DEVELOPMENT OF A HUMAN SOMATIC GENE MUTAGENICITY ASSAY

描述(改编自《调查者摘要》)：行业和监管 这两个机构都需要一种改进的测试来确定诱变剂的特征 毒品和化学品的潜力。目前的体外检测方法检测到特定的 单拷贝基因的DNA损伤亚型(即插入和缺失) 但不要检测到在复杂的细胞过程中可能导致的突变 例如同源重组和染色体分离。要解决这些问题 以及目前诱变性筛查的其他局限性，调查人员的 该小组已经构思了一种体外体细胞基因突变测试方法，该方法使用一种 人红细胞细胞系，是基于体内广泛使用的一种检测方法 血糖素A体细胞突变分析。这项建议的化验方法将能够 根据诱变剂诱导等位基因失活的能力来检测诱变剂 一种体细胞基因。如果完全发挥其潜力，这种化验方法将 补充诱变性检测以筛选药物制剂、化学品和 用于人类诱变剂的消费品。这个测试可以在很高的温度下进行 允许快速筛选大量化合物的吞吐量格式。 建议的商业应用： MB Research将为制药、生物技术、化妆品、 化工和消费品行业。客户经常询问关于 沙门氏菌试验(Ames试验)和CHO/HGPRT突变试验的替代品。 拟议中的化验将有能力检测到可能遗漏的人类诱变剂。 通过目前可用的致突变性检测。由于建议的化验方法将满足 合同测试行业对测试特定类型的现有需求 作为人类诱变剂，该检测方法具有巨大的商业价值。

DESCRIPTION (Adapted from the Investigator's Abstract): Industry and regulatory agencies are both in need of an improved test to characterize the mutagenic potential of drugs and chemicals. The present in vitro assays detect specific subtypes of DNA damage (i.e., insertions and deletions) of single-copy genes but do not detect mutation that may result during complex cellular processes such as homologous recombination and chromosome segregation. To address these and other limitations of the current mutagenicity screens, the investigator's group has conceptualized an in vitro test for somatic gene mutagenicity using a human erythroleukocyte cell line, a test is based on the widely used in vivo glycophorin A somatic cell mutation assay. This proposed assay would be able to detect mutagens based on their ability to induce the inactivation of an allele of a somatic gene. If developed to its full potential, this assay will complement the mutagenicity assays to screen drug formulations, chemicals and consumer products for human mutagens. This assay can be conducted in a high throughput format permitting the rapid screening of numerous compounds. PROPOSED COMMERCIAL APPLICATION: MB Research will offer this mutagenicity assay to the pharmaceutical, biotech, cosmetic, chemical and consumer products industries. Clients frequently make inquiries concerning alternatives to the Salmonella assay (Ames Test) and CHO/HGPRT mutagenicity assay. The proposed assay will have the ability to detect human mutagens that may be missed by the mutagenicity assays currently available. Since the proposed assay will satisfy an existing demand in the contract-testing industry for a test to detect specific types of human mutagens, the assay has tremendous commercial value.