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3 Marketing Facts Version 2.0 / August 2008 cobas c 311 launch binder For internal use only 95 3.4 Positioning & Knockout Arguments 3.4.1 Positioning the cobas ® Modular Platform y cobas ® 4000 analyzer series is an integral part of the cobas ® modular platform, offering flexible solutions for laboratory networks y The advantages for cobas ® modular platform are flexibility, efficiency, safety and convenience 3.4.2 Positioning cobas ® 4000 Analyzer Series More than 150 analytes > 50 assays for Thyroid, Cardiac, Hormones, Tumor Markers and ID > 100 assays for Clin. Chem., Electrolytes, Serum Proteins, DAT, TDM, etc. 5 modules 2 reagent carriers 1 User Interface More than 150 analytes > 50 assays for Thyroid, Cardiac, Hormones, Tumor Markers and ID > 100 assays for Clin. Chem., Electrolytes, Serum Proteins, DAT, TDM, etc. 5 modules cobas c 701 cobas c 311 cobas c 501 cobas e 411 cobas e 601 2 reagent carriers 1 User Interface cobas ® 8000 cobas ® 6000 cobas ® 4000 Large (>500 samples/day) Medium (200-500 samples/day) Small (80-200 samples/day) cobas c 311 analyzer cobas e 411 analyzer cobas a 242 platform ¾ The cobas ® 4000 analyzer series stands for: Convenience, Performance & Confidence ¾ Convenience from the cobas c & e packs along with IT connectivity ¾ Performance based on consistent and estab- lished technologies ¾ Confidence due to the proven reliability of Roche/Hitachi systems

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Page 1: c311 competative information

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3.4 Positioning & Knockout Arguments 3.4.1 Positioning the cobas® Modular Platform

cobas® 4000 analyzer series is an integral part of the cobas® modular platform, offering flexible

solutions for laboratory networks

The advantages for cobas® modular platform are flexibility, efficiency, safety and convenience

3.4.2 Positioning cobas® 4000 Analyzer Series

More than150 analytes

> 50 assays forThyroid, Cardiac,Hormones, Tumor Markers and ID

> 100 assays for Clin. Chem., Electrolytes,Serum Proteins, DAT,TDM, etc.

5 modules

cobas c 701

cobas c 311

cobas c 501

cobas e 411

cobas e 601

2 reagent carriers

1 User Interface

More than150 analytes

> 50 assays forThyroid, Cardiac,Hormones, Tumor Markers and ID

> 100 assays for Clin. Chem., Electrolytes,Serum Proteins, DAT,TDM, etc.

5 modules

cobas c 701

cobas c 311

cobas c 501

cobas e 411

cobas e 601

2 reagent carriers

1 User Interface

cobas® 8000

cobas® 6000

cobas® 4000

Large (>500 samples/day)

Medium (200-500 samples/day)

Small (80-200 samples/day)

cobas c 311 analyzer cobas e 411 analyzer

cobas a 242 platform

The cobas® 4000 analyzer series stands for: Convenience, Performance & Confidence

Convenience from the cobas c & e packs along with IT connectivity

Performance based on consistent and estab-lished technologies

Confidence due to the proven reliability of Roche/Hitachi systems

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3.4.3 cobas® 4000 Analyzer Series Knock-Out Arguments The Customer Wants It, We Have It & Competitors Don’t

Convenience Performance Confidence

! cobas c & e-packs offer consistent

reagent carriers across our Serum

Work Area platforms

! Offers the broadest menu with

200 assays to consolidate testing

on one platform

! Continues the Roche / Hitachi

legacy of delivering reliable prod-

ucts

! Integration of CC & IM with

middleware to offer patient-wise

workflow & result consolidation

! 9 min STAT assays on cobas e 411

offers the fastest TAT in the indus-

try

! Offers ECL technology, the gold

standard for Immunoassay estima-

tions

! cobas e-link offers electronic

downloads of assay / calibrator &

QC pack inserts & values

! Whole blood HbA1c application to

offer profile consolidation

! Intelligent clot detection and

contact free ultra-sonic mixing to

offer highly reliable results

! cobas c & e-packs offer accurate

inventory tracking with assay

specific pack sizes offering higher

efficiencies

! Highest on-board stability and

lot-to-lot calibration offers very

efficient usage of even low volume

assays

! Test specific Serum Indices to offer

consistent result integrity

Some of the Knock-Out Arguments in detail Performance: Broad Menu of Nearly 200 Assays

cobas® 4000 analyzer series will provide

at least 196 parameters in total:

– 117 photometric tests, 3 ISE tests,

8 formulas, 3 serum indices on the

cobas c 311 analyzer

– 65 heterogeneous tests with the

cobas e 411 analyzer

Dade Xpand and OCD Eci offer menus that

are less than half this size!

– This causes labs to keep legacy instru-

ments like Abbott AxSym and Beckman

Access or send out

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Performance: Superior Onboard Reagent Stability

The cobas c and cobas e packs match the

needs of even low volume labs who often

struggle with reagent usage efficiencies

The graph on the right compares the cobas c

pack with Dade Xpand reagents in terms of

average yield per cassette

The graph highlights that the cobas c pack

outperforms Dade Xpand reagents where

it counts: consistently better yields from

non-routine assays

Chart describes minimum efficient test usage/day by reagent.

Reference: Package Inserts.

