DNA Probes-based Diagnostics

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

• Study Reliability and Reporting Limitations I-1
• Disclaimers I-2
• Data Interpretation & Reporting Level I-2
• Quantitative Techniques & Analytics I-3
• Product Definitions and Scope of Study I-3
• Infectious Diseases I-3
• Cancer I-4
• Genetic Predisposition I-4
• Identity/Forensics I-4
• Molecular HLA Testing I-4
• Other Diagnostic Applications I-4

II. EXECUTIVE SUMMARY

1. Market Dynamics II-1

• Industry Overview II-1
• DNA Probes: Robust Growth Ahead II-1
• Decoding the Genetic Puzzle II-1
• Advantages of DNA-Probe Tests II-2
• Growth Drivers in a Nutshell II-2
• Growth Inhibitors in a Nutshell II-2
• Genetic Profiling of Pathogens: A Road Less Traveled II-3
• Roche' s Entry into the Hall of Molecular Fame II-3
• Non-Amplification Theory Threatens to Enervate Roche' s PCR Forte II-3
• DNA Technology: An Evolutionary Scan II-4
• An Era of Excellence: Tracking Landmark Breakthroughs in DNA Diagnostics II-5
• Opportunities II-6
• Market Trends/Issues II-6
• Molecular Diagnostics: Promising a Bright Future II-6
• DNA Tests: Finding Use in Numerous Applications II-6
• World' s Aging Population Drives the Popularity of DNA-Probe Tests II-6
• Reimbursements: "Under the Umbrella" II-7
• Evolution of New & Virulent Infectious Agents II-7
• The Enlightened Consumer of the 21st Century II-7
• Challenges In Widespread Deployment of DNA Based Diagnostics II-7
• Miniaturization: An Uphill Task II-8
• Improvements in Assay Capabilities II-8
• Detection: A Knotty Problem II-8
• Information Handling & Processing: The Soft Side of Diagnostics II-9
• Integration: The Ultimate Challenge II-9
• United States: Unraveling the Country' s Edge in DNA based Diagnostics II-9
• Tools for DNA Diagnostics Program: A Boost for DNA-Diagnostic Systems II-9

2. DNA Probes-Based Diagnostics - A Primer II-10

• Diagnostic Gene Detection Products II-10
• Molecular Diagnostics: A Powerful Disease Detection Tool II-10
• DNA Probes-Based Products II-11
• Direct Detection of Target Sequence II-11
• Nucleic Acid Amplification II-11
• Nucleic Acid Amplification Methods II-11
• Gene Detection Using DNA Chips II-11
• Gene Detection by DNA Sequencing II-12
• The Dynamics of Key Enabling Technologies II-12
• In Situ Hybridization II-12
• PCR: Polymerase Chain Reaction II-12
• Chemiluminescence II-12
• Gen-Probe Tigris II-13
• DNA Chips II-13
• Key Players II-13
• Players in Molecular Diagnostics Market II-13
• Product Portfolio of Industry Majors II-14
• Molecular Diagnostics - A Primer II-15
• Detracting Factors II-15
• The Cash Cachet II-15
• Implications for Clinical Diagnostics II-16
• Need of the Hour II-16
• Present Potential II-16
• Molecular Diagnostics: Marking the Convergence of Numerous Technologies II-16
• Impact of the Human Genome Project II-17
• Molecular Diagnostics: Domain of the Developed Countries II-17
• "Tailored Patient Management": An Epitomized Future of Molecular Diagnostics II-17
• Futuristics: A Rumination II-17

