SAN FRANCISCO, June 20, 2019 /PRNewswire/ -- At the ASM
Microbe Conference 2019 (www.asm.org), Bruker launches the new
MALDI Biotyper sirius system for all previously
FDA-cleared, and for all research-use-only (RUO) MALDI
Biotyper (MBT) reference libraries, which are used for
near-universal, fast and cost-effective microbial identification
from cultures in microbiology. The MALDI Biotyper
sirius for the first time now also supports novel
negative-ion mode assay research and clinical studies in fast
antibiotic-resistance testing. This new high-end system complements
the standard MALDI Biotyper and the high-throughput
MALDI Biotyper smart.
The global spreading of antibiotic resistances is a growing
healthcare problem, and the development and implementation of new,
fast and cost-efficient resistance tests are important for
advancing antibiotic stewardship. For gram-negative bacteria, the
resistance-problem is so serious in many countries that antibiotics
like colistin, with the risk of nephrotoxic side effects,
increasingly must be used as an 'antibiotic of last resort'.
Antibiotic stewardship aims to de-escalate the therapy in such
cases early, if possible, or switch patients to other therapeutic
options, if resistance is detected.
New, fast assays to detect colistin resistance in gram-negative
bacteria can now be further developed and validated on the
MALDI Biotyper Sirius, in addition to all routine
clinical FDA-cleared identification assays, on the same instrument.
The new RUO colistin-resistance assay uses lipid analysis in
negative-ion mode, and has been developed at Imperial College
London, UK (Larrouy-Maumus et al.,
presented at ECCMID 2019, submitted for publication).
The new MALDI Biotyper sirius uses the proprietary
smartbeam™ solid-state laser with a 200 Hz repetition
rate, and a lifetime of 500 million shots. This essentially makes
the smartbeam a 'lifetime laser' in typical
microbiology laboratories. The high-performance vacuum system
allows for an even faster exchange of target plates in laboratory
workflows, where multiple technicians prepare targets
independently. Moreover, the high-performance vacuum system reduces
downtime after service or preventive maintenance, which typically
can be completed on the same day. The MBT sirius
features new electronics, and LED strips indicate the system
status. In the RUO MBT sirius, polarity switching to
negative-ion mode is software-controlled and just takes a
minute.
Dr. Gerald Larrouy-Maumus, Group
Leader at the MRC-Centre for Molecular Bacteriology & Infection
at Imperial College London, UK,
commented. "The MALDI Biotyper sirius is a versatile
MALDI-TOF MS system, which is not only able to perform
near-universal bacterial identification very rapidly, but with its
additional negative-ion mode also has allowed us to develop a fast
and robust assay to detect colistin-resistant bacteria as an
important, potential future routine assay after regulatory
approvals. As my students say, the new MALDI Biotyper
sirius is just 'Wow!'"
In addition, Bruker introduces the MBT-STAR assays
for Selective-Testing of Antibiotic Resistance for carbapenems and
for cephalosporins as research-use-only (RUO) assays to support US
research and validation studies for the fast detection of
antibiotic resistance. The functional MBT-STAR assays
monitor molecular mass shifts due to the enzymatic metabolization
that occurs in the case of bacterial resistance against the
beta-lactam class of antibiotics.
Time-to-result (TTR) for both MBT-STAR assays is
only about 60 minutes after positive culture. Unlike gene-targeted
molecular resistance tests, the MBT-STAR assays are
functional tests that can detect not only known resistance
mechanisms, but also new, emerging resistances.
Dr. Wolfgang Pusch, Executive
Vice President for Microbiology & Diagnostics at Bruker
Daltonics, said: "Bruker has been driving the broad implementation
of near-universal, fast and cost-effective MALDI identification in
microbiology for many years. We are committed to enable important
new workflows, and with the MBT-STAR RUO assays, our
US customers now have access to research and validation studies for
fast, functional assays of important beta-lactamase resistances. We
are excited that the new MALDI Biotyper sirius is
designed for further research on fast colistin-resistance testing
in gram-negative bacteria, which is likely to become an important
future clinical MBT assay, once it is fully validated and has
regulatory approvals."
Moreover, Bruker introduces the Micronaut™
portfolio of veterinary antibiotic susceptibility tests (AST) to
the US market (not for human diagnostic use). The
Micronaut products for veterinary medicine can assist
in selecting targeted treatments of microbial infections in
companion animals, livestock and horses. The
Micronaut plates analyze true minimum inhibitory
concentrations (MIC) by broth microdilution.
True MIC testing is increasingly becoming the 'gold standard' in
veterinary testing. With the growing prevalence of resistant
bacteria in veterinary medicine, the Micronaut AST
plates help to guide veterinarians with the appropriate selection
of antibiotic therapy. Micronaut VET Com assays
support the analysis of bacteria isolated from companion animals,
while Micronaut VET CSH plates can be used for
bacteria isolated from live-stock animals and horses.
Micronaut VET Mas enables the analysis of antibiotic
resistance in bacteria that are causing bovine mastitis in
the dairy industry.
About the Bruker MALDI Biotyper (MBT) Platform
The MALDI Biotyper enables molecular identification of
bacteria, yeasts and fungi from cultures. 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 the typically much faster time-to-result
(TTR).
Applications of various MALDI Biotyper solutions include
clinical and veterinary 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 few years due to its accuracy,
speed, extensive species coverage, ease of use and cost
effectiveness. Traditional biochemical techniques detect
different metabolic properties of microorganisms, can take many
hours or even days, 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 according to EU
directive EC/98/79. The MALDI Biotyper also has
medical device registrations in many other countries.
RUO versions of the MALDI Biotyper software allow
selected, high-value antimicrobial resistance tests. The
CE-IVD MBT STAR®-Cepha kit allows rapid,
functional antibiotic resistance testing against
Cephalosporins, and the CE-IVD MBT STAR-Carba kit is
for fast Carbapenem-resistance testing.
About Bruker Corporation (Nasdaq: BRKR)
Bruker is enabling 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, improved productivity and customer success in life
science molecular research, in applied and pharma applications, in
microscopy and nanoanalysis, and in industrial applications, as
well as in cell biology, preclinical imaging, clinical phenomics
and proteomics research and clinical microbiology. For more
information, please visit: www.bruker.com.
Investor
Contact:
Pamela
Clark
Investor Relations
Bruker
Corporation
T: +1 (978) 663–3660, ext.
1479
E: pamela.clark@bruker.com
Contact for Media and Customers:
Philip Perry
Bruker Daltonics
T: +49-172-313-7216
E: Philip.Perry@bruker.com
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