Confidence: Proven Reliability of Roche/Hitachi Systems

Roche/Hitachi in design and manufacture,

cobas® 4000 analyzer series continues the

long tradition of proven reliability

– Over 15,000 Elecsys 2010 and Hitachi

911/912/904 systems have been placed

in the market

– Target MTBV is 300 days for the

cobas c 311 analyzer

Dade Xpand and OCD Eci cannot match

cobas® 4000’s reliability, serviceability and

consumable efficiencies

20 15 10 5 0 5 10 15 20

MyoAATHaptLactIgAIgMIgG

ASLOApoAApoB

C3C4RF

CeruPrealbTRSFHBDH

PrUCSFCKMB

NH3HDLLDLMGFerriACP

AMYPHbA1cFRUC

FePHOS

CRPCRPhs

CHECaCK

ALB AmyLDHALPBILDBILT

CreaeTRIG

TPGGTCO2AST ALT

LipUA

UreaCreaJ

GLUChol

DIMENSIONRxL / Expand

cobas c pack

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3.5 Targeting & Objection Handling 3.5.1 Small Segment Overview Active Lifecycle Management for a Large Installed Base

EOS1 CU2 EOL3 ICB4 Δ%5

Clinical Chemistry 8,369 0%

Roche/Hitachi 911/904 2000 2004 2009 1,020 -16%

Roche/Hitachi 912 2004 2008 2011 1,353 -7%

Roche/Hitachi 902 2008 N/A 2015 1,816 -12%

COBAS INTEGRA® 400/400+ 2010 2012+ 2016 4,180 15%

Immunochemistry 10,635 6%

Elecsys 1010 2001 2004 2008 2,085 -13%

Elecsys 2010 2007 2011+ 2014 7,988 5%

cobas e 411 562

1 End of sales, 2 End of Certified Use sales, 3 End of life, 4 Installed capacity base end 2007, 5 Change in ICB 06/07

3.5.2 Key Segments for cobas® 4000 Analyzer Series Primarily, it will be the Workhorse for Small Labs

cobas® 4000’s primary segment is small workloads labs wanting consolidated analyzers for

routine, STAT and special tests

It can also be used for STAT, special and backup in medium workload labs

COBAS INTEGRA® 400 plus can be positioned as an alternative for specials through 2010

CC IA CC IA CC IA

Large Mod P, D E170 cobas c 501 cobas e 601 I800/cobas c 501 cobas e 601

Medium cobas c 501 cobas e 601 cobas c 311 cobas e 411 I400/cobas c 311 cobas e 411

Small cobas c 311 cobas e 411 cobas c 111 cobas e 411 I400/cobas c 311 cobas e 411

X-Small cobas c 111 cobas c 111 cobas c 111

Consolidated STAT SpecialsLab Size

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0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

Inst

alle

d Ba

se (U

nits

)

Cobas Integra 400/400 plus 2,791 3,375 3,646 4,180

RD/Hitachi Small Systems 5,387 5,126 4,728 4,189

Y2004 Y2005 Y2006 Y2007

3.5.3 Primary Target Customers for cobas® 4000 Analyzer Series

3.5.3.1 Targeting Roche/Hitachi 902/911/912 Customers

With an Installed Base of over 4,000 Units, the Small Roche/Hitachi Series Systems are at High Risk ...

...While some have converted to COBAS INTEGRA® 400+, many customers have gone to Dade, OCD and Olympus

While COBAS INTEGRA® 400+ has had Recent Success, the Small Chemistry System Installed Based has Remained Flat

Installed Base RD/Hitachi Small systems by Region (Y2007)

NAM, 291

LAM, 835

APAC, 547

EMEA, 2,516

COBAS INTEGRA® 400

Elecsys® 2010

Competition

Roche/Hitachi 911/912

0

1,000

2,000

3,000

4,000

5,000

6,000

RD/

Hita

chi S

mal

l sys

tem

s

RD/Hitachi 912 1,562 1,546 1,449 1,353

RD/Hitachi 911/904 1,841 1,505 1,221 1,020

RD/Hitachi 902 1,984 2,075 2,058 1,816

Y2004 Y2005 Y2006 Y2007

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Converting Roche/Hitachi 911/912 to cobas c 311 Analyzer + cobas IT 3000 Focus benefits:

– Hardware reliability of Roche/Hitachi systems

– cobas c pack convenience & stability

– cobas IT 3000 benefits: optimized sample and data management

Objections – “I want an open system”

Yes, we will have Development Channels & a more extensive assay menu

– “I don’t need cobas IT 3000”

We can integrate the entire process today; competitive systems can be linked to

cobas IT 3000

Sample management: work lists become obsolete

Consolidation of QC for all systems in one software

Perform automatic technical validation on all systems

Auto re-run/repeat/reflex testing

Defending Against SHD Dade Xpand Focus benefits:

– Faster time to first result with superior analytical

performance

– Extensive assay menu (both CC & IA)

– Simple reagent handling with cobas c packs

– Hardware reliability of Roche/Hitachi systems

Objections

– “I’m considering consolidating my testing into one box”

You will still need a second instrument in order to be a full service IA lab

– “I like the ability to load reagents mid-run”

Dade’s small packs (unstable reagents), reconstituted reagents and small channel capacity

require increased set-up time and frequent changes

Keep in mind this is not nearly as convenient as on cobas® 6000

– “I like the 1 minute ISE panel”

1 minute analytical time requires 130 minutes set-up time

Trade-off is long turn around times for critical assays (e.g. β-hCG)

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3.5.3.2 Second Target: Stand-alone Competitors like OCD

Attack Vitros 350 & Eci

Focus benefits:

– Faster time to first result (9 min vs. 24 – 37 min)

– Extensive assay menu (both CC & IA)

– Simple reagent handling with cobas c packs

(vs. up to 3 hr prep time)

Objections – “I trust J&J because of its ability to ensure result integrity”

No serum indices, auto pre-dilution & potential

HAMA interferences

Inconvenience of manually loading pipette tips

– “I prefer J&J’s proven systems and slide technology”

Slides can take up to 3 hours to defrost

Concern for the future as future system & reagent pipeline

is limited

– “The Vitros is so easy to use”

