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QIAGEN与日本最大的临床试验检测公司SRL合作,加速推出伴随诊断

QIAGEN与日本最大的临床试验检测公司SRL合作,加速推出伴随诊断

QIAGEN与日本最大的临床试验检测公司SRL合作,加速推出伴随诊断

Qiagen今日宣布与日本最大的临床试验检测公司SRL.inc合作,准备在新药批准上市的同时引入新的伴随诊断试剂。此项临床试验研究服务的协议是非独家的,旨在加速SRL在QIAGEN配套的诊断工作平台上的业务快速实施,以获得日本医疗器械管理局(PMDA)的药物批准和测试。Qiagen与制药合作方共同开发的一些伴随诊断试剂预计将在未来几年如进入日本注册。

QIAGEN与SRL的Day-One实验室准备计划包括市场准入配套诊断的战略规划,报销申请以及SRL,QIAGEN和制药合作伙伴的医疗通信协调。 该协议将涵盖一系列QIAGEN伴随诊断业务,包括用于个性化医疗的实时聚合酶链反应(PCR)和新一代测序(NGS)解决方案。 最初的项目将涉及QIAGEN正在配合日本正在开发的用于实体瘤和白血病新药的伴随诊断试剂开发服务。

英文原文如下:

QIAGEN Creates Collaboration with Japan’s Largest Clinical Laboratory Testing Company, SRL, to Accelerate Launch of Companion Diagnostics

Day-one lab readiness speeds commercialization and reimbursement in personalized medicine

HILDEN, Germany & TOKYO–(BUSINESS WIRE)–QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a collaboration with SRL, Inc., the largest clinical testing laboratory company in Japan, to prepare for introduction of new companion diagnostics simultaneous with new drug approvals. The non-exclusive master collaboration agreement for clinical laboratory research services will enable rapid implementation by SRL of QIAGEN´s companion diagnostic workflows upon approval of the drugs and tests by Japan’s Pharmaceutical and Medical Devices Agency (PMDA). Several tests QIAGEN is co-developing with pharmaceutical partners are expected to enter registration in Japan in the coming years.

QIAGEN’s Day-One Lab Readiness initiative with SRL includes strategic planning for market access to companion diagnostics, filing for reimbursement, and alignment of medical communication by SRL, QIAGEN and pharmaceutical partners. The agreement will cover a range of QIAGEN companion diagnostics, including real-time polymerase chain reaction (PCR) and next-generation sequencing (NGS) solutions for Personalized Healthcare. Initial projects involve QIAGEN companion diagnostics paired with new drugs under development in Japan for solid tumors and leukemia.

文章版权归属触界科技。发布者:Betty Chen,转载请注明出处:http://www.chujietech.com/2018/08/1597/

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