UCLA/VA Study Demonstrates the Rapid Diagnosis of Urinary Tract Infections with GeneFluidics' Novel Biosensor Technology.

LOS ANGELES -- For the millions who suffer from urinary tract infections (UTI) 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 correctly identify the infection-causing gram-negative bacteria species in 98 percent of the tested clinical UTI 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 UTI -- 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 drawback of this century-old technique is the two-day lag between specimen collection and bacteria identification. As a result, physicians must decide whether to prescribe antibiotics and, if so, which type of bacteria to treat -- all without knowing the cause of the infection, if any. In contrast, the biosensor would allow physicians to prescribe targeted treatment without the wait.

"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 UTI pathogens in a timeframe that would enable physicians to make dramatically superior clinical decisions."

"There is considerable interest in decreasing 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."

UTI is the most common urological disease in the United States and the most common bacterial infection of any organ system. Urinary tract infection is a major cause of patient death and health care expenditures, accounting for more than 7 million office visits and more than 1 million hospital admissions per year. In the hospital, catheter-associated UTI accounts for 40 percent of all in-hospital acquired infections -- more than 1 million cases each year. The total cost of UTI to the United States health care system in 2000 was approximately 3.5 billion dollars.