POINT-OF-CARE BREATH TEST FOR DISEASES

描述（由申请人提供）：背景：已经开发出一种先进的呼吸分析仪系统，用于收集和分析肺泡呼吸中挥发性有机化合物（VOCs）的皮摩尔浓度（万亿分之一）。这项技术使识别肺癌、乳腺癌、肺结核等疾病的呼吸生物标志物成为可能。问题：这些测试采用的实验室技术速度慢且昂贵，需要训练有素的工作人员和昂贵的仪器。一种新的解决方案：远程诊断系统（RDS）： RDS是一种快速且具有成本效益的即时呼吸诊断系统。它采用便携式呼吸扫描仪来收集、浓缩和分析呼吸生物标志物。数据通过互联网上传到一台中央计算机，该计算机用诊断算法对数据进行解释，并通过电子邮件将报告发送给用户。RDS的优点：7 .对患者友好——呼吸检测本质上是安全的、无痛的、无创的；7 .用户友好——临床工作人员可以快速培训操作RDS； 7 .方便——RDS在任何地方操作，占用桌面空间很小；7 .反应迅速——呼吸样本在护理点几分钟内分析和解释；RDS的一个新应用——乳腺癌检测：在一项初步研究中，一种基于实验室的呼吸测试准确地识别出了患有乳腺癌的妇女。在最近的一项验证研究中，呼吸测试识别乳腺癌的准确性优于胶片或数字乳房x线摄影成像。一项即时呼吸测试也得出了类似的结果，证明了用RDS检测乳腺癌的可行性。RDS的临床作用：呼气测试是辅助程序，是补充，而不是替代，乳房成像或活检。RDS可以通过识别需要进一步检测的高危患者，同时安全地排除不需要进一步检测的低危患者，从而显著减少这些检测的使用。短期目标：在第一阶段，我们将评估RDS在三个地理位置不同的学术临床站点的技术可行性，以及b.在乳腺癌女性与无癌对照的试点研究中的临床价值。长期目标：a.科学性：验证RDS作为乳腺癌检测的新工具。b.监管：获得FDA批准RDS用于临床使用。c.商业：在美国和海外推广RDS。

DESCRIPTION (provided by applicant): Background: An advanced breathalyzer system has been developed to collect and analyze volatile organic compounds (VOCs) in alveolar breath in picomolar concentrations (parts per trillion). This technology has made it possible to identify breath biomarkers of diseases including lung cancer, breast cancer, and pulmonary tuberculosis. The problem: These tests employ laboratory-based technology that is slow and expensive, requiring highly trained staff and costly instrumentation. A new solution: The Remote Diagnosis System (RDS): The RDS is a rapid and cost-effective system for point-of-care breath diagnostics. It employs a portable Breathscanner that collects, concentrates, and analyzes breath biomarkers. Data are uploaded via the internet to a central computer that interprets the data with a diagnostic algorithm, and transmits a report to the user by e-mail. Advantages of the RDS: 7 Patient-friendly - breath testing is intrinsically safe, painless and non-invasive 7 User-friendly - clinical staff can be rapidly trained to operate the RDS 7 Convenient - the RDS operates anywhere, in a small footprint of table-top space 7 Rapid response - breath samples are analyzed and interpreted in minutes at the point-of-care 7Cost-effective - low capital cost of instrumentation, compared to laboratory assays 7 Safe - the RDS instrument employs non-inflammable helium carrier gas A new application of the RDS- Detection of breast cancer: In a pilot study, a laboratory-based breath test employing accurately identified women with breast cancer. In a recent validation study, the breath test identified breast cancer with accuracy superior to imaging with film or digital mammography. A point-of-care breath test yielded similar results, demonstrating the feasibility of detecting breast cancer with the RDS. Clinical role of the RDS: Breath testing is an ancillary procedure that is complementary to, not a substitute for, breast imaging or biopsy. The RDS could dramatically reduce utilization of these tests by identifying high-risk patients who require further testing, while safely excluding low-risk patients who do not. Short-term objectives: In Phase I, we will evaluate the RDS for: a. technical feasibility at three geographically diverse academic clinical sites, and b. clinical value in a pilot study of women with breast cancer versus cancer-free controls Long-term objectives: a. Scientific: Validate the RDS as a new tool for detection of breast cancer. b. Regulatory: Obtain FDA approval of the RDS for clinical use. c. Commercial: Market the RDS in the USA and overseas. PUBLIC HEALTH RELEVANCE: The Remote Diagnosis System (RDS) is a rapid and cost-effective system for point-of-care breath diagnostics. It employs a portable Breathscanner that collects, concentrates, and analyzes breath biomarkers of disease. Data are uploaded via the internet to a central computer which then transmits a report to the user by e-mail. We will evaluate the RDS at three clinical sites for technical feasibility, and for detection of women with breast cancer.