bioMérieux Receives FDA Clearance for Expanded Pathogen Identification Capability on VITEK® MS | 07/31/17


Regulatory News:


bioMérieux (Paris:BIM), a world leader in the field of in vitro
diagnostics, today announced that VITEK® MS, its MALDI-TOF1
Mass Spectrometry System for rapid pathogen identification, has received
510(k) clearance from the U.S. 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 U.S.


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 2,695 clinical isolates for
47 moulds, 19 mycobacteria, and 12 Nocardia. The FDA clearance of Mycobacterium
species was from both solid and liquid growth media.


We are honoured to receive the first 510(k) clearance from the FDA
for the identification of…

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