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FDA approval for expanded pathogen identification by MALDI-TOF

bioMérieux has announced that VITEK® MS, its MALDI-TOF mass spectrometry system for rapid pathogen identification, has received 510(k) clearance from the US Food and Drug Administration (FDA) for the expanded identification of mycobacteria, Nocardia and moulds. This database includes more than 15,000 distinct strains to provide extremely high accuracy and, for the first time, enables the safe identification of the Mycobacterium tuberculosis (TB) group, the most frequent non-tuberculous mycobacteria (NTM), Nocardia and the most medically important moulds. The VITEK® MS system’s newly expanded database and Mycobacterium/Nocardia and Moulds reagent kits are now commercially available in the US.

Mycobacteria, Nocardia and moulds are complex organisms to identify, requiring days or weeks of specific culture conditions for appropriate growth and subsequent advanced methods for reliable identification to the species level. With the newly expanded database, bioMérieux’s VITEK® MS system now offers simple, rapid, safe and reliable identification of these medically important pathogens, providing clinicians with actionable results to better manage these infections, such as tuberculosis, lung and bone infections, and other serious organ infections.

To gain new FDA clearance for these new species, bioMérieux submitted data from a multi-center study consisting of 2695 clinical isolates for 47 moulds, 19 mycobacteria and 12 Nocardia. The FDA clearance of Mycobacterium species was from both solid and liquid growth media.

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