3. Product Overview II-19

• Background II-19
• Gene Probe Technology II-19
• What is DNA? II-19
• DNA Probes II-19
• Miniaturization: A Revolutionary Method in DNA Analysis II-20
• Gene Chip Technology II-20
• DNA Chips II-20
• Chromosome Painting Probes II-20
• Diagnostic Applications Based on DNA Probes: An Overview II-20
• Infectious Diseases II-20
• Respiratory Tract Infections II-21
• Diagnosis of Mycoplasma II-21
• DNA Probes to Detect Legionella Pneumophila II-21
• Detecting Tuberculosis Through Rapid Diagnostic Tests II-21
• How the Technique Works II-21
• Limitations II-22
• Sexually Transmitted Diseases (STDs) II-22
• HIV II-22
• HTLV-1 Testing II-22
• Hepatitis Testing II-22
• Chlamydia DNA Probes II-22
• Detection of Intestinal Parasites II-23
• Entamoeba Histolytica II-23
• Campylobacter II-23
• Salmonella II-23
• Identity/Forensics II-23
• DNA Profiling: A Key Forensic Tool II-23
• DNA-Based Forensic Diagnostics II-24
• Tracing Human Origins II-24
• Assessing Genetic Predisposition of Disease II-24
• Molecular HLA Testing II-24
• Human Leukocyte Antigen (HLA) Typing II-24
• Cancer Testing II-24
• Cancer: A Deadly Disease Afflicting Millions II-25
• Slow Detoxifiers: Potential Cancer Candidates II-25
• Improving Cancer Surgery Through Diagnostic Tests II-25
• Types of Cancer II-25
• Chronic Lymphocytic Leukemia (CLL) II-25
• Fludara: Recommended Treatment for CLL II-25
• Breast Cancer II-26
• PCR Screening Technology for Breast Cancer II-26
• Eye Cancers II-26
• DNA Probes to Detect Retinoblastoma II-26
• Others II-26
• The Ames test II-26
• Genetic Testing II-27
• Other Diagnostic Applications II-27
• Cystic Fibrosis II-27
• Malaria Testing II-27
• Detection of Multidrug Resistance II-27
• Bacterial Resistance to Antibiotics II-28
• DNA Probes for Agriculture II-28
• Gene-Based Tests II-28
• ID Biomedical II-28
• Velogene Rapid MRSA Test II-28
• Valogene Rapid VRE Test II-28
• Valogene Rapid TB Test II-28
• Abbott/Vysis II-29
• DNA FISH Probes for Prenatal and Other Genetics II-29
• DNA FISH Probes for Microdeletion Syndromes II-29
• DNA FISH probes for Oncology and Pathology II-29
• WCP FISH Probes II-29
• CEP Chromosome Enumeration DNA FISH Probes II-29
• Related Markets II-30
• Prenatal Testing II-30
• Invasive Procedures II-30
• Amniocentesis II-30
• Chorionic Villus Sampling (CVS) II-30
• Non-Invasive Procedures II-30
• Alpha-Fetoprotein Test II-30
• Triple Test II-31
• Applied Imaging' s Prenatal Screening System II-31
• Flow Cytometry II-31
• Gene Therapy II-32

4. Product Developments/Introductions -

• Molecular Diagnostics II-33
• BD Launches New BD Viper™ System for AutomatingMolecular Diagnostic Testing Process II-33
• Affymetrix Unveils New GeneChip® Scanner withHigher Capacity Scanning II-33
• Genzyme Introduces EGFR Mutation Assay forDetecting Mutations II-33
• bioMérieux Rolls Out FoodExpert-ID Molecular
• Multi-Detection Test for Feed Analysis II-33Roche Launches Amplicor HPV in Europe II-34
• Bamburgh Marrsh Unveils Genetic Predisposition Kits II-34
• DNAPrint Genomics Unveils DNA Forensics II-34
• Vysis Announces Urovysion II-34
• Vysis Unleashes DNA Probe Test II-34
• Quest Diagnostics Unwraps HCV DupliType Testing II-34

