cobas® 4800 SystemInnovation that Simplifies

page 1 © 2014 Roche

cobas 4800 SystemInnovation made Simple

Minimal System Maintenance• Daily / Weekly maintenance requires ~ 2 – 7 minutes • No bleaching of the system or components• No Monthly maintenanceAutomated Specimen Preparation• Designed for pipetting directly from primary or secondary vial for

specimens with reduced volume, Secondary vial requires only 1 mL of volume

• On board bar-code scanner for positive patient identification• Reagents are ready to use• Air displacement system, no system fluids or priming cycles

Innovative System Design CO-RE Tips designed to reduce aerosols that can cause contamination TADM to ensure accurate sample and reagent pipetting LightCycler® Technology used for many years with the LightCycler®

instrument

cobas 4800 System

23 inches

cobas x 480 instrument

• Testing from primary and secondary specimen tube

• Specimen barcodes automatically read by system for positive specimen ID

• Batches of 24 or 96

cobas z 480 analyzer• Real-Time PCR• Based on LightCycler®

technology• 96 well plate format• 4 channel detection

66 inches

© 2014 Roche

HPV/HPV Genotype tests, CT/NG, and oncology markers & others on the same system

© 2014 Roche

HPV

CT / NG

cobas 4800 v2.0

BRAF

EGFR

EGFR RUO*

PI3K RUO*

KRAS RUO*

cobas 4800 v2.11

HPV, CT/NG, HSV1

BRAF, EGFR,

PI3K1, KRAS1

MRSA1/MSSA1, Cdiff1

* For Research Use Only. Not for use in diagnostic procedures. 1 Product is not available in the US. In development for the cobas 4800 system.

cobas 4800 v1.1

© 2014 Roche

PlateCarrier

Tip Carrier 1

Tip Carrier 2

StationaryCarrier

ReagentLoading

Area

cobas x 480 InstrumentInstrument Deck Overview

SampleLoadingArea

© 2014 Roche

Daily Maintenance• Once every 24 hrs.• Requires 2 – 7 min. of operator

time• No Bleaching of system

components

Preventive Maintenance Status• Performed bi-annually by

Roche Field Service

Weekly Maintenance • Includes daily maintenance• Operator should wipe down

carriers with water

cobas® 4800 SystemRequires Minimal Maintenance

No Monthly Maintenance

Sample Carriers

cobas x 480 Instrument Positive patient ID

• Specimen loading area holds up to 94 specimens

• 24 sample carriers & 12 sample carrier can be combined for a total of 94 samples on board for the cobas HPV test

• Specimen bar-codes are read by the on board barcode reader as the specimen carrier is loaded.

• The software links the specimen to the order providing positive specimen identification through out the testing process.

12 sample carrierholds up to 12 PreservCyt vials

24 sample carrier holds up to 24 PCR Media tubes or 24 Sarstedt tubes

© 2014 Roche

© 2014 Roche

Load samples1. Uncap samples.2. Place samples on corresponding carrier.3. Insert sample carriers on autoload tray.4. Click Load Samples.

cobas x 480 InstrumentLoad Samples and Work Order File

cobas x 480 Instrument Designed for reliabilityDesign Benefit

CO-RE tip technology • Reduces aerosol production upon tip ejection • Improved system reliability

Air Displacement Pipetting with total aspirate and dispense monitoring (TADM)

• Verifies sample transfer with digital audit trail• Liquid class optimization for all reagents and sample types• Detects pipetting errors during the aspiration step in real time

Anti-droplet control • Reduces droplet production from evaporative expansion in the tip• Reduces a source of contamination

Dynamic Positioning System

• Flexible, precise tip positioning• Adapts to any specimen container

© 2014 Roche

CO-RE Tip TechnologyCompression-Induced O-Ring Expansion

• Secure, air-tight tip seal • Gentle release to reduce

aerosol formation• Reduced mechanical

strain for reliability

O-ring

TipO-ring

groove

PistonO-ring in

groove

Tips locked in place by an O-ring that fits into a groove inside the neck of the tip

