Contents:

Foreword Introduction What are in vitro diagnostics? Market sectors Clinical chemistry Immunochemistry Haematology Haemostasis Microbiology Molecular diagnostics Point-of-Care Geographic trends Established markets Key emerging markets Regulatory environment US The Clinical Laboratory Improvement Amendments (CLIA) CLIA waivers CLIA categorisation European Union Company Profiles Abbott Diagnostics Overview Products/Technologies Technologies AbbottLink and EQC ABBOTT PRISM ACCELERATOR Automated Processing Systems (APS) AEROSET The ARCHITECT Family AxSYM/AxSYM Plus The CELL DYN Family IMx i-STAT TDx/TDxFLx Tests/Reagents Cancer Cardiology General/Special chemistry Infectious disease tests Metabolic Retrovirus Signify products Specific proteins Thyroid Major Developments Agreements Novation Celera Axis-Shield Financials Acolyte Biomedica Overview Products/Technologies Technology BacLite flex Tests BacLite Rapid MRSA Adaltis Overview Products/Technologies Instruments ALLERgen Systems Eclectica Tests/Reagents ALLERgen EasyLine Immunoassay Clinical Chemistry Microplate Assays Radioimmunoassay Turbidimetry Major Developments Mergers and Acquisitions Shanghai Hua Tai Biotechnology Agreements Financials ARKRAY Overview Products/Technologies Instruments/technologies Blood Ammonia Clinical Chemistry Electrolyte analysis Urinalysis Major Developments Mergers and Acquisitions HypoGuard Axis-Shield Overview Products/Technologies Technologies Point-of-Care analysers Tests/reagents AxSYM xtra Cardiovascular Point-of-care Rheumatoid arthritis Vitamin B12 deficiency Other tests Major Developments Agreements Abbott Bio-Rad Laboratories Financials Beckman Coulter Overview Products/Technologies Technologies Access/Access 2 ACL systems Array/IMMAGE Cell Lab Quanta/Cytomics Command Central COULTER haematology systems DL2000 Data Manager Paragon/Appraise Power Processor SYNCHRON UniCel Vidiera Tests/Reagents Anaemia Blood virus Bone metabolism Cancer Cardiology Drugs of abuse General/Special chemistry Haemostasis ICON/rapid tests Infectious disease Reproductive Specific proteins Thyroid Others Major Developments Mergers, Acquisitions & Divestitures Lumigen Agencourt Personal Genomics Agreements Financials BD Diagnostics Overview Products/Technologies Technologies BACTEC 9000 Family BBL CHROMagar Orientation//TSA II I Plate BBL Crystal Identification Systems BD Free Flow Electrophoresis System BD Phoenix Automated Microbiology System BD ProbeTec BD Viper Tests/reagents BD Affirm VP III BD BACTEC/F blood culture media BD Directigen tests Infectious disease Febrile diseases Major Developments Mergers, Acquisitions & Divestitures GeneOhm BD.id patient identification system Agreements Foundation for Innovative New Diagnostics Roche Financials BioMedica Diagnostics Overview Products/Technologies Instruments/technologies Clinical chemistry analysers Haemostasis systems Haematology Systems Immunochemistry systems Tests/reagents Rapid Cassette Tests Urinalysis Test Strips Major Developments Agreements Medex Laboratories bioMérieux Overview Products/Technologies Technologies BacT/ALERT 3D DAVINCI FlexTek 2 Informatics NucliSENS EasyQ Reader 250 VIDAS Immunoanalysers VIDIA VITEK Tests/reagents Cancer Cardiology Infectious Disease Major Developments Mergers and Acquisitions Biomedics Agreements Sysmex Eiken Chemical NuGEN Technologies AdvanDx Financials Bio-Rad Laboratories Overview Products/Technologies Technologies Autoimmune Enzyme Immunoassay (EIA) automation BioPlex 2200 system Clinical Chemistry Haematology/Immunohaematology Informatics