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Bruker Receives FDA Approval for Expanded MALDI Biotyper

NEW YORK (GenomeWeb) – Bruker said today it has received US Food and Drug Administration clearance for a third, expanded version of its MALDI Biotyper system.

The new version of the system adds 144 microbial species to its database covering a variety of anaerobes, gram-positive and gram-negative bacteria, and yeasts. According to Bruker, the system's library now includes 424 microbial species in 333 different groups.

George Goedesky, Bruker's vice president for microbiology, said in a statement that the Biotyper showed 99.8 percent correlation with sequencing methods in the company's claim submission for the expanded system to the FDA.

The new system also features Bruker's MBT Biotargets 96 US IVD, a disposable MALDI target technology that the company said eliminates the need for "target plate cleaning and the corresponding validation requirements." It also comes with the MBT Pilot tool for aiding target preparation, and the MBT Galaxy tool, which automates reagent addition steps.

The approval covers both the Biotyper based on Bruker's standard microflex MALDI instrument and a version of the system using the microflex smart MALDI instrument, which features a 200 Hz laser that allows for increased throughput.

A competing platform, BioMerieux's VITEK MS reapid pathogen identification system, also received expanded FDA approval today.