BILLERICA, Mass., July 31, 2017 /PRNewswire/ -- Bruker today
announces that it has received US Food & Drug Administration
(FDA) clearance for its third, further expanded claim for the
market-leading MALDI Biotyper-CA (MBT-CA) system for
fast, accurate and cost-effective microbial identification. The new
claim includes a significant expansion of the microbial reference
library for clinical microbiology, by adding 144 new species
covering anaerobes, gram-positive and gram-negative bacteria, as
well as yeasts. The library coverage of the MALDI
Biotyper-CA now includes 424 microbial species in 333
different groups that are FDA-cleared for the US clinical
microbiology market. This further significantly increases the
clinical utility of the MBT.
![Figure 1: Chris Doern, PhD, Associate Director of Microbiology at Virginia Commonwealth University Health System Figure 1: Chris Doern, PhD, Associate Director of Microbiology at Virginia Commonwealth University Health System](https://mma.prnewswire.com/media/540295/Bruker_Corporation_Chris_Doern.jpg)
The third claim now also includes the new disposable MBT
Biotargets 96 US IVD, disposable targets based on Bruker´s
proprietary AnchorChip™ technology, which provides
superior sample concentration. The barcoded 96-spot MBT
Biotargets are cost-efficient as there is no wastage of
spots, and they allow a convenient workflow without target plate
cleaning and the corresponding validation requirements.
The new expanded claim 3 library is now available in the US on
two different versions of Bruker´s MALDI Biotyper CA
system, either based on the standard microflex
MALDI-TOF mass spectrometer, or on the high-end microflex
smart, which uses Bruker´s proprietary
smartbeam™ laser. Under typical microbial
identification conditions, the 200 Hz smartbeam is a
'lifetime laser' for microbial identification, decreases
time-to-result and increases throughput. The MBT
smart is the platform of choice for laboratories requiring
high sample throughput, and for potential future assays 'beyond
identification', which are presently for research use only in the
United States. Both MBT systems are compact, bench-top
instruments requiring only 110V, operate in
Whispermode™ and require no special HVAC
infrastructure.
Finally, the MALDI Biotyper-CA now offers
additional workflow tools for US clinical microbiology customers:
the MBT Pilot™ is a unique, optically guided target
preparation assistance tool designed to reduce specimen transfer
human errors. The MBT Galaxy™ automates reagent
additions, reduces repetitive motions associated with target
preparation, and improves productivity and standardization.
Dr. Christopher Doern, Associate
Director of Microbiology at the VCU Medical Center in Richmond, Virginia, commented: "Implementation
of the MBT Pilot and MBT
Galaxy will be for the workflow of the MALDI
Biotyper, what implementation of MALDI-TOF MS has been for
the identification of microorganisms in clinical microbiology, game
changing! The MBT Pilot system virtually eliminates
the possibility of transcription error, while also greatly
improving efficiency. Similarly, the MBT Galaxy
system automates the time consuming and previously manual process
of repeatedly pipetting small volumes of liquids. Not only do
these workflow tools improve the quality and consistency of
results, but they free up precious technologist time and automate
the repeated motions required for MALDI-TOF target
preparation."
George Goedesky, the Bruker Daltonics Vice President for
Microbiology - Americas, added: "We are very pleased with the
collaboration with our clinical trial partners that has resulted in
this major library expansion for the MALDI Biotyper
CA system. Our latest FDA claim 3 submission showed
an impressive 99.8% correlation to sequencing methods, which
demonstrates the extremely high quality of the fast, affordable and
broad-based microbial identification with the MALDI
Biotyper-CA. "
About the Bruker MALDI Biotyper (MBT) Platform
The MALDI Biotyper family 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. The MALDI
Biotyper uses a molecular approach based on specific proteomic
fingerprints from bacterial strains. Many published studies
have highlighted the greater accuracy and lower cost, as well as
typically much faster time-to-result (TTR).
Applications of the MALDI Biotyper include clinical
microbial identification, environmental and pharmaceutical
analysis, taxonomical research, food and consumer product safety
and quality control, as well as marine microbiology. In many
laboratories, the MALDI Biotyper has replaced biochemical
testing for bacterial identification 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 often lack
specificity.
The robust MALDI Biotyper requires minimal sample
preparation and offers low consumables cost. The products of
the MALDI Biotyper family are available in a
research-use-only (RUO) version, as the U.S. FDA-cleared MALDI
Biotyper CA System, or in an IVD-CE version in accordance with
the EU directive EC/98/79. The MALDI Biotyper also has
medical device registrations in numerous other countries. RUO
versions of the MALDI Biotyper allow selected, high-value
antimicrobial resistance tests.
About Bruker Corporation (NASDAQ: BRKR)
For more than 55 years, Bruker has enabled scientists to make
breakthrough discoveries and develop new applications that improve
the quality of human life. Bruker's high-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, Bruker is enabling innovation,
productivity and customer success in life science molecular
research, in applied and pharma applications, in microscopy,
nanoanalysis 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.bruker.com
Investor
Contact:
Miroslava
Minkova
Bruker Head of Investor
Relations
T: +1 (978) 663–3660, ext.
1479
E: miroslava.minkova@bruker.com
Contact for Media and Customers:
George Goedesky
Vice President Microbiology - Americas
Bruker Daltonics Division
Tel: +1 (812) 844-7282
E: George.Goedesky@bruker.com
MALDI Biotyper®, MBT Pilot®, MBT
Galaxy® are registered trademarks in the European
Union and other regions.
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