Novel Medical Diagnostic Instrument Based on Real-time Breath Analysis

Los Gatos Research proposes to develop and test a novel medical diagnostic instrument that will non-invasively measure the ratio of the isotopic abundances of 13C to 12C in exhaled breath. The instrument, based on a new technology called Off-Axis ICOS, will be inexpensive, portable, easy to use, and report measurements with sufficient sensitivity and precision to replace mass spectrometry in 13C-labeled breath tests for diagnosis of several diseases, including diagnosis of liver fibrosis, bacterial overgrowth, pancreatitis, irritable bowel syndrome, sepsis, and infection. During Phase II, we will develop an instrument for measurement of the gastric emptying rate for diagnosis of gastroparesis and associated conditions. In addition, we will quantify the specificity and sensitivity of the instrument by incorporating it into clinical trials. The instrument will enable long-term studies of astronaut health based on non-intrusive breath analysis and thus addresses the needs of the Biomedical Research Program. The program will involve clinical testing in human subjects to demonstrate concept efficacy and thus meet Countermeasure Readiness Level 6. At the end of the program, the instrument will be available for evaluation with human subjects in controlled laboratory conditions simulating space flight environment and thus meet Countermeasure Readiness Level 7.