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Meeting demands of your laboratory The ARCHITECT Family

Nadya Makhova Commercial Manager Area Europe

Abbott Forum, Sofia/ Bulgaria Commitment To Science May 2010

Company Confidential Š 2010 Abbott

1

September 4, 2010


Abbott Global Diagnostics Three Business Areas Abbott Diagnostics Division (ADD)

Abbott Molecular

Point of Care

• >5,500 products • Direct sales/service in >70 countries

• 1,000 products • Direct sales/service in >30 countries

• Blood Gases/Coagulation • Cardiac • Chemistry

• • • •

Immunoassay Clinical Chemistry Hematology Blood Screening

– Infectious Disease – Oncology – Genetic Testing

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Company Confidential © 2010 Abbott

2


Abbott Diagnostics Around the Globe > 12,000 employees > 1,400 sales/service staff > 1,000 scientists

8 manufacturing / 9 R&D sites

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3


Abbott Diagnostics Division CORE Laboratory Solutions Hematology

Immunoassay

Chemistry

Hardware Automation

Software Automation

ARCHITECT Family

Low Volume Emerald

i1000SR

Ruby

ci4100*

c4000*

Sapphire & SMS

i2000SR

ci8200

c8000

Pre-Analytics

Hematology Automation

i4000SR

ci16200

c16000

Configurable Workcell

Very High Volume ACCELERATOR APS: Automation Processing Systems

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Company Confidential Š 2010 Abbott

4

Middleware Options


You want to focus on the most important tasks in a laboratory

You demand quality and accuracy with every result

You want to diagnose more patients with fewer resources

You have to deliver the results always on time

You want to reduce time handling samples and reagents

You want to improve your laboratories overall productivity

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Maximising Maximising Productivity Productivity

Cost Cost effectiveness effectiveness

Positive Positive Working Working Environment Environment

= Allowing Allowing you you to to achieve achieve your your targets targets

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Company Confidential Š 2010 Abbott

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The Complete ARCHITECT Family Chemistry

Integration

Flexibility

Low

Medium

High

Immunoassay

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ARCHITECT - works for you Universal ARCHITECT Sample Carrier

Identical Software

Helps to improve workflow

Easy to use for laboratory personnell

Integration Common Clinical Chemistry Reagents

Reduces your Sample handling

Common Immunoassay Reagents

Minimise your inventory

Minimise your inventory

Commitment To Science May 2010

Company Confidential Š 2010 Abbott

8


ARCHITECT - works for you Universal ARCHITECT Sample Carrier

Identical Software

Helps to improve workflow

Easy to use for laboratory personnell

Integration Common Clinical Chemistry Reagents

Reduces your Sample handling

Common Immunoassay Reagents

Minimise your inventory

Minimise your inventory

Commitment To Science May 2010

Company Confidential Š 2010 Abbott

9


The ARCHITECT ci4100

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ARCHITECT ci4100

+

Easy to use Optimise workflow Accurate result on time

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Company Confidential Š 2010 Abbott

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ARCHITECT ci4100 – Closer look at features and benefits

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ARCHITECT ci4100 – Overview Throughput of the ARCHITECT  c4000

• • •

Theoretical throughput is up to 400 t/hr photometric test Theoretical throughput ICT is up to 600 t/hr Actual throughput combined is approximately 425 t/hr

 i1000SR

• •

Theoretical throughput is up to 100 t/hr Actual throughput is approximately 55 t/hr

Number of samples on Robotic Sample Handler  c4000 – 100 samples  i1000SR – 65 samples  ci4100 – 180 samples

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ARCHITECT ci4100 – Overview 125 refrigerated reagent positions on the ci4100  c4000

• • •

single carousel 90 positions for both R1 and R2 Up to 55 different assays

 i1000SR

• •

25 reagent positions “on-the-fly” loading through RSH

Water consumption  On average only 15 l /h

Probe pressure monitoring  Reagent Probes  Sample Probes

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Integration Without Compromise  True integration with a single control center  Efficiency  Fewer tubes, no aliquoting  STATs quickly prioritized with the RSH

