SPECTROSCOPIC DIAGNOSTIC FOR BARRETTS DYSPLASIA

牛顿实验室公司(NLI)将设计一种原型仪器，供胃肠病学家对巴雷特食管（BE）患者进行内窥镜监测。该仪器将使用称为光散射光谱（LSS）的创新光谱技术实时识别发育异常的变化。LSS通过分析细胞核散射的光来测量食管粘膜表面细胞核的大小分布和密度。最近的一项临床研究表明，LSS可以准确地检测出BE患者的高度和低度异型增生。本研究中使用的仪器是一种实验室设备，旨在在临床环境中测试科学原理。在这个第一阶段计划中，NLI将设计一个临床仪器，在第二阶段进行建造和临床测试，这是易于使用和商业实用。该仪器将采用改进的方法来消除背景和提取临床信息，以便能够以自动方式真实的提供信息。将在组织体模上对新设计进行测试，以确定其符合性能目标。如果成功，该项目将成为胃肠病学家检测和诊断这种严重疾病的重要新工具。拟议的商业应用：LSS技术相对于当前依赖活检的监测方法具有显著的优势。与病理学家的平均诊断和共识诊断相比，LSS技术是微创的，提供实时诊断，允许对更多数量的部位进行采样，并且在其初始临床试验中已被证明是高度可靠的。因此，它将在执行这些监测程序的医院和诊所中找到现成的市场。

Newton Laboratories, Inc. (NLI) will design a prototype instrument for use by gastroenterologists performing endoscopic surveillance of patients with Barrett's esophagus (BE). The instrument will identify dysplastic changes in real-time using an innovative spectroscopic technique called Light Scattering Spectroscopy (LSS). LSS Measures the size distribution and density of cell nuclei in the surface of esophageal mucosa by analyzing light scattered from those nuclei. A recent clinical study has shown that LSS can accurately detect both high grade and low grade dysplasia in patients with BE. The instrument used in this study was a laboratory device designed to test the scientific principle in a clinical setting. In this Phase I program, NLI will design a clinical instrument, to be constructed and clinically tested in Phase II, which is easy to use and commercially practical. The instrument will incorporate improved methods for removing the background and extracting the clinical information, so that information can he provided in an automated fashion in real time. The new design will be tested on tissue phantoms to establish that it meets performance goals. If successful, this project will lead to an important new tool for routine use by gastroenterologists for detecting and diagnosing this serious condition. PROPOSED COMMERCIAL APPLICATIONS: The LSS technique has significant advantages over current biopsy- dependent surveillance methods, It is minimally invasive, provides diagnoses in real-time, allows a much greater number of sites to be sampled and has proven to he highly reliable in its initial clinical trials, compared to both the average and consensus diagnoses of pathologists. As such it will find a ready market in hospitals and clinics which perform these surveillance procedures.