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NIH award addresses common hospital infection

September 21, 2007

Researchers from the David Geffen School of Medicine at UCLA, the Veterans Affairs (VA) Greater Los Angeles Healthcare Center, GeneFluidics and ASU’s Biodesign Institute have received a five-year, $3.2 million award from the National Institutes of Health (NIH) to help rapidly diagnose and treat urinary tract infections (UTIs) – the most common cause of hospital-associated infection in the United States.

The initiative brings together academic and industry leaders to further advance the groundbreaking technology – initially developed by UCLA/VA researchers and corporate partner GeneFluidics – which correctly identified the first ever species-specific, rapid detection of bacteria in human clinical fluid samples using a microfabricated electrochemical sensor array.

Joseph Wang, director of the Biodesign Institute’s Center for Bioelectronics and Biosensors, will join the collaboration to improve the performance of the test by dramatically enhancing its sensitivity and speed. Wang has more than 25 years of success in biomedical applications and a strong track record of bringing similar sensors to the market for glucose monitoring.

“We are extremely fortunate to have Joe Wang and the Biodesign Institute as partners in this endeavor,” says David Haake, a professor of medicine at UCLA, an infectious diseases specialist at the VA and the principal investigator on the project. “Biodesign’s expertise will make it possible to quickly bring the electrochemical sensor to clinical reality. Working together, we hope to fundamentally change the way antibiotics are selected for treatment of infectious diseases.”

“The goal of our collaborative effort is to develop all of the technical components to produce a biosensor that can rapidly and reliably identify a bacteria and its spectrum of antibiotic susceptibility to aid point-of-care diagnostics for the clinic,” adds Wang, who also serves a dual appointment as professor in the Ira A. Fulton School of Engineering and College of Liberal Arts and Sciences.

Industrial partner GeneFluidics will help deliver a custom-built, fully functional prototype called PATHOSENSE within the time frame of the grant. At the conclusion of the grant period, the collaboration hopes to work with GeneFluidics for near-term deployment of the PATHOSENSE instrument in multi-center clinical testing.

“By combining our expertise, we will be able to bring outstanding pathogen screening products to health care professionals,” says Vincent Gau, president of GeneFluidics. “Using GeneFluidics’ proprietary electrochemical platform as the backbone of our tests allows for very high sensitivity and for a streamlined system that delivers antibiotics resistance results in record time: two hours instead of two to three days.”

The basis of the technology relies on the ability to detect the genetic signature of a bacterial pathogen. The researchers will use 16S rRNA, a ribosomal molecule found in all bacteria to identify the bacteria species. The research team will focus on enhancing the performance and validation of the electrochemical biosensor assay and also develop an antimicrobial susceptibility test to rapidly select the best antibiotic for treatment.

“Our mission is to create a new technology to solve an old problem which is the diagnosis of urinary tract infections – the second-most-common bacterial infection – in a clinically relevant time frame,” says Bernard Churchill, chief of pediatric urology at the Clark-Morrison Children’s Urological Center at UCLA.

In current laboratory practice, 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 antibiotic to use – all without knowing the actual cause of the infection, if any.

In contrast, the new biosensor technology would allow physicians to prescribe targeted treatment without the wait.

Urinary tract infection 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 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 U.S health care system in 2000 was about $3.5 billion.

The grant is funded by the National Institute of Allergy and Infectious Diseases (NIAID) branch of the National Institutes of Health.