马萨诸塞州比勒里卡。--(BUSINESS WIRE)--
Bruker Corporation（纳斯达克股票代码：BRKR）今天宣布已被授予美国
FDA根据第510（k）条的清除销售MALDI BIOTYPERCA Systemin
the United States为了鉴定从人类标本培养的革兰氏阴性细菌菌落。
布鲁克的Maldi Biotyper（照片：商业资讯）
这MALDI BIOTYPERCA Systemincludes the bench-top微杆™ MALDI-TOF (matrix-assisted laser desorption ionization time-of-flight) mass spectrometer, software, IVD labeled reagents, a 48-spot MALDI target and a library of microorganism reference spectra.
Brukerhas conducted a multi-site clinical trial comparing performance of theMALDI BIOTYPERCA System至16S核糖体RNA基因测序。总体准确性MALDI BIOTYPERCA Systemwas comparable to that of nucleic acid sequencing.
FDA清除MALDI BIOTYPERCA Systemis the latest achievement in Bruker’s continuous efforts to develop MALDI-TOF mass spectrometry into the most advanced platform for clinical microbiology identification.
In 2009,
Bruker发射MALDI BIOTYPERsystem in compliance with the European体外diagnostic directive EC/98/79, making the CE-IVD labelledIVD-MALDI Biotyper第一个基于MALDI-TOF的产品注册用于欧洲临床微生物学实验室。自那以后，
Brukerhas continued its effort to expand into routine clinical microbiology and other markets throughout the world. Currently the CE-IVD labelledIVD-MALDI Biotyperis available for clinical microbiology routine usage in
Europe, as well as in many countries around the world, including
Canada,
Argentina,
墨西哥,
Colombia和
Ecuador在里面
Americas并在
Japan,
Hong Kong,
新加坡,
Malaysia和
Taiwanin
Asia/Pacific。
Frank Laukien, President and Chief Executive Officer of
Bruker Corporation评论说:“我们对此感到非常兴奋major milestone in our effort to introduce MALDI-TOF mass spectrometry into clinical diagnostics. For the last seven years
Brukerhas been working on continuous innovation in the field of MALDI-TOF-based microbial identification, bringing theMALDI BIOTYPER临床常规实验室的平台。这MALDI BIOTYPERhas been a success with more than 1,000 systems sold or leased worldwide, which has positively affected the health of many patients.
Brukerhas initiated a continuing revolution in clinical microbiology towards theMALDI BIOTYPERas a next-generation identification technique. With clearance by the US FDA to market theMALDI BIOTYPERCA System, we expand our market reach into the largest clinical market in the world, with expected significant improvements in outcomes and reductions in the cost of healthcare.”
Dr.
Robert Jerris, PhD, D (ABMM), the Director of Clinical Microbiology at the Children´s Healthcare of
亚特兰大儿科医院补充说：“马尔代tof对儿童医疗保健的患者护理产生了巨大影响
亚特兰大。直接从板中识别生物的能力 - 与许多生物体的常规表型测试至少节省生物 - 已经影响了治疗，及时的感染控制，并有助于减少医疗保健支出。结果研究表明，可以说这项技术最终成为临床微生物学的主食是可以预见的。”
有关
BrukerMALDI BIOTYPER
这MALDI BIOTYPER系统家族可实现分子鉴定，分类学分类或对细菌，酵母菌和真菌等微生物的分类或消除。使用高通量MALDI-TOF质谱法蛋白质组学指纹识别微生物的分类和鉴定是可靠而快速实现的。这MALDI BIOTYPERuses a molecular approach based on specific proteomic fingerprints from bacterial strains and published studies have highlighted the greater accuracy and lower cost offered, as well as the typically much faster time-to-result.
各种应用MALDI BIOTYPERsolutions include clinical routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product safety and quality control, as well as marine microbiology. In many European and international laboratories theMALDI BIOTYPER由于系统的准确性，速度，广泛的物种覆盖范围，易于使用和成本效益，在过去五年中取代了经典的生化测试以进行细菌鉴定。经典的生化技术取决于检测微生物的不同代谢特性。但是，这些技术可能需要数小时甚至几天才能完成，并且通常缺乏特殊性。
这robustMALDI BIOTYPER方法需要最少的样品准备，并提供低消耗量的成本。这products of theMALDI BIOTYPERfamily are available in a research-use-only (RUO) version, as the U.S.
FDA-clearedMALDI BIOTYPERCA System, or in an IVD-CE version according to EU directive EC/98/79. TheMALDI BIOTYPERalso has medical device registrations in numerous other countries. Work-in-progress RUO versions of the MALDI Biotyper even allow selected high-value antimicrobial resistance tests in translational research.
关于
BRUKER CORPORATION(NASDAQ: BRKR)
Brukeris a leading provider of high-performance scientific instruments and solutions for molecular and materials research, as well as for IVD, industrial, security and applied markets. For more information:www.energie2point0.com
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来源：
Bruker Corporation