普洛麦格微卫星不稳定性（MSI）检测试剂获得中国国家药品监督管理局创新医疗器械特别审批程序的认定。
美国威斯康辛州麦迪逊市（2019 年 1 月 2 日）普洛麦格公司最新的微卫星不稳定性（MSI）检测试剂被中国国家药品监督管理局批准进入创新医疗器械特别审批程序。普洛麦格的 MSI 技术已经在全球各地的实验室得到广泛认知，在创新医疗器械特别审批程序认定下，中国国家药品监督管理局将会通过指派项目协调专员以及多项审批过程中的优先权益，提高该产品在申报应用于体外诊断过程中的工作效率。
「对国家药品监督管理局的此项决定我们感到非常兴奋和荣幸」，普洛麦格全球研发兼中国运营高级总监范凡博士说道，「普洛麦格中国团队感遇由于 MSI 技术的高灵敏度及在全球各地的广泛应用而对医疗健康领域带来的重要作用和机会。此次认定加速了我们尽快为临床医生提供最好的工具，为患者带来福音的期待。」
此款在中国申报 ProDx® 商标的 MSI 产品使用的是普洛麦格 MSI 技术平台下最新的 MSI 2.0 版本。MSI 是基因组不稳定性的一种，表现为在微卫星位点核心重复单元的错误插入或删除，它是由于 DNA 错配修复系统（MMR）功能障碍所产生的。MSI 是实体瘤中常见的 DNA 错配修复系统功能障碍的衡量指标，可以为肿瘤学家、病理学家和患者提供更多信息，以确定最佳治疗方案。这项最新的 MSI 2.0 技术正在全球发起研究者主导型申报以确定其在结直肠癌以外实体肿瘤中的应用。
普洛麦格持续在全球推广 MSI 技术，2018 年美国病理学家协会（College of American Pathologists，CAP）一项调查显示，70% 的受访实验室使用普洛麦格的 MSI 1.2 试剂盒进行 MSI 检测。在向中国国家药品监督管理局申报的同时，普洛麦格也在向美国 FDA 申报 MSI 1.2 在体外诊断领域的应用。
附：英文通讯原文
Promega Microsatellite Instability Technology Receives Innovation Designation from Chinese National Medical Products Administration.
Madison, WI USA (January 2, 2019) Promega Corporation’s latest microsatellite instability (MSI) technology has been granted innovation designation by the Chinese National Medical Products Administration (NMPA). Promega MSI technology has been validated in labs around the world. With innovation status, the path to become classified as an invitro diagnostic (IVD) will gain elevated efficiency by having a program coordinator assigned from NMPA and priority status for multiple processes.
「We are excited and honored with this decision from NMPA」, says Frank Fan, Senior Director of Research & China Operations at Promega.「Our Promega China team appreciated the emerging and important role our MSI technology can play in health care because of its sensitivity and prominent use around the world. Innovation Designation accelerates our hope to get the best tools in the hands of clinicians and bring benefits to patients.」
This version of the Promega MSI platform, trademarked ProDx® in China, is the latest version (MSI 2.0) of the Promega MSI technology. This technology is a PCR-based method for detecting MSI, a form of genomic instability caused by the insertion or deletion of repeating bases called microsatellites during DNA replication and the failure of the mismatch repair system to correct these errors. MSI status is a measure of mismatch-repair deficiency commonly found in solid tumors, providing oncologists, pathologists and patients more information to determine the best treatment path. This new MSI technology is currently being accessed globally in investigator-initiated trials to determine its application in solid tumors beyond colon cancer.
Promega continues to advance the promise of MSI technology globally. In the US, Promega intends to seek Food and Drug Administration (FDA) approval for IVD status of the MSI 1.2 platform. A 2018 College of American Pathologists survey indicated that 70% of respondents performing nucleic acid based MSI testing were doing so using the Promega MSI 1.2 panel of loci.
About Promega
Promega Corporation is a leader in providing innovative solutions and technical support to the life sciences industry. The company’s 4,000 products enable scientists worldwide to advance their knowledge in genomics, proteomics, cellular analysis, drug discovery and human identification. Founded in 1978, the company is headquartered in Madison, WI, USA with branches in 16 countries and over 50 global distributors. For more information about Promega, visit www.promega.com.