5. Recent Industry Activity II-35

• QIAGEN to Take Over Gentra II-35
• Bayer to Divest Diagnostics Division to Siemens II-35
• LGC Acquires AGOWA to Extend German Operations II-35
• ENZ Receives Patent for Phosphate Labeling for MedicalResearch & DNA Diagnostic Products II-36
• TMC Delivers Gene Assay Reagents to Jacobi Medical Center II-36
• TMC Achieves CE Mark for its Tag-It Cystic Fibrosis Test Kit II-36
• Toshiba Licenses Electrochemical Detection Technology to Antara II-37
• Affymetrix Licenses Multiple Patents to Invitrogen II-37
• Applied Biosystems Agrees to Acquire APG II-37
• Abbott Enters into Agreement with ALSI for Licensing ProGRP Biomarker II-38
• QIAGEN in Protein Crystallography Co-MarketingAgreement with ActiveSight II-38
• Warnex Acquires Pro-DNA Diagnostic II-38
• Celera Genomics Gains Complete Ownershipof Celera Diagnostics II-39
• Gen-Probe Licenses Exclusive Rights for Diagnostic TestsDevelopment from University of Michigan II-39
• QIAGEN Enters into Licensing Agreement with AppliedBiosystems for Real-Time PCR Technologies II-39
• IGC Collaborates with Roche for Cancer BiomarkerDiscovery II-40
• Affymetrix Acquires ParAllele BioScience II-40
• QIAGEN Enters into Distribution Agreement withOsmetech Molecular Diagnostics II-40
• GlaxoSmithKline Acquires Canada-Based ID Biomedical Corp. II-40
• Gen-Probe Obtains FDA Approval for APTIMA II-41
• Gen-Probe Signs Purchasing Agreement with Roche II-41
• MP Biomedicals Acquires Qbiogene II-41
• Roche Diagnostics Signs Agreement with Multilyte Limited II-41
• Roche Diagnostics Receives CE Mark Certifications for its Three Innovative Virology Tests II-41
• Roche Diagnostics Receives FDA Approval forAmpliChip CYP450 Test II-41
• Ventana Launches ISH Tests II-42
• Abbott Receives FDA Approval for Use of AutoVysion™ System II-42
• Affymetrix Opts Veridex for its GeneChip® Technology II-42
• Abbott Signs Distributive Agreement with BioGenex II-42
• Celera Diagnostics Receives Approval to DistributeViroSeq HIV-1 Genotyping System II-42
• Digene Announces PMAS Application Filing for Rapid Capture™ System II-43
• Roche Forms Alliance with decode II-43
• Abbott and Celera in Strategic Alliance for In VitroMolecular Diagnostic Products II-43 Fujirebio Inks an Agreement with Yale II-43
• Orchid Purchases Lifecodes II-44
• Abbott Acquires Vysis II-44
• Roche Partners with deCode II-44
• Vysis Acquires FDA Approval for DNA-Probe Test II-44
• EraGen Biosciences Grants Licenses to Bayer II-44
• Boston Probes Licenses LightUp Technologies II-45

6. Focus on Select Players II-46

• Abbott Laboratories (US) II-46
• Affymetrix Inc (US) II-46
• Applied Biosystems Group (US) II-47
• Bayer Diagnostics (Germany) II-47
• Becton Dickinson & Company (US) II-47
• Beckman Coulter (US) II-48
• bioMerieux (France) II-48
• Biogenex Laboratories (US) II-48
• Celera Genomics (US) II-49
• Digene Corporation (US) II-49
• Gen-Probe Inc (US) II-49
• Genzyme Corp (US) II-50
• MP Biomedicals (US) II-50
• Roche Diagnostics (Switzerland) II-50
• Tm Bioscience (Canada) II-50

