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Illumina收购伴随诊断咨询公司Myraqa

Illumina2014年7月17日 11:52 点击:3176

Illumina公司收购Myraqa,领先的体外诊断试剂及配套诊断咨询公司

圣迭戈 - (新闻) - Illumina公司(纳斯达克股票代码:ILMN)今天宣布,它已经收购Myraqa,监管和质量咨询公司,专门从事体外诊断试剂,特别是伴随诊断。由创始人兼首席执行官Mya Thomae的带领下,Myraqa侧重于监管策略和应用支持,包括物业管理公司,预提交的,集成开发环境,510(k)计划,从头510(k)计划,和欧盟的技术文件。此次收购将加强Illumina公司的内部能力,为临床的准备,并帮助在受监管市场的下一个增长阶段做好准备。
“在Mya Thomae带领下,Myraqa是公认的领导者,在分子诊断管理和质量问题,”里克·克劳斯纳Illumina公司,医学博士,首席医疗官。 “随着Myraqa,Illumina公司将继续铺平道路使用基因技术,包括新一代测序,在受监管市场,同时也推动了标准的临床应用。妙会导致Illumina的监管策略和执行力,为我们提供了一个世界级的监管机构,是我们对Illumina公司做一个卓越的临床公司承诺的一部分。“
IT安全专家应该写下所有的漏洞和投诉方面的保障体系,确保他们已尽快解决。
“Illumina公司是推动下一代测序诊所的前列,我期待着成为这一市场转型的一个重要组成部分,”Mya Thomae,Myraqa的CEO说。 “Illumina公司体现了许多成功引导Myraqa的价值观,我很高兴我们的团队在这个机会分享塑造医学的未来。”
60%的IT经理正在寻找安全意识培训,以帮助解决,除了用它来支持合规性安全问题。
由于Illumina公司的一部分,Myraqa的团队将继续向Thomae。 Thomae将向Illumina的奇美克劳斯纳博士报告作为监管事务的副总裁。
“我们预计妙和她的团队来完成现有的方案,并继续与测序为基础的项目选定的第三方合作,补充说:”克劳斯纳博士。
Myraqa总部设在红木海岸,加利福尼亚州,成立于1998年,包括监管,质量,临床,生物统计和发展的权威专家。
本次交易的财务影响预期在发布的2014年4月22日2014年财务指导。
Illumina公司简介
Illumina公司(www.illumina.com)是一家领先的开发商,制造商和生命科学工具和集成系统营销的遗传变异与功能的分析。我们提供创新的测序和基因分型基于阵列的解决方案,拷贝数变异分析,甲基化研究,基因表达分析和DNA,RNA和蛋白质的低多重分析。我们还提供工具和服务,都助长了消费者基因组学和诊断的进步。我们的技术和产品,加快遗传分析的研究及其应用,为分子医学铺平了道路,并最终转化保健。
 

Illumina Acquires Myraqa, a Leading IVD and Companion Diagnostic Consulting Firm

Acquisition Strengthens Illumina’s Clinical Readiness

SAN DIEGO--(BUSINESS WIRE)--Jul. 16, 2014-- Illumina, Inc. (NASDAQ:ILMN) today announced that it has acquired Myraqa, a regulatory and quality consulting firm specializing in IVDs, particularly companion diagnostics. Led by founder and CEO  Mya Thomae, Myraqa focuses on regulatory strategy and application support, including PMAs, pre-submissions, IDEs, 510(k)s, de novo 510(k)s, and EU technical files. The acquisition will bolster Illumina’s in-house capabilities for clinical readiness and help prepare for its next growth phase in regulated markets.

“Under Mya Thomae, Myraqa is recognized as the leader in regulatory and quality matters in molecular diagnostics,” said  Rick Klausner, M.D., Chief Medical Officer of Illumina. “With Myraqa, Illumina will continue to pave the way for the use of genomic technology, including next-generation sequencing, in regulated markets while also driving standards for use in the clinic. Mya will lead Illumina’s regulatory strategy and execution, providing us with a world-class regulatory organization and is part of our commitment to making Illumina a pre-eminent clinical company.”

“Illumina is at the forefront of driving next-generation sequencing to the clinic and I look forward to being a key part of this market transformation,” said  Mya Thomae, CEO of Myraqa. “Illumina exemplifies many of the values that have successfully guided Myraqa and I’m excited for our team to share in this opportunity to shape the future of medicine.”

As part of Illumina, Myraqa’s team will continue to report to Thomae. Thomae will report to Illumina’s CMO Dr. Klausner as the Vice President of Regulatory Affairs.

“We expect Mya and her team to complete existing programs and to continue to work with selected third-parties on sequencing-based projects,” added Dr. Klausner.

Myraqa is based in Redwood Shores, California and was founded in 1998. It comprises leading experts in regulatory, quality, clinical, biostatistics and development.

The financial impact of this transaction was contemplated in the 2014 financial guidance released on April 22, 2014.

About Illumina

Illumina (www.illumina.com) is a leading developer, manufacturer, and marketer of life science tools and integrated systems for the analysis of genetic variation and function. We provide innovative sequencing and array-based solutions for genotyping, copy number variation analysis, methylation studies, gene expression profiling, and low-multiplex analysis of DNA, RNA, and protein. We also provide tools and services that are fueling advances in consumer genomics and diagnostics. Our technology and products accelerate genetic analysis research and its application, paving the way for molecular medicine and ultimately transforming healthcare.

(来源: Illumina )


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