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The world leader in serving science

Solutions for Clinical Laboratories in Bulgaria

Oliver Hutton Regional Manager, Commercial Operations


The World Leader in Serving Science

We are the leading provider of analytical instruments, equipment, reagents and consumables, software and services for research, analysis, discovery and diagnostics.

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Topics ƒ Overview of Thermo Fisher Scientific the company ƒ Our Clinical Diagnostics Division ƒ Product highlights and new to Bulgarian Clinical Laboratories ƒ Aspirations for Clinical Diagnostics products in Bulgaria ƒ Summary

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Company Snapshot

Size and Scale

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Unmatched Capabilities

ƒ Complete portfolio ƒ World-class technologies ƒ Commercial and service strength

Leading Brands

$10.5 billion in revenues 34,000 employees in 40 countries 350,000 customers 150 countries served

ƒ Two premier brands

Technology and Innovation

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Choice and Convenience


Helping our Customers to be Successful

In research and analysis ƒ Advanced analytical instrument technologies (mass spectrometry, chromatography and optical spectroscopy) ƒ Solutions to improve laboratory workflows ƒ Pharmaceutical- and biotech companies, universities, research institutions and government agencies

In healthcare and clinical laboratories ƒ Diagnostic kits, reagents, Instruments and consumables ƒ Diagnostics community: health care laboratories, in hospitals, academic or reaseach institutes ƒ To detect a diagnose diseases

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In manufacturing and the field ƒ Safety-related products and personal protection (e.g radiation protection) ƒ Environmental Instruments (air and water quality, gas and particulate detection) ƒ Process instruments (physical elemental and compositional analysis, surface, thickness etc,)


2 Segments – 6 Groups/Divisions ƒ Analytical Technologies Segment • Analytical Instruments Group • Scientific Instruments Division (SID) • Process Instruments Division (PID) • Environmental Instruments Division (EID)

• Speciality Diagnostics Group • Anathomical Pathology & Speciality Glass Division (APD) • Microbiological products (MBD) • Clinical Diagnostics Division (CDD)

• Bioscience Division

ƒ Laboratory Products and Services Segment • Laboratory Products Group • Laboratory Equipment Division (LED), Laboratory ConsumablesDivision (LCD)

• Customer Channels Group • Research Market Division (RMD), Healthcare Market Division (HMD), Safety Market Division (SMD)

• BioPharma Services Division

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Clinical Diagnostics Division - Products Overview ƒ Clinical Chemistry Systems • Konelab® Instruments, system reagents, calibrators and controls • Chemistry, Proteins, DAT, TDM • Flexible automation solutions

ƒ Third party reagents for Clinical Chemistry and Coagulation • Formerly Trace® and Pacific Hemostasis® brands

ƒ Drugs of Abuse & Therapeutic Drug monitoring • Reagents and dedicated Instrumentation • Worldwide innovator and market leader • Microgenics, CEDIA® and DRI® Seradyn brands

ƒ Quality Control products and services • Liquid ready internal QC products for Chemistry, Immunoassay, Urine, Whole blood and CSF • MAS® and Monitrol® brands

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Clinical Diagnostics Division - Manufacturing ƒ CDD Fremont/USA: • • • •

DAT, TDM & ISD’s - CEDIA® DAT & Serum Toxicology - DRI® Quality Controls - MAS® Monitrol® OEM to industry

ƒ CDD Indianapolis/USA • TDM - QMS® , Innofluor ® • OEM to industry

ƒ CDD Austin/USA • External Proficiency Controls Contract manufacturing

ƒ CDD Middletown/USA • Chemistry and coagulation reagents and • Contract Manufacturing and OEM to industry

ƒ CDD Vantaa/Finland • Konelab ® , Laboratory automation • Industrial: Arena ® & Aquakem ®

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Clinical Diagnostics Products Highlights

ƒ 1. Konelab® Clinical Chemistry Systems ƒ 2. Drugs of Abuse & Therapeutic Drug monitoring ƒ 3. Quality Control products and services

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1. Konelab® Clinical Chemistry Systems

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Choose the Instrument capacity for your needs (KL20, 30 ,60) System reagents and applications • • • • •

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Clinical chemistry Electrolytes (ISE) Specific proteins TDM & DoA (DAT) System specified calibrators and controls

Complete CE marked system solution for Clinical Laboratories

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Latest trends in important tests

ƒDiabetes tests ƒLipid tests ƒKidney monitoring tests

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Konelab® for diabetes monitoring

For short term monitoring ƒGlucose

For long term monitoring ƒHbA1c ƒMicroalbumin

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HbA1c – now a fully automated assay on Konelab®

• HbA1c% calibrated to the IFCC or DCCT/NGSP • Excellent correlation with HPLC methods • FulIy automated method ƒ Automated sample pre-treatment, savings in manpower and consumables

• HbA1c results according to the consensus standardization in IFCC units (mmol/mol) and in the derived NGSP units (%) *)

*) Diabetes Care, Vol 30, Number 9, Sept 2007, 23992400.

