Low-cost microfluidic system for detection of CTCs

用于检测 CTC 的低成本微流体系统

• 批准号: 8742592
• 负责人: Mateusz Lukasz Hupert
• 金额: $ 99.99万
• 依托单位: BIOFLUIDICA, INC
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-20 至 2015-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8742592
• 关键词: Address; Biological Assay; Carcinoma; Clinical; Detection; Development; Diagnostic; Disease; Ductal Adenoma; FDA approved; Image; Label; Microfluidics; Nuclear; Pancreas; Patients; Performance; Phase; Population; Process; Production; Recovery; Research; Sampling; Services; Staining method; Stains; System; Techniques; Testing; Time; Whole Blood; cost; design; instrument; instrumentation; meetings; novel; operation; point of care; research clinical testing

Development of novel instrumentation and techniques for CTC selection and analysis in point-of-care (PoC) settings is essential in order to fully realize the diagnostic potential of CTCs. This Phase II project is focused on the development of an integrated, portable, system (i.e., disposable fluidic cartridge, instrument, and assay) for the rapid and fully automated processing of CTCs directly from whole blood. The specific aims are focused on: (i) Addressing the technical challenges emanating from the Phase I research related to the cartridge and instrument construction and operation; (ii) expansion of the instrument capabilities and ease of use by the addition of imaging functionality; and (iii) performance verification of the instrument for providing clinical utility via studies of pancreatic ductal adenoma carcinoma, PDAC, a disease that has not been serviced well by the FDA-approved system. The instrument will be able to directly process whole blood, select CTC sub-populations at >90% recovery and >80% purities, electronically enumerate CTCs, fluorescently label them with a set of nuclear and immunological stains, and image the selected CTCs. Operation of the instrument will be automated with overall sample-to-answer processing time of ~1.5 h. The final product of this Phase II effort will meet a set of targeted regulatory requirements for FDA-approval and CLIA moderate complexity.

为了充分实现CTC的诊断潜力，开发用于在床旁（Point-of-Care，CTC）环境中进行CTC选择和分析的新型仪器和技术至关重要。该第二阶段项目的重点是开发一个集成的便携式系统（即，一次性射流盒、仪器和测定），用于直接从全血快速和全自动处理CTC。具体目标侧重于：（一）解决第一阶段研究产生的与盒和仪器构造和操作有关的技术挑战;（二）通过增加成像功能，扩大仪器的能力和易用性;和（iii）通过胰腺导管腺瘤癌，PDAC，FDA批准的系统还没有很好地服务于这种疾病。该仪器将能够直接处理全血，以>90%回收率和>80%纯度选择CTC亚群，电子计数CTC，用一组核和免疫染色剂荧光标记它们，并对所选择的CTC进行成像。仪器操作将自动化，样本到答案的总处理时间约为1.5 h。第二阶段工作的最终产品将满足FDA批准和CLIA中等复杂性的一系列目标监管要求。