Microbiology Tests/reagents ANCA complete kits Autoimmune Enzyme Immunoassay (EIA) Genetic disorders Immunohaematology Microbiology Special chemistry Major Developments Mergers and Acquisitions Blackhawk BioSystems Agreements Axis-Shield Integrated DNA technologies Financials Biosite Overview Products/Technologies Technologies Triage system Tests/reagents Cardiology Drugs of abuse Infectious disease Major Developments Agreements Beckman Coulter Financials Cytyc Overview Products/Technologies Technologies FirstCyte Breast Test ThinPrep System Major Developments Mergers and Acquisitions Hologic Adiana Adeza Agreements ThinPrep Products Financials Dade Behring Overview Products/Technologies Technologies BN series BCS/BCT/BFT/PFA haemostasis systems Dimension systems Informatics systems LOCI Quadriga BeFree system Stratus StreamLAB Analytical Workcell Sysmex V-Twin/Viva WalkAway SI/autoSCAN microbiology systems Tests/reagents Drugs of abuse Microbiology panels Plasma protein tests Major Developments Agreements DiaSorin Novation Immunalysis Euro-Diagnostica Financials Dako Overview Products/Technologies Technologies ACIS III CyAn ADP Flow Cytometer Hybridizer/Pascal pressure chamber MoFlo Cell Sorter Staining Systems Tests/Reagents Clinical Immunochemistry Pharmacodiagnostics Major Developments Financials DiagnoCure Overview Products/Technologies Tests ImmunoCyt/uCyt+ PCA3 Test for Prostate Cancer Tests in development Major Developments Agreements Financials DiaMed Overview Products/Technologies Technologies Haemostasis Informatics Microbiology Instruments Tests/Reagents Cytokines Infectious Diseases Fertility Tumour Markers Others Major Developments Fujirebio diagnostics Overview Products/Technologies Tests/reagents Radio immunoassay (RIA) tests CanAg Enzyme Immunoassay (EIA) kits Other tests Major Developments Agreements Sanko Junyaku and Eisai ARUP Laboratories Genomic Health Overview Products/Technologies Tests Oncotype DX Major Developments Agreements Medical Solutions plc Financials Gen-Probe Overview Products/Technologies Technologies DTS Systems LEADER Luminometers Tigris DTS Tests/Reagents AccuProbe Culture Identification Blood Screening Sexually Transmitted Diseases Streptococcus Major Developments Agreements Millipore 3M DiagnoCure Financials Genzyme Diagnostics Overview Products Tests/reagents Cholesterol tests OSOM point-of-care Pancreatitis assays Major Developments Mergers and Acquisitions Equal Diagnostics Financials Hitachi Chemical Diagnostics Overview Products/Technologies Technologies CLA-1 Luminometer Tests CLA Pette Panels Major Developments Agreements Response Genetics Financials Inverness Medical Innovations Overview Products/Technologies Technologies CLONDIAG Wampole ELISA II Tests/reagents BioStar Binax Clearview Consumer diagnostics Determine InstaCheck II/MEDplus-ER drug screen INVERNESS MEDICAL TestPack +Plus Ischaemia Modified Albumin (IMA) Osteomark NTx SureStep ThyroTest TSH Major Developments Mergers and Acquisitions Biosite Quality Assured Services Instant Technologies First Check Diagnostics ACON Laboratories Clondiag Chip Technologies Joint Venture SPD Swiss Precision Diagnostics Financials Luminex Overview Products/Technologies Technologies Luminex 200 System Luminex 100 IS Luminex HTS System xMAP Technology xPONENT Software Tests/Reagents FlexmiR Microspheres Major Developments Mergers and Acquisitions Tm Bioscience Corporation Agreements Johns Hopkins University Fisher HealthCare Financials Overview Products/Technologies Instruments Luminex Instrument Tests Multiplex assays