TEST TO DETERMINE EFFECTIVENESS OF H PYLORI THERAPY

H.幽门螺旋杆菌在消化性溃疡中的作用提供了一个 有机会成功治疗数百万直到最近 都被认为是终生的问题有可能永久地 通过根除H.幽门感染然而，这种细菌是 很难根除。目前治疗的显著失败率 要求医生测试20%或更多的治疗患者， 反复出现的症状根除在质量方面的好处 生命和医疗费用的减少是巨大的。我们的目标是 市场上的测试，将允许医生很容易地确定 根除治疗的有效性。MSI开发了一种简单、单一的 血液样本测试以确定活性H的存在。幽门螺杆菌感染 基于细菌的尿素酶活性将尿素分解为二氧化碳。 给予小剂量的13 C-尿素，如果细菌存在， 13血液中检测到二氧化碳。基于血液的测试更快，更准确， 更便宜，更熟悉的医疗界比其他竞争对手 诊断测试在第二阶段，我们将进行验证研究， 需要FDA批准。该测试将是FDA批准的第一个 适用于该适应症的产品。 拟议的商业应用： 有数百万美国人与消化性溃疡的疾病正在接受治疗 螺杆幽门感染在这一组中，20%或更多将需要员额 治疗评价由于其成本低、准确性高， 和便利性将是确定有效性的最佳方法 用药

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.