Bruker Daltonics Obtains South Korean Registration of autoflex II MALDI-TOF Mass Spectrometer as Class I Medical Device for IVDB
August 10 2005 - 6:00AM
Business Wire
Bruker Daltonics Inc. today announces that it has obtained
registration of its leading autoflex(R) II MALDI-TOF mass
spectrometers as Class I Medical Devices with the Korea Food and
Drug Administration. MALDI-TOF mass spectrometry is increasingly
being applied to the areas of clinical proteomics, functional
genomics and biomarker discovery as a clinical research tool. With
recent advances, usage of MALDI-TOF in in-vitro diagnostics (IVD)
applications has become very promising. Bruker Daltonics has now
taken the important step of registering its autoflex II systems as
medical devices in the Republic of Korea, to facilitate regulatory
approval of novel mass-spectrometry based IVD methods by its Korean
customers. Bruker Daltonics has developed the innovative
ClinProt(TM) solution for peptide and protein biomarker profiling,
discovery, identification and validation from body fluids or tissue
samples. The ClinProt solution offers an unparalleled combination
of cost-effective scalable sample preparation using magnetic bead
arrays, high-performance MALDI-TOF and TOF/TOF detection, and
advanced analysis and visualization software. The Company's
cutting-edge autoflex II MALDI-TOF(/TOF) mass spectrometers are a
key part of the ClinProt solution. Offering throughput up to
thousands of samples per day, autoflex II is a high performance
24/7 system for advanced biomarker discovery and identification,
functional genomics and high-success expression proteomics.
Following registration as a Class I medical device, autoflex II is
now being used by GeneMatrix Inc. in Korea, an emerging molecular
diagnostics company and a leader in pharmacogenomics, for molecular
diagnostics applications, including the diagnosis of Lamivudine
resistant Hepatitis B virus (HBV), Hepatitis C virus (HCV)
genotyping and Human Papilloma Virus (HPV) genotyping, based on
GeneMatrix' proprietary Restriction Fragment Mass Polymorphism
(RFMP(TM)) technology. GeneMatrix' testing services are already in
use by a number of major medical centers and university hospitals
in the Republic of Korea. Clive Seymour, Vice President for
Asia-Pacific at Bruker Daltonics, commented: "Our continuing
development of the ClinProt solution towards IVD applications is
greatly accelerated by the acceptance by the South Korean
authorities of our autoflex II systems as Class I medical devices.
It gives the clinical research community the confidence to proceed
with their mass-spec based IVD research in the knowledge that our
MALDI-TOF systems will be accepted for IVD use in the clinical
environment." Note: ClinProt applications are for research use only
(RUO). ABOUT BRUKER BIOSCIENCES (NASDAQ: BRKR) Bruker BioSciences
Corporation, headquartered in Billerica, Massachusetts, is the
publicly traded parent company of Bruker AXS Inc. and Bruker
Daltonics Inc. Bruker Daltonics is a leading developer and provider
of innovative life science tools based on mass spectrometry. For
more information, please visit www.bdal.com or
www.bruker-biosciences.com. CAUTIONARY STATEMENT Any statements
contained in this press release that do not describe historical
facts may constitute forward-looking statements as that term is
defined in the Private Securities Litigation Reform Act of 1995.
Any forward-looking statements contained herein are based on
current expectations, but are subject to a number of risks and
uncertainties. The factors that could cause actual future results
to differ materially from current expectations include, but are not
limited to, risks and uncertainties relating to the Company's
reorganization strategies, integration risks, failure of
conditions, technological approaches, product development, market
acceptance, cost and pricing of the Company's products, changes in
governmental regulations, capital spending and government funding
policies, FDA and other regulatory approvals to the extent
applicable, competition, the intellectual property of others,
patent protection and litigation. These and other factors are
identified and described in more detail in our filings with the
SEC, including, without limitation, our annual report on Form 10-K
for the year ended December 31, 2004, our most recent quarterly
reports on Form 10-Q and our current reports on Form 8-K. We
disclaim any intent or obligation to update these forward-looking
statements.
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