Refocus on simple reagent handling & easy-to-use software

3.5.3.3 Active Lifecycle Management of Elecsys &

COBAS INTEGRA® Systems

Limited upgrade: – Customers with aging contracts should be actively managed

– Consider cobas® 6000 analyzer series for customers expanding their business

Focus benefits:

– Next generation user interface

– Compatible with cobas c 311 analyzer or cobas e 411 analyzer

Objections – “I don’t want PSM”

We can integrate entire process today; competitive systems can be linked to PSM

Sample management: work lists become obsolete

Consolidation of QC for all systems in one software

Perform automatic technical validation on all systems

Auto re-run/repeat/reflex testing

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3.6 Rollout Plan & Marketing Tools 3.6.1 Rollout Plan for cobas® 4000 Analyzer Series Promote cobas® 4000 analyzer series in phases to optimize sales potential Phase 1: Friends & Family – launch cobas e 411 analyzer and cobas c 311 analyzer as stand-alone

systems to aging Roche/Hitachi 911/912 and Elecsys 2010 installed bases

Phase 2: Limited Rollout – offer modified cobas IT 3000 as cobas® 4000 solution to selected

customer base, including MCE focused on workflow benefits

Phase 3: Full Launch – fully launch cobas® 4000 analyzer series to all customers with strong

competitive focus, including feedback from successful MCE

3.6.2 Bridging Strategies for cobas® 4000 Analyzer Series Before the Launch of the cobas c 311 Analyzer

Pre-sell cobas c 311 analyzer to the Roche/Hitachi 911/904/912 base, while positioning it as part

of the cobas® 4000 analyzer series

– Continue holding strategy

If possible, extend contracts to coincide with availability of cobas c 311 analyzer

– Customer-at-risk strategy

For customers at risk, place COBAS INTEGRA® 400 plus

Position cobas e 411 analyzer to at-risk Elecsys 2010 customers, and pre-sell cobas c 311 analyzer

as part of the cobas® 4000 analyzer series

cobas c 311

cobas IT 3000 / a 242

cobas 4000

cobas e 411

Q4/06 Q4/08Q3/08

Phase 1

Phase 2

Phase 3

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3.7 Competitive Information The following chapter is exclusively dedicated for ROCHE INTERNAL/CONFIDENTIAL use.

Summary

In the Launch Binder, three competitive offers have been analyzed. This selection focuses on the

small workload segment competitors with combined/integrated Clinical Chemistry and Immuno-

assay capabilities.

Some SWA systems target the small segment. The main selling arguments used concern convenience,

safety, efficiency/productivity and ease of use. Reliability, although an important value for most of

costumers, is not usually used as it is taken as granted. A new value proposition starting to be used

is family approach and networking laboratories. cobas® 4000 analyzer series is strong in these areas.

As can be seen on the Competitor Systems Overview table (next page), the cobas® 4000 analyzer

series offers a competitive combination of convenience, safety and power.

Likewise on the Assays table (next second page), the cobas® 4000 analyzer series provides a wide

menu of assays, supporting not only virtual consolidated work areas but also full-blown serum

work-areas, e.g. as a backup solution, exploring the laboratory full potential of productivity.

There is no doubt that cobas® 4000 analyzer series will have tough competition. However, due to

its well balanced characteristics, it is a very competitive solution, enabling Roche to be commercially

successful in the small segment for SWA, for routine/24H labs as well as STAT, networking and

Rapid Response Labs.

Further and more detailed information you will find on the RPD home page:

http://competitor-focus.mah.roche.com/

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Comparisons based on technical data provided by the company home pages and promotional material as of March 2007. Pictures shown are copyright protected. Dimension®, QuickLyte®, Stratus®, Dimension Xpand™, VLYTE™, Quicklyte™, and XLINK® are trademarks of Dade/Behring VITROS®, MicroSlide™, CuvetTip™, MicroTip™, and Intellicheck™ are trademarks of Ortho Clinical Diagnostics (OCD)

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Competitor Systems Overview

cobas c 311 analyzer

cobas e 411 analyzer

SHD DB Dimen-sion® Xpand®

Plus® HM

OCD Vitros® 350 OCD Vitros® ECiQ

Olympus AU 400

Short Description

The new CC-Analyzer for the small and networking segment featur-ing a compact system with new capabilities using a conve-nient universal reagent carrier. More than a system, it is a part of the cobas® modular platform.

Bench top analyz-er for heterogene-ous immunoas-says in laborato-ries with medium work-loads.

Performing immunoassays as simply as Clinical Chemistry. Easy to operate. Unique program-ming-by-loading concept: Barcode-based data entry is carried out au-tomatically by loading reagents, controls, and calibrators.

A non expandable combination of the Dimension Xpand and the optional Hetero-geneous Module (HM).

Successor of the VITROS 250 with a slightly higher throughput. Still using the dry chemistry slides, MicroSlide™.

Successor of the ECi with a slightly changed operator interface.

Stand-alone CC-analyzer with 41 channels (incl. ISE) and a throughput of up to 800 ts./hr. More then 100 Olympus System Reagent (OSR) are available. Serum indices. Low reagent and sample volumes.

Competitor Value proposition

Part of the cobas® modular platform, family approach

Part of the cobas® modular platform, family approach. Fastest HetIA system, 9 min applications.

Integrated chemi-stry system. Easy-to-use system. Tailored for small workload.

Easy to operate, Safety, “It’s that simple”.

Easy to operate, excellent assay protocols, result integrity.

The smallestmember of the AU family. STAT analyzer in large laboratories. Routine analyzer for the small laboratory. Specialty analyzer for the large routine laborato-ry.

Competitor Argumenta-tion

Platform com-monalities, e.g. reagent carrier, user interface, cobas® link. Up to 90 days on-board stability.

