SBIR Phase II: High multiplex visual mapping of heterogeneity in FFPE biospecimen

该SBIR第二阶段项目旨在促进对肿瘤细胞多样性的了解，这是一种导致获得性耐药性的现象。量化和了解这种差异可能有助于预测患者--S对某些药物的反应，从而为个别患者--S肿瘤选择理想的药物组合，从而实现个性化用药。这一第二阶段的项目将为药物开发人员和研究人员提供一种工具，通过将来自肿瘤的遗传和空间信息关联起来，提供目前缺失的关于肿瘤成分的关键信息，从而量化多样性。该项目将把这项技术转化为高效、高通量的工作流程，使药物开发人员、研究人员和参考实验室实现商业化，创造收入和多重就业机会。这项创新的商业化将对科学、企业和患者社区产生重大影响。研究人员将有一种新工具来改进癌症和其他疾病的药物开发，包括阿尔茨海默氏症、S和糖尿病。支付方，如保险公司和政府，将通过消除治疗无效患者的不必要支出来节省成本。最重要的是，患者将通过新的治疗方法和筛选方法获得更广泛的个性化药物，这些方法可以帮助确定最佳药物组合。单个肿瘤包含多个细胞群体，每个细胞都有独特的突变，有必要了解这些细胞的位置和遗传差异，以便提供有效的联合治疗，而不会导致整体治疗失败或复发。这个第二阶段的项目旨在为药物开发人员、研究人员和内科医生提供一种工具，将单个肿瘤的遗传和空间信息联系起来。使用附着在标准显微镜载玻片和组织活检上的专有微流控设备，并与激光耦合显微镜相结合，该工具能够提供当今任何其他方法无法获得的信息。在第一阶段项目可行性的基础上，第二阶段将包括进行NGS，以证明该仪器？S在为临床研究和生物标记物发现提供数据方面的有用性。它还将涉及建立一个完全集成的原型仪器，其特点是提高自动化和生产能力，使该技术在经济上可行于商业化。这些发展将向客户展示S仪器的价值，并使一项服务能够进行商业推出。

This SBIR Phase II project aims to facilitate understanding of cellular diversity in tumors, a phenomenon that contributes to acquired drug resistance. Quantifying and understanding this diversity may help predict a patient?s response to certain drugs which would allow the selection of ideal drug combinations for an individual patient?s tumor, thus enabling personalized medicine. This Phase II project will provide drug developers and researchers with a tool that can quantify diversity by correlating genetic and spatial information from tumors, providing crucial information about tumor composition that is currently missing today. This project will translate the technology into an efficient, high-throughput workflow that will enable commercialization with drug developers, researchers, and reference laboratories, generating both income and multiple job opportunities. The commercialization of this innovation will significantly impact scientific, corporate, and patient communities. Researchers will have a new tool improving drug development for cancer and other diseases, including Alzheimer?s and diabetes. Payers, such as insurance companies and the government, will save costs by eliminating unnecessary spending on treatments for patients who will not respond. Most importantly, patients will have broader access to personalized medicine through new treatments and screening methods that can help determine the optimum drug combinations for them.A single tumor contains multiple populations of cells that each have unique mutations, and it is necessary to understand the location and genetic differences of these cells in order to provide effective combination therapies that will not result in overall treatment failure or relapse. This Phase II project aims to provide drug developers, researchers, and physicians with a tool to correlate genetic and spatial information about individual tumors. Using a proprietary microfluidic device adhered to a standard microscope slide and tissue biopsy, incorporated with a laser-coupled microscope, this tool is capable of providing information that it is not possible to obtain from any other method today. Building upon the feasibility established during the Phase I project, Phase II will involve performing NGS to demonstrate the instrument?s usefulness in providing data for clinical research and biomarker discovery. It will also involve building a fully integrated prototype instrument with features that increase automation and throughput to make the technology economically feasible for commercialization. These developments will showcase the instrument?s value to customers as well as enable the commercial launch of a service.