A NOVEL METHOD TO DETECT HELICOBACTER PYLORI IN CHILDREN

描述（改编自申请人的摘要）：幽门螺杆菌 在消化性溃疡疾病中的作用导致了对 数百万直到最近还被认为有终身问题的人。 根除在生活质量和减少艾滋病毒/艾滋病感染方面的益处 医疗费用是巨大的。然而，有一部分人 这一点在大量的新测试和药物中几乎被忽视了， 围绕着疾病，即儿童。没有FDA批准的测试， 儿童，也没有多中心研究证明现有的疗效 儿童测试我们的目标是满足对合格的 儿童诊断测试MSI已开发并正在寻求FDA批准， 一个简单的，单一的血液样本测试，以确定活性H的存在。 成人幽门螺杆菌感染的基础是细菌的尿素酶活性分裂 尿素转化为二氧化碳。给予小剂量的13 C-尿素，如果H. 血液中检测到13 CO2。基于血液的测试是理想的 因为它简单、可靠、微创。测试将 是FDA批准的第一个用于该适应症的产品。 拟议商业应用：不可用

DESCRIPTION (Adapted from Applicant's Abstract): 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. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE