bioMérieux Receives FDA Clearance for Expanded Pathogen Identification Capability on VITEK® MS
31 Juillet 2017 - 07:00AM
Business Wire
With more than 15,000 distinct strains,
VITEK® MS provides the microbiology lab with the most
comprehensive Mass Spectrometry database to improve clinical
decision-making for infectious diseases
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 mycobacteria, Nocardia and moulds on
a MALDI-TOF system and to provide our U.S. customers with
additional features for the already well adopted VITEK® MS rapid
identification system,” said François Lacoste, bioMérieux Corporate
VP, Clinical Unit. “As the world leader in microbiology, one of our
priorities is to continuously develop high medical value solutions
that enable rapid and accurate detection of important
microorganisms, with the ultimate goal of improving patient
care.”
VITEK® MS is part of bioMérieux’s comprehensive and
complementary range of ID/AST solutions for infectious disease
diagnostics. Together, VITEK® MS for identification and VITEK® 2
for antimicrobial susceptibility testing provide seamless
integration and the flexibility needed to optimize laboratory
workflow and support appropriate antimicrobial treatment decisions.
The combination of VITEK® MS and VITEK® 2 provides confidence in
reporting results with speed and accuracy for routine diagnoses,
unusual or resistant organisms, or critical clinical
situations.
In cases where microorganisms are resistant to carbapenems (a
very broad spectrum antibiotic class), bioMérieux has also
developed and received FDA 510(k) clearance for its RAPIDEC® CARBA
NP test that enables the detection of carbapenemase producers
within two hours. RAPIDEC® CARBA NP helps health professionals make
vital treatment decisions and facilitates implementation of
infection prevention and control measures.
These highly complementary solutions help improve antibiotic
stewardship in the fight against antimicrobial resistance.
About bioMérieux
Pioneering Diagnostics
A world leader in the field of in vitro diagnostics for more
than 50 years, bioMérieux is present in more than 150 countries
through 42 subsidiaries and a large network of distributors. In
2016, revenues reached €2,103 million, with more than 90% of
international sales.
bioMérieux provides diagnostic solutions (systems, reagents,
software) which determine the source of disease and contamination
to improve patient health and ensure consumer safety. Its products
are mainly used for diagnosing infectious diseases. They are also
used for detecting microorganisms in agri-food, pharmaceutical and
cosmetic products.
bioMérieux is listed on the Euronext Paris stock market
Symbol: BIM - ISIN Code: FR0010096479
Reuters: BIOX.PA / Bloomberg: BIM.FP
Corporate website: www.biomerieux.com. Investor website:
www.biomerieux-finance.com
1 MALDI-TOF : Matrix Assisted Laser Desorption Ionization –
Time Of Flight
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Investor RelationsbioMérieuxSylvain Morgeau, + 33
(0)4 78 87 22 37investor.relations@biomerieux.comorMedia
RelationsbioMérieuxAurore Sergeant, + 33 4 78 87 20
53media@biomerieux.comorImage SeptLaurence Heilbronn, + 33 1
53 70 74 64lheilbronn@image7.frorClaire Doligez, + 33 1 53 70 74
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