UCLA/VA Study Demonstrates the Rapid Diagnosis of Urinary
Tract Infections With Novel Biosensor Technology
LOS ANGELES, CA - (BusinessWire) - February 2, 2006 - For the
millions of people who suffer from urinary tract infections
each year and the doctors who treat them, a promising new
biosensor technology has been developed that may replace
antiquated testing methods and save precious health care
dollars.
In a recent clinical study conducted by the David Geffen
School of Medicine at UCLA and the Veterans Affairs Greater
Los Angeles Healthcare System, researchers used a biosensor
developed by corporate partner GeneFluidics to identify
correctly the infection-causing gram negative bacteria species
in 98 percent of the tested clinical urinary tract infection
urine samples. These results represent the first ever
species-specific detection of bacteria in human clinical fluid
samples using a microfabricated electrochemical sensor array.
Of equal significance, the new test provided results in 45
minutes, compared to two days with conventional methods.
The research, reported in the February 2006 issue of the
peer-reviewed Journal of Clinical Microbiology, investigated a
new technology to solve an old problem: the diagnosis of
urinary tract infections - the second most common bacterial
infection - in a clinically relevant timeframe.
In current laboratory practice, contaminating pathogens in
urine specimens are grown in culture dishes until they can be
visually identified. The major drawback of this century-old
technique is the two-day time lag between specimen collection
and bacteria identification. As a result, physicians must
decide whether to prescribe antibiotic therapy and, if so,
which type of bacteria to treat - all without knowing the
cause of the infection, if any. In contrast, the new biosensor
technology would allow physicians to prescribe targeted
treatment without the wait.
"Our research also showed that GeneFluidics' biosensor avoided
problems inherent in alternative molecular approaches, such as
PCR, that require the repeated copying of bacterial DNA or RNA
prior to testing. We found that these amplification methods do
not provide reproducible results," said lead author Dr. Joseph
C. Liao, clinical instructor of urology at the David Geffen
School of Medicine at UCLA.
The clinical study was performed at the VA Greater Los Angeles
Healthcare System in the laboratory of Dr. David Haake, VA
staff physician and professor of medicine at UCLA. Researchers
studied samples received by the UCLA Clinical Microbiology
Laboratory.
Individual sensors on GeneFluidics' 16-sensor chips were
coated with UCLA-designed species-specific genetic probes.
Clinical urine samples were directly applied to the chips and
the electrochemical signal subsequently measured by
GeneFluidics' multi-channel reader instrument. The urinary
tract infection pathogens were identified by examining which
signals on the sensor chip were elevated. The entire
experiment from sample collection to result read-out took only
45 minutes.
The potential for rapid bacterial detection was discovered in
the laboratory of Dr. Edward McCabe, chair of pediatrics at
the Mattel Children's Hospital at UCLA and an adviser to
GeneFluidics. McCabe's group demonstrated that probes could
bind to species-specific bacterial sequences within minutes,
rather than hours. These exciting results were translated to
the biosensor protocol, leading to the development of the
biosensor for rapid identification of bacteria in urine from
patients with urinary tract infections.
"Results were impressive for this initial 78-sample clinical
study," said Dr. Bernard Churchill, chief of pediatric urology
at the Clark-Morrison Children's Urological Center at UCLA and
principal investigator. "By coupling UCLA's robust probes with
GeneFluidics' ultra-sensitive biosensor system, we were able
to identify urinary tract infection pathogens in a time frame
that would enable physicians to make dramatically superior
clinical decisions."
Ongoing work at UCLA and the VA Medical Center is focused on
developing even better detection methods to bring the urinary
tract infection biosensor chip from "bench to bedside." At
GeneFluidics, engineers are integrating the biosensors into
microfluidic cartridges and building a new instrument for
faster and completely automated experimentation. The team
anticipates the rapid test could become available in the next
two to three years.
"There is considerable interest in decreasing overall health
care costs by providing smarter medicine," added Dr. Vincent
Gau, chief executive officer of GeneFluidics. "When
laboratory-quality testing can be rapidly performed by anyone,
anywhere, and the results made available in 'real-time,' we
will see tremendous improvement in patient care. This joint
project with UCLA may spearhead that shift."
Urinary tract infection is the most common urological disease
in the United Sates and the most common bacterial infection of
any organ system. Urinary tract infection is a major cause of
patient death and health care expenditure for all age groups,
accounting for more than 7 million office visits and more than
1 million hospital admissions per year. In the hospital,
catheter-associated urinary tract infection accounts for 40
percent of all in-hospital acquired infections - more than 1
million cases each year. The total cost of urinary tract
infections to the United States health care system in 2000 was
approximately 3.5 billion dollars.
The collaboration between UCLA, VA and GeneFluidics began in
2001, thanks to initial funding from Frank W. Clark Jr., and
the Wendy and Ken Ruby Fund for Excellence in Pediatric
Urology Research.
Subsequently, the work has been supported by a $5.6 million
Bioengineering Research Partnership grant from the National
Institute of Biomedical Imaging and Bioengineering.
GeneFluidics' goal is to develop a fast, accurate and simple
testing system for improving worldwide health. By integrating
novel bionano and microfluidic technologies, the company's
revolutionary platform will enable complex tests that are
currently performed by skilled technicians in a laboratory to
be performed by anyone, anywhere.
For more than 50 years, the UCLA Department of Urology has
continued to break new ground and set the standards of care
for patients suffering from urological conditions. In
collaboration with UCLA's eminent research scientists, their
internationally acclaimed physicians have pioneered treatments
for many conditions, including cancers of the prostate,
bladder and kidney, kidney stones, pelvic floor disorders,
genitourinary tract conditions, incontinence and sexual
dysfunction in men and women.
CONTACT:
Vincent Gau
GeneFluidics, Inc.
323-269-0900
Amy Waddell
UCLA Health Sciences Media Relations
310-794-8672
