bioMérieux systems -...
Transcript of bioMérieux systems -...
bioMérieux systems March 2015
Overview
Microbiology P. 2
Immunoassays P. 10
Molecular Biology P. 12
Industrial Applications P. 15
Services P. 19
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Microbiology: VITEK®
Fully automated identification (ID) and antibiotic
susceptibility testing (AST)
Featuring Advanced Expert SystemTM result
interpretation software
The standard for routine identification
Coverage: 90% of the routine work in a normal
clinical laboratory
64-well cards with proprietary and innovative
substrates
The highest level of automation
Full automation and safety (inoculation, sealing,
and incubation of the card)
Accuracy
Rapid reporting (same day ID / AST results)
Resistance detection
Separate ID / AST testing
Reduced waste
After-sale service and high level of technical
support
21 CFR Part 11 compliant
Launched:
1977 - VITEK
1997 - VITEK®2
2004 - VITEK®2 Compact
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Mass spectrometry for identification of bacteria, yeast,
fungi, and mycobacteria
Fast ID
Broad range of organisms
Cost-effective solution for large laboratories
Workflow integration via MylaTM
Integrated with VITEK® 2 for AST*
The only clinical mass spectrometry MALDI-TOF-based
system available in the U.S. for use by microbiology labs
in the routine detection of a comprehensive menu of
disease-causing microorganisms
MALDI-TOF mass spectrometry (MS)
Extract the ions from the sample: Matrix-Assisted
Laser Desorption / Ionization (MALDI)
Separate the ions by m/z: Time-of-Flight Analysis
(TOF)
Detect the ions
European commercial launch in Q1 2011
FDA clearance in Q3 2013
Microbiology: VITEK® MS
Sample Prep Station VITEK® 2
* AST: antibiotic susceptibility testing
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Microbiology: BacT/ALERT®
Early detection of septicemia and industrial sterility
control
“Yes – No” test for bacteria
Automated colorimetric detection system -
with visual positive signal
Immediate notification of results
Plastic bottles to ensure safety
New media: synthetic resin beads to replace
activated charcoal suspension launched in Q4 2011
Neutralization of antibiotics in clinical samples
and industrial products
A clear Gram stain Launched:
BacT/ALERT® in 1991
BacT/ALERT® 3D in 1997
Bloodculture
Direct culture of blood samples and other fluids
VIRTUOTM: a new dimension in blood culture testing
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“Set and forget” loading
Final negative bottles
removed automatically
Smart scanning technology
Sample level sensing
Intuitive touchscreen New growth detection
algorithms
On-time alert
The first CE-marked fully automated blood culture system
maximizes laboratory efficiency and provides actionable and faster results
July 2014
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Microbiology: Lab Efficiency A strategic partnership with *
Fast growing customer needs:
automate tasks
enhance operational efficiency
make up for the growing shortage of specialized staff
obtain the accreditation they need to operate
The “bioMérieux - COPAN” offering is unique and the most complete
Streamline workflows
Deliver faster and more standardized results
Improve traceability of analyses
Transport media Decap / Recap Broth inoculation ID / AST prep.
Plates Gram smearing Incubation ID / AST run
Blood culture Gram / TB
staining Reading Middleware
Urinary screening Plate streaking Discs deposit Services
* Since January 2015, bioMérieux has been COPAN’s exclusive distributor in France, and a co-exclusive distributor in Germany
and the United Kingdom to distribute COPAN’s WASP® and WASPLabTM systems. Then bioMérieux’s commercialization rights
will gradually be expanded, on the basis of co-exclusive distribution, to a number of key countries.
WASP® and WASPLabTM systems
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Microbiology: Urinary screening - UF-1000i/500i
Distribution agreement in France,
Germany, the Netherlands, UK, South
Korea, and Australia
High quality by accurate detection and
enumeration of urine particles
Standardized results with capabilities
to screen out negative samples
In line with customer needs
Standardization
Time-saving
Traceability
Launched in September 2007
Advanced flow cytometry technology
with hydrodynamic focusing for urinary
screening
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Microbiology : PREVITM Color Gram
A fast, reliable & user friendly system
Result in less than 5 minutes
Accurate standardized results
No cross contamination
Clean and Safe
System entirely enclosed with
a waste container
Environmentally friendly system
Spray nozzles
Less consumption and waste
Pre-launch in about 10 European countries in 2008
Global launch in 2009
Full automated Gram staining system :
from fixation to the slide ready for
reading
Standard 12-slide capacity, upgradable
to 30-slide capacity
Direct analysis
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Microbiology: PREVITM Isola
Standardized plate inoculation
Time saving with high throughput
180 plates / hour
No cross contamination
Optimized colony isolation
High quality for plate streaking
Enhanced productivity
Breakthrough technology for
innovation in plate streaking
Pre-launched in 2008 in the Netherlands, Germany
and the U.S.
