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MALDI Biotyper IVD-CE system

Products Next higher product group MALDI-TOF mass spectrometer
Period Status 2009-05-16 registration start
Organisation Organisation Bruker Daltonik GmbH
  Group Bruker Corporation (Group)
     

Bruker Daltonics. (5/16/09). "Press Release: Bruker’s MALDI Biotyper Workflow for Microbial Identification Obtains IVD-CE Mark According to EU Directive 98/79/EC". Helsinki.

At the 19th European Congress of Clinical Microbiology and Infectious Disease (ECCMID) opening here today, Bruker Daltonics announces that its MALDI Biotyper workflow for microbial identification in clinical microbiology has successfully obtained an IVD-CE mark with a Declaration of Conformity in accordance with the European Union In Vitro Diagnostic Directive 98/79/EC.

At ECCMID 2008, Bruker Daltonik GmbH in Bremen, Germany had already announced the adaptation of its quality management system according to the ISO 13485 standard for the design, development, manufacturing, sales, distribution, installation and service of instruments and systems for in vitro diagnostic use.

In recent months, Bruker has organized and conducted extensive successful performance evaluation studies on the MALDI Biotyper workflow at several renowned centers for clinical microbiology. One clinical studies partner was Laboratory Limbach in Heidelberg, Germany which is the headquarters of a network of more than 25 associated private clinical laboratories in Germany. Another clinical studies partner was the Max von Pettenkofer-Institute in Munich, Germany.

During these clinical studies the overall identification accuracies for several microbial groups have been confirmed. Additionally, a stress test demonstrated the broad applicability of the MALDI Biotyper approach over a wide range of different microorganisms. The stress test also demonstrated that the MALDI Biotyper workflow can be applied on all linear-only Bruker MALDI-TOF mass spectrometers under IVD-CE, i.e. the microflex™ benchtop instrument, as well as the floor-standing, high-throughput autoflex™. Outside of the European Union, the MALDI Biotyper workflow is presently for research use only.

After obtaining the European Union IVD-CE label, the MALDI Biotyper is now ready to further penetrate clinical routine analysis markets for the reliable, fast and cost-effective identification of a very broad range of different micro-organisms, such as 1) non-fermenting gram-negative bacteria, 2) enterobacteriaceae, 3) other gram-negative bacteria, 4) gram-positive bacteria, and 5) yeasts.

Dr. Ulrich Eigner, Head of Molecular Studies at Laboratory Limbach, commented: "The MALDI Biotyper is a promising new molecular approach for microbial identification. The speed of identification is impressive, thus significantly decreasing the turnaround times in our laboratory."

Dr. Sören Schubert from the Max von Pettenkofer-Institute added: "As the MALDI Biotyper is using a molecular approach based on a mass spectrometric protein fingerprint, it has the potential to overcome many current problems in clinical microbiology. For example, the previously problematic analysis of so-called non-fermenting bacteria is of significant clinical relevance for samples from patients suffering cystic fibrosis."

Dr. Guido Mix, the Bruker Daltonics Director of MALDI Biotyper Business Development concluded: "We are very pleased that our MALDI Biotyper workflow met and even exceeded the validation criteria of these clinical studies. This further confirms the very positive feedback from our European customers since the market introduction of the MALDI Biotyper. We believe that the MALDI Biotyper has the potential to rapidly become the new 'gold standard' in microorganism identification in clinical microbiology."

About the Bruker MALDI Biotyper

Bruker's dedicated MALDI Biotyper solution enables identification, taxonomical classification or dereplication of microorganisms like bacteria, yeasts and fungi. Classification and identification of microorganisms is achieved reliably and fast using high-throughput MALDI-TOF mass spectrometry. Applications include clinical routine microbial identification (in EU only - for research use only elsewhere), environmental and pharmaceutical analysis, taxonomical research, food and consumer product processing and quality control, as well as in marine microbiology. Bruker's robust MALDI Biotyper method requires minimal sample preparation efforts and offers low cost per sample.

ABOUT BRUKER CORPORATION (NASDAQ: BRKR)

Bruker is a leading provider of high-performance scientific instruments and solutions for molecular and materials research, as well as for industrial and applied analysis. For more information, please visit: www.bruker.com

CAUTIONARY STATEMENT

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to adverse changes in conditions in the global economy and volatility in the capital markets, the integration of businesses we have acquired or may acquire in the future, changing technologies, product development and market acceptance of our products, the cost and pricing of our products, manufacturing, competition, dependence on collaborative partners and key suppliers, capital spending and government funding policies, changes in governmental regulations, intellectual property rights, litigation, and exposure to foreign currency fluctuations. These and other factors are identified and described in more detail in our filings with the SEC, including, without limitation, our annual report on Form 10-K for the year ended December 31, 2008, our most recent quarterly reports on Form 10-Q and our current reports on Form 8-K. We disclaim any intent or obligation to update these forward-looking statements other than as required by law.

Karin Hoffmann
MALDI Biotyper Marketing, Bruker Daltonics
Tel: +49-421-2205-2041
kho@bdal.de

   
Record changed: 2016-03-20

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