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Bruker宣布Avance™-IVDR作为临床筛查和体外诊断(IVD)发现和验证的标准化NMR平台

July 22, 2013

新的Avance-IVDR系统提供了高性能和吞吐量,用于开发和验证新兴的高质量,信息丰富和具有成本效益的IVD-NMR和临床筛查测定法

KARLSRUHE, Germany--(BUSINESS WIRE)--Jul. 22, 2013-- Bruker today announces a standardized nuclear magnetic resonance (NMR) spectroscopy platform for its clinical and diagnostics partners that enables cost-effective, high-performance NMR clinical screening and IVD-by-NMR discovery, development and validation of novel NMR assays.

新的AVANCE-IVDrsystem, presently for research use only, is a complete, proven and standardized platform for NMR clinical research and screening, as well as for IVD-by-NMR research. It features high sensitivity and information-rich output at 600 MHz proton-NMR frequency, and incorporates advanced hardware, software, automation, spectral libraries and standard operating procedures (SOPs) for high-performance bio-fluid screening and assay validation. Customer benefits include higher information content and spectral feature differentiation compared to low-field NMR systems, as well as excellent reproducibility, high throughput and potentially dramatically lower cost per sample for better clinical screening and IVD-by-NMR.

Dedicated to NMR-based clinical screening and diagnostics, theAVANCE-IVDris optimized for ease-of-use and highest data quality and reliability. The new standardized platform offers barcode analysis, control by a LIMS system, the high-throughput, temperature-controlled autosamplerSampleJet™,远程访问以及自动分析以及可自定义的分析结果报告。基于Bruker验证的SOP,AVANCE-IVDr平台可以开发可以解决各种医疗问题的身体流体甚至活检样本的诊断工具。SOP保证生产高度可重现的临床数据,从而在全球实验室之间对实验室之间的新型NMR分析进行交换和验证。在转化临床研究环境中,这些NMR分析产生的结果很容易转移到临床筛查和未来的IVD使用中。

Bruker的NMR光谱系统已经在全球40多个临床研究中心中使用,包括从事现代健康相关筛查技术(例如人类替代工程学)的医院。这AVANCE-IVDrsystem in its latest, standardized configuration has been installed already at several customer and strategic partner sites. Cross calibrations performed by Bruker across several centers have demonstrated NMR's unique advantage that spectra from samples prepared and measured under the Bruker SOPs are identical, independent of a center's location or operating staff.

由于与伦敦帝国学院的长期合作,AVANCE-IVDrplatform is already enabling the analysis of over 100,000 samples per year at the UK's recently opened MRC-NIHR Phenome Centre. This level of large-scale health-related NMR screening is paving the way for worldwide epidemiological studies as well as for clinical research and diagnosis. The benefits have been significant: facilitated by the low cost per sample and the even lower cost per parameter as compared to established single parameter screening methods, novel NMR methods for determining the cause of disease, delivering individualized patient treatment and developing strategies for prevention are now available to many clinical researchers.

Professor Jeremy Nicholson, Director of the MRC-NIHR Phenome Centre and Head of the Department of Surgery and Cancer at Imperial College London, commented: "The latest generation of Bruker NMR instruments gives us staggering day to day and long term reproducibility and reliability of spectral acquisition, coupled with the ability to do automated digital quantification of multiple metabolites. Thus, uniquely, the NMR technology platform can be used in simultaneous exploratory and targeted modes. We are totally committed to the use of NMR spectroscopy (in association with mass spectrometry) as a definitive bio-screening tool, and the latest technology developments now allow the deployment of the platform on an industrial scale."

Dr. Manfred Spraul, Bruker's Director of Applied NMR Business Development, added: "Migrating from translational research to clinical diagnostics requires robust, identical instrumentation in research facilities and hospitals, which is why Bruker has decided to offer the standardizedAVANCE-IVDr平台,可以从健康研究和大型流行病学研究中平稳转移到我们的合作伙伴的新兴IVD分析,其质量最高和可重复性。借助现代NMR技术和正确的SOP,我们和我们的合作者使用按钮技术为复杂混合物分析开辟了道路,将NMR确立为用于代谢分析和筛查的两种主要技术之一。”

About Bruker Corporation

Bruker Corporation (NASDAQ: BRKR) is a leading provider of high performance scientific instruments and solutions for molecular and materials research, as well as industrial, diagnostics and applied analysis.

For more information, please visitwww.energie2point0.com

资料来源:布鲁克公司

Bruker
Dr. Thorsten Thiel, +49 (721) 5161 - 6500
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