c311 Competative Information

3 3.
Marketing Facts Positioning & Knockout Arguments
3.4.1 Positioning the cobas Modular Platform

Large (>500 samples/day)
cobas 8000 cobas 6000 cobas 4000
More than 150 analytes

> 100 assays for Clin. Chem., Electrolytes, Serum Proteins, DAT, TDM, etc.
5 modules
cobas c 701
2 reagent carriers
cobas c 501
1 User Interface
Medium (200-500 samples/day)
cobas c 311
Small (80-200 samples/day)
> 50 assays for Thyroid, Cardiac, Hormones, Tumor Markers and ID
cobas e 601
cobas e 411
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
The cobas 4000 analyzer series stands for: Convenience, Performance & Confidence
cobas a 242 platform
Convenience from the cobas c & e packs along with IT connectivity Performance based on consistent and established technologies Confidence due to the proven reliability of Roche/Hitachi systems
cobas c 311 analyzer
cobas e 411 analyzer
Version 2.0 / August 2008

cobas c 311 launch binder
95 For internal use only
Marketing Facts
3.4.3 cobas 4000 Analyzer Series Knock-Out Arguments

The Customer Wants It, We Have It & Competitors Dont
Convenience ! cobas c & e-packs offer consistent
reagent carriers across our Serum Work Area platforms
Performance ! Offers the broadest menu with

200 assays to consolidate testing on one platform
Confidence ! Continues the Roche / Hitachi

legacy of delivering reliable products
! 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 industry offer profile consolidation
! Offers ECL technology, the gold

standard for Immunoassay estimations contact free ultra-sonic mixing to offer highly reliable results
! cobas e-link offers electronic

downloads of assay / calibrator & QC pack inserts & values
! Whole blood HbA1c application to ! Intelligent clot detection and
! 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 instruments like Abbott AxSym and Beckman Access or send out

Marketing Facts
Performance: Superior Onboard Reagent Stability

Chol GLU CreaJ Urea UA Lip ALT AST CO2 GGT TP TRIG Creae BILT BILD ALP LDH Amy ALB CK Ca CHE CRPhs CRP PHOS Fe FRUC HbA1 c AMYP ACP Ferri MG LDL HDL NH3 CKMB PrUCSF HBDH TRSF Prealb Ceru RF C4 C3 ApoB ApoA ASLO IgG IgM IgA Lact Hapt AAT Myo
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
DIMENSION RxL / Expand cobas c pack
Chart describes minimum efficient test usage/day by reagent. Reference: Package Inserts.
20 15 10 5 0 5 10 15 20
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 4000s reliability, serviceability and consumable efficiencies

3 3.5
Marketing Facts Targeting & Objection Handling
3.5.1 Small Segment Overview

Active Lifecycle Management for a Large Installed Base
EOS1 Clinical Chemistry Roche/Hitachi 911/904 Roche/Hitachi 912 Roche/Hitachi 902 COBAS INTEGRA 400/400+ Immunochemistry Elecsys 1010 Elecsys 2010 cobas e 411
1
CU2
EOL3
ICB4 8,369
%5
0% -16% -7% -12% 15% 6% -13% 5%
2000 2004 2008 2010
2004 2008 N/A 2012+
2009 2011 2015 2016
1,020 1,353 1,816 4,180 10,635
2001 2007
2004 2011+
2008 2014
2,085 7,988 562
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
Consolidated Lab Size CC Large Medium Small X-Small Mod P, D cobas c 501 cobas c 311 cobas c 111 IA E170 cobas e 601 cobas e 411 CC cobas c 501 cobas c 311 cobas c 111 cobas c 111 IA cobas e 601 cobas e 411 cobas e 411 CC I800/cobas c 501 I400/cobas c 311 I400/cobas c 311 cobas c 111 IA cobas e 601 cobas e 411 cobas e 411 STAT Specials
cobas 4000s 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

Marketing Facts
3.5.3 Primary Target Customers for cobas 4000 Analyzer Series
Roche/Hitachi 911/912 Competition Elecsys 2010 COBAS INTEGRA 400

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 ...
6,000 5,000 RD/Hitachi Small systems 4,000
Installed Base RD/Hitachi Small systems by Region (Y2007)
APAC, 547
3,000 2,000 1,000 0 RD/Hitachi 912 RD/Hitachi 911/904 RD/Hitachi 902
LAM, 835
Y2004 1,562 1,841 1,984
Y2005 1,546 1,505 2,075
Y2006 1,449 1,221 2,058
Y2007 1,353 1,020 1,816
NAM, 291
EMEA, 2,516
...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
9,000 8,000 7,000 Installed Base (Units) 6,000 5,000 4,000 3,000 2,000 1,000 0 Cobas Integra 400/400 plus RD/Hitachi Small Systems Y2004 2,791 5,387 Y2005 3,375 5,126 Y2006 3,646 4,728 Y2007 4,180 4,189