7. Global Market Perspective II-52

• Table 1: World Recent Past Current & Future Analysisfor DNA Probes-based Diagnostics by Geographic Region- US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Latin America Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) II-52
• Table 2: World 10-Year Perspective for DNA Probes-based Diagnostics by Geographic Region- Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Latin America for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart) II-52
• Table 3: World Recent Past Current & Future Analysis for DNA Probes-based Diagnostics (Infectious Disease Diagnosis) by Geographic Region- US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Latin America Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) II-53
• Table 4: World 10-Year Perspective for DNA Probes-based Diagnostics (Infectious Disease Diagnosis) by Geographic Region- Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Latin America for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart) II-53
• Table 5: World Recent Past Current & Future Analysis for DNA Probes-based Diagnostics (Cancer Diagnosis) by Geographic Region- US, Canada, Japan, Europe,Asia-Pacific (excluding Japan) and Latin America Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) II-54
• Table 6: World 10-Year Perspective for DNA Probes-based Diagnostics (Cancer Diagnosis) by Geographic Region- Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Latin America for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart) II-54
• Table 7: World Recent Past Current & Future Analysis for DNA Probes-based Diagnostics (Genetic Predisposition Diagnosis) by Geographic Region- US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Latin America Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) II-55
• Table 8: World 10-Year Perspective for DNA Probes-based Diagnostics (Genetic Predisposition Diagnosis) by Geographic Region- Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Latin America for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart) II-55
• Table 9: World Recent Past Current & Future Analysis for DNA Probes-based Diagnostics (Identity/Forensics Diagnosis) by Geographic Region- US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Latin America Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) II-56
• Table 10: World 10-Year Perspective for DNA Probes-based Diagnostics (Identity/Forensics Diagnosis) by Geographic Region- Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Latin America for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart) II-56
• Table 11: World Recent Past Current & Future Analysis for DNA Probes-based Diagnostics (Molecular HLA Testing) by Geographic Region- US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Latin America Markets Independently Analyzed with Annual Sales Figures in US$ Million for
• Years 2000 through 2010 (includes corresponding Graph/Chart) II-57
• Table 12: World 10-Year Perspective for DNA Probes-based Diagnostics (Molecular HLA) by Geographic Region- Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Latin America for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart) II-57
• Table 13: World Recent Past Current & Future Analysis for DNA Probes-based Diagnostics in Other Types of Diagnosis by Geographic Region- US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Latin America Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) II-58
• Table 14: World 10-Year Perspective for DNA Probes-based Diagnostics in Other Types of Diagnosis by Geographic Region- Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Latin America for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart) II-58

III. MARKET

1. The United States III-1

• A. Market Analysis III-1
• Outlook III-1
• United States: Unraveling the Country' s Edge in DNA based Diagnostics III-1
• Tools for DNA Diagnostics Program: A Boost for DNA-Diagnostic Systems III-1
• STD (Sexually Transmitted Diseases) Tests Segment III-2
• Review of Leading Players III-2
• Product Launches III-6
• Strategic Developments III-9
• Historical Perspective III-16
• Technological Developments III-16
• Product Launches III-18
• Strategic Developments III-19
• B. Market Analytics III-26
• Table 15: US Recent Past, Current & Future Analysis for DNA Probes-based Diagnostics by Application Area- Infectious Diseases, Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) III-26
• Table 16: US 10-Year Perspective for DNA Probes-based Diagnostics by Application Area Percentage Breakdown of Dollar Sales for Infectious Diseases, Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart) III-26

2. Canada III-27

• A. Market Analysis III-27
• Outlook III-27
• Review of Leading Players III-27
• Strategic Developments III-27
• B. Market Analytics III-29
• Table 17: Canadian Recent Past, Current & Future Analysis for DNA Probes-based Diagnostics by Application Area- Infectious Diseases, Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) III-29
• Table 18: Canadian 10-Year Perspective for DNA Probes-based Diagnostics by Application Area Percentage Breakdown of Dollar Sales for Infectious
• Diseases, Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart) III-29

3. Japan III-30

• A. Market Analysis III-30
• Outlook III-30
• Strategic Developments III-30
• Historic Developments III-30
• B. Market Analytics III-31
• Table 19: Japanese Recent Past, Current & Future Analysis for DNA Probes-based Diagnostics by Application Area- Infectious Diseases, Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) III-31
• Table 20: Japanese 10-Year Perspective for DNA Probes-based Diagnostics by Application Area Percentage Breakdown of Dollar Sales for Infectious Diseases,
• Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart) III-31

