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| Bruker´s MALDI Biotyper Workflow for Microbial Identification Obtains IVD-CE Mark According to EU Directive 98/79/EC |
At ECCMID 2008,
In recent months,
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 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. 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.
About the 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
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 Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5966529&lang=en
Source:
Karin Hoffmann |