Marketing Facts
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 dont 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 Im 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 Dades 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. -hCG)

Marketing Facts
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&Js 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 dont 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

3 3.6
Marketing Facts 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
cobas e 411 cobas c 311 cobas IT 3000 / a 242 cobas 4000
Q4/06 Q3/08 Q4/08
Phase 1 Phase 2 Phase 3
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

3 3.7
Marketing Facts 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 Immunoassay 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/

Marketing Facts
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)

Marketing Facts
Competitor Systems Overview
cobas c 311 analyzer Short Description The new CCAnalyzer for the small and networking segment featuring a compact system with new capabilities using a convenient universal reagent carrier. More than a system, it is a part of the cobas modular platform.
cobas e 411 analyzer Bench top analyzer for heterogeneous immunoassays in laboratories with medium workloads. Performing immunoassays as simply as Clinical Chemistry. Easy to operate. Unique programming-by-loading concept: Barcodebased data entry is carried out automatically by loading reagents, controls, and calibrators. Part of the cobas modular platform, family approach. Fastest HetIA system, 9 min applications.
SHD DB Dimension Xpand Plus HM A non expandable combination of the Dimension Xpand and the optional Heterogeneous Module (HM).
OCD Vitros 350
OCD Vitros ECiQ Successor of the ECi with a slightly changed operator interface.
Olympus AU 400
Successor of the VITROS 250 with a slightly higher throughput. Still using the dry chemistry slides, MicroSlide.
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
Integrated chemi- Easy to operate, stry system. Easy- Safety, Its that to-use system. simple. Tailored for small workload.
Easy to operate, excellent assay protocols, result integrity.
The smallest member of the AU family. STAT analyzer in large laboratories. Routine analyzer for the small laboratory. Specialty analyzer for the large routine laboratory. AU family approach. Important communalities from the small to the mega large workload labs.
Competitor Argumentation
Platform commonalities, e.g. reagent carrier, user interface, cobas link. Up to 90 days onboard stability.
Platform commonalities, 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 consumption only 8l/1000 tests. Offered assays: 73. Onboard capacity (incl. HetIA): 44 channels.
Advanced security: Ensure worry-free result reporting. Load-and-go reagent preparation, up to 6 month calibration stability. More then 40 onboard chemistries, 300 ts./hr.. Customized patient reports for physician office labs.
Advanced processing centre. Ensures result integrity for quality result reporting Intellicheck technology verifies Microwell dispense and assay reagent aspiration and dispense.
Expected Launch
3rd Q. 2008
In commercializa- In commercializa- In commercialization since 2006. tion since 2001. tion since 2006.
In commercializa- In commercialization since 2005. tion since 1998.

Marketing Facts
Convenience All reagents ready to use. Very simple to use (Rating = 4) Safety State-of-the-art pipetting, with clot and level detection. Contact free mixing of sample and reagents.
All reagents ready to use Very simple to use. (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) Up to 88 t/h, up 18 channels.
Requires a second All reagents ready All reagents ready HetIA system due to use. Very simple to use. Very to the limited to use. simple to use. menu. (Rating = 2) Carry-over possible (immunoassays) (Rating = 4) (Rating = 4) Carry-over free pipetting due to disposable tips.
No opportunity/ offer of a HetIA system for small or network labs. (Rating = 2) No clot detection.
(Rating = 4) Consolidation and Throughput Up to 300 t/h, up to 45 channels
(Rating = 3)
(Rating = 3)
(Rating = 4) Up to 90 t/h 20 channels
(Rating = 2) Up to 800 t/h (w ISE). 41 channels onboard (w ISE). Reaction volume 150 l with a sample volume approximately by 2l (Rating = 4) 8
CC: up to 250 t/h, Up to up to 180 t/hr. ISE 300 nominal t/h, Up to 44 channels up to 40 channels. on board. IA: 83 t/h, xx assays.
(Rating = 4) Rating TOTAL 12
(Rating = 3) 11
(Rating = 4) 9
(Rating = 4) 11
(Rating = 4) 12

Marketing Facts
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-theclock 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.

Marketing Facts
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 throughput 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 stability, 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, OCDs slogan Its 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, TDMs and DAUs, 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.