4. Europe III-32

• A. Market Analysis III-32
• Outlook III-32
• Strategic Developments III-32
• B. Market Analytics III-33
• Table 21: European Recent Past, Current & Future Analysis for DNA Probes-based Diagnostics by Geographic Region - France, Germany, Italy, UK and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) III-33
• Table 22: European 10-Year Perspective for DNA Probes-based Diagnostics by Geographic Region - Percentage Breakdown of Dollar Sales for France, Germany, Italy, UK and Rest of Europe Markets for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart) III-33
• Table 23: European Recent Past, Current & Future Analysis for DNA Probes-based Diagnostics by Application Area- Infectious Diseases, Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) III-34
• Table 24: European 10-Year Perspective for DNA Probes-based Diagnostics by Application Area Percentage Breakdown of Dollar Sales for Infectious Diseases, Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart) III-34

4a. France III-35

• A. Market Analysis III-35
• Outlook III-35
• Key Player III-35
• Product Launch III-35
• Historic Development III-35
• B. Market Analytics III-36
• Table 25: French Recent Past, Current & Future Analysis for DNA Probes-based Diagnostics by Application Area- Infectious Diseases, Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) III-36
• Table 26: French 10-Year Perspective for DNA Probes-based Diagnostics by Application Area Percentage Breakdown of Dollar Sales for Infectious Diseases,Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart) III-36

4b. Germany III-37

• A. Market Analysis III-37
• Outlook III-37
• Key Player III-37
• Strategic Developments III-37
• Historic Development III-38
• B. Market Analytics III-38
• Table 27: German Recent Past, Current & Future Analysis for DNA Probes-based Diagnostics by Application Area- Infectious Diseases, Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) III-38
• Table 28: German 10-Year Perspective for DNA Probes-based Diagnostics by Application Area Percentage Breakdown of Dollar Sales for Infectious Diseases, Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart) III-39

4c. Italy III-40

• Market Analysis III-40
• Table 29: Italian Recent Past, Current & Future Analysis for DNA Probes-based Diagnostics by Application Area- Infectious Diseases, Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) III-40
• Table 30: Italian 10-Year Perspective for DNA Probes-based Diagnostics by Application Area- Percentage Breakdown of Dollar Sales for Infectious Diseases,
• Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart) III-41

4d. The United Kingdom III-42

• A. Market Analysis III-42
• Outlook III-42
• Strategic Development III-42
• Historic Developments III-42
• B. Market Analytics III-43
• Table 31: UK Recent Past, Current & Future Analysis for DNA Probes-based Diagnostics by Application Area- Infectious Diseases, Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and
• Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) III-43
• Table 32: UK 10-Year Perspective for DNA Probes-based Diagnostics by Application Area- Percentage Breakdown of Dollar Sales for Infectious Diseases,Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart) III-43

4e. Rest of Europe III-44

• A. Market Analysis III-44
• Outlook III-44
• Clinical Diagnostics in Russia III-44
• Key Player III-44
• Strategic Developments III-45
• Historic Developments III-46
• B. Market Analytics III-47
• Table 33: Rest of Europe Recent Past, Current & Future Analysis for DNA Probes-based Diagnostics by Application Area - Infectious Diseases, Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) III-47
• Table 34: Rest of Europe 10-Year Perspective for DNA Probes-based Diagnostics by Application Area- Percentage Breakdown of Dollar Sales for Infectious Diseases, Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart) III-47

5. Asia-Pacific III-48

• A. Market Analysis III-48
• Outlook III-48
• Historic Development III-48
• B. Market Analytics III-48
• Table 35: Asia-Pacific Recent Past, Current & Future Analysis for DNA Probes-based Diagnostics by Application Area- Infectious Diseases, Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) III-48
• Table 36: Asia-Pacific 10-Year Perspective for DNA Probes-based Diagnostics by Application Area- Percentage Breakdown of Dollar Sales for Infectious Diseases, Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart) III-49

6. Latin America III-50

• Market Analysis III-50
• Table 37: Latin American Recent Past, Current & Future Analysis for DNA Probes-based Diagnostics by Application Area- Infectious Diseases, Cancer, Genetic Predisposition, Identity/Forensics, Molecular HLA Testing, and Others Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) III-50
• Table 38: Latin American 10-Year Perspective for DNA Probes-based Diagnostics by Application Area- Percentage Breakdown of Dollar Sales for Infectious Diseases, Cancer, Genetic Predisposition, dentity/
• Forensics, Molecular HLA Testing, and Others Markets for 2000, 2005 & 2010 (includes corresponding Graph/Chart) III-51

