AMSTERDAM, April 15, 2019 /PRNewswire/ -- At the
European Congress of Clinical Microbiology and Infectious Diseases
(www.eccmid.org), Bruker announces new assays, software and library
extensions for its MALDI Biotyper, IR
Biotyper and Fluorocycler XT product lines
for microbial identification, infection control and molecular
diagnostics of infectious diseases.
For the MALDI Biotyper (MBT)
platform, 238 new bacteria and yeast species have been added in the
new CE-IVD marked in-vitro diagnostics (IVD) and research-use-only
(RUO) reference libraries. This brings the number of different
bacterial and fungal species that can be reliably and quickly
identified with the CE-IVD marked MALDI Biotyper to
2,887. This achievement makes the MBT an almost universal and
always evolving platform for fast microbial identification from
isolates by molecular protein fingerprinting, with outstanding data
quality and robustness, lower cost per ID, and dramatically broader
identification scope than all other molecular platforms.
A focus for the new MBT library expansions introduced at ECCMID
2019 is the rapid inclusion of emerging pathogens like
Elizabethkingia anophelis, in order to keep
MBT users up to date with the latest healthcare
threats. Moreover, the MBT Mycobacteria Library (IVD &
RUO) has been expanded by 14 species, and now covers 178
mycobacteria species. The MBT Filamentous Fungi Library
(RUO) has been expanded by 27 new species, and now covers 180
fungal species. With the modular MBT bioinformatics architecture
any new isolates of interest can be added for further learning and
expansion of this 'gold standard' fast microbial ID system. In the
MBT RUO library version, new isolates can even be added by trained
microbiology customers themselves.
For higher throughput, the new MBT HT™ software
(RUO) has been launched to support, e.g., larger microbiome
research projects with a culturomics approach. The new
MBT HT software significantly reduces the data
analysis time per isolate using an optimized multi-threading
approach.
The improved Sepsityper kit (CE-IVD) for rapid and
cost-effective microbial ID from positive blood cultures (PBC) is
now available with a new formulation that increases MBT ID rates
even further. It also improves the PBC ID workflow and reduces
hands-on time.
Miriam Cordovana, Microbiologist
in the Department of Bacteriology and Mycobacteriology of the S.
Orsola-Malpighi University Hospital in Bologna, Italy, stated: "We have been successfully
using the Sepsityper kit for fast ID from positive
blood cultures in our laboratory since more than a year. The
recently introduced rapid workflow has shortened the time-to-result
and includes fewer manual steps. With the new
Sepsityper formulation, we were able to further
increase the identification rate from PBCs to more than 90% of all
tested isolates in a recent internal study."
For infection control and hospital hygiene, further improvements
in visualization, statistics and bioinformatics have been
implemented in the IR Biotyper 2.1 (RUO), which
assists infection control specialists to analyze potential outbreak
scenarios on site within minutes after cultivation. The major
benefits are the fast turn-around-times (TAT) that are required to
provide actionable results for timely infection control decisions.
In other cases, an outbreak can be ruled out, and time-consuming,
costly molecular analysis or outsourced NGS with much longer TATs
can be avoided.
Dr. Wolfgang Pusch, Executive
Vice President Microbiology & Diagnostics at Bruker Daltonics,
commented: "We are very pleased with the continuous improvements of
our market-leading MALDI Biotyper platform in
microbial species coverage and throughput. We also continue to
expand the MBT menu of assays with significant clinical benefit,
such as the MBT Sepsityper kit for fast ID from PBCs,
and selected, high-value MBT antibiotics resistance assays. The
'gold standard' MBT fast ID platform is complemented in infection
control by our enhanced IR Biotyper for better,
faster and more cost-effective strain-typing compared to
conventional hygiene testing methods."
In March 2019, Bruker launched the
high-performance FluoroCycler XT platform (CE-IVD), a
novel, next-generation PCR thermal cycler and reader that enables
the unique new Liquid Array™ family of
high-sensitivity, fast turn-around and cost-effective mid-plex
assays, directly from sample without culturing steps. A novel
tuberculosis assay FluoroType MTBDR 2.0 (CE-IVD)
detects more than 60 mutations in MTB genes for up to 522
resistance patterns to guide therapy.
At ECCMID 2019, an assay for transplant medicine has been added
to the FluoroCycler XT, i.e. the Fluorotype
HSV assay for herpes simplex viral analysis, which
complements the Fluorotype BKV HT assay for the BK
polyoma-virus on the established FluoroCycler
platform.
Moreover, all Bruker molecular assays for invasive fungal
diseases, including Fungiplex Aspergillus,
Fungiplex Aspergillus Azole-R, Fungiplex
Candida (all CE-IVD), Fungiplex Candida auris
(RUO) and Fungiplex Universal (RUO screening), plus
the Carbaplex assay (CE-IVD) for carbapeneme
resistance detection, have been added on the new
FluoroCycler XT platform.
David Hain and Wolfgang Pusch, Managing Directors of
Bruker-Hain Diagnostics, concluded: "Bruker is very excited about
the novel, high-performance Fluorocycler XT PCR
platform, and our ECCMID release of a growing menu of fast,
ultra-sensitive, and clinically differentiated Liquid
Array and real-time PCR assays for tuberculosis, invasive
fungal diseases and selected viral infections."
About the Bruker MALDI Biotyper (MBT)
Platform
The MALDI Biotyper enables molecular
identification of 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 the typically much faster
time-to-result (TTR).
Applications of 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 few years 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 they 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 numerous other countries.
RUO versions of the MALDI Biotyper software allow
selected, high-value antimicrobial resistance tests. The
CE-IVD MBT STAR®-Cepha kit now allows rapid,
functional antibiotic resistance testing against
Cephalosporins, and the CE-IVD MBT STAR-Carba kit is
for fast Carbapenem-resistance testing.
About Bruker-Hain Diagnostics
Bruker-Hain Diagnostics
was formed after the recent acquisition of a majority share of the
Hain Lifescience GmbH as a Business Unit for Molecular Diagnostics
(MDx) products in Bruker´s Microbiology & Diagnostics business.
Hain Lifescience GmbH is the legal manufacturer of the
Fluorocycler XT and the MTBDR 2.0
assay. For more information, please visit,
www.hain-lifescience.de.
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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