SBIR Phase I: Novel Breath Diagnostic Instrument for Detection of Disease

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This Small Business Innovation Research (SBIR) Phase I project proposes to develop a carbon isotope ratio analyzer based on Off-Axis Integrated Cavity Output Spectroscopy to measure the ratio of C13 to C12 in exhaled breath in real time. The analyzer will serve as a medical diagnostic instrument that will operate in a point-of-care setting and reference labs. The instrument will be inexpensive, portable, easy-to-use and report C13/ C12 measurements with sufficient sensitivity and precision to replace mass spectrometry in C13-labeled breath tests for diagnosis of a number of conditions, including exposure to chemical and biological warfare agents, sepsis, assessment of liver and pancreatic function, delayed gastric emptying, bacterial overgrowth, irritable bowel syndrome and viral infection. The Phase I Project will develop an instrument to determine infection due to Helicobacter pylori, a Class-1 carcinogen, using the C13-urea breath test. The follow on Phase II Project will develop a prototype commercial instrument for clinical trials.The commercial application of this project is in the area of medical diagnostics.