MALDI-TOF Product Line Receives Russian Medical Device Registration

Bruker Daltonics Inc. 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.

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."