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Biomarker Technology Platforms for Cancer Diagnoses and Therapies --- Aarkstore Enterprise

Posted Nov 18 2010 9:49am

Until superior therapeutic treatments are developed to prevent, treat and cure cancer, the best means of reducing mortality and morbidity in a disease this complex is early detection and diagnosis. In the major solid cancer types such as lung, breast, colon and prostate, long-term survival rates drop precipitously once metastatis has occurred. The case is clear for development of biomarkers for early detection and screening tests for diseases such as breast, colon, ovarian and lung cancer. In addition, diagnostic measurement of cancer disease progression is essential to successful disease management. For these reasons, development of new and effective biomarkers for cancer detection and diagnosis is central to the cancer problem. The use of nucleic acid biomarker diagnostics have begun to answer these questions. Protein biomarkers are also useful. The purpose of this Publications report is to describe the specific segment of the cancer diagnostics market which develops new biomarker technology platforms for diagnosing and treating cancer. Biomarkers are useful in following the course of cancer and evaluating which therapeutic regimes are most effective for a particular type of cancer, as well as determining long-term susceptibility to cancer or recurrence. This study particularly examines those clinical measurement devices, and their reagents and supplies, which are meant to be used in hospitals, clinics, commercial laboratories and doctor’s offices to diagnose and monitor cancer. The examination also provides an in-depth discussion of the application of biomarkers in developing novel targeted cancer therapeutics, their predication response and efficacy, as well as their use in diagnosis of cancer.



Table of Contents :
1. Overview 12
1.1 Statement of Report 12
1.2 About This Report 12
1.3 Scope of the Report 12
1.4 Objectives 13
1.5 Methodology 14
1.6 Executive Summary 15

2. Introduction to Cancer Biology and the Diagnostic Industry 17
2.1 Biomarkers 17
2.1.1 The Biomarker Market Drivers 17
2.1.1.1 The Sector 17
2.1.1.2 The Critical Path Opportunities 17
2.1.1.3 The Capital Markets 17
2.2 Cancer Detection and Treatment with Biomarkers 18
2.2.1 The Problem 19
2.3 Cancer: The Disease 21
2.3.1 Metastasis 21
2.3.2 Demographics and Statistics of Cancer 22
2.4 Drivers of the Biotech and Diagnostics Industry 28
2.4.1 Venture Funding of Biotech Sector 29
2.4.2 Technological Innovation 30
2.4.3 Government Funding 30
2.4.4 Pharmaceutical Development and Bioanalytical Services 30
2.4.5 The War on Cancer 32
2.4.6 Current Oncology Drug Development 32
2.5 Outlook for Tumor Markers 32
2.6 Focus on Proteomics 35
2.6.1 Scientific Background 35
2.6.2 The Relationship between Proteins and Diseases 35
2.6.3 Limitations of Existing Diagnostic Approaches 36
2.6.4 Addressing the Heterogeneity of Cancer 36
2.6.5 Validation of Biomarkers Through Proper Study Design 37
2.6.6 Exploiting the Power of Mass Spectrometry to Improve Assay Specificity 37
2.6.7 Creating and Maintaining a Multi-Disease Product Pipeline 39
2.6.8 Partnerships for Developing Proteomic Biomarkers 39
2.7 Epigenic Markers for Cancer 40
2.8 Molecular Diagnostics Testing for Cancer 41
2.9 Market Opportunities 41
2.9.1 Industry Overview 42
2.9.2 Medical Indications and Medically Useful Information 44
2.9.3 Research Market 45
2.9.4 Competition 46
2.9.5 Diagnostic Services 46
2.9.6 Clinical Image Analysis 46
2.9.7 Research Imaging Market 46
2.9.8 Genomic Disease Management and In Vitro Diagnostic Multivariate Index Assays (IVDMIA) 46
2.9.9 Predictive Expression Profiles 47