Gradual rollout to other regions in 2009
Pre-analytical processing
Specimen inoculation automation
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Immunoassays : VIDAS®,mini VIDAS® and VIDAS® 3
VIDAS® : launched in 1991
mini VIDAS®: launched in 1992
VIDAS® 3:
CE-marked: Q2 2013 - SFDA-approved: Q2 2014
Antigen-antibody reaction
Detects and measures infectious agents:
bacteria, viruses, parasites, hormones,
proteins
ELFA - Enzyme Linked Fluorescent Assay
technology
* College of American Pathologists: Automated Immunoassay Analyzers – June 2009 **Mean Time Between Failures
The world’s largest installed base* in IA
laboratories, with about 29,000 VIDAS® ,
mini VIDAS® and VIDAS® 3 clinical systems
Multi-parameter instrument
Large menu with 100 parameters
One of the most reliable instrument: MTBF**
VIDAS® = 660 days / mini VIDAS® = 1,150 days
Flexible and easy-to-use
Single test concept tailored to the small volume
market
Mini VIDAS®
VIDAS®
VIDAS ® 3
VIDAS® B.R.A.H.M.S PCTTM - bioMérieux’s
best-selling test : a test to measure procalcitonin (PCT),
a biomarker recognized as the gold standard
for the early detection of sepsis in critically ill patients
VIDAS® B.R.A.H.M.S PCTTM
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Immuoassays: DA VINCI®
Microplate immunoassay tests*
Up to 192 sample tubes loaded
at one time
Used by medium-sized blood banks
and large laboratories
Extensive set of in-process controls
Loading tower: 15 microplates
Traceability
Easy to operate
« Open » system: possibility of
adding other assays
Launched in 2003
DA VINCI® QUATTROTM
* Non strategic product line - Under divestiture process
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Molecular Biology: NucliSENS® easyMAG®
A single generic protocol for all samples
Up to 240 extractions in an 8-hour shift
Less than 15 minutes of hands-on-time
per 24 extractions
Simultaneous processing different samples
and volumes
User comfort
Simplicity
Flexibility
Quality
Time saving
Simplification and automation of sample
preparation in molecular biology laboratories
BOOM® technology: the reference
technology in extraction
Automated nucleic acid extraction - magnetic
extraction
Launched in 2005
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Molecular Biology: DiversiLab®
Launched in 2007
Microbial genotyping of bacteria and
fungi
Based on patented rep-PCR
technology
For tracking the spread and source
of microbial infection, contamination,
or epidemics
Microbial isolates to be quickly and
accurately distinguished at the
subspecies and strain level
Precise and economical solution
Results in 4 hours
just-in-time and syndromic molecular testing
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FilmArray®
FilmArray® 2.0
Molecular syndromic approach to infectious diseases
A unique value proposition
Rapidity: results in about 1 hour
Automation and ease-of-use: 2 minutes of hands-on time
Comprehensiveness: more than 20 micro-organisms in
one single panel whatever their nature
FilmArray® instrument: 2 commercially-available versions
3 CE-marked and FDA-approved FilmArray® panels
The FilmArray® Respiratory Panel: 20 respiratory
viruses and bacteria
The FilmArray® Gastrointestinal Panel: 22 common
gastrointestinal pathogens including viruses, bacteria
and parasites
The FilmArray ® Blood Culture Identification (BCID)
Panel: 24 pathogens and 3 antibiotic resistance genes
associated with bloodstream infections
Launched:
FilmArray® in 2011
FilmArray® 2.0 in 2015
Emergency Use Authorization
(EUA) from the FDA received by
FilmArray® clinical Ebola virus
detection test (BioThreat-E test™)
in October 2014
bioMérieux and AES A winning combination
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Food sample preparation: AES Blue LineTM
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DilumatTM range
SmasherTM
Blender easyMIXTM
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VIDAS® and
mini VIDAS®
Pathogen detection
TEMPO®
Quality indicator enumeration
BacT/ALERT® 3D Chemunex®
Rapid microbial detection & sterility
testing
VITEK® 2 compact
Automated identification
Environment monitoring
Labguard®
Industrial Applications
VITEK® MS
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Industrial applications : TEMPO®
Ease of use
Fast turnaround time for accurate and
standardized results
Standardization of numerous
preparation steps, interpretation, and
test results
TEMPO® system’s menu: a broad
range of 10 cards to answer different
needs
Incubation of 24 to 48 hours
Launched in 2005
Automated solution for the enumeration
of quality indicator microorganisms
bioMérieux Performance SolutionsTM
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Building an Efficient, Empowered, Learner lab