BILLERICA, Mass.--(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.
Source: Bruker Corporation