IV. COMPETITION

• 1. Abbott Laboratories (USA) IV-1
• Table 39: Half Yearly Sales Analysis by Quarters: 2005-2006 (H1) (In US$ million) IV-3
• Table 40: Half Yearly Sales Analysis by Business Segment: 2005-2006 (H1) (In US$ million) IV-3
• Table 41: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million) IV-3
• Table 42: Annual Sales Analysis by Business Segment: 2004-2005 (In US$ million) IV-3
• Table 43: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million) IV-4
• Abbott Diagnostics Division of Abbott Laboratories (USA) IV-12
• 2. ActiveSight (USA) IV-16
• 3. Advanced Life Science Institute, Inc. (ALSI) (Japan) IV-18
• 4. Affymetrix, Inc. (USA) IV-19
• Table 44: Half Yearly Sales Analysis: 2005-2006 (H1) (In US$ million) IV-20
• Table 45: Quarterly Sales Analysis: 2005-2006 (H1) (In US$ million) IV-20
• Table 46: Annual Sales Analysis: 2004-2005 (In US$ million) IV-20
• 5. Antara BioSciences, Inc. (USA) IV-25
• 6. Applied Biosystems (USA) IV-26
• Table 47: Nine Months Sales Analysis by Quarter: 2005-2006 (Nine Months Ended, March) (In US$ billion) IV-27
• Table 48: Nine Months Sales Analysis by Product Segment: 2005-2006 (Nine Months Ended, March) (In US$ billion) IV-27
• Table 49: Nine Months Sales Analysis by Business Segment: 2005-2006 (Nine Months Ended, March) (In US$ billion) IV-27
• Table 50: Nine Months Sales Analysis by Geographic Region: 2005-2006 (Nine Months Ended, March) (In US$ billion) IV-27
• Table 51: Quarterly Sales Analysis: 2004-2005 (In US$ billion) IV-28
• Table 52: Annual Sales Analysis by Product Segment: 2004-2005 (In US$ billion) IV-28
• Table 53: Annual Sales Analysis by Business Segment: 2004-2005 (In US$ billion) IV-28
• Table 54: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ billion) IV-28
• 7. Bayer Healthcare, Diagnostics Division (USA) IV-33
• 8. Beacon Diagnostics, Inc. (USA) IV-38
• 9. Beckman Coulter, Inc. (USA) IV-39
• Table 55: Half Yearly Sales Analysis: 2005-2006 (H1) (In US$ million) IV-43
• Table 56: Quarterly Sales Analysis: 2005-2006 (H1) (In US$ million) IV-43
• Table 57: Half Yearly Sales Analysis by Business Segment: 2005-2006 (H1) (In US$ million) IV-43
• Table 58: Half Yearly Sales Analysis by Geographical Region: 2005-2006 (H1) (In US$ million) IV-43
• Table 59: Annual Sales Analysis by Business Segment: 2004-2005 (In US$ million) IV-43
• Table 60: Annual Sales Analysis by Geographical Region: 2004-2005 (In US$ million) IV-44
• Table 61: Quarterly Sales Analysis: 2004-2005 (In US$ million) IV-44
• 10. Becton Dickinson and Company (USA) IV-47
• Table 62: Half Yearly Sales Analysis: 2005-2006 (H1) (In US$ million) IV-49
• Table 63: Half Yearly Sales Analysis by Segment: 2005-2006 (H1) (In US$ million) IV-49
• Table 64: Annual Sales Analysis: 2004-2005 (In US$ million) IV-49
• BD Diagnostic Systems (USA) IV-52
• 11. Biogenex Laboratories, Inc. (USA) IV-55
• 12. bioMerieux SA (France) IV-58
• Biomerieux, Inc. (USA) IV-63
• 13. Biotest AG (Germany) IV-66
• Biotest Diagnostics Corporation (USA) IV-67
• 14. Celera Diagnostics (USA) IV-70
• 15. Celltech Group PLC (UK) IV-72
• 16. Chiron Corporation (USA) IV-73
• 17. Cytogen Corporation (USA) IV-80
