The objective of this program is to develop a new inexpensive, simple, and robust diagnostic instrument that will enable routine point-of-care (POC) detection of H. Pylori infections (implicated in peptic ulcer disease) by the urease breath test method, in which the ratio of 13CO2 to 12CO2 in the breath is measured following ingestion of isotopically labeled urea. This instrument is based on proprietary technology and has been shown to have the sensitivity and selectivity necessary to detect normal physiologic concentrations of 13CO2 and 12CO2 in human breath. The Phase I effort is directed towards development of a prototype instrument and demonstration of the measurement precision required to accurately diagnose H. pylori infections. We will also collaborate with the Bureau of Veterans Affairs Medical Center in Palo Alto, CA, to perform measurements on patients for correlation with other diagnostic techniques currently employed there.In Phase II, we will perform engineering development and manufacturing development and will address approval of the device by the FDA. The need for this diagnostic test has been established by the NIH and is recommended by NIH for use in treatment of all current and new cases of peptic ulcer disease, numbering approximately 4.8 million and 480,000/year, respectively, in the U.S. alone. The test will be used in private and group practices, clinics, and medical laboratories. Other methods for diagnosing H. pylori infection include intrusive endoscopic biopsies followed by histologic demonstrations of organisms, direct detection of urease activity, or culture. Noninvasive methods include serology for antibodies and urease breath or serum tests of the C02 isotope ratio. The NIH recommends the urease breath test based on nonradioactive 13C as the diagnostic of choice. Because of our cost and operational advantages, we expect to replace mass spectrometer-based diagnoses and capture a significant share of this new market.National Institute of Allergy and Infectious Diseases (NIAID)