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Konelab® for Lipid profiling

ƒTotal Cholesterol ƒHDL and LDL Cholesterol ƒTriglycerides ƒApolipoproteins A1 and B ƒLipoprotein (a)

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Lipoprotein(a) – NEW! for the Konelab lipid profile

A powerful predictor for development of atherosclerotic vascular disease • Lipoprotein(a) is a dimer consisting of LDL molecule bound to Apo(a) via a disulphide bridge • Lp(a) is a risk factor for coronary heart disease (CHD) that is independent of all other lipid parameters • Lp(a) is a special tool for doctors

• The CHD risk predictor is high, especially when Lp(a) and LDL are elevated simultaneously => lipid lowering therapy recommended

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Lipoprotein(a) – a ’killer molecule’


Konelab® for kidney function monitoring

ƒCreatinine/Enzymatic Creatinine ƒUrea / BUN ƒCystatin C ƒMicroalbumin ƒTotal protein

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GFR – kidney monitoring ƒ CKD (Chronic kidney disease), background • The prevalence of CKD (chronic kidney disease) is increasing. • This increase is partly explained by the increasing prevalence of diabetes and hypertension. ƒ Needs for analysis • Early detection of CKD (chronic kidney disease). • Reliable kidney monitoring tools for accurate medical decisions. • Globally harmonized assays and accurate results.

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Cystatin C - a Novel Serum Marker for GFR *)

Why Cystatin C together or instead of Creatinine? • Specificity • Creatinine is affected by age/sex/muscle mass/inflammatory process • Cystatin C is not dependent of any of the above • Sensitivity • Creatinine measurement is able to detect kidney dysfunction when app. 50% of kidney mass is ‘non-working’ • Cystatin C test has the sensitivity to detect already mild renal dysfunction • Other highlights • Elevated serum Cystatin C is a strong predictor of the risk of death and cardiovascular events in elderly persons *) GFR = Glomerular Filtration Rate 18


Latest scientific reports and evaluations ƒ

Evaluation of the IDMS Traceable Jaffé Creatinine Method on Konelab Clinical Chemistry Analyzers Marjoniemi, E. (1), Karppelin, M. (2), Kytö, R.(2), Vainio, U-M.(1) and Lampinen, H.(2) (1) Clinical Laboratory, Oulaskangas Hospital, Oulainen, Finland (2) Thermo Fisher Scientific, Vantaa, Finland Published in XXXI Nordic Congress in Clinical Chemistry (LabMed 2008), Helsinki, Finland, 14 - 18 June 2008

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Evaluation of a Fully Automated Whole Blood Glycohemoglobin (HbA1c%) Assay on Konelab 60 Clinical Chemistry Analyzer Marjoniemi, E. (1), Kurki, M. (2), Kytö, R.(2), Lampinen, H.(2), Vainio, U-M.(1) and Finell, J (2) (1) Clinical Laboratory, Oulaskangas Hospital, Oulainen, Finland (2) Thermo Fisher Scientific, Vantaa, Finland Published in XXXI Nordic Congress in Clinical Chemistry (LabMed 2008), Helsinki, Finland, 14 - 18 June 2008

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Evaluation of the Konelab PRIME 60i Clinical Chemistry Analyser Marjoniemi E. (1), Vainio U-M (1), Kinnunen H. (2), Sajanti E (3), Niemelä O (3), Lampinen H. (2) (1) Clinical Laboratory, Oulaskangas Hospital, Oulainen, Finland (2) Thermo Fisher Scientific, Vantaa, Finland (3) Clinical Laboratory, Oulu University Central Hospital, Oulu, Finland Published in EUROMEDLAB 2007, 17th IFCC-FESCC European Congress of Clinical Chemistry and Laboratory Medicine, Amsterdam, the Netherlands, 3-7 June 2007

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Evaluation of a new Konelab Assay for Plasma Creatinine using Enzymatic Method Dunder U. (1), Väisänen SB (1), Lampinen H. (2), Harmoinen A (3), Romppanen J (1) (1) Kuopio University Hospital, Department of Clinical Chemistry, Laboratory Centre, Finland (2) Thermo Fisher Scientific, Vantaa, Finland (3) Savonlinna Central Hospital, Finland Published in XXX Nordic Congress in Clinical Chemistry (NFKK 2006), Copenhagen, Denmark, 14-17 June 2006

