TEST TO DETERMINE EFFECTIVENESS OF H PYLORI THERAPY

幽门螺杆菌在消化性溃疡疾病中的作用的发现为 成功治疗数百万人的机会，直到最近 被认为有一个终生的问题。有可能永久地 通过根除幽门螺杆菌感染来治疗溃疡。然而，这种细菌是 很难根除。当前疗法的显著失败率 要求医生对20%或更多的治疗患者进行检测， 反复出现的症状。就质量而言，根除的好处是 生命和医疗费用的降低是不朽的。我们的目标是 推出一种测试，使医生能够轻松地确定 根除治疗的有效性。MSI已经开发出一种简单的、单一的 血液样本化验以确定是否有幽门螺杆菌活动性感染 根据细菌的尿素酶活性将尿素分解为二氧化碳。 注射小剂量的13C-尿素，如果细菌存在， 13在血液中检测到二氧化碳。基于血液的检测更快、更准确， 与其他竞争对手相比，价格更低，医学界也更熟悉 诊断性测试。在第二阶段，我们会进行验证研究。 FDA批准所需的。这将是FDA批准的第一个测试 此适应症的产品。 建议的商业应用： 数百万患有消化性溃疡的美国人正在接受治疗 幽门螺杆菌感染。在这一组中，20%或更多的人需要员额 治疗评价。建议的测试是因为它的低成本、准确性 而便利性将是确定其有效性的最佳方法 治疗。

The discovery of H. pylori's role in peptic ulcer disease offers an opportunity to successfully treat millions of people who until recently were assumed to have a life long problem. It is possible to permanently cure ulcers by eradicating H. pylori infection. However, this bacteria is difficult to eradicate. The significant failure rate of current therapies requires physicians to test 20% or more of treated patients exhibiting recurring symptoms. The benefits of eradication in terms of quality of life and reduction in medical care costs are monumental. Our objective is to market a test that will allow physicians to easily determine the effectiveness of eradication treatment. MSI has developed a simple, single sample blood test to determine the presence of active H. pylori infection based on the bacteria's urease activity to split urea to carbon dioxide. A small dose of 13C -urea is administered and if the bacteria is present, 13 CO2 is detected in blood. A blood-based test is quicker, more accurate, less expensive, and familiar to the medical community than other competing diagnostic tests. In Phase II, we will conduct the validation studies required for FDA clearance. The test will be the first FDA approved product for this indication. Proposed commercial applications: There are millions of Americans with peptic ulcer disease being treated for H. pylori infection. In this group, 20% or more will require post treatment evaluation. The proposed test because of its low cost, accuracy and convenience will be the best method to determine the effectiveness of the treatment.