BILLERICA, Mass.--(BUSINESS WIRE)--
Bruker Corporation (NASDAQ: BRKR) today announced that it has been
granted U.S. FDA clearance under Section 510(k) to market its MALDI
Biotyper CA System in the United States for the
identification of Gram negative bacterial colonies cultured from human
specimens.
Bruker's MALDI Biotyper (Photo: Business Wire)
The MALDI Biotyper CA System includes the bench-top microflex™
MALDI-TOF (matrix-assisted laser desorption ionization time-of-flight)
mass spectrometer, software, IVD labeled reagents, a 48-spot MALDI
target and a library of microorganism reference spectra. Bruker has
conducted a multi-site clinical trial comparing performance of the MALDI
Biotyper CA System to 16S ribosomal RNA gene sequencing. The overall
accuracy of the MALDI Biotyper CA System was comparable to
that of nucleic acid sequencing. FDA clearance of the MALDI Biotyper
CA System is the latest achievement in Bruker’s continuous efforts
to develop MALDI-TOF mass spectrometry into the most advanced platform
for clinical microbiology identification.
In 2009, Bruker launched a MALDI Biotyper system in compliance
with the European in vitro diagnostic directive EC/98/79, making
the CE-IVD labelled IVD-MALDI Biotyper the first MALDI-TOF based
product registered for use in European clinical microbiology
laboratories. Since then, Bruker has continued its effort to expand into
routine clinical microbiology and other markets throughout the world.
Currently the CE-IVD labelled IVD-MALDI Biotyper is available for
clinical microbiology routine usage in Europe, as well as in many
countries around the world, including Canada, Argentina, Mexico,
Colombia and Ecuador in the Americas and in Japan, Hong Kong, Singapore,
Malaysia and Taiwan in Asia/Pacific.
Frank Laukien
, President and Chief Executive Officer of Bruker
Corporation, commented: “We are very excited about this major milestone
in our effort to introduce MALDI-TOF mass spectrometry into clinical
diagnostics. For the last seven years Bruker has been working on
continuous innovation in the field of MALDI-TOF-based microbial
identification, bringing the MALDI Biotyper platform into
clinical routine laboratories. The MALDI Biotyper has been a
success with more than 1,000 systems sold or leased worldwide, which has
positively affected the health of many patients. Bruker has initiated a
continuing revolution in clinical microbiology towards the MALDI
Biotyper as a next-generation identification technique. With
clearance by the US FDA to market the MALDI Biotyper CA System,
we expand our market reach into the largest clinical market in the
world, with expected significant improvements in outcomes and reductions
in the cost of healthcare.”
Dr.
Robert Jerris
, PhD, D (ABMM), the Director of Clinical Microbiology
at the Children´s Healthcare of Atlanta pediatric hospital, added:
“MALDI-TOF has had a dramatic impact on patient care at Children’s
Healthcare of Atlanta. The ability to identify organisms directly from
plates - saving at minimum a day over conventional phenotypic tests for
many organisms - has impacted therapy, timely infection control and
contributed to decrease in healthcare expenditures. Outcome studies have
shown such significant positive results that it is predictable to say
that this technology will eventually be a staple in clinical
microbiology.”
About the Bruker MALDI Biotyper
The MALDI Biotyper family of systems enables molecular
identification, and taxonomical classification or dereplication 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 and published studies have
highlighted the greater accuracy and lower cost offered, as well as the
typically much faster time-to-result.
Applications of the various MALDI Biotyper solutions include
clinical routine microbial identification, environmental and
pharmaceutical analysis, taxonomical research, food and consumer product
safety and quality control, as well as marine microbiology. In many
European and international laboratories the MALDI Biotyper has
replaced classical biochemical testing for bacterial identification in
the past five years due to the accuracy, speed, extensive species
coverage, ease of use and cost effectiveness of the system. Classical
biochemical techniques depend upon detecting different metabolic
properties of microorganisms; however, these techniques can take hours
or even days for completion and they often lack specificity.
The robust MALDI Biotyper method 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 according to EU directive EC/98/79. The MALDI
Biotyper also has medical device registrations in numerous other
countries. Work-in-progress RUO versions of the MALDI Biotyper even
allow selected high-value antimicrobial resistance tests in
translational research.
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 IVD,
industrial, security and applied markets. For more information: www.bruker.com
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Source: Bruker Corporation