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Evaluation of new immunoturbidimetric method for measuring Myoglobin on Konelab analyser Lukkarinen JA (1), Penttilä IM (2), Savolainen K (3) (1) Thermo Fisher Scientific, Vantaa, Finland (2) Kuopio Research Institute of Exercise Medicine, Kuopio, Finland (3) Laboratory Centre, Kuopio University Hospital, Kuopio, Finland Published in XXX Nordic Congress in Clinical Chemistry (NFKK 2006), Copenhagen, Denmark, 14-17 June 2006

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Evaluation of a high-sensitive C-reactive protein method on Konelab analyzer Tähtelä R.K. (1), Mattila K. S. (2), Irjala K. (1), Riistama-Laari S. (3), Lampinen H. (3) (1) Mehiläinen Oy Laboratoriopalvelut, Helsinki, Finland (2) Department of Clinical Chemistry, Turku University Hospital, Turku, Finland (3) Thermo Scientific Oy, Vantaa, Finland Published in EuroMedLab 2005, 16th IFCC-FESCC European Congress of Clinical Chemistry and Laboratory Medicine, Glasgow, UK, 8 -12 May 2005

All reports available on our web page (www.Thermo.com/konelab) 19


2. Drugs of Abuse & Therapeutic Drug monitoring

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We are a worldwide market leader and innovator Assays for DAT, TDM and ISD OEM to most of IVD Industry and market our own branded product, which include unique and innovative assays NEW! Bench-top dedicated DAT/TDM/ISD Instrument - CDx90 NEW! Novel Alcohol marker Ethyl Glucuronide (EtG) in automated Immunoassay format

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The most comprehensive DAT menu available Amphetamine / Ecstasy* Amphetamine Ecstasy Barbiturates Benzodiazepines Hs Benzodiazepines* Buprenorphine* Cannabinoids (THC) Cocaine Cotinine* Ethyl Alcohol

Ethyl Glucuronide (EtG)* Ketamine* LSD Methadone Methadone Metabolite (EDDP)* Methaqualone Opiates Heroin Metabolite (6-AM)* Oxycodone* Phencyclidine Propoxyphene

* Unique assay 21


The most comprehensive TDM menu available Anti Microbial Drug Assays (AMD)

Cardio Active Drug Assays (CAD)

Gentamicin Tobramycin Vancomycin

Digoxin Digitoxin Quinidine

Amikacin Teicoplanin*

Anti Epileptic Drug Assays (AED) Carbamazepine Phenobarbital Phenytoin Valproic Acid

Zonisamide* Lamotrigine * Topiramate*

Procainamide NAPA Primidone

Anti Asthmatic Drug Assay (AAD) Theophylline Antidepressant Infinity速 Lithium

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NEW! CDx 90 – Bench-top TDM, DAT and ISD Analyser ƒ ƒ ƒ ƒ ƒ ƒ ƒ

Small and Smart dedicated drug testing solution Up to 90 tests per hour All of our DAT,TDM, ISD and sample validity menu Great replacement for ageing TDx Instruments Up to 20 Reagents and 10 Samples on board Innovative touch screen and ease of use Reliable and consistent results from the sample of your choice •

Urine, blood, oral fluid and hair Acute Under the influence Impairment Induced behavioral effects

Oral Fluid Blood

Recent Abstinence Compliance

Urine Sweat Hair

Chronic Forensic

Time

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NEW! Immunoassay for Ethyl Glucuronide (EtG)

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Extend the detection window to up to 80 hours from 8 hours No interferences – highly specific to ethanol intake Alcoholism relapse testing Pre-liver transplant testing Forensics Employee/safety screening Addiction treatment abstinence monitoring Excellent correlation with reference method (LC/MS/MS)


3. Quality Control Products and Services

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MAS pioneered liquid stabilisation in 1970s No. 2 Market position worldwide Expanding our QC product range into Distribution markets Philosophy is liquid convenience with market leading stability Comprehensive product line for routine Clinical Diagnostics Quality Control

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Considerations in choice of Quality Control materials

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MAS Product range

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MAS UA Control/UA Dip Tube – Urine DipStick and Micro ƒ Human urine matrix ƒ Components from human sources and purified chemicals ƒ Liquid refrigerated ready ƒ Dipstick, microscopics and pregnancy ƒ Assayed for most major reagent strips and strip systems ƒ Vials (6*15 mL or 4*60 mL) ƒ Dip Tube (10*12 mL) ƒ 24 months shelf life at 2-8°C ƒ 3 months open-vial stability at 2-8°C ƒ 6 weeks open-vial stability at room temp ƒ 20 dip/8 weeks at 2-8°C or 10 dip/2 weeks at 20°C ƒ Patient like ƒ User friendly and extremly stable ƒ Fits both large Labs and POCT

