解码生命 守护健康

2018年1月4日，全球基因测序巨头Illumina（纳斯达克：ILMN）与中国第三医学检验行业领先者金域医学（上交所：603882）共同宣布，双方将利用Illumina的下一代测序（NGS）技术共同为中国患者开发肿瘤及遗传病检测系统，专门用于分子肿瘤及遗传性肿瘤检测。本次合作是符合中国食药监总局（CFDA）审查条件并获取相关批准的重要一步，并将成为以精准医疗造福中国患者的契机。

根据双方签订的协议，Illumina与金域医学将在Illumina基因测序平台的基础上合作开发一款整合的NGS系统，并提供兼具性价比、易用的体外诊断（IVD）方法用于分子肿瘤及遗传性肿瘤检测。该系统以Illumina的MiniSeq测序系统及相关的测序耗材为基础，将金域医学专有的检测组件（包括文库制备试剂盒与分析软件）与测序仪进行整合。今后，该整合系统将有望通过金域医学超过8000家的二、三级医院客户网络，惠及全中国的癌症患者。

“金域医学的动力源自于为中国每年超过400万的新增癌症患者提供诊断与治疗。我们的使命是为中国患者引入经验证的最新技术，提升护理水平，改善患者疗效”。金域医学董事长兼CEO梁耀铭表示，“Illumina作为首个通过美国FDA批准的下一代测序仪的制造商，具有与中国企业丰富的合作经验，是我们理想的合作伙伴”。

“金域医学是中国领先的第三方医学实验室，对于能够和他们共同合作定制基于MiniSeq系统的、符合CFDA审批条件可应用于临床肿瘤检测的测序系统，Illumina感到非常兴奋。”Illumina临床基因组学执行副总裁Garret Hampton博士如是说。

Illumina中国总经理Ruilin Zhao博士则表示， 本协议代表了Illumina愿意与中国甚至全球的综合型医学检验提供商开展共同合作，协助他们开发基于下一代测序的体外诊断产品并商业化。“通过进一步扩充在中国的临床合作网络，我们将专注于为全中国患者提供最优质的医疗解决方案”。

资料显示， 总部位于美国加州圣地亚哥的Illumina是全球领先的，专门进行开发、制造和销售用于大规模分析遗传变异和基因功能的生命科学工具及一体化系统的厂商，为科研、临床和应用市场的客户提供服务。该公司产品应用在生命科学、肿瘤学、生殖保健、农业及其他新兴市场上。

广州金域医学检验集团股份有限公司则创建于2003年，是中国领先的第三方医学实验室，医疗机构客户超过21000家。通过其建立的遍布全国的37家实验室，金域为广大医疗和健康机构开发并应用了超过2400项的医学检测、病理诊断及基因检测项目。金域医学2017年在上交所成功上市。其2017年半年报显示，金域医学基因组学检验2017年上半年营业收入为4.33亿元，成为该公司第一大业务板块。

Illumina and KingMed Diagnostics Partner to Develop Next-Generation Sequencing Technology for Chinese FDA Approval

Companies Target Review Aimed at Molecular Oncology and Hereditary Diseases

SAN DIEGO--January 4, 2017--Illumina, Inc. (NASDAQ: ILMN) and KingMed Diagnostics (SSE: 603882.SS) announced an agreement to jointly develop novel oncology and hereditary disease testing applications utilizing Illumina’s next-generation sequencing (NGS) technology.The collaboration is a significant step toward China Food and Drug Administration (CFDA) review and approval, and serves as a starting point to deliver precision medicine to patients throughout China.

Under the agreement, Illumina and KingMed Diagnostics will partner to co-develop an integrated NGS system that provides cost-effective and ready-to-use in-vitro diagnostic (IVD) assays for molecular oncology and hereditary cancer testing. The new system, which is based on Illumina’s MiniSeqSystem and related sequencing consumables, will integrate KingMed Diagnostics’ proprietary testing components, which include library preparation kits and analysis software, with a sequencing instrument.

“KingMed Diagnostics’ motivation is to improve diagnosis and treatment for the more than 4 million new cancer patients identified in China each year. Our mission is to bring state-of-the-art technology to Chinese patients by enhancing their standard of care and improving their outcomes,” said Professor Yaoming Liang, Chairman and CEO of KingMed Diagnostics. “Illumina is the ideal collaborator because they have a proven track-record of working with multiple domestic companies in China, in addition to being the first company with a U.S. FDA-cleared, next-generation sequencing instrument.”

“KingMed Diagnostics is one of the leading independent clinical laboratory service providers in China, and as such, we are excited to partner with them to help customize the MiniSeqSystem under CFDA requirements for clinical oncology applications,” said Garret Hampton, Ph.D., Executive Vice President of Clinical Genomics at Illumina.

“This agreement is a clear demonstration of our commitment to working with broader clinical testing service providers in China who want to develop and commercialize IVD based on NGS,” said Ruilin Zhao, Ph.D., Illumina’s General Manager of China. “As we continue to expand our clinical partner networks, we are focused on providing the best healthcare solutions to patients throughout China.”

About KingMed Diagnostics

Guangzhou KingMed Diagnostics Group Co., Ltd. (www.kingmed.com.cn) was established in 2003 as the leading independent clinical testing laboratory in China that has been serving over 21000 medical institutions as our customers. KingMed develops and commercializes an extensive medical, pathological and genomic testing offering with over 2,400 testing items to a wide range of medical and healthcare institutions with its 37 established testing laboratories across China. KingMed made a successful IPO at Shanghai Stock Exchange in 2017.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. 

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