Bruker’s IVD MALDI Biotyper Now Available to Clinical Microbiology Sites in Canada for Proteomic Identification of Microorg...
April 07 2011 - 1:12PM
Business Wire
At the 2011 Annual Meeting of the Canadian Association for
Clinical Microbiology and Infectious Diseases (CACMID), the
companies i2A Canada and Bruker Ltd. announced together that they
have met the relevant Health Products and Food Branch (HPFB) of
Health Canada regulations for the Bruker IVD MALDI Biotyper,
and that this product is now available for sale as a Class 1
Medical Device to all clinical microbiology sites in Canada.
i2a Canada, as the exclusive sub-distributor of the Bruker
IVD MALDI Biotyper for clinical microbiology in Canada since
2009, offers this robust, rapid and cost-effective method for
bacterial identification. Optionally, the IVD MALDI Biotyper
is also available in combination with the i2A SirWeb-MALDITOF
software as a fully integrated solution for clinical
microbiology laboratories.
The Bruker MALDI Biotyper is a MALDI-TOF mass
spectrometry based bench-top platform for rapidly identifying
bacteria and yeasts. Its carefully curated database includes
quality-controlled entries of over 3,900 strains from over 2,000
well-characterized microbial species. Starting from a cultured
colony, identification is performed by matching the measured
protein fingerprint against the proprietary MALDI Biotyper
database, followed by a final review by a trained microbiologist.
Including the database search, identification can be performed in
minutes. Multiple colonies can be spotted on a single target, and
about 30-60 identifications can be performed every hour with no
pre-testing required. The MALDI Biotyper offers considerably
faster time-to-result (TTR), high specificity, very low false
positive rates, low operational costs, and low technical barriers
for new operators.
The MALDI Biotyper is available in a research-use-only
version, as well as in the IVD MALDI Biotyper IVD-CE version
according to EU directive EC/98/79 in certain European countries.
Bruker has installed over 250 MALDI Biotyper systems
worldwide in routine clinical and other laboratories for microbial
identifications. Over 50 peer-reviewed papers have examined the
capabilities of the MALDI Biotyper with excellent results
reported to date. The Bruker MALDI Biotyper is rapidly
becoming a new standard for robust, rapid microbial identification.
Further applications are under development, including the
research-use-only MALDI Sepsityper™ consumables kit for
identification from blood cultures using the BD (Becton, Dickinson
and Company) Bactec system and associated BD consumables. This
rapid method for processing positive blood culture bottles is
intended to reduce time to result for this critical specimen with
results available in as little as 30 minutes.
Mr. George Goedesky, Bruker’s Executive Director - MALDI
Biotyper, stated: “We have been very encouraged by the excellent
results seen in clinical evaluations on-going in Canada and the
results generated have been very consistent to those seen in papers
published to date. The Bruker IVD MALDI Biotyper offers
clinical microbiologists an opportunity to reduce turn-around time,
time-to-result and improve identification accuracy with an
efficient, cost effective modern, molecular method. We are pleased
to be partnering with i2A to bring this revolutionary technology to
the clinical microbiology market in Canada.”
About i2A Canada
Founded in 1988, i2a SA in France, and i2a Canada (2003) in
Val-David, Quebec develop, manufacture and sell instruments,
epidemiology and nosocomial infection control management software
and reagents serving life science researchers, clinical
laboratories and veterinarian laboratories. For more
information about i2a, please visit www.i2a.info (no reagents yet
available in Canada).
About Bruker Ltd. (Canada)
Bruker Ltd. in Milton, Ontario was incorporated in 1970, and is
the Canadian subsidiary of Bruker Corporation (NASDAQ: BRKR). The
Bruker MALDI Biotyper produces a proteomic fingerprint which
when evaluated by the microbiology technologist in conjunction with
other data can provide rapid and robust identifications of various
types of micro-organisms. It can be applied to gram-positive and
gram-negative bacteria, and yeasts without pretesting such as gram
stain, catalase or oxidase. Starting from isolated colonies on
culture plates, identifications can be made in less than 10 minutes
at low cost. Located in Milton, Ontario are the sales, service and
support center for Bruker Ltd. for Canada. For more information
about Bruker Corporation, please visit www.bruker.com.
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