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Bruker Daltonics Obtains South Korean Registration of autoflex II MALDI-TOF Mass Spectrometer as Class I Medical Device for IVD.


SEOUL, Republic of Korea & BILLERICA, Mass. -- Bruker Daltonics Inc. today announces that it has obtained registration of its leading autoflex(R) II MALDI-TOF MALDI-TOF Matrix Assisted Laser Desorption Ionization - Time of Flight  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 HBV hepatitis B virus.

HBV
abbr.
hepatitis B virus
), Hepatitis C virus
This page is for the virus. For the disease, see Hepatitis C.
The Hepatitis C virus (HCV) is a small (50 nm in size), enveloped, single-stranded, positive sense RNA virus in the family Flaviviridae.
 (HCV HCV
abbr.
hepatitis C virus


HCV 1 Hepatitis C virus, see there 2. Human coronavirus. See Coronavirus.
) genotyping and Human Papilloma Virus human papilloma virus
n. Abbr. HPV
A DNA virus of the genus Papillomavirus, certain types of which cause cutaneous and genital warts in humans, including condyloma acuminatum.
 (HPV HPV human papillomavirus.

HPV
abbr.
human papilloma virus


Human papilloma virus (HPV) 
) genotyping, based on GeneMatrix' proprietary Restriction Fragment Mass Polymorphism (RFMP RFMP Read the Flaming Manual Page (polite form)
RFMP Radio Frequency Mission Planning
(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 NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: BRKR)

Bruker BioSciences Corporation Bruker Biosciences Corporation is a Massachusetts-based company formed in 2003 which develops and manufactures scientific instrumentation for academic research and industrial use. , 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 and other regulatory approvals to the extent applicable, competition, the intellectual property of others, patent protection and litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called 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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No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Aug 10, 2005
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