- 用于MALDI BIOOTYPER基于高风险碳酸碳纤维酶抗生素耐药性（MBT Star）的首个CE-IVD套件，
- CE-IVD MBT Mycobacteria IVD Library & Software for identification of 164 mycobacteria species,
- Further Enhancements for MALDI Biotyper-based Microbial Subtyping for Clinical Research, and
- Novel CE-IVD Genetic Assays with 2-3 Hours of Time to Result for Invasive Aspergillosis and Carbapenem Resistance Gene Testing without Culture;
VIENNA,
2017年4月21日/PRNewswire/ -- At the 27th
European Congress of Clinical Microbiology and Infectious Diseases(ECCMID),
Bruker明天将引入重要的新临床微生物学分析和消耗品套件，以进一步增强MALDI BIOTYPER®(MBT)platform. Bruker will also introduce novel, real-time PCR assays and kits for fast molecular testing of invasive曲霉病和carbapenemresistance.
With our newMBT STAR®-Carba IVDkit,
Brukerexpands theMALDI BIOTYPERworkflow beyond accurate and very broad microbial identification to additional fast functional testing of resistance against selected antibiotics of high clinical relevance. TheMBT Star-Carba IVDkit is the first validated diagnostic assay for mass spectrometry-based resistance testing on the market. It offers rapid turnaround time, and also gives information on the resistance mechanism. Independent of the resistance gene(s) involved, this novel assay detects the bacterial antibiotic resistance mechanism, e.g. the degradation of carbapenems, from isolates or from positive blood cultures. Specifically, theMBT Star-Carba IVDassay is testing against carbapenem-resistance in Gram-negative bacteria, thus addressing a currently urgent healthcare problem. TheMBT Star-Carba IVDKit and Software Module for the automated data interpretation are labeled according to EU directive EC/98/79. Bruker is planning to further expand the portfolio ofMBT STARassays in the future for the detection of additional resistance mechanisms.
Bruker还宣布了日常工作的重要增强MALDI BIOTYPERmicrobiology fast identification workflows, including aMBT Mycobacteria IVD图书馆和软件模块, labeled according to EU directive EC/98/79, which make mycobacteria identification available for clinical diagnostic purposes. The new library covers 164 out of currently 180 described mycobacteria species, and it is by far the most comprehensive library for MALDI-based mycobacteria identification on the market.
For research use only,
Brukeris further broadening its application portfolio of theMBT Subtyping Module. This MALDI subtyping module now also enables the automated differentiation betweenMycobacterium chimaera和Mycobacterium intracellulare,和between the pathogenicListeria monocytogenes和otherListeriaspecies.
Professor Dr. Sören Schubert from the
Max-von-Pettenkofer Instituteat the
Ludwig-Maximilians Universityin
Munich, Germanystated: "I am impressed by the continuous innovations that
Bruker优惠MALDI BIOTYPERplatform. The new diagnosticMBT Star-Carba IVDassay is of significant clinical relevance, becausecarbapenemase生产细菌是日益增长的医疗保健问题，并且迅速functionalanalysis is very important. This novel assay for rapid resistance testing for selected antibiotics can be run on the sameMALDI BIOTYPERplatform which has been successfully used for identification of bacteria and fungi in the microbiological lab. This is yet another milestone for the broad introduction of MALDI-TOF technology into clinical routine microbiology."
而且，
Brukerintroduces two novel CE-IVD marked, real-time PCR assays from its recently established
Glasgowmolecular testing branch:
- 新的Fungiplex®Aspergillus多路传输、实时PCR检测不到2小时s from extraction identifies the most common pathogens associated with invasive aspergillosis, providing rapid results with high sensitivity and specificity, and without the need for any culture. For this assay, DNA can be extracted from whole blood, serum, plasma and bronchoalveolar lavage (BAL), so that theFungiplex Aspergillusassay can support clinicians in providing an earlier diagnosis of invasive aspergillosis in order to improve patient outcomes, or alternatively reduce the cost of unnecessary anti-fungal drugs.
- 新的Carbaplex®测定是一种多重实时PCR测定法，可在不到3小时的时间内检测和区分最重要的碳青霉烯酶基因家族，即KPC，NDM，VIM，IMP和OXA-48样。该测定法对从不需要任何培养物的直肠拭子提取的DNA进行了验证。该测试也可用于从分离株中鉴定这些基因作为验证性测试。这Carbaplexassay offers the potential to rapidly identify colonization and improve patient management decisions.