SmartWash technology controls sample-to-sample carryover (<0.1 ppm)

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Company Confidential Š 2010 Abbott

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Value of ARCHITECT Advanced Technology Be Productive

Gain Efficiency

Ensure Quality

Reduce Risk

Universal Carrier

Robotic Sample Handler

ICT Module Flex Rate

SmartWash

Serum Indices

 Simplify processes  fewer resource

STAT prioritized for a consistently fast turnaround time

• less time

• reduce interruptions and stress in lab • medical staff can make critical treatment decisions

handling and sorting samples • one tube for both IA and CC testing

Commitment To Science May 2010

• Less maintains for ICT • Less reruns • Standardize sample integrity reporting • Safeguarding the integrity of results

Company Confidential © 2010 Abbott

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Reduce the risk of reporting incorrect results • < 0.1 ppm sample

carryover • clot, bubble, foam, and insufficient sample detection


Value of ARCHITECT Advanced Technology Be Productive Universal Carrier

Simplify processes to handle growing workloads with fewer resource • spend less time

handling and sorting samples • one tube for both IA and CC testing

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Company Confidential © 2010 Abbott

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The sample carrier

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Pediatric Tube Handling  Two customer studies:

• •

Rautenberg et al. Alexander et al.

 ARCHITECT pipettes directly from pediatric- or microtainer-tubes

Eliminates mistakes due to manual aliquoting into sample cups

Less time consuming, increased efficiency

Pediatric tube direct sampling by the Abbott ARCHITECT Integrated ci8200 chemistry / immunochemistry analyser Rautenberg et al., Conference Poster, EuroMedLab 2005 Feasibility of Direct Sampling of Primary Pediatric Collection Tubes by the ARCHITECT ci8200 System Alexander et al., Conference Poster, IFCC/AACC 2005 Annual Meeting, Orlando, FL

Commitment To Science May 2010

Company Confidential © 2010 Abbott

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Value of ARCHITECT Advanced Technology Gain Efficiency Robotic Sample Handler

STAT samples prioritized for a consistently fast turnaround time • reduce interruptions and stress in lab • medical staff can make critical treatment decisions

Commitment To Science May 2010

Company Confidential © 2010 Abbott

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Improved Workflow and Better Patient Outcomes ARCHITECT Robotic Sample Handler (RSH)  Spend less sorting sample  At a glance sample status  Fast and consistent STAT turnaround times

• •

Physicians can depend on you for critical results Minimizing the time patients spend in critical care and emergency departments

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ARCHITECT Integration – Superior STAT TAT Average Turn-Around-Time (TAT) – STAT Specimens* 50 45

40 ci8200 ci1600

33

Lxi 725 29

30

27

Minutes

In an independent study by Enterprise Analysis Corporation (EAC), the ci8200 delivered the fastest overall STAT TAT for integrated systems in the Mid volume segment

23

22

21

20

21 1717

16 14

27

23 19

18 14

28

29

19

Modular 20

17

10

11

10

10

0

ci4100 Familiarization Throughput Study

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Average TAT STAT Chem

Average TAT STAT IA

Average TAT STAT Chem/IA

15

17

7

*Source EAC STAT TAT Study 2007 AR4187 Commitment To Science May 2010

Company Confidential © 2010 Abbott

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cobas 6000 Workcell

14

13

Average TAT STAT

DxC 600i DxC 880i

24

24

20

28

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Value of ARCHITECT Advanced Technology Ensure Quality ICT Module Flex Rate Serum Indices

•Less maintains for ICT •Less reruns •Standardize sample integrity reporting • Safeguarding the integrity of results

Commitment To Science May 2010

Company Confidential © 2010 Abbott

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Integrated Chip Technology: Ease Of Use  Long Lasting