Platform com-monalities, e.g. reagent carrier, user interface, cobas® link. Up to 60 days onboard stability.

Up to 250 photometric tests/hr., 180 ISE tests/hr. plus 83 HetIA tests/hr. Water consump-tion only 8l/1000 tests. Offered assays: 73.Onboard capacity (incl. HetIA): 44 channels.

Advanced security: Ensure worry-free result reporting. “Load-and-go” reagent prepara-tion, up to 6 month calibra-tion stability. More then 40 on-board chemistries, 300 ts./hr.. Customized patient reports for physician office labs.

Advanced processing centre. Ensures result in-tegrity for quality result reporting Intellicheck tech-nology verifies Microwell dis-pense and assay reagent aspiration and dispense.

AU family approach. Important com-munalities from the small to the mega large work-load labs.

Expected Launch

3rd Q. 2008 In commercializa-tion since 2006.

In commercializa-tion since 2001.

In commercializa-tion since 2006.

In commercializa-tion since 2005.

In commercializa-tion since 1998.

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Convenience All reagents

ready to use. Very simple to use (Rating = 4)

All reagents ready to use Very simple to use. (Rating = 4)

Requires a second HetIA system due to the limited menu. (Rating = 2)

All reagents ready to use. Very simple to use. (Rating = 4)

All reagents ready to use. Very simple to use. (Rating = 4)

No opportunity/offer of a HetIA system for small or network labs. (Rating = 2)

Safety State-of-the-art pipetting, with clot and level detection. Contact free mixing of sample and reagents. (Rating = 4)

State-of-the-art pipetting, with clot, foam and level detection. 100% carry over free pipetting system due to disposable tips and reaction cells. Contact free mixing of sample and reagents. (Rating = 4)

Carry-over possible (immu-noassays) (Rating = 3)

(Rating = 3)

Carry-over free pipetting due to disposable tips. (Rating = 4)

No clot detection. (Rating = 2)

Consolida-tion and Throughput

Up to 300 t/h, up to 45 channels (Rating = 4)

Up to 88 t/h, up 18 channels. (Rating = 3)

CC: up to 250 t/h, up to 180 t/hr. ISEUp to 44 channels on board. IA: 83 t/h, xx assays. (Rating = 4)

Up to 300 nominal t/h, up to 40 channels. (Rating = 4)

Up to 90 t/h 20 channels (Rating = 4)

Up to 800 t/h (w ISE). 41 channels onboard (w ISE). Reaction volume 150 μl with a sample volume approximately by 2μl (Rating = 4)

Rating TOTAL

12 11 9 11 12 8

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Ortho Clinical Diagnostics (OCD) VITROS® 350

System Concept The Ortho Clinical Diagnostics (OCD) VITROS® 350 is the successor of the VITROS® 250.

VITROS® 350 is the smallest member of the VITROS® family, VITROS® 950 and 5.1 FS.

The VITROS® 350 Chemistry System offers easy operation, maintenance, and training.

Whether you use it as a primary, STAT, or back-up to the VITROS® 5,1 FS.

The VITROS® 350 does not require highly-trained operators – simple procedures allow around-the-

clock availability to all members of the lab staff.

Up to 300 results per hour .

On-board capacity for all 45 assays.

Sample processing capabilities like disposable tips, bubble and clot detection.

No plumbing, drains, vents, de-ionized water is required; all “waste” is contained in used test slides

which are disposed daily.

MicroSlide™ reagents are used on all OCD Clinical Chemistry systems.

Use of disposable tips to eliminate carry-over and cross-contamination.

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Main Features and Benefits Ease of operate, high skilled staff necessary.

Long lot calibration stability of the Microslides.

Reagent compatibility with VITROS® 950 and 5.1 FS.

Proven in the markets based on the installed VITROS® 250.

High customer loyalty especial in the USA.

Strengths, Weaknesses and Argumentation

No major technical differences between 350 and 250. OCD is promising a marginal higher through-

put of theoretically 50 ts/hr. up to 300 ts/hr.

All concerns, e.g. menu, maintenance, deep frozen slides, etc., of the VITROS® still exist at the

VITROS® 350.

The dry chemistry with all there beauties and restrictions, like cost for the slides, short onboard sta-

bility, no serum indices, are not changed with the VITROS® 350.

Limited menu with out expansion of major test over the last 3 years.

Some tests, e.g. Creatinine, Bilirubin, etc. are still weak in case of precision in the decision range since

there introduction.

But keep in mind OCD customers are loyal and they like the easy operation of the system, OCD’s

slogan “It’s simple” fits perfect to there mind set.

With cobas c 311 analyzer, Roche will provide a similar ease of operation system due to the

cobas® packs, ready-to-use reagents with unique “one-grip-loading”, but with whole menu of

Clinical Chemistry, Proteins, TDM’s and DAU’s, in total more then 100 assays.

Means the “power of consolidation” of the cobas® 6000 analyzer series is provided now to the small

workload segment.

The 45 channels (incl. ISE) on the cobas c 311 analyzer compared with 39 channels (incl. ISE)

of the VITROS® 350 are supporting much more the convenience in a routine laboratory in this

segment.

