NOVEL BREATH TEST TO DETERMINE MITOCHONDRIAL FUNCTION

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The management of liver disease is severely hampered because accurate and sensitive measures of liver function do not exist. Hepatologists universally agree that current tests and methods do not provide enough information necessary to make critical decisions about efficacy of treatment or how to identify the best candidates for liver transplantation. Our objective is to address this need by developing a test to determine the degree and progression of liver impairment in patients with varying causes of liver disease. In Phase I, we took the first step in achieving our objective by demonstrating the potential of the Methionine Breath Test (MBT). The novelty of the MBT is that it is a specific measure of liver function. This is achieved by using the stable isotope labeled substrate, 13C- methionine, which is metabolized exclusively by hepatic mitochondria. When C-methionine is metabolized, the concentration of 13C02 increases in expired breath. Our studies show the test is reproducible, responds to changes induced in mitochondrial function, and correlates with standard serum tests. In Phase II, we will conduct the validation studies required for FDA clearance to demonstrate the MBT's ability to provide prognostic information. The test will be the first FDA approved product for this indication. Proposed commercial applications: Liver disease in the form of alcohol related cirrhosis and hepatitis is a serious and extensive problem in the United States. There are 1 million end stage liver patients and 6 million cases of viral hepatitis. The MBT will be used by physicians to determine appropriateness of liver transplantation, serially follow the disease progression, and evaluate the benefit of drug therapies.