NEW YORK – Promega said Tuesday that its ProDx MSI Detection Kit has received an innovative medical device registration certificate from China's National Medical Products Administration (NMPA).

纽约——Promega公司周二表示，其ProDx MSI检测套件已获得中国国家药品监督管理局（NMPA）的创新医疗器械注册证书。

According to a company spokesperson, the certificate 'represents full approval for the ProDx MSI Detection Kit to be used for diagnostic testing in China.' The kit was reviewed through the NMPA's innovative device pathway, which expedites approval for certain technologies deemed to have significant clinical value..

据公司发言人介绍，该证书“代表 ProDx MSI 检测试剂盒已获得在中国用于诊断测试的完全批准”。该试剂盒通过了 NMPA 的创新设备通道进行审查，这一通道可加快被认为具有显著临床价值的某些技术的审批进程。

Following the approval, the kit is now available for clinical testing in China to screen for high-frequency microsatellite instability (MSI-H) in colorectal cancer patients in order to identify those who may benefit from additional genetic testing for Lynch syndrome.

获批后，该试剂盒现在中国可用于临床测试，以筛查结直肠癌患者中的高频微卫星不稳定性（MSI-H），从而识别出可能受益于林奇综合征进一步基因检测的患者。

The kit uses fluorescent PCR coupled with capillary electrophoresis to qualitatively detect eight microsatellite loci in tumor tissue.

该试剂盒采用荧光PCR结合毛细管电泳的方法，对肿瘤组织中的八个微卫星位点进行定性检测。

'This certificate is the culmination of a yearslong effort to bring this innovative technology into clinical laboratories in China,' Tom Duan, general manager of Promega Shanghai, said in a statement.

“这份证书是多年努力的结晶，旨在将这种创新技术引入中国的临床实验室，”普洛麦格上海总经理Tom Duan在一份声明中表示。

Promega's OncoMate MSI Dx Analysis System, which uses the same MSI technology, has already been

Promega的OncoMate MSI Dx分析系统，使用相同的MSI技术，已经被

cleared

已清除

by the US Food and Drug Administration and

美国食品和药物管理局以及

CE-marked

CE标志

as an IVD medical device.

作为体外诊断医疗器械。