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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