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Competitor Roche Ortho

System cobas c 311 analyzer VITROS® 250/350

Launch date 2008 1993/2005

List price $110.000

Worldwide placements > 3000

Complete

Footprint/m2 1.7 1.4

Test throughput/hr (photo+ISE) 300 300

Parameters available 101 41

Reagent concept 10 development channels Closed

Tests onboard + ISE 45 45

Samples onboard 108 40

Convenient

Data management Onboard & via cobas a 242 Onboard

Sample handling Disk Rack

Clot detection Yes Yes

Cuvette concept Washable Slide

Automatic repeat, rerun, reflex Yes No

Test-specific serum indices Yes No

Confidence

Auto pre-dilution Yes No

Ave calibration stability (days) Each lot Each lot

Ave onboard stability (days) 90 14

Online application download Yes No

Sample volume (μl) 1 to 35 10

MTBRV (days) Target of 300

Ave daily maintenance 3 min 4 min (up to 22)

Remote service Yes No

Key Selling Points

Menu breadth Ease of use

Result integrity Compatibility with V 950

Reagent cassettes Customer loyalty

Convenient operation Proven in the market

True random access

Long onboard stability

Long cal. stability

Rerun, repeat, reflex

Superior serviceability

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Competitor Roche Ortho

System cobas c 311 analyzer VITROS® 250/350

Limitations

Limited menu

Slide prep up to 3 hours

Slide cost

Short onboard stability

Generally low precision

Short cal. stability

Bili-d & neonate calc’td

No serum indices

No onboard dilutions

Future portfolio

No remote service

Ortho Clinical Diagnostics VITROS® ECiQ

System Concept

VITROS® ECiQ is the successor of the aged ECi.

The ECiQ includes now the so called “intellicheck”. This function takes care for the clot and bubble

detection during the sample and reagent aspiration, nothing else.

ECi and ECiQ have the same throughput and technically there are not differences.

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Main Features and Benefits

The VITROS® ECiQ offers a throughput of 90 ts/hr. and 20 channels on board.

e-ConnectivityTM via VPN tunnel for a bi-directional communication between the ECiQ and the

OCD-support centre, remote help desk, remote preventive service and automated data download.

Strengths, Weaknesses and Argumentation

OCD doesn’t have any alternative system for the small workload laboratories like Roche with the

cobas e 411 analyzer. ECiQ is still dealing with a limited menu and longer reaction times, 24 up to

37 min compared with cobas e 411 analyzer with 9 min up to 18 min.

cobas e 411 analyzer offers the whole Elecsys® assay menu and the commonalities of the cobas®

modular platform, e.g. user interface, e-pack, “on-grip-loading”, cobas® link, etc.

The size of the ECiQ is too big for the small workload segment but not the practical throughput of

only 40 to 60 ts/hr.

The reagent menu has big gaps, e.g. no Diabetes assays, no Thyroid anti-bodies, etc. (see spread sheet

below).

Competitor Roche Ortho

System cobas e 411 analyzer VITROS® ECiQ

Launch date 1996/2006 1997/2004

List price $150,000

Worldwide placements 7,000 (E2010) 2000

Com

plet

e

Footprint/m2 0.7 1.08

Technology ECL CL/coated microwell

Test throughput/hr 88 90

Test throughput/m2 131 83

Parameters available (HET only) 55 30

Parameters available in future 65 30

Tests onboard 18 20

Tests onboard/m2 27 18

β-hCG time to result (min) 9 24

Samples onboard 30 (disk), 75 (rack) 60

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Con

veni

ent Data management Onboard & via cobas a 242 Onboard

Sample handling Disk or rack Trays

Clot detection Yes Yes

Closed tube sampling No No

Auto calibration or request Yes Yes

Automatic rerun, repeat, reflex Yes Yes

Con

fiden

ce Ave calibration stability (days) 30 28

Calibrator levels 2 1 to 3

Ave onboard stability (days) 56 56

Reagent (un)loading during run No No

Sample (min) + dead volume (μl) 110 70

Sample pipetting Disposable tips Manually loaded tips

Walkaway time (min) 120 360

MTBRV (days) 300

Ave daily maintenance (min) 4 (up to 31) 10 (up to 45)

Remote service Optional Yes

Limitations

Menu gaps 24 – 37 min incubation times

3 point cals

No HAMA avoidance

Susceptible to air bubbles

Noisy

Low throughput

Manual tip loading

Reagent menu

LH + +

FSH + +

Prolactin + +

Progesterone + +

Estradiol + +

Testosterone + +

hCG+β + +

SHBG +

hCG free-β + +

C-peptide +

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Competitor Roche Ortho

System cobas e 411 analyzer VITROS® ECiQ

Insulin +

Cortisol + +

PAPP-A +

ACTH +

DHEA-S +

α-HAV + +

α-HAV IgM + +

HBsAg + +

HBsAg Confirmatory + +

α-HBs + +

α-HBc + +

α-HBc IgM + +

HBeAg + +

α-HBe + +

HIV Combi + +

HIV Ag +

HIV Ag Confirmatory +

Anti-HCV + +

Troponin T +

Troponin I +

CK-MB + +

Myoglobin + +

NT-pro BNP + +

Homosystene +

Rubella IgG + +

Rubella IgM +

Toxo IgG + +

Toxo IgM +

Chlamydia Ag *

Chlamydia Ag Confirmatory *

TSH 3rd Gen + +

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Competitor Roche Ortho

System cobas e 411 analyzer VITROS® ECiQ

FT3 +

FT4 + +

T3 + +

T4 + +

T-uptake + +

TG +

α-TG +

α-TPO +

α-TSH-rAb +

TBG +

PSA total + +

PSA free +

AFP + +

CA 125 II + +

CA 15-3 + +

CA 19-9 + +

CA 72-4 +

CEA + +

Cyfra 21-1 +

NSE +

S-100 +

Ferritin + +

B12 + +

Folate + +

RBC Folate + +

Anti-CCP +

ß-Crosslaps + +

Vitamin D-25(OH) +

Intact PTH +

Osteocalcin +

P1NP +

IgE +

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Competitor Roche Ortho

System cobas e 411 analyzer VITROS® ECiQ

β2-Microglobulin +

Calcitonin +

N-Telopeptide +

Digoxin +

Dixitoxin +

Olympus AU 400

System Concept

“The smallest member of the clinical chemistry analyzer family and technology platform is the

Olympus AU 400. With a throughput of up to 800 tests per hour and an on board capacity of

41 different analytes in parallel the Olympus AU 400 is the ideal main analyzer for small to medium

sized laboratories. But it fits as a special chemistry or STAT analyzer in large laboratories as well.”

