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FDA Clears Bruker's MALDI Biotyper for Clinical Microbiology Use

NEW YORK (GenomeWeb News) – The Food and Drug Administration has granted 510(k) clearance to Bruker's MALDI Biotyper CA system for identifying gram negative bacterial colonies cultured from human specimens, Bruker said today.

The MALDI Biotyper instrument uses proteomic fingerprinting to enable molecular identification and taxonomical classification of microorganisms including bacteria, yeasts, and fungi. They can be used in routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer safety and quality control, as well as in marine microbiology.

The system includes the microflex MALDI-TOF mass spectrometer, software, IVD labeled reagents, a 48 spot MALDI target, and a library of microorganism reference spectra. Bruker said that it conducted a multisite clinical trial comparing the Biotyper with 16S ribosomal RNA gene sequencing, and the overall accuracy of the instrument is comparable with nucleic acid sequencing.

As GenomeWeb Daily News sister publication ProteoMonitor reported this summer, MALDI mass spectrometry has been poised to expand further into clinical microbiology markets, but the two main players in this field – Bruker and BioMérieux – were awaiting FDA approval for the use of these tools in clinical diagnostics.

BioMérieux received the FDA nod for its Vitek MS Microbiology System three months ago.

The MALDI Biotyper has been available for clinical microbiology use in Europe, as well as Canada, Argentina, Mexico, Colombia, Ecuador, Japan, Hong Kong, Singapore, Malaysia, and Taiwan, Bruker said.

"With clearance from the US FDA to market the MALDI Biotyper CA System, we expand our market reach into the largest clinical market in the world, with expected significant improvements in outcomes and reductions in the cost of healthcare," Bruker President and CEO Frank Laukien said in a statement.