New Instrument for Breath Test Detection of H Pylori

The objective of this program is to develop a new inexpensive, simple, and robust diagnostic instruenable routine point-of-care (POC) detection of H. Pylori infections (implicated in peptic ulcer distest method, in which the ratio of 13CO2 to 12CO2 in the breath is measured following ingestion of iurea. This instrument is based on proprietary technology and has been shown to have the sensitivitynecessary to detect normal physiologic concentrations of 13CO2 and 12CO2 in human breath. The Phasetowards development of a prototype instrument and demonstration of the measurement precision requirediagnose H. pylori infections. We will also collaborate with the Bureau of Veterans Affairs MedicalCA, to perform measurements on patients for correlation with other diagnostic techniques currently ePhase II, we will perform engineering development and manufacturing development and will address appby the FDA. The need for this diagnostic test has been established by the NIH and is recommended bytreatment of all current and new cases of peptic ulcer disease, numbering approximately 4.8 millionrespectively, in the U.S. alone. The test will be used in private and group practices, clinics, andmethods for diagnosing H. pylori infection include intrusive endoscopic biopsies followed by histoloorganisms, direct detection of urease activity, or culture. Noninvasive methods include serology forbreath or serum tests of the CO2 isotope ratio. The NIH recommends the urease breath test based on nthe diagnostic of choice. Because of our cost and operational advantages, we expect to replace massdiagnoses and capture a significant share of this new market.