The Olympus AU 400 doesn’t offer new features since launch in 1998, except the switch from

Windows NT to Windows 2000, touch screen and rack sampler.

AU 400 is still using bottled reagents separated in R1 and R2.

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Main Features and Benefits

The Olympus AU 400 is comparable with the Roche/Hitachi 911 with one feature more, the clot

detection.

The AU 400 is using the same bar-coded reagents as the other analyzers out of the AU-family and has

46 tests onboard (inclusive ISE).

80 samples on 10 position racks (no STAT racks) are possible to load as one batch.

Serum indices are included, like on Roche/Hitachi systems.

Sample volumes in average 2 μl and the total reaction volume is 150 μl.

The AU 400 has a well known reliability as well as Roche/Hitachi analyzers.

AU 400 offers 24 cooled positions on a sample disk for QC and calibrators. These positions are

shared with the STAT samples (!?).

Strengths, Weaknesses and Argumentation The AU 400 is a system with a theoretical throughput of 400 ts/hr.

The system is still using the two bottle reagent concept like Roche/Hitachi 912 without the conveni-

ence of the cobas® pack, one cassette for R1 & R2 – “on-grip-loading”.

Olympus doesn’t offer the AU 400 on a global base, means in different countries, e.g. USA, Canada,

Mexico, etc. the system isn’t available on the market places.

It could be that local dealer are taking care for the AU 400 business, but is this what a customer in a

major country like USA is expecting?

Who is taking care for the after-sales-service?

Olympus doesn’t have small immunoassay analyzer to be able to offer a virtual integrated serum

Work Area solution to the small workload segment like cobas® 4000 analyzer series.

Olympus has still menu gaps (see the list above).

The biggest gap they have is in TDM testing, here it would be better to list what they are offering then

what they don’t. Because they are offering following assays:

Carbamazepine, NAPA, Tobramycin and Valproic Acid, that’s all.

It could be that Olympus is offering 3rd party reagents, e.g. from Micro Genetics, as open channel

applications. But what about IVD and FDA regulatory who is taking care for documentation,

application and quality if problems are occur?

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Competitor Roche Olympus

System cobas c 311 analyzer AU 400e

Launch date 2008 1998/2002

List price $130,000

Worldwide placements 2,500

Complete

Footprint/m2 1.7 1.8

Test throughput/hr (photo + ISE) 300 400

Parameters available 101 69

Reagent concept 10 development channels Open

Tests onboard + ISE 45 41

Samples onboard 110 80

Convenient

Data management Onboard & via cobas a 242 Optional

Sample handling Disk Rack & STAT

Clot detection Yes Yes

Cuvette concept Washable Washable

Automatic repeat, rerun, reflex Yes No

Test-specific serum indices Yes No

Confidence

Auto pre-dilution Yes Yes

Ave calibration stability (days) Each lot Open system

Ave onboard stability (days) 90 Open system

Online application download Yes No

Sample volume (μl) 1 to 35 2 to 50

MTBRV (days) Target of 300 180

Ave daily maintenance 3 min 6 min (up to 45)

Remote service Yes No

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Competitor Roche Olympus

System cobas c 311 analyzer AU 400e

Key Selling Points

Menu depth Throughput

Result integrity Low system price

Reagent cassettes Open system

Convenient operation

True random access

Long onboard stability

Long cal stability

Rerun, repeat, reflex

Superior serviceability

Limitations

Limited menu

No result traceability

No remote service

Short onboard stability

Short cal stability

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SHD Dade Behring Dimension® Xpand TM Plus HM

System Concept

The Dade Behring family of Dimension analyzers is made of the Vista 3000, Vista 1500, RxL Max

HM*, RxL and Xpand Plus HM for large, medium and small workload labs respectively.

The Dimensions performs a very limited number heterogeneous immunoassays (FT4, TSH, T4, T3,

T-uptake, NTpro-BNP, Myoglobine, CK-MB mass, Troponin I, β-HCG, PSA, fPSA, B 12, Folate,

RCB-Folate and Ferritin) to cover Thyroid, Cardiac Marker, Anemia and Hormones in parallel with

routine clinical chemistry parameters; conceptually, it has been one of the first systems with consoli-

dation for the heterogeneous together with Clinical Chemistry and Homogeneous Immunoassay.

Other frequently promoted features are:

The reagent carrier FLEX is promoted as an advantage but in matter of fact its size and stability

are too small.

A “wide menu of assays” hides basic limitations like some important assays gaps and the lack of

real consolidation power that require several boxes in one lab.

Troponin on the main analyzer has been a common reason for Customers selecting these systems

(also available in cobas® 4000 analyzer series).

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Main features and Benefits

Features SHD Dimension® Xpand™ Plus HM

cobas® 4000 analyzer series

Platform concept

(Includes integration with other systems, modularity, etc.)

• Dimension Xpand may “part-ner” for smaller labs but its li-mited assay menu doesn’t allow designing modern lab concepts

• The new cobas® 4000 analyzer series includes cobas c 311 analyzer for clini-cal chemistry and cobas e 411 analyzer for immunoassays. The combination of the two analyzers provides true operational integration for small work-load laboratories.

Flexibility and Expand-ability

• Upgrades for one heterogeneous module available to the basic Xpand.

• With a capacity of 63 combined onboard tests and the wide range of applicable parameters cobas® 4000 analyzer series fits perfect to the target segment of small workload, STAT and network laboratories. No separate and optional module is necessary.

