POINT-OF-CARE BREATH TEST FOR DISEASES

描述(申请人提供)：背景：开发了一种先进的呼气测定仪系统，用于收集和分析肺泡呼气中的挥发性有机化合物(VOC)，其浓度为皮摩尔浓度(万亿分之一)。这项技术使识别包括肺癌、乳腺癌和肺结核在内的疾病的呼吸生物标记物成为可能。问题是：这些测试使用的是基于实验室的技术，速度慢，成本高，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是一种快速且经济高效的点式呼吸诊断系统。它使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中央计算机，中央计算机用诊断算法解释数据，并通过电子邮件将报告发送给用户。RDS的优势：7患者友好的呼气测试本质上安全，无痛，非侵入性7用户友好-临床工作人员可以快速培训来操作RDS 7方便-RDS在任何地方操作，在很小的桌面空间7快速反应-呼吸样本在几分钟内分析和解释在护理点7成本效益-仪器的低资本成本，与实验室分析7安全-RDS仪器使用不可燃的氦气载气RDS的一个新的应用-乳腺癌检测：在一项试点研究中，以实验室为基础的呼气测试使用了准确识别的乳腺癌妇女。在最近的一项验证研究中，呼气测试识别乳腺癌的准确性高于胶片或数字乳房X光摄影成像。一项护理点呼气测试产生了类似的结果，证明了使用RDS检测乳腺癌的可行性。RDS的临床作用：呼吸测试是一种辅助程序，是乳房成像或活检的补充，而不是替代。RDS可以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风险患者，从而极大地减少这些检测的使用。短期目标：在第一阶段，我们将评估RDS的以下方面：a.在三个不同地理位置的学术临床地点的技术可行性，以及b.在乳腺癌女性与非癌症对照的试点研究中的临床价值长期目标：a.科学：验证RDS作为检测乳腺癌的新工具的有效性。监管：获得FDA对RDS临床使用的批准。C.商业：在美国和海外推广RDS。 公共卫生相关性：远程诊断系统(RDS)是一种快速且经济实惠的呼吸诊断系统。它采用了一种便携式呼吸扫描仪，收集、浓缩和分析呼吸疾病的生物标志物。数据通过互联网上传到中央计算机，然后中央计算机通过电子邮件将报告发送给用户。我们将在三个临床地点评估RDS的技术可行性，并用于检测女性乳腺癌患者。

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.