Researchers from the David Geffen School of Medicine at UCLA, the Veterans Affairs Greater Los Angeles Healthcare System, GeneFluidics Inc. and the Biodesign Institute at Arizona State University have received a five-year, $3.2 million award from the National Institutes of Health to help rapidly diagnose and treat urinary tract infections -- the most common cause of hospital-associated infection in the United States.
The initiative brings together academic and industry leaders to further advance a groundbreaking technology -- initially developed by UCLA/VA researchers and corporate partner GeneFluidics -- that allows for rapid, species-specific detection of bacteria in human clinical fluid samples using a microfabricated electrochemical sensor array.
Joe 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, used for glucose monitoring, to the market.
"We are extremely fortunate to have Joe Wang and the Biodesign Institute as partners in this endeavor," said principal investigator Dr. David Haake, professor of medicine at UCLA and an infectious diseases specialist at the VA. "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 the 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," Wang said.
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 team hopes to work with GeneFluidics for near-term deployment of the PATHOSENSE instrument in multicenter clinical testing. "By combining our expertise, we will be able to bring outstanding pathogen screening products to health care professionals," said Dr. 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 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 will 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," said Dr. 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. It is a major cause of patient death and health care expenditures for all age groups, accounting for more than 7 million office visits and more than 1 million hospital admissions per year. Catheter associated urinary tract infection accounts for 40 percent of all 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 approximately $3.5 billion.
The grant is funded by the National Institute of Allergy and Infectious Diseases, a branch of the National Institutes of Health.
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, the department's 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.
The Biodesign Institute at Arizona State University is focused on innovations that improve heath care; provide renewable sources of energy and clean our environment; outpace the global threat of infectious disease; and enhance national security. Using a team approach that converges the biosciences with nanoscale engineering and advanced computing, the institute aims to find solutions to complex global challenges and accelerate these discoveries to market. The institute also educates future scientists by providing hands-on laboratory research for more than 250 students each semester.
GeneFluidics was founded in 2000 by Vincent Gau, who received his doctorate in biomedical engineering from UCLA. GeneFluidics' goal is to develop a fast, accurate and simple testing system for improving worldwide health. By integrating novel bio-nano and microfluidic technologies, the company's revolutionary platform will enable complex tests currently performed by skilled technicians in a laboratory to be performed by anyone, anywhere.