BREATH COLLECTION APPARATUS FOR DIAGNOSIS OF DISEASE

描述(改编自申请人的摘要)： 呼气中的挥发性有机化合物(VOCs)随 血液中循环的挥发性有机化合物的组成。因此，分析 呼吸提供了一种非侵入性的血液化学探头。最新研究 配有高灵敏度的Series 2.0呼气采集器(BCA) 已经表明，呼气中的VOCs是肺癌、乳腺癌的标志 癌症，心脏移植排斥反应。为了建立在这些发现的基础上 并确立呼吸测试的临床价值，它将是 进行下一轮临床研究所必需的。这将是 需要一个包含进化改进的改进的BCA。一个 将构建改进的3.0代BCA，并在试验台上进行评估 顶尖的和人类研究。其目的是开发一种改进的和“用户-- 将允许对挥发性有机化合物进行常规收集和分析的BCA 以皮摩尔浓度存在于呼吸中。它计划雇用 这种BCA在临床研究中确定呼气测试的价值 作为一种检测疾病的非侵入性工具。FDA的批准将 用于BCA，呼气测试疾病，并推向市场 临床诊断应用的技术。 建议的商业应用： 呼气测试可以提供一种新的非侵入性诊断工具 监测几种疾病的严重程度，包括肺癌， 乳腺癌、缺血性心脏病和心脏移植排斥反应。 在实践中，呼气收集装置(BCA)将被 最终用户(例如医生或医院)采集呼气样本 来自患者的样本；样本将被送到中心实验室 用气相色谱和质谱仪进行分析。自动化 对呼气色谱图的分析可以确定患者的 特定疾病的风险，如肺癌，以及这些结果 然后会被传达给医生。

DESCRIPTION (Adapted from applicant's abstract): The composition of volatile organic compounds (VOCs) in the breath varies with the composition of VOCs circulating in the blood. Therefore, analysis of breath provides a non-invasive probe of blood chemistry. Recent studies with a highly sensitive Series 2.0 breath collecting apparatus (BCA) have shown that VOCs in breath are markers of lung cancer, breast cancer, heart transplant rejection. In order to build on these findings and establish the clinical value of breath testing , it will be necessary to perform the next round of clinical studies. This will require an improved BCA incorporating evolutionary improvements. An improved Generation 3.0 BCA will be constructed, and evaluated in bench top and human studies. The aim is to develop an improved and "user- friendly" BCA which will permit the routine collection and assay of VOCs present in breath in picomolar concentrations. It is planned to employ this BCA in clinical studies to determine the value of breath testing as a non-invasive tool for the detection of disease. FDA approval will be obtained for the BCA, breath tests for disease, and to market the technology for clinical diagnostic applications. PROPOSED COMMERCIAL APPLICATION: Breath testing could provide a new and non-invasive diagnostic tool for monitoring the severity of several diseases, including lung cancer, breast cancer, ischemic heart disease and heart transplant rejection. In practice, the breath collection apparatus (BCA) would be employed by an end user (e.g. a physician or a hospital) to collect breath samples from patients; the samples would them be sent to a central laboratory for analysis by gas chromatography and mass spectroscopy. Automated analysis of the breath chromatogram could then identify the patient's risk for a particular disease, such as lung cancer, and these results would then be communicated to the physician.