Marketing Facts
Competitor System
Roche cobas c 311 analyzer
Ortho VITROS 250/350
Launch date List price Worldwide placements Complete Footprint/m2 Test throughput/hr (photo+ISE) Parameters available Reagent concept Tests onboard + ISE Samples onboard Convenient Data management Sample handling Clot detection Cuvette concept Automatic repeat, rerun, reflex Test-specific serum indices Confidence Auto pre-dilution Ave calibration stability (days) Ave onboard stability (days) Online application download Sample volume (l) MTBRV (days) Ave daily maintenance Remote service Key Selling Points
2008
1993/2005 $110.000 > 3000
1.7 300 101 10 development channels 45 108 Onboard & via cobas a 242 Disk Yes Washable Yes Yes Yes Each lot 90 Yes 1 to 35 Target of 300 3 min Yes Menu breadth Result integrity Reagent cassettes Convenient operation True random access Long onboard stability Long cal. stability Rerun, repeat, reflex Superior serviceability Ease of use
1.4 300 41 Closed 45 40 Onboard Rack Yes Slide No No No Each lot 14 No 10 4 min (up to 22) No
Compatibility with V 950 Customer loyalty Proven in the market

Marketing Facts
Competitor System Limitations Limited menu Slide prep up to 3 hours Slide cost Short onboard stability Generally low precision Short cal. stability Bili-d & neonate calctd No serum indices No onboard dilutions Future portfolio No remote service Roche cobas c 311 analyzer Ortho VITROS 250/350
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.

Marketing Facts

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.

OCD doesnt 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 System Roche cobas e 411 analyzer Ortho VITROS ECiQ
Launch date List price Worldwide placements Footprint/m2

Complete
1996/2006 7,000 (E2010) 0.7
1997/2004 $150,000 2000 1.08
Technology Test throughput/hr Test throughput/m

2
ECL 88 131 55 65 18 27 9 30 (disk), 75 (rack)
CL/coated microwell 90 83 30 30 20 18 24 60
Parameters available (HET only) Parameters available in future Tests onboard Tests onboard/m
2
-hCG time to result (min) Samples onboard

Marketing Facts
Data management Onboard & via cobas a 242 Onboard
Convenient
Sample handling Clot detection Closed tube sampling Auto calibration or request Automatic rerun, repeat, reflex
Confidence
Disk or rack Yes No Yes Yes 30
Trays Yes No Yes Yes 28
Ave calibration stability (days)
Calibrator levels Ave onboard stability (days) Reagent (un)loading during run Sample (min) + dead volume (l) Sample pipetting Walkaway time (min) MTBRV (days) Ave daily maintenance (min) Remote service Limitations
2 56 No 110 Disposable tips 120 300 4 (up to 31) Optional
1 to 3 56 No 70 Manually loaded tips 360 10 (up to 45) Yes 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+ SHBG hCG free- C-peptide + + + + + + + + + + + + + + + + + +

Marketing Facts
Competitor System Insulin Cortisol PAPP-A ACTH DHEA-S -HAV -HAV IgM HBsAg HBsAg Confirmatory -HBs -HBc -HBc IgM HBeAg -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 + + + + + + + + * * + + + + Roche cobas e 411 analyzer + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Ortho VITROS ECiQ

Marketing Facts
Competitor System FT3 FT4 T3 T4 T-uptake TG -TG -TPO -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 -Crosslaps Vitamin D-25(OH) Intact PTH Osteocalcin P1NP IgE
Roche cobas e 411 analyzer + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +
Ortho VITROS ECiQ + + + +
+ + + + + +
+ + + + +

Marketing Facts
Competitor System 2-Microglobulin Calcitonin N-Telopeptide Digoxin Dixitoxin
Roche cobas e 411 analyzer + +
Ortho VITROS ECiQ
+ + +
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 doesnt 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.

Marketing Facts

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 l and the total reaction volume is 150 l. 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 (!?).

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 convenience of the cobas pack, one cassette for R1 & R2 on-grip-loading. Olympus doesnt offer the AU 400 on a global base, means in different countries, e.g. USA, Canada, Mexico, etc. the system isnt 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 doesnt 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 dont. Because they are offering following assays: Carbamazepine, NAPA, Tobramycin and Valproic Acid, thats 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?

