinkedIn and Twitter @TGen
About Northern Arizona University
Northern Arizona University has a student population of more than 25,000 with its main campus at the foot of the San Francisco Peaks in Flagstaff, Arizona. NAU provides an outstanding undergraduate residential education strengthened by research, graduate and professional programs, and sophisticated methods of distance delivery and innovative new campuses and programs throughout the state. NAU’s mission and goals are based on core values including placing learner needs at the center of planning, policies and programs; providing all qualified students with access to higher education; achieving multicultural understanding as a priority of educational and civic life; operating with fairness, honesty, and the highest ethical standards; and supporting a civil, engaging and respectful campus climate.
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.
About University of Arizona Bio5 Institute
The BIO5 Institute at the University of Arizona mobilizes the collaboration of top researchers in agriculture, bioengineering, biomedicine, pharmacy, basic science, and biotechnology to find creative solutions to humanity’s most pressing health and environmental challenges. BIO5 encourages an entrepreneurial culture, with scientists working across disciplines to accelerate commercial applications of research breakthroughs. Since 2001, this interdisciplinary approach has been an international model of how to conduct collaborative research, and has resulted in improved food crops, innovative diagnostics, devices, technologies, and promising new therapies. Learn more at http://BIO5.org
About Sonora Quest Laboratories
Sonora Quest Laboratories, a joint venture between Banner Health and Quest Diagnostics (NYSE: DGX), is part of the nation’s largest integrated laboratory system with approximately 3,100 employees serving more than 23,000 patients every day throughout Arizona. Sonora Quest Laboratories is the market share leader in clinical laboratory testing in Arizona, performing more than 60 million diagnostic tests per year. Sonora Quest Laboratories offers a local comprehensive test menu, which encompasses routine, molecular, prescription drug monitoring, genetics/genomics, and pathology testing services. Ninety-eight percent of all testing is performed at our primary testing facilities located in Tempe, Tucson, Flagstaff, Prescott and Yuma. Sonora Quest Laboratories is accredited by the College of American Pathologists (CAP), which is the gold standard in laboratory accreditation, helping laboratories to maintain accuracy of test results and ensure accurate patient diagnosis. This accreditation ensures the highest standard of care for all laboratory patients as CAP inspectors examine laboratory staff qualifications, equipment, facilities, safety program and records, and overall management. For more information, visit www.SonoraQuest.com.
About TriCore Reference Laboratories
TriCore Reference Laboratories is an independent, not-for-profit clinical reference laboratory founded and headquartered in Albuquerque, NM, co-sponsored by Presbyterian Healthcare Services and University of New Mexico Health Sciences Center. TriCore provides over 1,700 full-service, state-of-the-art laboratory tests to healthcare professionals and their patients. TriCore also provides analytics and research services, supporting healthcare and scientific organizations worldwide. For more information, visit tricore.org.
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 of infected patients develop symptoms that can be highly debilitating including cough, chest pain, fever, night sweats 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 and contributes to better antibiotic stewardship.
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