• Table 65: Half Yearly Sales Analysis by Business Operations: 2005-2006 (H1) (In US$ million) IV-80
• Table 66: Quarterly Sales Analysis: 2004-2005 (In US$ million) IV-81
• Table 67: Annual Sales Analysis by Business Operations: 2004-2005 (In US$ million) IV-81
• 18. Dade Behring Holdings, Inc. (USA) IV-84
• Table 68: Half Yearly Sales Analysis by Segment: 2005-2006 (H1) (In US$ million) IV-85
• Table 69: Half Yearly Sales Analysis by Geographic Region: 2005-2006 (H1) (In US$ million) IV-85
• Table 70: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million) IV-86
• Table 71: Annual Sales Analysis by Segment: 2004-2005 (In US$ million) IV-86
• Table 72: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million) IV-86
• 19. DiaSorin, Inc. (USA) IV-89
• 20. Digene Corporation (USA) IV-90
• Table 73: Nine Months Sales Analysis: 2005-2006 (Nine Months Ended March) (In US$ million) IV-90
• Table 74: Annually Sales Analysis by Quarter: 2004-2005 (In US$ million) IV-91
• 21. Enzo Life Sciences, Inc. (USA) IV-94
• 22. Gen-Probe, Inc. (USA) IV-99
• Table 75: Half Yearly Sales Analysis: 2005-2006 (H1) (In US$ million) IV-99
• Table 76: Annual Sales Analysis by Segment: 2004-2005 (In US$ million) IV-100
• Table 77: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million) IV-100
• 23. Gentra Systems, Inc. (USA) IV-105
• 24. Genzyme Corporation (USA) IV-107
• Table 78: Half Yearly Sales Analysis: 2005-2006 (H1) (In US$ million) IV-110
• Table 79: Half Yearly Sales Analysis by Quarter: 2005-2006 (H1) (In US$ million) IV-110
• Table 80: Half Yearly Sales Analysis by Segment: 2005-2006 (H1) (In US$ million) IV-110
• Table 81: Annual Sales Analysis: 2004-2005 (In US$ million) IV-110
• Table 82: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million) IV-111
• Table 83: Annual Sales Analysis by Segment: 2004-2005 (In US$ million) IV-111
• Table 84: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ billion) IV-111
• 25. Glaxosmithkline PLC (UK) IV-117
• Table 85: Half Yearly Sales Analysis: 2005-2006 (H1) (In £ million) IV-118
• Table 86: Half Yearly Sales Analysis by Segment: 2005-2006 (H1) (In £ million) IV-118
• Table 87: Annual Sales Analysis: 2004-2005 (In £ million) IV-118
• Table 88: Annual Sales Analysis by Segment: 2004-2005 (In £ million) IV-119
• 26. Healthgene Corporation (Canada) IV-128
• 27. Idaho Technology, Inc. (USA) IV-129
• 28. Idexx Laboratories, Inc. (USA) IV-132
• Table 89: Nine Months Sales Analysis: 2005-2006 (Nine Months Ended, September) (In US$ million) IV-134
• Table 90: Quarterly Sales Analysis: 2005-2006 (Nine Months Ended, September) (In US$ million) IV-134
• Table 91: Nine Months Sales Analysis by Business Segment: 2005-2006 (Nine Months Ended, September) (In US$ million) IV-134
• Table 92: Annual Sales Analysis: 2004-2005 (In US$ million) IV-134
• Table 93: Annual Sales Analysis by Business Segment: 2004-2005 (In US$ million) IV-135
• Table 94: Annual Sales Analysis by Geographical Region: 2004-2005 (In US$ million) IV-135
• Table 95: Quarterly Sales Analysis: 2004-2005 (In US$ million) IV-135
• 29. Innogenetics NV (Belgium) IV-140
• 30. LGC Limited (UK) IV-149
• AGOWA (Germany) IV-154
• 31. Millipore Corporation (USA) IV-156