© 2014 Roche

© 2014 Roche

cobas x 480 InstrumentAspiration and Dispense Monitoring

• Reagent Carriers

cobas x 480 Instrument Instrument Deck Overview

200 ml Reagent Reservoir

50 ml Reagent Reservoir

Assay Specific Reagents

© 2014 Roche

cobas x 480 InstrumentStationary Carrier

Heater / Shaker

Magnetic Plate

Home position for DWP

Loading position forPCR Plate

© 2014 Roche

cobas x 480 InstrumentSample Preparation on the stationary carrier

Lyse Bind Wash Elute

Heater / Shaker• Lyse• Bind to Magnetic glass particle

Magnetic Plate• Wash steps

Extraction (deep well plate) holder• Sample and reagent addition

AD Plate holder• Extracted specimen + Master Mix

© 2014 Roche

cobas z 480 Analyzer

© 2014 Roche

© 2014 Roche

cobas z 480 InstrumentSeal Microwell plate and begin real-time PCR

• Following sample preparation

the AD plate is sealed and moved to the cobas z 480 analyzer

• The sealed plate is placed on the loader and the Real-time PCR begins when the load button is pressed and the plate is pulled into the cobas z 480 analyzer

• Positive specimen ID is maintained via the bar-coded microwell plate

© 2014 Roche

cobas z 480 System High Performance Real-Time PCR

Design Benefit

Unique fluid filled Therma-Based layer in the block provides uniform heating and cooling across the entire plate

• Shortened cycle times • Improved temperature

homogeneity• Improved accuracy

cobas z 480 analyzerHigh Performance Real-Time PCR

Design Benefit

Single step processing with few moving parts

• More reliable• More reproducible

High performance optical system with 5 optical channels

• Multiple target detection from a single reaction tube

• Accurate data capture across the entire plate

Advanced Digital Optics Design

© 2014 Roche

• Instrument-level processing corrects for optical system variability

• Filter design and manufacturing process minimized spectral cross-talk

• Primary data reduction algorithm is fluorescence scale invariant

• No more simplistic threshold methods for Ct calculations

Multivariable AlgorithmEliminate the guessing game

Expanding System Capabilities User Defined Workflow software

Design Benefit

Dual boot setup with a partitioned hard drive and separate database

Based on the LightCycler® 480 Software v.1.5

• Full functionality of the current LightCycler® software

• Allows user defined assay development to expand menu

• Limited training required for customers already familiar with the LightCycler® 480 Analyzer

© 2014 Roche

© 2014 Roche

cobas 4800 SystemResults

RunsTest Results

Accept Results

Print Report

cobas® 4800 System Workflow

© 2014 Roche

cobas 4800 system Process Map for 96 samplesRequires minimal hands on time; frees staff to perform other tasks in the laboratory

Source: Argent Global Services

Maintenance

• Daily / Weekly• No Monthly• Bleach is

never used on the cobas 4800 system

Load

• Samples in primary or secondary vials

• Consumables• Reagents, no

preparation required

Sample Preparati

on

• Directly from primary vial or secondary vial

• PCR ready plate is transferred to cobas z 480 Analyzer (1 min)

Real-Time PCR

• Multiplex Real-time PCR with multiple targets in one reaction

End of run clean

up

• Dispose of extraction plate

• Dispose of reagent reservoirs and tubes

• Dispose of AD plate

2 – 7 min

16 – 30 min

102 – 167 min

86 – 120min

~8 min

Walk Away Time

cobas® HPV Test96 HPV results with genotyping for 16& 18 in 5 hrs.no reflex testing required

Source: Argent Global Services, 2012

96 HPV Samples

24 HPV Samples

1 hr 2 hr 3 hr 4 hr 5 hr 6 hr 7 hr

146 min.

120 min.30

8 hr

83 min. 120 min.16

cobas HPV TestParallel testing provides flexibility

Source: Argent Global Services, 2012

24 HPV Samples

48 HPV Samples

72 HPV Samples

96 HPV Samples

1 hr 2 hr 3 hr 4 hr 5 hr 6 hr 7 hr 8 hr 9 hr 10 hr

83 min 120 min16

96 fully automated HPV with types 16 & 18 in 5 hoursHigh volume throughput – 288 results in under 12 hrs

96 HPV Samples

192 HPV Samples

288 HPV Samples

384 HPV Samples

1 hr 2 hr 3 hr 4 hr 5 hr 6 hr 7 hr

146 min.

