The discovery of H. pylori's role in peptic ulcer disease has resulted in the successful treatment of millions of people who until recently were assumed to have a life long problem. The benefits of eradication in terms of quality of life and reduction in medical costs are monumental. However, there is one segment of the population that has been virtually ignored in the avalanche of new tests and drugs surrounding the disease, namely children. There are no FDA approved tests for children, nor are there multi center studies demonstrating efficacy of existing tests in children. Our objective is to address the need for a qualified diagnostic test in children. MSI has developed and is seeking FDA approval for a simple, single sample blood test to determine the presence of active H. pylori infection in adults based on the bacteria's urease activity to split urea to carbon dioxide. A small dose of 13C-urea is administered and if H. pylori is present 13CO2 is detected in blood. The blood-based test is ideal for children because it is simple, reliable and minimally invasive. The test will be the first FDA approved product for this indication.
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