Mikrogen Overview Products/Technologies Tests recomBlot recomLine recomWell Olympus Diagnostic Systems Division Overview Products/Technologies Technologies AU clinical chemistry/immunochemistry systems Data management Lab automation systems PK7300 blood grouping analyser Tests/reagents Cancer Cardiology Drugs of abuse Liver/Pancreas disorders Metabolites/specific proteins Major Developments Mergers and Acquisitions Bacus Laboratories Single molecule detection technology from Evotec Agreements Material Science Europa and Saladax Biomedical VisEn Medical Horiba ABX Financials Orion Diagnostica Overview Technologies QuikRead 101 Turbox system Tests/reagents Bone and tissue assays Dental diagnostic tests Gastroenterology tests Hormone assays Iron deficiency assays Other bacterial tests Point of care Specific proteins Financials Ortho-Clinical Diagnostics Overview Products/Technologies Technologies/Instruments Automation Blood Donor Screening Chemistry/Immunodiagnostics Tests/Reagents Blood Donor Screening Clinical Chemistry Immunodiagnostics Major Developments Agreements Financials Johnson & Johnson financial results, 2002-2006 (US$ millions) Radiometer Overview Products/Technologies Technologies ABL/NPT blood gas analysers IT systems Samplers and QC Tests Major Developments Acquisition by Danaher Accumetrics Financials Roche Diagnostics Overview Products/Technologies Technologies Cardiac Reader Cobas AmpliPrep Instrument Cobas Clinical Chemistry/Immunochemistry Cobas Critical Care Systems Cobas s 201 Blood Screening System Cobas TaqMan Analyser Elecsys Analysers Informatics MODULAR SYSTEMS platform Reflotron Systems Roche 9180 Electrolyte Analyser Roche/Hitachi Clinical Chemistry STAGO Systems Urisys Systems Tests/reagents Accutrend Lactate System AmpliChip Microarray tests Bone Markers Cardiology Combur-Test Urine Test Strips Drugs of Abuse/Therapeutic Drug Monitoring Enzymes/Substrates Specific Proteins Others Major Developments Mergers and Acquisitions Financials Roche financial results 2002-2006 (CHF millions) Siemens Medical Solutions Diagnostics Overview Products/Technologies Technologies Automation/Integration RapidSystems blood gas analysers Clinical chemistry systems DCA diabetes system ADVIA haematology systems Immunodiagnostics Molecular diagnostics Urinalysis analysers Tests/reagents Allergy Autoimmune Cardiovascular Drugs of abuse General chemistry Infectious disease Inflammation markers Other tests Reproductive endocrinology Special chemistry Specific proteins TDM Thyroid Tumour markers Major Developments Mergers and Acquisitions Dade Behring Diagnostic Products Corporation Financials Sysmex Overview Products/Technologies Instruments/Technologies Haematology Haemostasis Immunochemistry Informatics Point of Care Urinalysis Major Developments Agreements Amerinet Bio-Rad Laboratories Premier Purchasing Partners Defence Supply Center Philadelphia Affymetrix CellaVision Financials TREK Diagnostic Systems Overview Products/Technologies Instruments/technologies onSite Urine Culture Device para-JEM systems Sensititre Microbiology Systems Software solutions VersaTREK Major Developments Acquisition by Magellan Biosciences Veridex, LLC Overview Products/Technologies Technologies CellSearch System GeneSearch System Major Developments Agreements Immunicon LabCorp OncoMethylome Sciences Financials Johnson & Johnson financial results, 2002-2006 (US$ millions) SOURCES Espicom Sources Others List of Tables Clinical chemistry products Immumochemistry products Haematology products Haemostasis products Microbiology