Consolidation power / Reagent slots

• 44 flexes on board, 22 – 44 simultaneous parameters due to …

• Large number of very small “flexes”, require double and triple flexes on board compro-mising the on-board menu

• 63 combined onboard tests • cobas c 311 analyzer side: 45 slots

incl. 3 ISE • cobas e 411 analyzer: 18 slots

Effective Throughput • CC: 250 t/h plus • HetIA: 83 t/h

300 t/h (cobas c 311 analyzer with ISE) + 88 t/h (cobas e 411 analyzer)

• Suitability to run round the Clock / high up-time

• Records of reliability problems; demand double placements for “redundancy”

• Very high up-time due to the high reliability of the Roche/Hitachi; low level for on-demand maintenance

• All reagents ready • Load sample and reagents during

operation (short interruption)

• Support for automat-ic intelligent diagnostics and required sample management (repeat, reflex, rerun)

• N.A. • Using external software (like IT 3000) its possible to implement intelligent (rules based) diagnostic protocols

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Features SHD Dimension® Xpand™ Plus

HM cobas® 4000 analyzer series

• Safety Features, State-of-Art Sample pipet-ting

• No clot detection • Sample clot, bubble (cobas e 411 analyzer) detection and liquid level de-tection

• Carry-over free ultrasonic mixing of sample and reagent

• Electronic download capability of applications, control- and calibrator values

• Pipetting disposable tips and reaction cells

• Integration of Serum Index to test result data flag

• Traceability data available

• Traceability and compliance features

• N.A. • Traceability data available with external tool

• Auto QC with Westguard Rules • Automatic application download via

cobas® link • Fully compliant procedures / CE Marks

etc.

• Launch date (1st known system installed), worldwide installed base

• 2003 (Xpand™ Plus HM) • ~2000 Xpand + Xpand™ Plus

HM

• End 2006 (cobas e 411 analyzer) • 3rd Q. 2007 (cobas c 311 analyzer)

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Pictures and Legends Xpand Plus HM

The “flex” is a small reagent carrier that has 6 “cells”. Depending on the parameter, they may have one reagent type (6 vials), 2 reagents types (3 vials of each) etc. Very small test volume requires frequent changes and reduces the on-board parameters capacity. Same carrier for photometric and for the limited immunoassays.

The sample rotor accommodates 60 primary or secondary tubes (one type per segment).

The OPTIONAL heterogeneous immunoassay module uses micro-particle based Elisa technology for a very limited assay menu: Troponin, CK-MB, HCG, Ferritin, PSA, FT4 and TSH.

The plastic Cuvettes are made out of a film inside the system for single use and sealed afterwards prior to disposal. The consumables are supplied as a roll of plastic film.

The reagent carrousel accommo-dates up to 44 “flexes”. In case RMS is present one position is kept free to exchange reagents. All flexes in RMS have to be brought to this rotor prior to use. Throughput reduction happens when a wide range of assays are on board.

Continuous loading of “flexes” more than a option is mandatory because of the small “flexes” size (between 15 and 240 T, average 100T). Typical on-board stability is just 3 days.

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Strengths/Weaknesses Xpand Plus HM Strengths: Weaknesses* Xpand Plus HM:

Technical reliability User-friendly handling and Software Heterogeneous immunology is possible

(but: just 7 assays, on Xpand Plus HM) Cyclosporine test without sample preparation

Requires frequent presence and intervention of technicians Incomplete parameter menu – gaps in Serum Proteins,

TDM, DAT (inconsistent with a STAT type of analyzer) Low consolidation power / one system per indication –

need of 2nd system. Unsuitable package sizes (small lab: CA FLEX: 6 wells x

10 tests each = 60 tests; open CA-well stable for one day) (mid size labs: causing frequent reload – interruption of routine) 44 channels/on board reagents limited HETIA testing reduces real throughput of CC testing

throughput Lack of reagent stability – considerably shorter; ISE only

for 5 days Smaller analytical range causes additional dilutions –

prolonging TAT Disruption through interferences (e.g.: Cholesterol, CK,

Glucose, Triglyceride, Magnesium) Calibration concept (more frequent calibrations with

more calibrators) High maintenance effort (approx. 1 hour per day) Environment polluting additives (and amount) High hidden cost, in case it’s no Cost-per-reportable-

result deal

Individually molded cuvettes from a film are argued as cost reducing criteria, compared to disposable

Cuvettes or the washing of reused Cuvettes. If so, why D/B is reducing the cuvette price by 10%

automatically? It seams so that the reason for this “offer” is the high amount of non used cuvettes

(up to 2000, cuvettes for 100 samples). One is the not calculable interruption of workflow, when a

defined number of cuvettes (100) had been molded by one diaphragm. This causes breakdown time

and additional hands on for: service, re-typing the requests and re-starting the system.

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Argumentation

Immunochemistry requires additional systems, e.g. Stratus® CS, as the Xpand Plus HM is not able

to consolidate HETIAs to a minimum extent.

Lab Organization, workflow and consolidation are the keys for a productive, fast and high quality

laboratory. Not possible with Xpand Plus HM.

