Microfluidic Point-of-care Cancer Cell Analyzer

描述（由申请人提供）： Aluminics，Inc.，和Xtrana，Inc.，将开发一种廉价的癌症标记检测设备。该设备将集成和自动化血液样品制备，细胞分选和富集的显微细胞术，抗原（CD标记）分析，DNA序列和基因表达分析。Aluminics开发了一种技术平台，用于在基于层压材料的一次性用品上执行微流体工艺。该技术包括由塑料层压件组装的微流体盒、计算机控制的流体驱动器系统、使用精确的低脉动泵的气动和被动芯片上阀门能力以及控制盒中流体运动的计算机软件。Xtrana开发了一系列新的产品和应用，这些产品和应用围绕着核酸样品制备的独特功能。样品制备的关键是一系列被称为Xtra Bind的材料，其基本上不可逆地结合核酸，但仍允许使用常规方法如PCR扩增结合的DNA或RNA。 该项目将需要在微流控细胞标记识别和分选领域以及芯片上细胞裂解和基于微流控的核酸扩增和检测领域进行研究和原理验证实验。具体而言，最初将进行涉及在显微细胞仪卡上进行荧光检测、准确计数和显示不同大小的荧光珠以及与抗原结合、抗体标记并在显微细胞仪上计数的珠的实验，然后在显微细胞仪上进行分选/荧光门控。 同时，Xtransa将开发Xtra BindTM BCR/ABL mRNA表达测量方案，并将通过实验确定加标到白色血细胞或血液中的对照细胞系的bcr/abl mRNA转录本的检测限和检测线性范围。在第二阶段，将开发一种能够诊断慢性粒细胞白血病（CML）的BCR/ABL基因易位和相关嵌合mRNA表达的仪器。

DESCRIPTION (provided by applicant): Micronics, Inc., and Xtrana, lnc., will develop an inexpensive point of care cancer marker detection device. The device will integrate and automate blood sample preparation, cell sorting and enrichment by microcytometry, antigen (CD marker) analysis, and both DNA sequence and gene expression analysis. Micronics has developed a technology platform for performing microfluidic processes on laminate-based disposables. The technology comprises microfluidic cartridges assembled from plastic laminates, a computer-controlled fluid driver system, pneumatic and passive on-chip valving capability using accurate Iow-pulsatility pumps, and computer software to control fluid motion in the cartridge. Xtrana has developed a novel series of products and applications centered around unique capabilities in nucleic acid sample preparation. Key to the sample preparation is a family of materials, referred to as Xtra Bind, that bind nucleic acids essentially irreversibly, but still allow the bound DNA or RNA to be amplified using conventional methods like PCR. The project will require research and proof-of-principle experiments in the area of microfluidic cell marker identification and sorting, as well as in on-chip cell lysing and microfluidics-based nucleic acid amplification and detection. Specifically, experiments involving fluorescence detection on micro-cytometer card, accurate counting and display of fluorescent beads of different sizes as well as beads conjugated with antigen, tagged by antibody and counted on micro-cytometer will be performed initially, followed by sorting/fluorescence gating on micro-cytometer. At the same time, Xtrana will develop the protocols for the Xtra BindTM BCR/ABL mRNA expression measurement and will experimentally determine limit of detection and linear range of detection of bcr/abl mRNA transcripts for control cell lines spiked into white blood cells or blood. In Phase II, an instrument capable of BCR/ABL gene translocation diagnostic of chronic myeloid leukemia (CML) and the associated chimeric mRNA expression will be developed.