3. Market Analysis of the Cancer Biomarkers Space 48
3.1 Scope of this Chapter 48
3.2 The Overall Market Opportunity and Segmentation of the Total Cancer Biomarkers Marketplace 48
3.3 Potential Cancer Biomarker Commercial Applications 51
3.3.1 Market for Routine Tumor Markers 52
3.3.2 Market for Genomic Cancer Biomarkers 57
3.3.3 Market Size and Forecasts for Companion Diagnostic Tests for Cancer Therapeutics 59
3.3.4 SWOT Analysis of the Major Cancer Biomarker Market Segments 61
3.3.4.1 Traditional Serum Cancer Biomarkers 61
3.3.4.2 Proteomic Cancer Biomarkers 62
3.3.4.3 Companion Diagnostic Cancer Biomarkers 63
3.4 Cancer Biomarker Market Estimates by Tissue of Origin 64
3.4.1 Colorectal 64
3.4.2 Prostate 65
3.4.3 Lung 65
3.4.4 Breast 65
3.4.5 Ovarian 66
3.5 Challenges Facing Cancer Biomarker Developers 66
3.6 Unmet Product Needs in the Cancer Biomarkers Space 68
3.7 Competitive Landscape of the Cancer Biomarkers Marketplace 70

4. Major Clinical Applications of Cancer Biomarkers 73
4.1 Launched Products and Pipeline 73
4.2 CYP2C9 Pharmacogenetics and Role in Personalized Medicine 75
4.3 Personalized Breast Cancer Therapy 75
4.4 Personalized NSCLC Therapy 76
4.5 AmpliChip®-based Personalized Medicine 76

5. Breast Cancer 77
5.1 Overview of Breast Cancer Disease 77
5.2 BRCA1 and BRCA2 Genes 78
5.2.1 Types of Genetic Testing Available for Breast Cancer 80
5.2.1.1 DNA Sequencing 80
5.2.1.2 Multi-Site Analysis 81
5.2.1.3 Single-Site Analysis 81
5.2.2 BRCA Test Results 81
5.2.2.1 What Does a Positive BRCA1 or BRCA2 Test Result Mean? 81
5.2.2.2 What Does a Negative BRCA1 or BRCA2 Test Result Mean? 81
5.2.2.3 What Does an Ambiguous BRCA1 or BRCA2 Test Result Mean? 82
5.2.2.4 What are the Options for a Person Who Tests Positive? 82
5.2.3 What are Some of the Benefits of Genetic Testing for Breast Cancer Risk? 83
5.2.4 What Are Some of the Risks of Genetic Testing for Breast and Ovarian Cancer Risk? 83
5.3 Estrogen Receptors and Breast Cancer 83
5.3.1 Expression and Prognostic Value of ER 83
5.3.2 Progesterone Receptors and Breast Cancer 84
5.3.3 ER and PR Predict Response to Endocrine Therapy 84
5.4 HER2 Gene and Protein 85
5.4.1 HER2 Tests 85
5.4.1.1 IHC Test 85
5.4.1.2 FISH Test 86
5.4.1.3 Questions About Testing 88
5.4.1.4 HER2 Tumor Status 89
5.5 Herceptin® Treatment 89
5.6 Tumor Assays for Adjuvant Chemotherapy 91
5.7 Use of Genomics to Understand Breast Cancer 92
5.8 Genetic Analysis Solution 93
5.8.1 The Use of Proteomics in Breast Cancer 94
5.8.2 Tissue Microarrays 95
5.8.3 Protein Microarrays 97
5.9 Gene Expression Microarrays and Recurrence Prediction 98
5.9.1 Oncotype DX 99
5.9.2 Oncotype DX for Breast Cancer 100
5.9.3 Risk Assessment 100
5.9.4 Use of Chemotherapy 100
5.9.5 Utility of the Oncotype Test 100
5.9.6 Clinical Development and Validation of Oncotype DX 101
5.9.6.1 Clinical Development of the Oncotype DX Recurrence Score 101
5.9.6.2 Clinical Validation of Prediction of Recurrence and Survival in N−, ER+ Patients Treated with Tamoxifen 101
5.9.6.3 Oncotype DX Predicts the Likelihood of Recurrence 102
5.9.6.4 Oncotype DX Predicts the Likelihood of Breast Cancer Survival in a Community Hospital Setting 102
5.9.6.5 Oncotype DX Predicts both Prognosis and Tamoxifen Benefit 103
5.10 Economic Benefits of Oncotype DX 103
5.11 Increased Clinical Utility of Oncotype DX 104
5.12 Second Generation Oncotype DX 105
5.12.1 Recurrence and Benefit Test for N−, ER− Breast Cancer 105
5.12.2 Taxane Benefit Test 105
5.13 MammaPrint 105
5.14 Rotterdam Signature 76-Panel 106
5.15 Summary of Microarray Technologies 106
5.16 Mass Spectrometry-based Approaches 107
5.16.1 Gel-based Approaches 107
5.16.2 Non-Gel-based Approaches 108
5.16.2.1 SELDI-TOF MS 108
5.16.2.2 SELDI and Prognosis 109
5.16.2.3 SELDI and Treatment Monitoring 110
5.16.3 Limitations of Mass Spectroscopy 110
5.17 Outlook 111
5.18 Future Perspectives 113
5.19 Breast Cancer Program (NMP66) 114
5.20 Myriad Genetics 114
5.21 Veridex GeneSearch™ Breast Lymph Node 115
5.22 OncoVue Cancer Risk Test 115
5.23 Research Biomarkers for Breast Cancer 115
5.24 Protein Biomarkers for Breast Cancer Prevention 116
5.25 Biomarker Prognosis of Breast Cancer Treated with Doxorubicin 116

