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Illumina同Asuragen合作开发新型的伴随诊断技术

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Asuragen公司今天表示将同Illumina合作共同开发新型的伴随诊断技术。

  Asuragen公司今天表示将同Illumina合作共同开发新型的伴随诊断技术。
  基于这项合作协议,Asuragen将利用其Quantidex的新一代测序产品平台和Illumina的MiSeq Dx设备,来为其生物技术和制药领域伙伴开发定制化的伴随诊断技术;目前Asuragen已经向美国FDA递交了510(k)文件。
  Asuragen表示,这种新型的Quantidex DNA测试将会是一种多路复用的定量PCR测试,其可以测定样品中经PCR扩增放大的DNA的完全拷贝数。另外,公司最近还推出了其Quantidex Pan癌症检测试剂盒,其是一种仅供研究用的产品,可以对来自21个基因的46个扩增进行分析。
  Asuragen公司总裁Matt McManus在一项声明中表示,公司的Quantidex 新一代测序技术产品平台或将帮助制药和生物技术公司开发新型的基于DNA或RNA的检测盘;此外,他还表示,该系统是以cGMP的设施来进行控制和设计的,可以为调节性的诊断产品的开发提供高质量的基础保证。(转化医学网360zhyx.com)
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Illumina, Asuragen to Collaborate on Companion Diagnostics Development

Illumina and Asuragen plan to collaborate on companion diagnostics development, Asuragen said today.


Under the agreement, Asuragen will leverage its Quantidex next-generation sequencing product platform and Illumina's MiSeq Dx instrument, which has US Food and Drug Administration 510(k) clearance, to develop customized companion diagnostics for its biotech and pharmaceutical partners.

The Quantidex DNA assay is a multiplexed quantitative PCR assay that measures the absolute copy number of PCR-amplifiable DNA in a sample, according to Asuaragen. In addition, the firm recently launched its Quantidex Pan Cancer kit,  a research-use-only product that analyzes 46 amplicons from 21 genes.

President and CEO of Asuragen Matt McManus said in a statement that the firm's Quantidex NGS product platform would enable pharmaceutical and biotech companies to develop "a unique DNA and/or RNA panel of interest." In addition, he said, the system is "built under design control and manufactured in our cGMP facility, providing a high-quality basis for regulated diagnostic product development."

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