WILMINGTON, Del.--(BUSINESS WIRE)--Exalenz Bioscience, Inc., a provider of breath testing equipment for the diagnosis and management of digestive system and liver conditions, today announced the installation of its BreathID® System for Helicobacter pylori (H. pylori) detection in the Emergency Department at The George Washington University Hospital as part of a clinical trial. The company believes emergency rooms and urgent care centers represent a compelling new market opportunity for the BreathID System.
The BreathID® Urea Breath Test System offers a highly accurate, rapid, point-of-care assessment of H. pylori, which infects approximately 30 percent of the United States population. BreathID delivers results in less than 10 minutes – about half the time of competitive devices – making it ideal for emergency room and urgent care settings.
H. pylori, a bacterium that resides in the stomach and small intestine, has been demonstrated to contribute to a variety of conditions, ranging from relatively common symptoms such as dyspepsia and abdominal pain to more severe conditions, including gastritis, ulcers and, in some cases, gastric cancer. Conclusively eradicating H. pylori through treatment depends on an accurate diagnosis of active H. pylori infection.
“The BreathID system fits perfectly with our goal of improving bedside diagnostic testing in the ER. Along with other point-of care diagnostic tools, the Breath ID system is highly suited for the emergency department environment,” said Andrew Meltzer, M.D., Assistant Professor, Department of Emergency Medicine at George Washington University School of Medicine. “The test is safe and works without a radioactive substrate. It is also quick and gives an easy to interpret result in less than ten minutes and is very accurate with reportedly high sensitivity and specificity. By performing urea breath tests for H. pylori, we gain a critical differential diagnosis in symptomatic patients.”
According to a survey conducted by the Centers for Disease Control National Center for Health Statistics (CDC/NCHS), abdominal pain is the primary diagnosis for more than 7,000,000 visits to the ER each year, representing 11.3 percent of all non-injury visits to the ER. Accurate assessment of H. pylori infection can provide an important differential diagnosis in these cases.
Urea breath testing (UBT) is the non-invasive mode of choice for diagnosing H. pylori. According to the American College of Gastroenterology’s (ACG) 2007 guidelines, the tests most widely used by physicians (blood antibody tests) are “no better than a coin toss in predicting active infection.” UBT – and the BreathID System – has been proven to accurately and reliably detect active infection, and its use is supported by the ACG clinical guidelines.
“We are pleased that The George Washington University Hospital has chosen to implement the BreathID System to diagnose H. pylori infection in its patients,” said Sean Hanlon, Vice President of Marketing at Exalenz Bioscience. “Exalenz believes emergency rooms and urgent care centers represent an opportunity for the BreathID System, which will enable these facilities to improve care delivery and, ultimately, facilitate enhanced quality of life for those patients who might otherwise go undiagnosed.”
The installation at The George Washington University Hospital follows two installations of BreathID Systems at prominent hospitals in major metropolitan areas.
About Exalenz Bioscience
Exalenz Bioscience develops and markets medical equipment for breath testing for the purposes of diagnosis and management of digestive system and liver conditions. The company sells the BreathID® System together with proprietary disposable test kits. The BreathID® System has been proven effective for clinical use in the task of identifying the presence of the H. pylori bacteria and is presently undergoing clinical tests for use in the field of liver function, liver cirrhosis, and digestive disturbances. Exalenz holds regulatory approvals in Europe and the U.S. for some of the applications and the company is currently in process of applying for approvals for additional applications.
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