6. Ovarian Cancer 117
6.1 Serum Markers 119
6.2 Biomarkers 120
6.2.1 Strategies for Discovering New Cancer Biomarkers 121
6.3 Serum Protein Biomarkers for Ovarian Cancer 121
6.3.1 Clinical Proteomics 122
6.4 Ovarian Cancer Triage Testing 123
6.4.1 Vermillion’s Ovarian Cancer Triage Diagnostic Program 124

7. Prostate Cancer 126
7.1 Overview 126
7.1.1 Prevalence 126
7.1.2 Prostate Cancer Progression and Recurrence Test 126
7.1.3 Current Market Size 126
7.2 Genes Involved in Prostate Cancer 127
7.3 Androgen Independence 128
7.4 Gene Markers in Prostate Cancer 129
7.5 Microarray Gene Identification of Prostate Biomarkers 129
7.6 GEArray DNA Microarrays 131
7.7 Vermillion’s Cancer Diagnostic Program 132
7.8 Hepsin 132
7.9 Matritech’s Prostate Cancer Program (NMP48) 132
7.10 Gen-Probe’s PCA3 Assay 133
7.11 Early Prostate Cancer Antigen-2 (EPCA-2) 133
7.12 Mass Spectrometry 134
7.13 Summary 136

8. Bladder Cancer 137
8.1 Overview 137
8.1.1 Prevalence 137
8.1.2 Progression and Recurrence 137
8.1.3 Bladder Cancer Risk Factors 137
8.1.4 Bladder Cancer Symptoms 137
8.2 Bladder Cancer Tests 137
8.3 UroVysion Bladder Cancer Kit 138
8.4 Ikoniscope® Robotic Digital Microscopy Platform 139
8.4.1 The CellOptics Platform 139
8.4.2 Cell Staining and Genetic Characterization 139
8.4.3 Ikoniscope/IkoniLAN Automated Microscopy 139
8.5 Nuclear Matrix Protein Markers 140
8.6 ImmunoCyt™/uCyt+™ 142

For more information, please visit : http://www.aarkstore.com/reports/Biomarker-Technology-Platforms-for-Cancer-Diagn

Contact :Sanaa

Aarkstore Enterprise

Tel : +912227453309

Mobile No: +919272852585

Email : contact@aarkstore.com

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