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【资讯翻译】Qiagen Slips 2% – FDA Issues Warning Letter on Blood Test...

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发表于 2016-6-29 08:53:12 | 显示全部楼层 |阅读模式
Qiagen Slips 2% – FDA Issues Warning Letter on Blood Test QuantiFERON-TB Gold (NASDAQ:QGEN)

Shares of Qiagen (NASDAQ:QGEN) were sliding Tuesday after the Food and Drug Administration sent a letter to the maker of diagnostic products in which it detailed results of an inspection carried out on its QuantiFERON-TB Gold blood testing product. The inspections which occurred between Jan. and Feb. revealed methods used to produce the QuantiFERON test device weren’t in conformity with current good manufacturing practice requirements as laid out in the Quality System regulation found in Title 21 Code of Federal Regulations, Part 820.

The FDA also said the blood test device is misbranded under U.S. regulations. The agency said it reviewed the company’s responses and concluded they are not adequate. Unless these violations are corrected, the FDA said it may initiate regulatory action without further notice, which may include seizure, injunction and civil money penalties. QGEN was down more than 2% in recent trade, moving in the lower end of the 52-week range of $20.10 to $28.53.

The stock is down 2.66% or $0.56 after the news, hitting $20.5 per share. About 2.09M shares traded hands or 176.05% up from the average. Qiagen NV (NASDAQ:QGEN) has declined 15.86% since October 16, 2015 and is downtrending. It has underperformed by 16.60% the S&P500.

QIAGEN N.V. provides sample to insight solutions that transform biological samples into valuable molecular insights worldwide. It offers sample technologies to isolate, purify, and stabilize nucleic acids and proteins in plasmid deoxyribonucleic acid (DNA) purification, ribonucleic acid purification and stabilization, genomic and viral nucleic acid purification, DNA cleanup after polymerase chain reaction (PCR) and sequencing, and library preparation for sequencing applications; and assay technologies to detect molecular targets. The company also offers ingenuity variant analysis, a cloud-based platform to evaluate data generated by NGS technologies; CLC cancer research workbench, a cancer-focused informatics solution; and GeneGlobe, a Web-based portal that enables researchers to search and select from pre-designed and custom PCR assay kits and NGS assay panels. In addition, it provides co-development, technology licenses and patent sales, and custom services, such as whole genome amplification services, DNA sequencing, and non-cGMP DNA production.

Further, the company offers instrumentation systems for laboratories to perform nucleic acid sample preparation, assay setup, target detection, and interpretation of genomic information. Its automation platforms include QIAsymphony, a modular system; EZ1 Advanced XL for automated nucleic acid purification; QIAcube, a sample processing instrument; QIAcube HT for automated nucleic acid purification; Rotor-Gene Q, a rotary real-time PCR cycler system; PyroMark, a high-resolution detection platform; QIAgility, a compact benchtop instrument; QIAxcel for nucleic acid separation; and ESEQuant Tube Scanners. The company serves molecular diagnostics, applied testing, pharma, and academia customers. It has collaboration agreement with Astellas Pharma Inc., AstraZeneca PLC, Eli Lilly and Company, Exosome Diagnostics Inc., 10x Genomics, and Novartis AG. QIAGEN N.V. was founded in 1986 and is headquartered in Venlo, the Netherlands.

信源地址:http://sonoranweeklyreview.com/q ... tb-gold-nasdaqqgen/

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发表于 2016-6-30 15:21:01 | 显示全部楼层
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发表于 2016-7-1 11:40:35 | 显示全部楼层
                      Qiagen公司股票跳水2%–FDA对其QuantiFERON-TB Gold血液测试发出警告信(纳斯达克股票代码:qgen)

       自从周二美国FDA致函Qiagen公司——诊断产品制造商,Qiagen公司股票(纳斯达克股票代码:qgen)持续下滑。在这封函李,详细罗列了该公司QuantiFERON-TB Gold血液测试产品的检查结果。该调查在1月和2月之间进行,显示QuantiFERON测试装置与《美国联邦法规》第21篇,820部《现行良好生产规范》的要求不符。

       FDA还表示,根据美国法规,Qiagen公司的血液检测装置是冒牌的。FDA审查了该公司的反馈报告后得出的结论是,他们的理由是不充分的。除非这些违规被纠正,美国FDA指出他们可能会在没有进一步通知的情况下启动监管行动,其中可能包括扣押,禁止令和民事罚款。在最近的交易中,QGEN股票跌幅超过2%,达到52周20.10美元至28.53美元范围的低端。

       该消息后,股价下跌2.66%或0.56美元,每股收20.5美元。将近有209万股发生交易,高于平均值176.05%。自2015年10月16日以来,QIAGEN NV(纳斯达克股票代码:qgen)下降了15.86%,并保持这下降趋势。它的表现比标准普尔500指数(S&P500)低16.60%。

       QIAGEN N.V.为全世界提供样品解决方案,将生物样品转化为有价值的分子信息。它提供核酸和蛋白的分离、纯化和稳定等样品技术,包括质粒脱氧核糖核酸(DNA)的纯化,核糖核酸的纯化和稳定、基因组和病毒核酸纯化、经聚合酶链反应(PCR)后DNA清理和测序,测序用文库制备;靶分子检测方法等。该公司还提供了独创性的变异分析(一种用于评价NGS技术生成数据的云计算平台);CLC癌症研究工作台(一个聚焦于癌症的信息解决方案);GeneGlobe(使研究人员能够从预先设计和定制的PCR检测试剂盒和NGS检测面板进行研究和选择的基于web的门户)。此外,它提供了共同发展、技术许可和专利销售和定制服务,如全基因组扩增服务、DNA测序、和非cGMP DNA生产。

       此外,该公司为实验室提供仪器系统进行核酸样品的制备,检测设置,目标检测和基因组信息解析。Qiagen公司的自动化平台包括:QIAsymphony模块化的系统;EZ1高级XL自动核酸纯化系统;QIAcube样品处理仪器;QIAcube HT自动核酸纯化系统;Rotor-Gene Q旋转实时PCR仪系统;PyroMark高分辨率检测平台;QIAgility,小型台式仪器; QIAxcel核酸分离系统和ESEQuant管扫描仪。该公司服务于分子诊断,应用测试,制药和学术界客户。它与Astellas制药公司,阿斯利康公司,礼来公司,exosome诊断公司,10X基因组学和诺华公司达成合作协议。QIAGEN公司成立于1986,总部位于荷兰的芬洛。

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 楼主| 发表于 2016-7-12 09:40:14 | 显示全部楼层
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