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- Posted Thursday August 13, 2015
DxNA LLC opens Valley Fever multicenter clinical trial
Rapid, accurate test for coccidioidomycosis developed by TGen's Pathogen Genomics Division to accelerate patient care
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.
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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.
About TGen
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:www.tgen.org.
Press Contact:
Steve Yozwiak
TGen Senior Science Writer
602-343-8704
[email protected]
