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Robotic Diagnostic System For Cancer Diagnosis.
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Sample Preparation
Deparafinization
Rehydration
Pre-Treatment
High-temperature heating and rehydration recovers tissue antigenicity
Antibody Incubation
Primary antibody selectively binds to proteins of interest on cells for accurate diagnosis
Detection System
Enhance the sensitivity and allow for signal amplification
Substrate
Chromogen addition results in detection of signal
Permanent Mounting Applies clear adhesive mounting medium to slide
Coverslip
Protects tissue from scratches & improves optical quality
Typical IHC/ISH Work Flow
Critical steps in manual procedure include
• Reagent application• Incubation Time• Incubation Temperature• Wash• Drying
These can affect the quality of staining
Accessible to Automation
*Ref Approach to automation in IHC, Moreau et al Clin Chim Acta. 1998 Dec;278(2):177-84.
Approach to Automation*
Molecular Pathology Automated…
Sample Preparation
Deparafinization
Rehydration
Pre-Treatment
High-temperature heating and rehydration recovers tissue antigenicity
Antibody Incubation
Primary antibody selectively binds to proteins of interest on cells for accurate diagnosis
Detection System
Enhance the sensitivity and allow for signal amplification
Substrate
Chromogen addition results in detection of signal
Permanent Mounting- Applies clear adhesive mounting medium to slide
Coverslip
Protects tissue from scratches & improves optical quality
•Consistent Results
•Traceability of Operation
•Walk-away operations
•Economical use of reagents
•Low Cost
•Biosafety
•Flexibility of Operation
DIAGNOSTICS
INFINITY
Automation Ensures
KEY FEATURESKEY FEATURES
• Multi-functional system supports - IHC, ISH and FISH
• Slide processing options – Random (perform template test at any time), Continuous
(access new slides on an on-going basis) and STAT [Short Turn Around Time]
• Multi-format specimen processing
• Frozen or FFPE Tissues.
• Cell preparations.
• Smears and Fine Needle Aspirates.
• LIS connectivity
KEY FEATURESKEY FEATURES
Reproducible and Reliable Results
• Standardized pre-optimized process from baking through final cover slip.
• Walk away automation - RFID tagged reagent vials and bar-coded slides (eliminates
mix ups and errors)
• Optimized protocols and ready-to-use reagents( no protocol tweaking)
• Liquid level sensor ensures accurate dispensing and real time reagent tracking (keep
track of reagent quantity so runs are not affected due to insufficient reagents)
KEY FEATURESKEY FEATURES
Adaptable, Efficient, Productive and Cost-Effective
• Adaptable workflow solution with complete automation.
• Predictable cost structure (reagent cost per SLIDE can be calculated).
• Efficient use of resources, free-up highly skilled technicians for more demanding tasks.
• High Throughput - 40 slides in 6 - 8 hour shift (40 at a time).
• Start delayed run and return to view the completed slides.
KEY FEATURESKEY FEATURES
Easy to Use
•Color coded GUI with real time assay parameters display
•Real time audio and visual alerts
•Color coded bulk reagent carboys
•Step-by-step slide information log for every slide (can backtrack in case of improper
staining result)
ENABLING TECHNOLOGIESENABLING TECHNOLOGIES
Reaction Micro-chamber with Micro-fluidics
• Reaction micro-chamber : 25 µL to 100 µL.
• Reduced reagent consumption up to 75%.
• Even distribution of reagents on the specimen.
• Overnight incubation/ hybridization without drying of specimen.
ENABLING TECHNOLOGIESENABLING TECHNOLOGIES
eXACTTM Temperature Control on Every Slide
• Optimum operating temperature irrespective of laboratory conditions
• Temperature range from Ambient to 105°C
• Temperature uniformity across slide +/-2°C
• Active heating and cooling to minimize cross talk
•Thermocycling: Ambient 95°C in <2 min
ENABLING TECHNOLOGIESENABLING TECHNOLOGIES
RFID and Barcode Enabled Platform Technology
• RFID tagged reagents vials and bar coded slides
• Accurate and precise real-time reagent usage tracking.
Liquid Level Sensor and Reagent Dispensing System
• Accurate dispensing in micro-volumes
• Eliminates false negatives by error-free reagent dispensing
• Redundant automated processes to eliminate human error
• Disposable pipette tips prevent cross contamination
ENABLING TECHNOLOGIESENABLING TECHNOLOGIES
On-board Dehydration and Final Cover slip
• Dehydration and clearing.
• Permanent Mounting with glass cover slip.
• Curing and cooling.
LIS Enabled System
• Intuitive software designed to adapt any manual protocols.
• Easy to edit protocols.
• Reports for inventory management and regulatory compliance.
Why are these features important?Why are these features important?
Critical steps in manual procedure include• Reagent application.• Incubation Time.• Incubation Temperature.• Wash.• Drying.These can affect the quality of staining.