Dr.
Lewis White, Principal Clinical Scientist at NPHS Microbiology Cardiff, commented on the newFungiplex Aspergillusassay: "Fungal diseases such as Invasive Aspergillosis pose an extremely serious healthcare risk to immunocompromised patients, especially in the haemato-oncology cohort. Current diagnostic methods, including culture, struggle due to low sensitivity. Expensive prophylactic and empiric drug use is common, whereas PCR, as a key component of combined biomarker surveillance strategies, prevents the overuse of unnecessary antifungals and allows the targeted use of antifungal drugs. Bruker'sFungiplex Aspergillusreal-time PCR assay, when combined with international recommendations on DNA extraction, provides a standardised approach that displays excellent clinical sensitivity and specificity, providing a commercial solution with the potential to improve the diagnosis and treatment of at-risk patients."
Dr.
Wolfgang Pusch, Executive Vice President for Clinical MALDI at Bruker Daltonics, added: "We are pleased with the innovation that Bruker´s microbiology business has generated and its further organizational evolution. With theMBT Star-Carba IVDas the first commercial diagnostic kit for MALDI-based rapid, functional resistance testing, plus further significant improvements of our successfulMALDI BIOTYPERplatform, we have underlined our passion for innovation in routine clinical microbiology. Our parallel introductions of theFungiplex Aspergillus和Carbaplexmultiplex PCR assays, with 2-3 hours of time to result, are expected to offer significant patient benefits at affordable cost, and further strengthen our microbiology portfolio."
About the
BrukerMALDI BIOTYPER(MBT) Platform
这MALDI BIOTYPERfamily of systems enables molecular identification of microorganisms like bacteria, yeasts and fungi. Classification and identification of microorganisms is achieved reliably and quickly using proteomic fingerprinting by high-throughput MALDI-TOF mass spectrometry. TheMALDI BIOTYPERuses a molecular approach based on specific proteomic fingerprints from bacterial strains. Many published studies have highlighted the greater accuracy and lower cost offered, as well as typically much faster time-to-result (TTR).
Applications of variousMALDI 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 BIOTYPERhas replaced classical biochemical testing for bacterial identification in the past few years due to the accuracy, speed, extensive species coverage, ease of use and cost effectiveness of the system. Traditional biochemical techniques detect different metabolic properties of microorganisms, can take many hours or even days for completion, and they often lack specificity.
这robustMALDI BIOTYPERrequires minimal sample preparation and offers low consumables cost. The 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 BIOTYPER在许多其他国家 /地区也有医疗设备注册。RUO版本MALDI BIOTYPERallow selected, high-value antimicrobial resistance tests.
About
Bruker Corporation(NASDAQ: BRKR)
For more than 55 years,
Bruker越是加大使科学家能够取得突破eries and develop new applications that improve the quality of human life.
Bruker'shigh-performance scientific instruments and high-value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular and microscopic levels. In close cooperation with our customers,
Brukeris enabling innovation, productivity and customer success in life science molecular research, in applied and pharma applications, in microscopy, nano-analysis and industrial applications, as well as in cell biology, preclinical imaging, clinical phenomics and proteomics research, clinical microbiology and molecular pathology research. For more information, please visit:www.energie2point0.com
Investor Contact:
Miroslava Minkova
Head of Investor Relations
T: +1 (978) 663–3660, ext. 1479
E:miroslava.minkova@bruker.com
Contact for Media and Customers:
Dr.
Winfried Busch
Bruker Daltonics Division
Tel: +49-421-2205-1242
E:Winfried.Busch@bruker.com
MALDI BIOTYPER®, MBT STAR®, MBT Sepsityper®, Fungiplex®和Carbaplex®are registered trademarks of
布鲁克·道尔顿克（Bruker Daltonik Gmbh）在里面
European Union和other regions.
Prof. Dr. Sören Schubert, Max-von-Pettenkofer Institute at Ludwig-Maximilians University Munich
MBTStar®-Carba IVD套件
要在PR Newswire上查看原始版本，请访问：bob体育竞技风暴http://www.prnewswire.com/news-releases/bruker-introduces-new-clinical-microbiology-assays-and-kits-at-eccmid-300443186.html
SOURCE
Bruker Corporation