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NEW YORK – Medicover Genetics on Monday announced that its next-generation sequencing-based TarCET genetic testing kit has received certification under Europe's In Vitro Diagnostic Regulation.
纽约——Medicover Genetics周一宣布,其基于测序的下一代TarCET基因检测试剂盒已获得欧洲体外诊断法规的认证。
The reagent kit, along with the firm’s UltraVerse Index Oligos that go with it, has been categorized as Class A, the lowest-risk class. The kit contains a 'comprehensive suite of panels covering a range of genetic conditions' including metabolic disorders, cardiovascular diseases, hereditary cancers, infertility, and neonatal screening, the company said in a statement.
该试剂盒与该公司的UltraVerse Index Oligos一起被归类为A类,风险最低。该公司在一份声明中说,该试剂盒包含一套“涵盖一系列遗传疾病的综合面板”,包括代谢紊乱、心血管疾病、遗传性癌症、不孕症和新生儿筛查。
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The reagent kit includes library preparation and targeted capture enrichment and is intended for use with genomic DNA from human cells. It can be used to target specific regions of the genome with validated DNA hybridization probe panels that are supplied in the kit.
该试剂盒包括文库制备和靶向捕获富集,旨在与人类细胞的基因组DNA一起使用。它可以用于通过试剂盒中提供的经过验证的DNA杂交探针面板靶向基因组的特定区域。
The IVDR certification 'underscores our commitment to advancing genetic science while ensuring the highest standards of safety and quality,' Stefan Mehrle, head of Medicover Genetics, said in a statement.
Medicover Genetics负责人斯特凡·梅勒(StefanMehrle)在一份声明中说,IVDR认证“强调了我们对推进遗传科学的承诺,同时确保了最高的安全和质量标准”。
Medicover Genetics, formerly NIPD Genetics, is based in Cyprus. It is part of healthcare and diagnostic services company Medicover, which acquired a majority stake in the firm in 2021.
Medicover Genetics,前身为NIPD Genetics,总部位于塞浦路斯。它是医疗保健和诊断服务公司Medicover的一部分,Medicover于2021年收购了该公司的多数股权。