Bruker Corporation (NASDAQ: BRKR) today announced that it has
received clearance from the China Food and Drug Administration
(CFDA) to market and sell its IVD MALDI Biotyper System as a
medical device in China for the identification of microorganisms
isolated from human specimens.
Dr. Lisong Shen, the Director of
Laboratory Medicine at Xin Hua Hospital affiliated with Shanghai
Jiao Tong University School of Medicine and President of the
Shanghai Society of Laboratory Medicine (Photo: Business Wire)
MALDI Biotyper-based microbial identification has major
advantages compared to classical automated biochemical testing,
including faster time to result (TTR) and better information with
deeper and broader species coverage. Starting from a culture, the
IVD MALDI Biotyper allows for microbial identification in a few
minutes without further time-consuming incubation steps.
With this paradigm shift in clinical practice, microbial
identification is typically available one day earlier than with
biochemical techniques. Additionally, MALDI-TOF mass
spectrometry-based identification does not have the limitations of
biochemical testing and can analyze species that have been
difficult to identify by previous microbiology techniques.
An increasing number of case reports describe the identification
of microorganisms causing human infections which previously have
been isolated only from environmental sources. The comprehensive
IVD MALDI Biotyper reference library now covers more than 2,300
microbial species of gram-negative bacteria, gram-positive
bacteria, anaerobes and yeasts, and often enables the
identifications of unexpected microorganisms.
The IVD MALDI Biotyper System includes the bench-top microflex™
MALDI-TOF (matrix-assisted laser desorption ionization
time-of-flight) mass spectrometer, automated analysis software, the
IVD Bacterial Test Standard (BTS), a 96-spot MALDI target and an
extensive library of microorganism reference entries. The microflex
is the market-leading MALDI-TOF mass spectrometer for microbiology
with a number of unique features specifically designed for
applications in routine laboratories:
- State-of-the-art benchtop system
to save lab space
- Fiber optics laser coupling for
optimized robustness after preventive maintenance or service
- Self-cleaning ion source for
optimized robustness in high-throughput applications
- Oil-free membrane pump for quiet
operation in routine laboratories
- Rapid exchange of target plates
to reduce delays between measurement runs
- Smart Spectra Acquisition™ saves
laser life-time and increases speed of analysis
Commenting on the CFDA clearance, Dr. Lisong Shen, the Director
of Laboratory Medicine at Xin Hua Hospital affiliated with
Shanghai Jiao Tong University School of Medicine, and
President of the Shanghai Society of Laboratory Medicine,
said: “The importance of MALDI-TOF mass spectrometry
technology in the clinical microbiology field is widely recognized
in mainland China now. The approval of Bruker´s IVD MALDI Biotyper
system will further promote the development of clinical
microbiology science in the country, not only in laboratory
medicine, but also for infection control work within the hospitals.
With the significant reduction of the time-to-result for
identification of pathogenic bacteria, the patient outcomes will
improve and the cost of care will be reduced significantly.”
Dr. Lu Xinxin, the Director of the Clinical
Laboratory Department at the Capital Medical
University-Affiliated Beijing Tongren Hospital, added:
“MALDI-TOF MS is a revolutionary technology in microbiology. It is
rapid, easy to operate and enjoyable to navigate in the microbial
world."
Dr. Wolfgang Pusch, Executive Vice President of the Microbiology
Business at Bruker Daltonics, commented: “The regulatory approval
of the IVD MALDI Biotyper System in China is a major milestone and
another achievement in our regulatory strategy to support the
future growth of our business. We are committed to fully supporting
our growing customer base in China. After the regulatory approval,
we have immediately received positive feedback and have seen strong
demand for the IVD MALDI Biotyper from the Chinese clinical
microbiology market.”
Fast species ID is an important component to improve antibiotic
stewardship by helping to guide selection of the right therapeutic
drug(s). This is getting more and more important because of the
increasing threat by multi-resistant bacteria causing severe
infections. The IVD MALDI Biotyper System combines the most
advanced MALDI-TOF mass spectrometer with the most extensive
microbial species library in the market. Bruker continuously
invests in bringing the MALDI Biotyper into clinical routine
laboratories.
In 2009, the IVD MALDI Biotyper received the CE-mark according
to the European IVD directive EC/98/79. Since then Bruker has
continuously expanded the species coverage of the system and the
geographic coverage of regulatory clearance, thereby adding
clinical value for the existing customer base, as well as expanding
access by new customers in additional countries. The IVD MALDI
Biotyper is now available in most of Europe; in the Americas in
Canada, Argentina, Colombia, Ecuador and Mexico; and in the
Asia/Pacific region in Japan, China, Hong Kong, Singapore, Taiwan
and Australia. Additionally, in November 2013 the MALDI Biotyper CA
System received clearance for a first claim by the United States
Food & Drug Administration.
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 better accuracy and lower cost,
as well as typically much faster time-to-result (TTR).
Applications of the various MALDI Biotyper solutions include
clinical routine microbial identification, veterinary applications,
use by national, regional or local health and other regulatory
agencies, 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 recent 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, and can take hours or even days for analysis, and
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, or 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 industrial, diagnostics and applied analysis. For more
information visit: www.bruker.com.
Photos/Multimedia Gallery Available:
http://www.businesswire.com/multimedia/home/20140625005158/en/
For IVD MALDI Biotyper System Information in China:Bruker
DaltonicsOlia Wang, T: +86-13370119788Microbiology Business
Director Asia/PacificE: olia.wang@bruker.com.cnorInvestor
Contact:Bruker CorporationJoshua Young, T: +1-978-667-9580,
ext. 1479Vice President, Investor RelationsE:
joshua.young@bruker.com
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