• •

45,000 determinations 15,000 sample capacity Serum, Plasma, Urine

 Discrete Sampling  No Flushing or Continuous Calibration  Indirect; 24 fold dilution  Automated maintenance and easy to change

• •

Commitment To Science May 2010

No delay in changing modules Simple for all staff

Company Confidential © 2010 Abbott

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Sample Interference Indices Hemolysis, Icterus, Lipemia HIL  Provide awareness of the quality/integrity of specimens  Aid in decisions to accept or reject specimens and/or results  Objective vs. subjective  Fast TAT

Minimal to no impact to throughput

 Flexible reporting options

Semi-quantitative, Qualitative

 Trigger comments, yield permanent documentation

Tool to visualize potential impact of HIL

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FlexRate for Superior CC Assay Linearity FlexRate •

Uses 2 absorbance read windows:  Main read window  Flex read window

If 3 consecutive points are within the main read window and linear, the final absorbance value is translated into numerical result

If the values are non-linear, then FlexRate uses the absorbance’s from an earlier read window to calculate the patient result.

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Flexrate and Specimen Reruns 700

# of Samples Needing Dilution/Per Year*

600 500

Abbott Ortho

400

Beckman Dade/Siemens

300

Roche

200

89% 89%reduction reductionin in specimen specimen dilutions dilutionswith with reduced reducedlabor labor time timeand andcost cost

100 0

3

4

0

0 AlkP

ALT

AST

CK

GGT

•FlexRate reduces sample reruns •RSH improves TAT for reruns

ARCHITECT ARCHITECTcSystems cSystemsreduce reducereruns rerunsand andimprove improveresult resultTAT TAT *An Evaluation of Extended Linearity Enzyme and β-hCG Assays with FlexRate on Abbott ARCHITECT Analyzer: C. Elizabeth Elefano, Jabeen Rukshana, J.R. Petersen, A.O. Okorodudu and Amin A. Mohammad, Department of Pathology, University of Texas Medical Branch, Galveston, TX; 38th Annual Oak Ridge Conference • April 20 – 21, 2006 • San Jose, CA Commitment To Science May 2010

Company Confidential © 2010 Abbott

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Value of ARCHITECT Advanced Technology Reduce Risk SmartWash

Built in safeguards reduce the risk of reporting incorrect results • < 0.1 ppm sample

carryover • clot, bubble, foam, and insufficient sample detection

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Company Confidential © 2010 Abbott

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Reduce Risk â&#x20AC;&#x201C; Probe Smart Wash Patented probe wash design to reduce the risk of reporting a false positive result by preventing clinically significant sample to sample carryover Curve A: After optimized wash

Curve B: Before optimized wash

1.00 Upper Specification Limit: 0.1ppm

Between Sample Carryover (ppm)

0.90 1.69 ppm

0.80 0.70 0.60 0.50 0.40 0.30 0.20 0.10 0.00 0

10

20

30

40

50

60

70

80

-0.10

Pooled Normal Human Serum Replicates Each replicate was processed immediately following a concentrated contaminant

Optimized Sample Probe Wash on the Abbott ARCHITECT ci8200 Analyzer, T.H. Ravalico, C.W. Wilson, et al., Presented at the 18th International Congress of Clinical Chemistry and Laboratory Medicine, Oct 20-25, 2002 Commitment To Science May 2010

Company Confidential Š 2010 Abbott

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90


Reduce Risk â&#x20AC;&#x201C; Clot, Bubble detection

- Clot, bubble, foam, fibrin and insufficient samples detection during sample aspiration assure reporting of correct results - Reagent Pressure Monitoring provides immediate detection of bubbles

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Company Confidential Š 2010 Abbott

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Instrument Reliability ARCHITECT c8000