Marketing Facts
Competitor System
Olympus AU 400e
Launch date List price Worldwide placements Complete Footprint/m2 Test throughput/hr (photo + ISE) Parameters available Reagent concept Tests onboard + ISE Samples onboard Convenient Data management Sample handling Clot detection Cuvette concept Automatic repeat, rerun, reflex Test-specific serum indices Confidence Auto pre-dilution Ave calibration stability (days) Ave onboard stability (days) Online application download Sample volume (l) MTBRV (days) Ave daily maintenance Remote service
2008
1998/2002 $130,000 2,500
1.7 300 101 10 development channels 45 110 Onboard & via cobas a 242 Disk Yes Washable Yes Yes Yes Each lot 90 Yes 1 to 35 Target of 300 3 min Yes
1.8 400 69 Open 41 80 Optional Rack & STAT Yes Washable No No Yes Open system Open system No 2 to 50 180 6 min (up to 45) No

Marketing Facts
Competitor System Key Selling Points Menu depth
Olympus AU 400e Throughput Low system price Open system
Result integrity Reagent cassettes 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

Marketing Facts
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, -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 consolidation 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).

Marketing Facts
Main features and Benefits

Features Platform concept (Includes integration with other systems, modularity, etc.) SHD Dimension Xpand Plus HM Dimension Xpand may partner for smaller labs but its limited assay menu doesnt allow designing modern lab concepts cobas 4000 analyzer series The new cobas 4000 analyzer series includes cobas c 311 analyzer for clinical chemistry and cobas e 411 analyzer for immunoassays. The combination of the two analyzers provides true operational integration for small workload laboratories. 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. 63 combined onboard tests cobas c 311 analyzer side: 45 slots incl. 3 ISE cobas e 411 analyzer: 18 slots
Flexibility and Expandability
Upgrades for one heterogeneous module available to the basic Xpand.
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 compromising the on-board menu CC: 250 t/h plus HetIA: 83 t/h Records of reliability problems; demand double placements for redundancy
Effective Throughput Suitability to run round the Clock / high up-time
300 t/h (cobas c 311 analyzer with ISE) + 88 t/h (cobas e 411 analyzer) 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) Using external software (like IT 3000) its possible to implement intelligent (rules based) diagnostic protocols
Support for automat- N.A. ic intelligent diagnostics and required sample management (repeat, reflex, rerun)

Marketing Facts
Features
SHD Dimension Xpand Plus HM
cobas 4000 analyzer series Sample clot, bubble (cobas e 411 analyzer) detection and liquid level detection 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 data available with external tool Auto QC with Westguard Rules Automatic application download via cobas link Fully compliant procedures / CE Marks etc. End 2006 (cobas e 411 analyzer) 3rd Q. 2007 (cobas c 311 analyzer)
Safety Features, State- No clot detection of-Art Sample pipetting
Traceability and compliance features
N.A.
Launch date (1st known system installed), worldwide installed base
2003 (Xpand Plus HM) ~2000 Xpand + Xpand Plus HM

Marketing Facts
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 accommodates 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.

Marketing Facts
Strengths/Weaknesses Xpand Plus HM

Strengths: Technical reliability User-friendly handling and Software Heterogeneous immunology is possible (but: just 7 assays, on Xpand Plus HM) Cyclosporine test without sample preparation Weaknesses* Xpand Plus HM: 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 its no Cost-per-reportableresult 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.

Marketing Facts
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 System Roche cobas c 311 analyzer Dade Behring Dimension Xpand Plus HM
Launch date List price Worldwide placements Complete Footprint/m2 Test throughput/hr (photo + ISE) Parameters available Reagent concept Tests onboard + ISE Samples onboard Convenient Data management Sample handling Clot detection Cuvette concept Automatic repeat, rerun, reflex Test-specific serum indices Confidence Auto pre-dilution Ave calibration stability (days) Ave onboard stability (days) Online application download Sample volume (l) MTBRV (days) Ave daily maintenance Remote service
2007
2001 2,000
1.7 300 101 10 development channels 45 110 Onboard or via cobas a 242 Disk Yes Washable Yes Yes Yes Each lot 90 Yes 1 to 35 Target of 300 3 min Yes
1.8 250 81 (+Het) 10 open channels 47 60 Optional Rack Yes Disposable No No Yes 90 30 Yes 2 to 60
7min (up to 30) Yes

Marketing Facts
Competitor System Key Selling Points Menu depth
Dade Behring Dimension Xpand Plus HM CC, IA + some HET 1 min chem 7 Whole blood A1c STAT cardiac profile Closed tube sampling Rgnt loading drng run Good DAT antibodies CsA w/o pretreatment
Result integrity Reagent cassettes Convenient operation True random access Long onboard stability Long cal stability Rerun, repeat, reflex 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

Marketing Facts
Competitive CC Assay Comparison*

Roche OCD (J&J) Olympus SHD DADE
Category
Albumin
Assay
cobas c 311
Vitros 250/350
AU 400
Xpand
Albumin urine Ammonia Bilirubin direct Bilirubin total Calcium
Substrates Electrolytes Diabetes
Creatinine Lactate Magnesium Phosphorus Pre-Albumin Total protein Total protein U / CSF Urea/BUN Uric Acid
Bicarbonate Chloride Lithium Potassium Sodium
Fructosamine Glucose HbA1c (hemolysate) HbA1c (whole blood)

