Bruker Daltonics Obtains Russian Medical Device Registration for all Flex™-Series MALDI-TOF Mass Spectrometers

Bruker Daltonics Inc. today announces that it has obtained registration of its complete MALDI-TOF product line of microflex™, autoflex™ TOF or TOF/TOF, and ultraflex™ TOF/TOF mass spectrometers, as well as of its ClinProRobot™ sample preparation platform, as medical devices from the Ministry of Health and Social Development of the Russian Federation.

MALDI-TOF mass spectrometry is increasingly being applied as a clinical research tool in biomarker discovery, clinical proteomics, functional genomics, molecular imaging, and microorganism identification. Bruker Daltonics now has taken the important step of registering its flex™ 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™ 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 BioTyper™ 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™ 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 application. We anticipate using the MALDI BioTyper in the diagnosis of sexually transmitted diseases, 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). 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.”