Bruker Daltonics Obtains Russian Medical Device Registration for all Flex(TM)-Series MALDI-TOF Mass Spectrometers.
BILLERICA, Mass. and MOSCOW -- Bruker Daltonics Inc. today announces that it has obtained registration of its complete MALDI-TOF MALDI-TOF Matrix Assisted Laser Desorption Ionization - Time of Flight product line of microflex(TM), autoflex(TM) TOF (Top Of Form) The beginning of a physical paper form. To position paper in many printers, the printer is turned offline, the forms are aligned properly and the TOF button is pressed. or TOF/TOF, and ultraflex(TM) TOF/TOF mass spectrometers, as well as of its ClinProRobot(TM) sample preparation platform, as medical devices from the Ministry of Health and Social Development of the Russian Federation.
MALDI-TOF mass spectrometry mass spectrometry
or mass spectroscopy
Analytic technique by which chemical substances are identified by sorting gaseous ions by mass using electric and magnetic fields. is increasingly being applied as a clinical research tool in biomarker discovery, clinical proteomics, functional genomics, molecular imaging, and microorganism microorganism /mi·cro·or·gan·ism/ (-or´gah-nizm) a microscopic organism; those of medical interest include bacteria, fungi, and protozoa. identification. Bruker Daltonics now has taken the important step of registering its flex(TM) series MALDI-TOF mass spectrometers as medical devices in the Russian Federation, to facilitate upcoming future regulatory approvals of novel mass-spectrometry based in vitro diagnostic assays by its Russian 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 robust, reproducible and scalable sample preparation using various functionalized magnetic bead surfaces, high-performance MALDI-TOF and TOF/TOF detection, and advanced analysis and visualization software packages.
On the same mass spectrometer platform, the company's MALDI MALDI Matrix-Assisted Laser Desorption/Ionization BioTyper(TM) enables identification and taxonomical classification of microorganisms, like bacteria, yeasts, and fungi, for infectious disease research and other microbiology applications. In addition, the Company's new MALDI Molecular Imager(TM) is a novel system for in-vitro imaging of peptide and protein biomarker distributions in tissue sections and cell clusters, for example in tumor regions, that addresses the need for high-sensitivity imaging of the spatial distribution of protein biomarkers in biology, pathology and clinical research.
Following their registration as medical devices, both microflex and ultraflex instruments equipped as MALDI BioTypers are now being used by Professor Vadim Govorun from the Institute of Physico-Chemical Medicine in Moscow in the development of a novel system for the identification and characterization of clinically relevant microorganisms.
Professor Govorun stated: "I am very pleased to have Bruker Daltonics' leading MALDI-TOF platforms certified as medical devices. This will enable us to use the same instrument platforms during the development of validated Russian clinical protocols as in their later routine in vitro diagnostics In vitro diagnostic (IVD) tests are medical tests conducted in a test tube, or more generally in a controlled environment outside a living organism. In vitro means in glass in Latin. application. We anticipate using the MALDI BioTyper in the diagnosis of sexually transmitted diseases Sexually transmitted diseases
Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely , infections of the respiratory tract and blood infections, as well as in the monitoring of corresponding bacterial antibiotic resistance."
Alexander Harder, Director of Sales Support at Bruker Daltonics, commented: "In general, it is a major opportunity to apply mass spectrometry in clinical research and in vitro diagnostics (IVD (Interactive VideoDisc) See interactive video. ). Particularly in Russia, the Ministry of Health has recognized that in infectious disease control in hospitals unequivocal identification of microorganisms using our MALDI BioTyper has great potential to improve the health of patients."
Dr. Wolfgang Pusch, Assistant Vice President for Clinical Research Solutions at Bruker Daltonics, said: "The development of our CLINPROT solution towards IVD applications is greatly accelerated by the acceptance of our complete flex series of MALDI-TOF and TOF/TOF systems as medical devices by the Russian Ministry of Health. This gives our clinical research costumers the confidence to proceed with their mass-spec based diagnostics research with the knowledge that our MALDI-TOF systems will be suitable for later IVD registration of their respective assays."
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 BRKR Breaker )
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.
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
Food and Drug Administration
n.pr See Food and Drug Administration.
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, 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.