• • •

Launch 2003 YTD ~2300 Instruments < 3 service calls per year

ARCHITECT c16000

• • •

Launch 2007 YTD ~ 200 Instruments < 4.5 service calls per year

ARCHITECT c4000

• • •

Launch July 2009 YTD > 200 Instruments < 3 service calls per year

Commitment To Science May 2010

Company Confidential © 2010 Abbott

31


Value of ARCHITECT Advanced Technology Be Productive

Gain Efficiency

Ensure Quality

Reduce Risk

Universal Carrier

Robotic Sample Handler

ICT Module Flex Rate

SmartWash

Serum Indices

•Simplify processes •fewer resource • spend less time

handling and sorting samples • one tube for both IA and CC testing

STAT samples prioritized for a consistently fast turnaround time • reduce interruptions and stress in lab • medical staff can make critical treatment decisions

Commitment To Science May 2010

•Less maintains for ICT •Less reruns •Standardize sample integrity reporting • Safeguarding the integrity of results

Company Confidential © 2010 Abbott

32

Built in safeguards reduce the risk of reporting incorrect results • < 0.1 ppm sample

carryover • clot, bubble, foam, and insufficient sample detection


Adding value with the ARCHITECT Reagents

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Company Confidential Š 2010 Abbott

33


ARCHITECT Immunoassay Reagents Immunoassay Reagents  100 test kits  500 test kits

25 On-Board Refrigerated Reagent Positions Color Coded, 2-D Bar-coded Reagents     

Assay Name Lot Number Test Size Expiration Date Master Cal Curve Information

Minimum 30 Day Calibration Stability 30 Day On-board Stability Key Operator Benefit: Easy Inventory Management

Commitment To Science May 2010

Company Confidential Š 2010 Abbott

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ARCHITECT Chemistry Reagents  Liquid, Ready to Use Reagents  28-day average on-board and calibration stability  Automatic reagent integrity checks  Flexible kit reagent kit sizes to optimize efficiency  2-D barcodes

• • • • •

Lot # Expiration date On-board/cal stability tracking Reagent volume tracking 3rd party reagent barcode capabilities

Key Operator Benefit: Easy Inventory Management

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Company Confidential © 2010 Abbott

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Menu Completion & New Markers Thyroid TSH T4 FT4 T3 FT3 T-Uptake Anti-TPO Anti-Tg

Cancer CEA AFP PSA Free PSA CA 19-9 CA 15-3 CA 125 SCC Pro-GRP HE4 CYFRA 21-1 NSE Thyroglobulin PIVKA

Fertility/ Pregnancy Estradiol LH FSH Prolactin Progesterone Testosterone DHEAS SHBG ßHCG Testosterone 2nd gen

Hepatitis/ Anemia/ Retrovirus/Other Metabolic/Renal Ferritin Infectious Diseases

Cardiac BNP Troponin CKMB Myoglobin Homocysteine MPO

B12 Folate Insulin Intact PTH Cortisol C-Peptide Anti-CCP NGAL Vitamin D Active B12

HBsAg HBsAg Conf. Anti-HBs Anti-HBcII (2008) Anti-HBc IgM HBe Anti-HBe HCV Anti-HAV IgM Anti-HAV IgG HIV Ag/Ab Syphilis TP rHTLV I/II HCV Antigen HBsAg II HBsAg ADV HCV Ag/Ab Chagas Malaria, EBV

TDM Theophylline Phenytoin Vancomycin Phenobarbital Digoxin Valproic Acid Carbamacep Gentamicin Methotrexate

Transplant Tacrolimus Sirolimus Cyclosporine

Congenitals Rubella IgG Rubella IgM CMV IgG CMV IgM CMV Avidity Toxo IgG Toxo Avidity Toxo M

>>84 84common commonassays assaysshared sharedacross acrossall alliSystems iSystems Commitment To Science May 2010

Company Confidential © 2010 Abbott

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Orange = Immunoassays in development / launch 2010, Yellow = Immunoassays beyond 2010 / in research


