BREATH COLLECTION APPARATUS FOR DIAGNOSIS OF DISEASE

描述（改编自申请人摘要）： 呼吸中的挥发性有机化合物（VOC）随着呼吸的变化而变化。 挥发性有机化合物在血液中循环。 因此分析 呼吸提供了血液化学的非侵入性探针。 最近的研究 高灵敏度2.0系列呼吸收集器（BCA） 研究表明，呼吸中的挥发性有机化合物是肺癌、乳腺癌、 癌症心脏移植排斥反应 为了在这些发现的基础上 并确立呼吸测试的临床价值， 进行下一轮的临床研究。 这将 需要结合进化改进的改进的BCA。 一个 将构建改进的3.0代BCA，并在台架上进行评估 top和人类研究。 目的是开发一个改进的和"用户- 友好的"BCA，这将允许对VOC进行常规收集和分析 以皮摩尔浓度存在于呼吸中。计划雇用 本BCA在临床研究中确定呼吸测试的价值 作为检测疾病的非侵入性工具。 FDA批准将 获得BCA，呼吸测试疾病，并销售 临床诊断应用技术。 拟定商业应用： 呼吸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。 在实践中，呼吸收集装置（BCA）将被采用， 最终用户（例如，医生或医院）采集呼吸样本 从病人身上采集;样本将被送到中心实验室 用于气相色谱和质谱分析。自动化 呼吸色谱分析可以识别患者的 肺癌等特定疾病的风险，以及这些结果 然后会被告知医生。

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.