FDA approves expanded third claim for Bruker in vitro diagnostics system
Bruker (Billerica, MA) has received U.S. FDA clearance for its third, further expanded claim for the MALDI Biotyper-CA (MBT-CA) in vitro diagnostics (IVD) system for microbial identification. The new claim includes a significant expansion of the microbial reference library for clinical microbiology by adding 144 new species covering anaerobes, gram-positive and gram-negative bacteria, and yeasts. The library coverage of the MALDI Biotyper-CA now includes 424 microbial species in 333 different groups that are FDA-cleared for the U.S. clinical microbiology market. This further significantly increases the clinical utility of the MBT.
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The third claim now also includes the new disposable MBT Biotargets 96 U.S. IVD, disposable targets based on the company's AnchorChip technology that provides sample concentration. The barcoded 96-spot MBT Biotargets do not waste spots, or require target plate cleaning and the corresponding validation requirements.
The expanded claim 3 library is now available in the U.S. on two different versions of the company's MALDI Biotyper CA system, either based on the standard microflex MALDI-TOF mass spectrometer or on the microflex smart that uses the company's smartbeam laser. Under typical microbial identification conditions, the 200 Hz smartbeam is a lifetime laser for microbial identification, decreases time-to-result, and increases throughput.
The MALDI Biotyper-CA now offers additional workflow tools for U.S. clinical microbiology customers: the MBT Pilot optically guided target preparation assistance tool for reducing specimen transfer human errors, and the MBT Galaxy for automating reagent additions, reducing repetitive motions associated with target preparation, and improving productivity and standardization.
The company's latest third submission showed a 99.8% correlation to sequencing methods, says George Goedesky, Bruker Daltonics Vice President for Microbiology - Americas.
For more information, please visit www.bruker.com.
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