Competitor Roche Dade Behring

System cobas c 311 analyzer Dimension Xpand Plus HM

Launch date 2007 2001

List price

Worldwide placements 2,000

Complete

Footprint/m2 1.7 1.8

Test throughput/hr (photo + ISE) 300 250

Parameters available 101 81 (+Het)

Reagent concept 10 development channels 10 open channels

Tests onboard + ISE 45 47

Samples onboard 110 60

Convenient

Data management Onboard or via cobas a 242 Optional

Sample handling Disk Rack

Clot detection Yes Yes

Cuvette concept Washable Disposable

Automatic repeat, rerun, reflex Yes No

Test-specific serum indices Yes No

Confidence

Auto pre-dilution Yes Yes

Ave calibration stability (days) Each lot 90

Ave onboard stability (days) 90 30

Online application download Yes Yes

Sample volume (μl) 1 to 35 2 to 60

MTBRV (days) Target of 300

Ave daily maintenance 3 min 7min (up to 30)

Remote service Yes Yes

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Competitor Roche Dade Behring

System cobas c 311 analyzer Dimension Xpand Plus HM

Key Selling Points

Menu depth CC, IA + some HET

Result integrity 1 min chem 7

Reagent cassettes Whole blood A1c

Convenient operation STAT cardiac profile

True random access Closed tube sampling

Long onboard stability Rgnt loading drng run

Long cal stability Good DAT antibodies

Rerun, repeat, reflex CsA w/o pretreatment

Superior serviceability

Limitations

Lack of menu depth

TTFR = 130 min

A1c not IFCC stand.

Cannot upgrade IA mod.

High maintenance costs

High waste of cuvettes

More individual cals

CA 1d onboard stability

Ave onboard stability

Cal stability really 60d

Small reagent kit size

Possible IA carryover

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Competitive CC Assay Comparison*

Roche OCD (J&J) Olympus SHD DADE

Category Assay cobas® c 311 Vitros® 250/350 AU 400 Xpand®

Sub

stra

tes

Albumin ■ ■ ■ ■

Albumin urine ■ ■

Ammonia ■ ■

Bilirubin direct ■ ■ ■ ■

Bilirubin total ■ ■ ■ ■

Calcium ■ ■ ■ ■

Creatinine ■ ■ ■ ■

Lactate ■ ■ ■ ■

Magnesium ■ ■ ■ ■

Phosphorus ■ ■ ■ ■

Pre-Albumin ■ ■

Total protein ■ ■ ■ ■

Total protein U / CSF ■ ■ ■ ■

Urea/BUN ■ ■ ■ ■

Uric Acid ■ ■ ■ ■

Elec

trol

ytes

Bicarbonate ■ ■ ■ ■

Chloride ■ ■ ■ ■

Lithium ■ ■ ■

Potassium ■ ■ ■ ■

Sodium ■ ■ ■ ■

Dia

bete

s Fructosamine ■

Glucose ■ ■ ■ ■

HbA1c (hemolysate) ■ ■

HbA1c (whole blood) ■

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Roche OCD (J&J) Olympus SHD DADE

Category Assay cobas® c 311 Vitros® 250/350 AU 400 Xpand®

Enzy

mes

Acid phosphatase ■ ■ ■

Alkaline phosphatase ■ ■ ■ ■

ALT / GPT ■ ■ ■ ■

Amylase pancreatic ■ ■

Amylase total ■ ■ ■

AST / GOT ■ ■ ■ ■

Cholinesterase ■ ■ ■ ■

CK ■ ■ ■ ■

GGT ■ ■ ■ ■

GLDH ■

HBDH ■ ■

LDH ■ ■ ■ ■

Lipase ■ ■ ■

Ane

mia

Ferritin ■ ■

Iron ■ ■ ■ ■

STfR ■

Transferrin ■ ■

UIBC / TIBC ■ ■ ■ ■

Car

diac

APO A1 ■ ■ ■

APO B ■ ■ ■

Cholesterol ■ ■ ■ ■

CK-MB ■ ■ ■ ■

CRP high sensitive ■ ■

D-Dimer ■ ■

Digitoxin ■ ■

Digoxin ■ ■ ■

HDL-Cholesterol ■ ■ ■ ■

LDL-Cholesterol ■ ■ ■

Lipoprotein (a) ■ ■

Myoglobin ■ ■ ■

Triglyceride ■ ■ ■ ■

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Roche OCD (J&J) Olympus SHD DADE

Category Assay cobas® c 311 Vitros® 250/350 AU 400 Xpand®

Ther

apeu

tic

drug

mon

itor

ing

Acetaminophen ■ ■ ■

Amikacin ■

Carbamazepine ■ ■ ■

Gentamycin ■ ■

Lidocaine ■ ■

Mycophenolic acid (MPA) ■ ■

NAPA ■ ■

Phenobarbital ■ ■ ■

Phenytoin ■ ■ ■

Procainamide ■ ■

Quinidine ■

Salicylate ■ ■ ■

Theophylline ■ ■ ■

Tobramycin ■ ■

Valpxoic acid ■ ■

Vancomycin ■ ■

Dru

gs o

f abu

se

Amphetamines ■ ■ ■

Barbiturates ■ ■ ■

Benzodiazepines ■ ■ ■

Cannabinoids (THC) ■ ■ ■

Cocaine ■ ■ ■

Ethanol / Alcohol ■ ■ ■

LSD ■

Methadone ■ ■ ■

Methaqualone ■ ■

Opiate ■ ■ ■

Phencyclidine (PCP) ■

Propoxyphene ■ ■

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Roche OCD (J&J) Olympus SHD DADE

Category Assay cobas® c 311 Vitros® 250/350 AU 400 Xpand®

Spe

cific

pro

tein

s

a1-Acid Glycoprotein ■ ■ ■

a1-Antitrypsin ■ ■

a1-Microglobulin ■

Anti-Thrombin III ■

ASLO / ASO ■ ■ ■

b2-Microglobulin ■ ■

C 3 ■ ■ ■

C 4 ■ ■ ■

Ceruloplasmin ■ ■

CRP ■ ■ ■

Haptoglobin ■ ■ ■

IgA ■ ■ ■

IgG ■ ■ ■

IgM ■ ■ ■

Kappa LC ■

Lambda LC ■

Rheumatoid factor ■ ■ ■

* Source: Internal & respective websites as of July 2007