Bruker Announces FDA Clearance for Second, Expanded Claim for the MALDI Biotyper CA System
April 03 2015 - 7:03AM
Business Wire
Bruker (NASDAQ: BRKR) today announced that it has received
510(k) clearance from the US Food and Drug Administration for
library and methods expansion for the MALDI Biotyper CA System,
sold in the United States for clinical microbiology.
In November 2013, Bruker received FDA 510(k) clearance for a
first claim for the MALDI Biotyper CA System, an IVD solution,
which included Bruker’s global market leading MALDI Biotyper
instrumentation; software; a library of 40 aerobic Gram negative
bacterial species or species groups, covering 100 clinically
relevant species; in vitro diagnostic reagents; and standard
operating procedures.
The recent clearance of a second, expanded claim now adds 170
species and species groups, representing 180 clinically-relevant
species of aerobic Gram positive, fastidious Gram negatives,
Enterobacteriaceae, anaerobic bacteria and yeasts. In addition,
customers will have additional specimen preparation options to
further optimize workflows.
As a result of the latest 510(k) clearance, the MALDI Biotyper
CA System can now in total identify 210 species or species groups,
covering 280 clinically relevant bacteria and yeast species, and
representing more than 98% of the typical bacterial identification
workflow of clinical microbiology laboratories.
As part of its continued, recent clinical trials, Bruker had
submitted data from multi-center studies to the FDA, consisting of
more than 10,000 spectra. Results generated by the MALDI Biotyper
CA System were compared to 16s rRNA molecular sequencing for
bacteria and ITS sequencing for yeasts. This was supplemented by
protein gene sequencing, which showed that 98.9% of the isolates
tested have resulted in correct identifications to the genus or
species level, with only 0.9% of isolates unable to be identified.
This level of performance is the highest identification accuracy
for any mass spectrometry-based bacterial and yeast identification
system.
Frank H. Laukien, Ph.D., President and CEO of Bruker
Corporation, stated: “The MALDI Biotyper has changed the paradigm
of bacterial identification worldwide due to its dramatically
faster time-to-result, exceptional identification performance, ease
of use, cost effectiveness and robust, compact instrumentation. The
most recent 510(k) clearance for the MALDI Biotyper CA System
further expands its clinical utility by offering the largest
FDA-cleared library for expedited, high-accuracy identification of
bacteria and yeasts. This latest clearance allows an even larger
segment of US hospitals and clinical microbiology laboratories to
adopt this revolutionary technology for serving their infectious
disease physicians and patients, and opens the door for making it
the new standard of care.”
Some MALDI BioTyper CA identification results displayed are
non-clinically validated organisms. These results are displayed in
the MALDI Biotyper CA report in the interest of public health as a
means of directing the required additional laboratory testing.
About the MALDI Biotyper Platform and the MALDI Biotyper CA
System
The MALDI Biotyper platform achieves classification and
identification of microorganisms reliably and quickly using
proteomic fingerprinting by high-throughput MALDI-TOF mass
spectrometry. The FDA cleared MALDI Biotyper CA System is offered
for US clinical microbiology laboratories.
MALDI Biotyper applications include clinical routine microbial
identification, environmental and pharmaceutical analysis,
taxonomical research, food and consumer product processing, and
quality control, as well as veterinary microbiology. Bruker’s
robust MALDI Biotyper methods requires minimal sample preparation
and offers low consumables cost per sample. Over 1,500 microbiology
laboratories worldwide have selected Bruker as their supplier of
MALDI-TOF systems for microbiology testing, with over 300 systems
sold in the Americas to date.
The MALDI Biotyper is available in a Research Use Only (RUO)
version, as well as in an IVD-CE version according to EU directive
EC/98/79 in certain European countries. Currently the CE-IVD
labelled IVD-MALDI Biotyper is available for clinical microbiology
routine usage around the world including Europe, Canada, Argentina,
Mexico, Colombia and Ecuador in the Americas and in China, Japan,
Hong Kong, Singapore, Malaysia, Taiwan and Australia in Asia
Pacific. For more information: www.maldibiotyper.com
About Bruker Corporation
For more than 50 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
research 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, nano-analysis and industrial applications, as well as
in cell biology, preclinical imaging, clinical research,
microbiology and molecular diagnostics. For more information,
please visit www.bruker.com.
Media Contact:Bruker
Daltonics Inc.Tony Lewtas, +1-978-663-3660, Ext. 1212Sr. Marketing
Communications Managertony.lewtas@bruker.comorInvestor contact:Bruker
CorporationJoshua Young, +1-978-663-3660, ext. 1479Vice President,
Investor Relationsjoshua.young@bruker.com
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