• Table 96: Half Yearly Sales Analysis by Quarter: 2005-2006 (H1) (In US$ million) IV-157
• Table 97: Half Yearly Sales Analysis by Business Segment: 2005-2006 (H1) (In US$ million) IV-157
• Table 98: Half Yearly Sales Analysis by Geographical Region: 2005-2006 (H1) (In US$ million) IV-157
• Table 99: Annual Sales Analysis: 2004-2005 (In US$ million) IV-157
• Table 100: Annual Sales Analysis by Business Segment: 2004-2005 (In US$ million) IV-157
• Table 101: Annual Sales Analysis by Geographical Region: 2004-2005 (In US$ million) IV-158
• Table 102: Quarterly Sales Analysis: 2004-2005 (In US$ million) IV-158
• Chemicon International, Inc. (USA) IV-164
• 32. MP Biomedicals (USA) IV-168
• 33. Myriad Genetics, Inc. (USA) IV-170
• Table 103: Nine Months Sales Analysis by Quarter: 2005-2006 (Nine Months Ended, March) (In US$ million) IV-171
• Table 104: Nine Months Sales Analysis by Segment: 2005-2006 (Nine Months Ended, March) (In US$ million) IV-171
• Table 105: Annual Sales Analysis: 2004-2005 (In US$ million) IV-171
• Table 106: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million) IV-171
• Table 107: Annual Sales Analysis by Segment: 2004-2005 (In US$ million) IV-172
• 34. Osmetech, Inc. - Critical Care Division (USA) IV-173
• 35. PerkinElmer, Inc. (USA) IV-175
• Table 108: Half Yearly Sales Analysis by Quarter: 2005-2006 (H1) (In US$ million) IV-177
• Table 109: Half Yearly Sales Analysis by Business Segment: 2005-2006 (H1) (In US$ million) IV-177
• Table 110: Annual Sales Analysis: 2003-2005 (In US$ million) IV-177
• Table 111: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million) IV-177
• Table 112: Annual Sales Analysis by Business Segment: 2004-2005 (In US$ million) IV-178
• Table 113: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million) IV-178
• 36. Promega Corporation (USA) IV-188
• 37. Qbiogene, Inc. (USA) IV-189
• 38. Qiagen GmbH (Germany) IV-192
• 39. Roche Diagnostics AG (Switzerland) IV-199
• Table 114: Annual Sales Analysis: 2005-2006 (In CHF million) IV-200
• Roche Diagnostics Corporation (USA) IV-202
• Roche Diagnostics (Deutschland) GmbH (Germany) IV-204
• 40. Sigma-Genosys, Ltd. (UK) IV-205
• 41. Signet Laboratories, Inc. (USA) IV-206
• 42. Therion International, LLC (USA) IV-207
• 43. TM Bioscience Corporation (Canada) IV-208
• Table 115: First Quarter Sales Analysis: 2005-2006 (Q1) (In Can$ million) IV-209
• Table 116: Annual Sales Analysis: 2004-2005 (In Can$ million) IV-209
• Table 117: Annual Sales Analysis by Quarter: 2004-2005 (In Can$ million) IV-209
• 44. Ventana Medical Systems, Inc. (USA) IV-213
• Table 118: Half Yearly Sales Analysis by Quarter: 2005-2006 (H1) (In US$ million) IV-214
• Table 119: Half Yearly Sales Analysis by Geographic Region: 2005-2006 (H1) (In US$ million) IV-214
• Table 120: Annual Sales Analysis: 2004-2005 (In US$ million) IV-214
• Table 121: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million) IV-214
• Table 122: Annual Sales Analysis by Segment: 2004-2005 (In US$ million) IV-214
• Table 123: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million) IV-215
• 45. Veridex LLC (USA) IV-219
• 46. Warnex (Canada) IV-220
• Table 124: Half Yearly Sales Analysis: 2005-2006 (H1) (In US$ million) IV-220