SBIR Phase II: Magnetic Capture Device for Rapid Isolation of Rare Cells

这个小企业创新研究（SBIR）第二阶段项目的更广泛影响/商业潜力是开发一种技术，为患者提供个性化医疗保健。该项目将开发一种分离装置，用于从癌症中回收可分析基因突变的循环肿瘤细胞（CTC）等稀有细胞。从长远来看，这些信息可以指导每个患者的癌症治疗。目前可用的CTC测试只能计数罕见的癌细胞，这对医生来说价值有限。这个SBIR项目将产生一个自动化系统，从血液中捕获癌细胞，并恢复活细胞进行分析。通过一小部分血液样本，癌症患者的肿瘤可能被基因分型，这可能使未来的定制治疗成为可能。该平台对任何类型的罕见细胞捕获和分析都有许多研究和临床用途。提出的自动化细胞分离装置将通过简化罕见的细胞分离过程，使基础研究转化为临床应用。这个SBIR二期项目提出开发一种改进的设备，用于检测和分析从癌症部位流入血液的循环肿瘤细胞（CTCs）。CTCs是癌症扩散过程的一部分，早期发现是改善治疗的关键。ctc的检测、量化和表征有可能改变肿瘤学，但在常规条件下对这些罕见的、十亿分之一的细胞进行分离仍然存在问题。正在开发的CTC样品制备技术成本低，速度快，并且可能提供捕获细胞的高信息量分析。它有望实现影响患者护理的新一代癌症诊断。在这个二期项目中，目标是设计和生产分离装置、流体工作站和供应套件；然后，评估其从癌症患者血液中捕获和恢复ctc的能力。第一阶段的数据证明了这种方法的可行性。本研究的结果将评估捕获和回收ctc的替代方法，目标是在60分钟或更短的时间内回收90%的细胞。二期试验的第二个目标是评估该设备从母体血液中分离胎儿细胞的潜力，从而实现无创产前诊断。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to develop a technology to enable personalized healthcare for patients. This project will create a separation device to recover rare cells, including circulating tumor cells (CTC) from cancer, which can be analyzed for genetic mutations. In the long term, this information could direct cancer therapy for each patient. Currently available CTC tests only count rare cancer cells, which is of limited value to doctors. This SBIR project will produce an automated system to capture cancer cells from blood, and recover live cells for analysis. Through a small sample of blood, a cancer patient's tumor may be genotyped, which may enable custom therapy in the future. The platform has many research and clinical uses for any type of rare cell capture and analysis. The proposed automated cell separation device will enable the translation of basic research to clinical application by simplifying the rare cell isolation process. This SBIR Phase II project proposes to develop an improved device for the detection and analysis of circulating tumor cells (CTCs) shed into the blood from cancer sites. CTCs are part of the process of spreading cancer, and early detection is key to improved treatment. Detection, quantification, and characterization of CTCs has the potential to transform oncology, yet isolation under routine conditions of these rare, one-in-a-billion cells, remains problematic. The proposed CTC sample preparation technology under development is low-cost, rapid, and potentially may provide a highly informative analysis of captured cells. It promises to enable a new generation of cancer diagnostics that impact patient care. During this Phase II project, the goal is to design and produce the separation device, a fluidic workstation, and supply kit; then, evaluate its ability to capture and recover CTCs from the blood of cancer patients. The Phase I data demonstrate the feasibility of this approach. The results of this study will evaluate alternative means of capturing and recovering CTCs, with the goal of 90% recovery of cells in a procedure requiring 60 minutes or less. A secondary goal of Phase II is to evaluate the potential of the device for the isolation of fetal cells from maternal blood, which could enable noninvasive prenatal diagnostics.