products Molecular diagnostics products Point-of-care products EU Notified Bodies, September 2007 Abbott financial results, 2002-2006 (US$ millions) Adaltis financial results, 2004-2006 (C$ thousands & US$ thousands) Axis-Shield financial results, 2003-2006 (£ millions & US$ millions) Beckman Coulter financial results, 2002-2006 (US$ millions) Becton Dickinson financial results, 2002-2006 (US$ millions) bioMérieux financial results, 2004-2006 (EUR millions) Bio-Rad financial results, 2004-2006 (US$ millions) Biosite financial results, 2004-2006 (US$ millions) Cytyc financial results, 2002-2005 (US$ millions) Dade Behring financial results 2002-2006 (US$ millions) Dako financial results 2002-2006 (DKK millions) DiagnoCure financial results, 2004-2006 (US$ thousands) Genomic Health financial results, 2002-2006 (US$ thousands) Gen-Probe financial results, 2002-2006 (US$ millions) Genzyme financial results, 2002-2006 (US$ millions) Hitatchi financial results 2003-2007 (¥ millions) Inverness financial results 2002-2006 (US$ millions) Luminex financial results, 2002-2006 (US$ thousands) Olympus financial results, 2002-2007 (¥ millions) Orion financial results, 2004-2006 (EUR millions & US$ millions) Danaher financial results, 2004-2006 (US$ millions) Siemens Medical Solutions financial results, 2001-2006 (EUR millions) Sysmex financial results, 2002-2007 (¥ millions & US$ millions) List of Figures Abbot Diagnostics net sales, 2002-2006 (US$ millions) Adaltis revenue, 2004-2006 (US$ thousands) Axis-Shield revenue by business sector, 2003-2006 (US$ millions) Beckman Coulter net sales, 2000-2006 (US$ millions) BD Diagnostics revenues, 2000-2006 (US$ millions) bioMérieux net sales, 2004-2006 (US$ millions) Bio-Rad net sales for Clinical Diagnostics, 2004-2006 (US$ millions) Cytyc net sales, 2002-2005 (US$ millions) Dade Behring revenues 2000-2006 (US$ millions) Dako net sales 2002-2006 (US$ millions) DiagnoCure revenues, 2004-2006 (US$ thousands) Genomic Health total revenues, 2003-2006 (US$ thousands) Gen-Probe total revenues, 2002-2006 (US$ millions) Genzyme revenues, 2002-2006 (US$ millions) Hitachi revenues, 2003-2007 (US$ millions) Inverness sales, 2002-2006 (US$ millions) Inverness sales by product group, 2006 (%) Luminex revenues 2002-2006 (US$ thousands) Olympus sales by business segment, 2005-2007 (¥ millions) Sales by geographic location, 2007 (%) Orion net sales, 2004-2006 (US$ millions) Orion net sales by business sector, 2006 (%) Net sales by geographic region, 2006 (%) J&J Medical Devices & Diagnostics sales by subsidiary, 2006 (US$ millions) Ortho-Clinical Diagnostics sales, 2004-2006 (US$ millions) Danaher Medical Technologies sales, 2004-2006 (US$ millions) Roche sales 2000-2006 (US$ millions) Diagnostics division sales by business segment, 2006 (%) Diagnostics division sales by geographical region, 2006 (%) Siemens net sales 2001-2006 (EUR millions) Sysmex sales by business segment, 2003-2007 (¥ millions) J&J Medical Devices & Diagnostics sales by subsidiary, 2006 (US$ millions)

Companies Mentioned

-Abbott Diagnostics -Acolyte Biomedica -Adaltis -Axis-Shield -ARKRAY -Beckman Coulter -Becton Dickinson -BioMedica Diagnostics -bioMérieux -Bio-Rad -Biosite -Cytyc -Dade Behring -Dako -DiagnoCure -DiaMed -Fujirebio Diagnostics -Genomic Health -Gen-Probe -Genzyme Diagnostics -Hitachi Chemical Diagnostics -Inverness Medical Innovations -Luminex -Microbionix -Mikrogen -Olympus -Orion Diagnostica -Ortho-Clinical Diagnostics -Radiometer -Roche Diagnostics -Siemens Medical Solutions -Sysmex -TREK Diagnostics -Veridex