BREATH COLLECTION APPARATUS FOR DIAGNOSIS OF DISEASE

描述（改编自申请人摘要）：的组成

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.