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Liquimmune – Multi-control for Immunoassay ƒ Human serum matrix ƒ Liquid ready ƒ 69 components (hormones, TDM, anemia, special) ƒ Level 1, 2, 3 can be bought separately ƒ Assayed values on available major platforms (6*5 mL) ƒ 36 months shelf life at -20°C ƒ Storage at -15° to -25°C ƒ 90 days unopened-vial stability at 2-8°C ƒ 30 days open-vial stability for all analytes at 2-8°C ƒ Patient like ƒ User friendly ƒ Can be used to last drop – no waste ƒ ALL components stable in opened vial ƒ Popular for its superior stability

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MAS T-Marker – Multi-control for cancer antigens ƒ Human serum matrix ƒ Liquid ready since 2002 ƒ 25 components (wide range) ƒ Level 1, 2, 3 can be bought separately ƒ Assayed values on available major platforms (6*3 mL) ƒ 36 months shelf life at -20°C ƒ Storage at -15° to -25°C ƒ 90 days unopened-vial stability at 2-8°C ƒ 30 days open-vial stability at 2-8°C

ƒ Patient like ƒ User friendly ƒ Comprehensive range – compliments Liquimmune ƒ Can be used to last drop – no waste ƒ ALL components stable in opened vial

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Cardioimmune XL and TL - Cardiac diagnostics ƒ Human serum matrix ƒ Liquid ready ƒ Wide range (Troponins, CK-MB, NT-ProBNP, Myo, Digitoxin, hs CRP) ƒ Plus BNP-32, Homocysteine in Cardiommune XL ƒ Level Low,1, 2, 3 can be bought separately or as Multi-Pack ƒ Risk stratification for Troponin I in level Low ƒ Assayed values on available major platforms (6*3 mL) ƒ Storage at -15° to -25°C ƒ 36 months shelf life at -20°C ƒ 15-30 days open-vial stability at 2-8°C ƒ Patient like ƒ User friendly ƒ Very good assay ranges ƒ Can be used to last drop – no waste ƒ ALL components stable at least 15 days (several 30) in opened vials

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MAS Immunology – Multi-control proteins ƒ Human serum matrix ƒ Liquid refrigerated ready ƒ Wide range (23 common proteins including light chains, RF, CRP and ASO) ƒ Level 1, 2, 3 can be bought separately ƒ Assayed values on available major platforms (turbidimetry/Immunoassay), and Nephelometry systems ƒ 6*3 mL ƒ 24 months shelf life at 2-8°C ƒ 30 days open-vial stability at 2-8°C ƒ Patient like ƒ User friendly ƒ Comprehensive range ƒ Can be used to last drop – no waste ƒ Shipment without Dry ice

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MAS Liquid Diabetes Control – HbA1c ƒ Human whole blood based matrix ƒ Component from purified human HbA1c ƒ Liquid ready ƒ Assayed on HPLC and immunoassay systems ƒ Real 3rd party assessment of Bio-Rad HPLC systems ƒ Bi-level, Multi-Pack ƒ Assayed (2*3*1 mL) ƒ Storage at -15 to -25°C ƒ 24 months shelf life at -20°C ƒ 21 days open-vial stability at 2-8°C ƒ Aliquots can be re-frozen ƒ Patient like (good HPLC curves) ƒ Biorad open stability 14 days ƒ User friendly – liquid stable ƒ Can be used to last drop – no waste

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Why consider MAS Quality Controls? User friendly ƒ ƒ ƒ ƒ

Stable ƒ ƒ

Liquid Very good Open Vial Stability, with few analyte exceptions Shelf life at 2-8 °C for many products Multi-parameter

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Patientlike

Long Shelf life >2-3 years Market leading open vial stability Stability gives confidence

Affordable ƒMany multi-controls to help consolidate ƒWell suited volumes and open vial stability gives minimal waste ƒTechnical support

ƒ Human matrix ƒ Majority of spiked components are human ƒ NaAzide excluded where it can interfere with some assays

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Summary ƒ More to our Clinical Diagnostics division than first meets the eye ƒ Accessibility to our products with sound support and technical back-up through our Distribution partners ƒ Hope you have seen something today which is applicable to your Laboratory’s needs

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Thank you!

The World Leader in Serving Science

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