120 min.

30

8 hr 9 hr 10 hr 12 hr

11 hr

13 hr

14 hr

Source: Argent Global Services, 2012

HPV Comparison StudyLeast amount of hands on time

Source: HPV Comparison Study; Argent Global Services, 2010

*Cervista hrHPV test performed on the Tecan DNA Extractor with the ABI 9700 Thermalcycler** hc2 HPV test performed with the Rapid Capture System

cobas HPV test hc2 HPV test Cervista hrHPV test

# of Reportables 94 88 48

Hands-On Time (min.) 33.17 149.02 129.01

Hands-On Time (min.) without daily man=intenance 29.3 142.71 125.84

Total Cycle Time (min.) without Daiuly Maintenance 295.84 404.64 471.43

Total Cycle Time (min.) 299.71 416.5 476.64

Walk-Away Time (min.) 266.55 248.97 309.19

Walk-Away Time (% of Total) 90% 62% 66%

Daily Maintenance Time (min.) 3.87 11.86 5.21

HPV Comparison StudyReduced time to results with minimal hands on time

Source: HPV Comparison Study; Argent Global Services, 2010

# of Reportables Hands-On Time (min.) Total Cycle Time (min.) Walk-Away Time (% of Total)

0

60

120

180

240

300

360

420

480

cobas HPV testhc2 HPV testCervista hrHPV test

cobas HPV test hc2 HPV test Cervista hrHPV test# of Reportables 94 88 48Hands-On Time (min.) 33.17 149.02 129.01Total Cycle Time (min.) 299.71 416.5 476.64Walk-Away Time (% of Total) 90% 62% 66%

Includes daily maintenance

cobas CT/NG v2.0 TestWorkflow

16

27 153 86

102 86

16

86

86105

28 167

1 hr 2 hr 3 hr 4 hr 5 hr

cobas CT/NG v2.0 TestParallel Testing

1 hr 2 hr 3 hr 4 hr 5 hr 6 hr

1 hr 2 hr 3 hr 4 hr 5 hr 6 hr 7 hr 8 hr

25,000 tests / year

50,000 tests / year

cobas CT/NG v2.0 TestParallel testing flexibility with HPV

1 hr

2 hr 3 hr 4 hr 5 hr 6 hr 7 hr 8 hr 9 hr 10 hr

11 hr

1 hr 2 hr 3 hr 4 hr 5 hr 6 hr 7 hr 8 hr

CT/NG Assay Comparison StudyMinimal system maintenance, minimal hands on time

Source: CT/NG Comparison Study; Argent Global Services, 2012

 cobas 4800

CT/NG

Abbott m2000 CT/NG

BD Viper CT/NG

Hologic Panther

HologicTigris CT/NG

# of Reportables 94 92 92 98 96

Hands-On Time (min.) 39.84 50.55 87.36 50.15 88.6

Hands-On Time (min.) without Daily Maintenance

35.99 39.45 66.48 36.21 53.76

Total Cycle Time (min.) 278.87 380.01 270.11 371.86 359.04

Total Cycle Time (min.) without Daily Maintenance

275.02 368.91 249.23 357.92 321.11

Walk-Away Time (% of total)

86% 81% 62% 87% 75%

Walk-Away Time (% of total) without Daily Maintenance

87% 83% 67% 90% 83%

Source: CT/NG Comparison Study; Argent Global Services, 2012

cobas CT/NG testLeast amount of hands on time

Includes daily maintenance

 cobas 4800

CT/NGAbbott m2000

CT/NGBD Viper CT/NG

Hologic Panther

HologicTigris CT/NG

Hands-On Time (min.) 39.84 50.55 87.36 50.15 88.6

Total Cycle Time (min.) 278.87 380.01 270.11 371.86 359.04

Walk-Away Time (% of total) 86% 81% 62% 87% 75%