Marketing Facts
Category
Assay
Acid phosphatase Alkaline phosphatase ALT / GPT Amylase pancreatic Amylase total
cobas c 311
Vitros 250/350
AU 400
Xpand
Enzymes
AST / GOT Cholinesterase CK GGT GLDH HBDH LDH Lipase
Ferritin
Anemia
Iron STfR Transferrin UIBC / TIBC
APO A1 APO B Cholesterol CK-MB CRP high sensitive
Cardiac
D-Dimer Digitoxin Digoxin HDL-Cholesterol LDL-Cholesterol Lipoprotein (a) Myoglobin Triglyceride

Marketing Facts
Category
Assay
Acetaminophen Amikacin Carbamazepine Gentamycin
cobas c 311
Vitros 250/350
AU 400
Xpand
Therapeutic drug monitoring
Lidocaine Mycophenolic acid (MPA) NAPA Phenobarbital Phenytoin Procainamide Quinidine Salicylate Theophylline Tobramycin Valpxoic acid Vancomycin
Amphetamines Barbiturates Benzodiazepines
Drugs of abuse
Cannabinoids (THC) Cocaine Ethanol / Alcohol LSD Methadone Methaqualone Opiate Phencyclidine (PCP) Propoxyphene

Marketing Facts
Category
Assay
a1-Acid Glycoprotein a1-Antitrypsin a1-Microglobulin Anti-Thrombin III ASLO / ASO b2-Microglobulin
cobas c 311
Vitros 250/350
AU 400
Xpand
Specific proteins
C3 C4 Ceruloplasmin CRP Haptoglobin IgA IgG IgM Kappa LC Lambda LC Rheumatoid factor
* Source: Internal & respective websites as of July 2007


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3 3.

Marketing Facts Positioning & Knockout Arguments

3.4.1 Positioning the cobas Modular Platform

cobas 8000 cobas 6000 cobas 4000

More than 150 analytes

Medium (200-500 samples/day)

Small (80-200 samples/day)

> 50 assays for Thyroid, Cardiac, Hormones, Tumor Markers and ID

3.4.2 Positioning cobas 4000 Analyzer Series

cobas c 311 analyzer

cobas e 411 analyzer

Version 2.0 / August 2008

95 For internal use only

3.4.3 cobas 4000 Analyzer Series Knock-Out Arguments

Performance ! Offers the broadest menu with

Confidence ! Continues the Roche / Hitachi

! Integration of CC & IM with

! 9 min STAT assays on cobas e 411

! Offers ECL technology, the gold

! cobas e-link offers electronic

! Whole blood HbA1c application to ! Intelligent clot detection and

! cobas c & e-packs offer accurate

! Highest on-board stability and

! Test specific Serum Indices to offer

Version 2.0 / August 2008

96 For internal use only

Performance: Superior Onboard Reagent Stability

Confidence: Proven Reliability of Roche/Hitachi Systems

Version 2.0 / August 2008

97 For internal use only

Marketing Facts Targeting & Objection Handling

3.5.1 Small Segment Overview

2000 2004 2008 2010

2004 2008 N/A 2012+

2009 2011 2015 2016

1,020 1,353 1,816 4,180 10,635

2,085 7,988 562

3.5.2 Key Segments for cobas 4000 Analyzer Series

Version 2.0 / August 2008

98 For internal use only

3.5.3 Primary Target Customers for cobas 4000 Analyzer Series

Roche/Hitachi 911/912 Competition Elecsys 2010 COBAS INTEGRA 400

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

Y2004 1,562 1,841 1,984

Y2005 1,546 1,505 2,075

Y2006 1,449 1,221 2,058

Y2007 1,353 1,020 1,816

Version 2.0 / August 2008

99 For internal use only

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

Defending Against SHD Dade Xpand

Version 2.0 / August 2008

100 For internal use only

3.5.3.2 Second Target: Stand-alone Competitors like OCD

3.5.3.3 Active Lifecycle Management of Elecsys & COBAS INTEGRA Systems

Version 2.0 / August 2008

101 For internal use only

Marketing Facts Rollout Plan & Marketing Tools

3.6.1 Rollout Plan for cobas 4000 Analyzer Series

Phase 1 Phase 2 Phase 3

3.6.2 Bridging Strategies for cobas 4000 Analyzer Series

Version 2.0 / August 2008

102 For internal use only