ARCHITECT cSystems Menu General Chemistries (43) Acid Phosphatase Albumin BCG Albumin BCP Alkaline Phosphatase ALT & Activated ALT~ AST & Activated AST~ Ammonia Amylase Amylase, pancreatic~ Bile Acids~ Bilirubin, Direct Bilirubin, Total Calcium Chloride Cholesterol Cholinesterase~ Cholinesterase, dibucaine~ CK CO2 Creatinine Creatinine, Enzymatic GGT Glucose HDL, Ultra HIL Iron Iron, Plasma Lactic Acid LD LDL, Direct

Lipase Magnesium Phosphorus Potassium TIBC Total Protein Triglyceride Sodium UIBC Urea Nitrogen Uric Acid CSF Applications (2) Glucose and Protein Urine Applications (13) Amylase Calcium Cl, K, Na Creatinine Creatinine, Enzymatic Glucose Magnesium Phosphorus Urea Nitrogen Uric Acid Total Protein

Proteins (23) A1AGP A1AT Apo A1 Apo B ASO B2M Ceruloplasmin C3 C4 CRP CRP Vario Haptoglobin IgA IgE IgG IgM Kappa lt chains~ Lambda lt chains~ Lp(a) Microalbumin Prealbumin RF Transferrin

DOA/TOX (15) Acetaminophen Amphetamines Barbiturates Benzodiazepines Benzodiazepines (S) Cannabinoids Cocaine Ecstasy Ethanol Methadone Opiates Phencyclidine Propoxyphene TCA Salicylate Other (5) Copper~ Cystatin C~ Fructosamine~ HBDH~ D-Dimer~

Cardiac (2) CK MB~ Myoglobin~ TDM (13) Amikacin Carbamazepine Digoxin Digitoxin~ Gentamicin Lithium Phenobarbital Phenytoin Quinidine Theophylline Tobramycin Valproic Acid Vancomycin Metabolic (2) Ferritin HbA1c

>>120 120common commonassays assaysshared sharedacross acrossall allcSystems cSystems

Commitment To Science May 2010

~Available outside the US ONLY

Company Confidential Š 2010 Abbott

37


Menu expansion - 2010

1.

uNGAL

Early Detection of AKI

2.

HE4

Risk stratification/monitoring Ovarian Ca

3.

CYFRA 21-1

Differential diagnosis Lung Ca

4.

Testost. 2nd gen Suitable for women/children

5.

Active B12

Early detection B12 deficiency

6.

Vitamin D

25-OH Vitamin D (D2/D3) status

7.

Chagas

Detection of Chagas Disease

8.

Gentamicin

TDM Aminoglycoside

9.

Carbamazepin

TDM Antiepileptics

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Novel Markers in the Pipeline

Neuron Neuronspecific specificEnolase Enolase

Differential diagnosis small cell Lung Ca (with ProGRP)

PIVKA PIVKA

Diagnosis of Liver Cancer

NSE NSE

Protein Proteininduced inducedby byvit vitKKabsence absence

HBsAg HBsAg ADV ADV

Improved clincial sensitivity and mutant detection

EBV EBV EBNA EBNA VCA VCA IgG IgG VCA IgM VCA IgM

Differential Diagnosis and staging of Mononcucleosis

Troponin Troponin Next Next Gen Gen

Increased sensitivity

cPlGF cPlGF

Early diagnise of pre-eclapsia

Galectin Galectin 33

Advanced diagnosis of heart failure

Epstein-Barr-Virus Epstein-Barr-Virus

Placental PlacentalGrowth GrowthFactor Factor

Commitment To Science May 2010

Company Confidential Š 2010 Abbott

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ARCHITECT ci4100

Efficiency Productivity

Optimize Workflow Reducing Risk

Quality Commitment To Science May 2010

Company Confidential Š 2010 Abbott

40


Thank you

Commitment To Science May 2010

Company Confidential Š 2010 Abbott

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