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错误纠正测序技术的应用用于体内调节性致变性评估

Carole L Yauk¹, Anthony M Lynch², Vasily N Dobrovolsky³

¹Department of Biology, University of Ottawa, Ottawa, ON, Canada.

Regulatory toxicology and pharmacology : RTP

|November 10, 2025

概括

错误纠正测序 (ECS) 提供了敏感的体内致变性评估,克服了传统方法的局限性. 专家建议支持将其纳入监管指南,以便更广泛地应用.

科学领域:

基因毒性测试是指基因毒性测试.
分子毒理学分子毒理学
监管科学是一种监管科学.

背景情况:

转基因动物 (TGR) 试验在标准毒性研究和与3R原则一致方面存在局限性.
错误纠正测序 (ECS) 为体内致变性评估提供了一种敏感的方法.
监管的接受需要达成共识,并与国际准则保持一致.

研究的目的:

审查错误纠正测序 (ECS) 技术用于体内致变性评估.
为ECS纳入经济合作与发展组织 (OECD) 测试指南制定建议.
支持监管机构接受ECS用于基因毒性测试.

主要方法:

专家工作组对国际遗传毒性测试研讨会 (IWGT) 进行了ECS技术的审查.
评估ECS与经过验证的转基因动物试验的一致性.
评估ECS在标准重复剂量毒性研究中的整合.

主要成果:

经过验证的转基因动物试验,ECS产生了与验证的转基因动物试验一致的结果.
可以将ECS纳入标准≥28天重复剂量毒性研究.
数据的解释应侧重于相对于并发车辆控制的突变频率.

结论:

对于目前的突变致病性测试来说,ECS是一个显著的进步,可以使用多样化的模型.
强调与经合组织原则一致的统一数据报告.
工作组完全支持ECS提交监管文件,并建议将其纳入未来的经合组织测试指南.

关键词:

双重测序是指双重的测序.-seqq 的意思在HiFi-seqq.玉-seqqq 的时间.突变突变是一种突变.在PECC测序中,PECC测序这就是SMM-Seqq.

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