University of Texas Health Science Center Using NanoLogix Technology in 300 Patient Clinical Trial
October 19 2010 - 9:45AM
Business Wire
NanoLogix (PINK SHEETS: NNLX), an innovator in the accelerated
detection and identification of microorganisms, announced today
that the University of Texas Health Science Center in Houston is
enrolling 300 patients in an ongoing clinical trial to study the
speed and accuracy of NanoLogix technology. The trial is designed
to compare NanoLogix technology to current methods in use for
detection and identification of Group B Streptococcus (GBS) in
pregnant women. Initial results obtained last spring at
UTHSC-Houston show the technology identifies GBS in two to six
hours. This is 8 to 24 times faster than the conventional methods
of PCR (DNA sequencing) and traditional petri culturing, either of
which can take 48 hours or more.
Statement from University of Texas Health Science Center in
Houston:
"The University of Texas Health Science Center in Houston
obstetrical service, as do most obstetrical services, has been
following the CDC guidelines for the prevention of neonatal GBS
infection,” said Jonathan Faro, M.D., Ph.D., Chief Resident In
Obstetrics & Gynecology and the director of the clinical trial
at the University of Texas Health Science Center. “Therefore, all
women receiving prenatal care are screened for vaginal colonization
of GBS between 35 and 37 weeks. GBS not only causes significant
infection which can result in death of the newborn, but can also
cause significant infection in the mother. Therefore, universal
screening and the administration of antibiotics during labor have
become the standard care in the United States and many other
countries."
"I am currently Chief Resident in Obstetrics & Gynecology,
and as the practicing obstetrician I have observed that penicillin
is administered to countless number of women whose GBS status is
not immediately known. Traditional GBS determination requires at
least 48 hours, even if PCR is used. When using PCR the detection
of GBS is not performed from a direct patient specimen but the
organism (GBS) must be isolated in pure culture. Traditional
detection of GBS takes time but because of this, antibiotic is
being administered to women who are not colonized by GBS. The
administration of antibiotic unnecessarily adds to the potential of
the bacteria developing antibiotic resistance."
"Thus, the current methodology presents two problems; (1) delay
in determining if the patient is colonized with GBS and (2)
administration of antibiotic unnecessarily. The Nanologix method of
detecting GBS offers a definite advantage over the current methods
of detecting GBS. The Nanologix technology allows the
identification of GBS in as little as two to six hours, a fraction
of time compared to previous methods. This has the potential to
change the way physicians approach GBS colonization in labor.
Initial studies are now underway to compare the Nanologix method
with the traditional culture technique. We at the University of
Texas Health Science Center in Houston are excited to be a part of
these early studies. A clinical trial is underway in which 300
patients will be enrolled, and the traditional method of culturing
and identifying GBS will be compared with the Nanologix method. We
will also begin work with Nanologix in the near future to study
growth and identification of MRSA, as rapid detection of this
microbe would be of great benefit."
"When it comes to bacterial cultures, physicians and patients
have grown accustomed to waiting days for results. We are forced to
treat empirically even in the face of active infection. The new
method offered by Nanologix has the potential of cutting the wait
time down drastically. It is clear that microbes aren’t waiting for
us–why should we wait for them?"
End of statement
NanoLogix CEO Bret Barnhizer stated that "We at the company are
excited that NanoLogix has been invited to work with the University
of Texas Health Science Center on this clinical trial. Our
association has progressed from initial lab testing of our
technology beginning in 2009 to the present project. We anticipate
much additional work over time focused on GBS and other bacteria,
including MRSA (methicillin-resistant staph aureus), and would like
to thank Dr. Faro and the other physicians and technicians at
UTHSC-Houston who are involved in this trial".
Nanologix has set the date for their general shareholder meeting
for 22 April 2011.
About NanoLogix, Inc.
NanoLogix is a biotechnology company focused primarily on rapid
diagnostics. Its products offer accelerated detection and
identification of microorganisms. In addition to medical and
homeland security applications, NanoLogix technology is applicable
in pharmaceutical, industrial, veterinary and environmental
testing.
Patents granted to NanoLogix can be used in the areas of applied
microbiology, soil microbiology and bioremediation, microbial
physiology, molecular biology, pharmacology, pharmaco-kinetics, and
antibiotic sensitivity.
For more information visit www.nanologix.com.
This press release contains statements, which may constitute
"forward- looking statements" within the meaning of the Securities
Act of 1933 and the Securities Exchange Act of 1934, as amended by
the Private Securities Litigation Reform Act of 1995. Those
statements include statements regarding the intent, belief or
current expectations of NanoLogix, Inc., and members of its
management as well as the assumptions on which such statements are
based. Prospective investors are cautioned that any such
forward-looking statements are not guarantees of future performance
and involve risks and uncertainties, and that actual results may
differ materially from those contemplated by such forward-looking
statements. The Company undertakes no obligation to update or
revise forward-looking statements to reflect changed assumptions,
the occurrence of unanticipated events or changes to future
operating results.
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