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转录基因生物标志物的审查,这些生物标志物可以预测人体细胞系中的体外基因毒性

Heng-Hong Li¹, Jiri Aubrecht¹, Tatyana Y Doktorova²

¹Department of Oncology, Georgetown University Medical Center, Washington, Washington, DC, USA.

Environmental and molecular mutagenesis

|March 4, 2025

概括

新的转录基因生物标志物为基因毒性测试提供了改进的机械洞察力,解决了预测人类致癌性的局限性. 三个关键生物标志物 (GENOMARK,TGx-DDI,MU2012) 在评估化学品安全方面显示出有望获得监管机构的接受.

科学领域:

毒理学毒理学毒理学
基因组学就是基因组学.
生物标志物开发生物标志物开发

背景情况:

目前的基因毒性测试缺乏机械细节和人类致癌性预测准确度.
基因组技术提供全基因组的转录数据,以了解化学作用机制.
转录基因生物标志物正在出现,以加强对各种化学品类的基因毒性危害评估.

研究的目的:

批判性地审查用于基因毒性测试的体外转录生物标记物的开发和应用.
根据系统化审查,识别和分析有前途的转录生物标志物候选者.
讨论这些新生物标志物的挑战和进展,以实现对这些新生物标志物的监管接受.

主要方法:

对已发表的关于体外转录生物标记物的文献进行了系统的审查和分析.
确定生物标志物候选物,并定义使用上下文,验证数据和案例研究.
基因毒性测试国际研讨会 (IWGT) 小组的研讨会讨论.

主要成果:

只有五种体外转录组生物标记候选物被确定,其中三种 (GENOMARK,TGx-DDI,MU2012) 符合纳入标准.
这些生物标志物是为制药,化品和医疗/环境化学品独立开发的,解决了标准基因毒性测试中缺乏特异性的问题.
所有已识别的生物标志物在转录基因水平上检测出基因毒性诱导的应激反应.

结论:

转录基因生物标志物比传统的基因毒性测试方法有了显著的进步.
GENOMARK,TGx-DDI和MU2012显示出改变基因毒性危险评估的潜力.
需要进一步的进展和验证才能实现对这些生物标志物的广泛监管接受.

关键词:

对DNA损伤的反应反应负面结果的途径.遗传毒性遗传毒性遗传毒性遗传毒性在 p53 里,p53 是一个 p53 的代码.转录简介转录简介转录的生物标志物

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