Flow Cytometric Method to Analyze Micronuclei

描述：体内微核(MN)试验是一种广泛使用的检测方法 筛选化合物具有破坏染色体的活性。这也是一次关键的考验 新药的注册。Litron实验室已经开发出一种 用流式细胞术(FCM)自动计分MN。这个系统有 几个好处：分析的细胞数量增加，能够处理更多 样本时间更少，客观分析/评分。 在第二阶段工作中，Litron将进行旨在验证其试剂盒的实验 得分MN。具体来说，他们和他们的合作者将分析： 具有不同作用模式的遗传毒性化合物，执行整个测试 从动物给药到血液固定和分析，进行显微 对这些相同的血液样本进行评估，以与FCM进行比较 实验室间可变性，并准备一份文件提交给ICCVAM 监管部门的批准。 建议的商业应用： Litron基于FCM的MN检测的验证和监管批准将导致Litron开发的小鼠外周血MN分析试剂盒的销售增加。类似的研究也计划用于分析试剂盒，以测量小鼠和大鼠骨髓、大鼠外周血以及人外周血中的MN。这些工具包的销售存在着巨大的商业机会。

DESCRIPTION: The in vivo micronucleus (MN) assay is a widely used test to screen compounds for chromosome-damaging activity. It is also a key test for the registration of new pharmaceuticals. Litron Laboratories has developed an automated method of scoring MN using flow cytometry (FCM). This system has several benefits: increased numbers of cells analyzed, ability to process more samples in less time, and objective analysis/scoring. In Phase II work Litron will perform experiments designed to validate their kit for scoring MN. Specifically, they and their collaborators will: analyze genotoxic compounds with different modes of action, perform the entire assay from animal dosing to blood fixation and analysis, perform microscopic evaluations of these same blood samples for comparison with FCM, measure interlaboratory variability, and prepare a document to submit to ICCVAM for regulatory approval. PROPOSED COMMERCIAL APPLICATION: The validation and regulatory approval of Litron's FCM based MN assay would result in increased sales of Litron's developed mouse peripheral blood MN analysis kits. Similar studies are planned for analysis kits to measure MN in mouse and rat bone marrow, rat peripheral blood and also human peripheral blood. Enormous commercial opportunity exists from the sale of these kits.