Development of a New 13c Aminopyrine Breath Test Kit

The aminopyrine breath test (ABT) is a noninvasive assay of hepatic mixed- function oxidase that cothe active hepatocyte volume. This measurement has potential diagnostic utility in assessing liver dabuse, drug-drug interactions, and in predicting the survival of liver transplants. The use of 13C-ahampered by a lack of fully developed kits and analysis facilities. Phase I of this application coveconstruction of a kit embodying new concepts in breath collection, storage, and analysis to make theavailable to, and usable by, physicians. Kit design and production of 1000 kits will be completed beevaluation trials of Phase II. Clinical experience with the breath test kit and the diagnostic utiliPhase II will be used in the FDA approval process. In Phase III, approval of the ABT kit will enableincorporate its use for the first time into routine patient evaluation and management. The test kitMeretek Diagnostics, Inc., developers of the 13C-urea breath test for active Helicobacter pylori inf