Reaction Micro-chamber with Micro-fluidics.
eXACTTM Temperature Control on Every Slide
Liquid Level Sensor and Reagent Dispensing System.
RFID and Barcode Enabled Platform Technology (Record Keeping).
Applications: Technologies for todayApplications: Technologies for today
• IMMUNOHISTOCHEMISTRY
• DOUBLE-STAINING
• CISH
Applications: Technologies for the FutureApplications: Technologies for the Future
• Multiplexing Assays of Nucleic Acid and Protein Biomarkers.
• In situ PCR.
• Quantitative gene expression profiling.
• Microarray technologies.
KEY FEATURESKEY FEATURES
• Simultaneous optimization of up to forty parameters in a single run.
• Co-detection of multiple nucleic acid and protein biomarkers.
• Multiplexing of single or multiple specimens on a single slide.
• Multi-format specimen analysis:
• Tissues - Frozen or FFPE.
• Cell preparations.
• Smears.
• Fine Needle Aspirates (FNA).
KEY FEATURESKEY FEATURES
• Intuitive software designed for ease of use and flexibility.
• Automate any or all steps from baking through final cover slip.
• Reagent choice
Open format or pre-optimized ready to use
User Defined
• Adapts and automates any protocol.
Enabling TechnologiesEnabling Technologies
Reaction Micro-chamber with Micro-fluidics
• Reaction micro-chamber: 10 μL to 80 μL (Customizable volumes).
• Reduces micro-reagent usage up to 90%.
• Even distribution of reagents on the specimen.
• Overnight incubation/hybridization without drying of specimen.
Enabling TechnologiesEnabling Technologies
eXACTTM Temperature Control and Thermo-cycling
• Forty independently thermo-cyclable (PCR) work stations
• Thermocycling: Ambient 95°C in <2 min
• High precision, active heating and cooling on each slide
• Temperature uniformity across entire slide +/- 2°C
• Temperature range of Ambient to 105°C.
Enabling TechnologiesEnabling Technologies
On-board Dehydration and Final Cover slip
• Eco-friendly (Non-Xylene) dehydration.
• Permanent mounting and cover slipping.
• Curing and cooling.
Ease of Use
• Real time slide map.
• Intelligent bulk fluidics system.
• Efficient waste management system.
• Reports for inventory management and regulatory compliance.
SIMULTANEOUS OPTIMIZATIONSIMULTANEOUS OPTIMIZATION
An example of the procedure:
•Baking
•Dewax
•Antigen retrieval
•Superblock
•Antibody
•Super enhancer
•Polymer HRP
•DAB work solution
•Hematoxylin
•Clearmount
•Xmount
Parameters that can be changed:
Unlimited addition or deletion of steps
Change of reagents and applied volume
Change of incubation time
Change of times of washes
Change the incubation temperature
Why are these features important?Why are these features important?
“BioGenex Laboratories Xmatrx system provides two unique capabilities, including the
ability to dispense as little as 10 µL of reagent and apply cover slips directly onto slides
(both of which are designed to conserve ISH probe reagents).”
- A review of automated slide stainers for IHC and ISH by Joe Myers
http://findarticles.com/p/articles/mi_m3230/is_1_40/ai_n24254665/pg_2/?tag=content;col1
SummarySummary
Diagnostics Infinity
High Throughput 40 slides in 8 hour Simultaneous Optimization of 40 assay parameters
25 µL – 70 µL (pre-optimized quantities) 10 µL – 80 µL (useful for FISH and microRNA research)
Closed System Open System
REAGENTS AND CONSUMABLESREAGENTS AND CONSUMABLES
IHC- REAGENTS
• Primary antibodies in RFID tagged vials (for 200 slides)
• Detection Kits
• XVizTM Detection System (Standard IHC reagents optimized for automation and BioGenex
protocols)
• SuperSensitiveTM One-step Polymer-HRP Detection Kit
• XVizTM Double Staining Polymer Detection Kit
• Antigen Retrieval Solutions : EZ-ARTM Elegance Solutions
• Enzymatic Pre-Treatment Solutions
REAGENTS AND CONSUMABLESREAGENTS AND CONSUMABLES
ISH Reagents
• ISH Probes packaged in RFID vials for staining upto 100 slides
• Detection Kits
• XISHTM Detection Kit (Standard ISH reagents optimized for automation and BioGenex
protocols)
• XISHTM Double Staining Detection Kit
• Nucleic Acid Retrieval Solution : increase target nucleic acid accessibility for ISH and eliminate
the variability generated by Proteinase K digestion step.
Xmatrx Diagnostics and Infinity ConsumablesXmatrx Diagnostics and Infinity Consumables
• Barrier Slides ( 18X18mm, 25X25mm for Infinity and 25X40 mm Diagnostics and Infinity)
• Cover slips
• OptiMiser Reagent Vials
• Pipette Tips
• Reagent Vials
• RFID tagged reagent volumes