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Molecular Diagnostics Markets -New medical report of Aarkstore Enterprise

Posted Jan 10 2011 8:29am
The technologies that constitute molecular diagnostics--like first-generation amplification, DNA probes, fluorescent in situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors, and molecular labels--are influencing the discovery of therapeutic molecules, the screening and diagnosis of patients, and the optimization of drug therapy. In the past few years, this rapidly evolving field has seen several fascinating developments. This Publications report describes the specific market segment of the in vitro diagnostics market known as molecular diagnostics and includes all of the generally accepted clinical analytical activities in use today. It examines the prevalent clinical-measurement devices, as well as their reagents and supplies as utilized in hospitals, clinics, large reference laboratories and doctor�"'""s offices. Diagnostic tests marketed primarily as over-the-counter are generally not included in this report, although there is inevitably some overlap. The main objectives of this analysis are: 1) identifying viable technology drivers through a comprehensive look at platform technologies for molecular diagnostics, including probe-based nucleic acid assays, microarrays and sequencing; 2) obtaining a complete understanding of the chief molecular diagnostics tests--i.e., predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic--from their basic principles to their applications; 3) discovering feasible market opportunities by identifying high-growth applications in different clinical diagnostic areas and by focusing on expanding markets, such as communicable diseases, cardiology and oncology; and 4) focusing on global industry development through an in-depth analysis of the major world markets for molecular diagnostics, including growth forecasts.

Table of Contents :
1. Overview 9
1.1 Statement of Report 9
1.2 About This Report 9
1.3 Scope of the Report 9
1.4 Objectives 9
1.5 Methodology 10
1.6 Executive Summary 12

2. Introduction to Molecular Diagnostics and PCR Technology 15
2.1 Science Overview: Introduction to Genomics and Its Opportunity 15
2.2 Impact of the Human Genome Project on Molecular Diagnostics 17
2.3 Considerations for Molecular and Clinical Diagnosis 18
2.4 Molecular Diagnosis in the Post-Genomic Era 19
2.5 Advances in Molecular Diagnostics Technologies 20
2.6 Genetic Variability and Disease 22
2.7 Major Technology Platforms 22
2.7.1 Gene-based Amplification Technologies 23
2.7.2 Detection of Amplified Gene Products 23
2.7.3 Target-Based Gene Amplification 24
2.7.3.1 Polymerase Chain Reaction 24
2.7.3.2 Real-time PCR 25
2.7.3.3 Nucleic Acid Sequence-Based Amplification 26
2.7.4 Probe-Based Amplification 26
2.7.4.1 Ligase Chain Reaction 26
2.7.4.2 Strand Displacement Amplification 26
2.7.4.3 Q�'-replicase Amplified Probe Assay 26
2.7.5 Signal-Based Amplification 27
2.7.5.1 Branched DNA (bDNA) 27
2.7.6 Other Gene Amplification Technologies 27
2.7.6.1 Immuno-PCR 27
2.7.6.2 Bio-Barcode Assay 27

3. Nucleic Acid Test Applications 29
3.1 Blood Testing and Infectious Diseases 30
3.1.1 Molecular Diagnostics Market 30
3.1.1.1 Methods for DNA Detection and Gene Sequencing 42
3.1.1.2 Products and Applications 43
3.1.1.3 Oncology 44
3.1.2 SNPs and Genes: Medical Utility (Clinical Applications) 44
3.1.2.1 Clinical Application Initiatives 46
3.1.2.2 A Sampling of Clinical Application Collaborations 47
3.1.2.3 Collaborative Relationships 49
3.2 Diagnostic Testing Using DNA 50
3.2.1 HIV 52
3.2.2 Hepatitis Serologic Markers and Nucleic Acid Testing 54
3.2.2.1 Hepatitis A Virus (HAV) 54
3.2.2.2 Hepatitis B Virus (HBV) 55
3.2.2.3 Hepatitis C Virus (HCV) 58
3.2.2.4 Hepatitis D Virus (HDV) 63
3.2.2.5 Hepatitis E Virus (HEV) 63
3.2.2.6 HBV/HCV Viral Load and Drug Resistance 63
3.2.3 Severe Acute Respiratory Syndrome (SARS) 65
3.2.3.1 New Approach to Diagnosing Avian Influenza 66
3.2.3.2 Microarray or DNA Chip-Based Tests 68
3.2.4 Cancer Detection Using PCR 69
3.2.4.1 Lung Cancer 69
3.2.4.2 Oral Cancer 70
3.2.4.3 Prostate Cancer 70
3.2.4.4 Chronic Myelogenous Leukemia 70
3.2.4.5 Malignant Gliomas 71
3.2.4.6 Colorectal Cancer 71
3.2.4.7 Breast Cancer 71
3.2.4.8 Bladder Cancer 71
3.2.5 Microbiology Testing 71
3.2.5.1 Chlamydia 72
3.2.5.2 Gonorrhea 72
3.2.5.3 Tuberculosis 72
3.2.5.4 Group B Streptococcus 75
3.2.5.5 Pathogenic Enteric Bacteria 77
3.2.5.6 Bordetella pertussis 78
3.2.5.7 Legionella Pneumophila 78
3.2.5.8 Peridontal Bacteria 78
3.2.5.9 Pneumocystis Carinii 78
3.2.5.10 Methicillin-resistant Staphylococcus Aureus 79
3.2.6 Blood Screening 79
3.3 SNPs in Clinical Diagnostics 84
3.3.1 Functional Genomics 88
3.3.2 Paternity Testing 88
3.4 Industrial Testing and Food Diagnostics 89
3.4.1 The Market 89
3.4.2 Detection of H. pylori by PCR 92
3.4.3 Detection of E. coli 0157 92
3.4.4 Detection of Enteric Viruses 92
3.5 Forensics Market 93
3.5.1 Isolation of DNA for PCR Profiling 94
3.5.2 Analysis by PCR-Based DNA Typing 95
3.5.3 Rapid Isolation of DNA for RFLP and PCR 95
3.5.4 DNA for PCR-STR Typing 95
3.6 Bioterrorism and Molecular Diagnostics 95
3.6.1 Introduction 95
3.6.1.1 Current Biological Threat Detection Systems 98
3.6.1.2 Use of DNA Microarrays and Biochips for Gene Expression Profiles in BWA 99
3.6.1.3 Advantages and Disadvantages of Host Gene Expression Profiling as a Biothreat Detection System 100
3.6.2 Biological Warfare Agents 101
3.6.2.1 Anthrax 101
3.6.2.2 Botulinum Toxin 102
3.6.2.3 Ricin 102
3.6.2.4 IVD Industry and Bioterrorism Preparedness 102
3.6.2.4.1 Brucellosis 102
3.6.2.4.2 Cholera 103
3.6.2.5 Rapid Lateral Flow Immunoassays 104
3.6.2.6 Biosensors 105
3.6.2.6.1 Antibody and Synthetic Receptor-Based Sensors 105
3.6.2.6.2 DNA Sensors 106
3.6.2.6.3 Reagentless Sensors 107
3.6.3 Anthrax in Clinical Samples 108
3.6.3.1 Overview of Anthrax and Its Infectivity 108
3.6.3.2 Rapid Tests 110
3.6.3.2.1 PCR Tests 110
3.7 Cystic Fibrosis Testing 111
3.8 HLA Sequencing-Based Typing Kits 113
3.9 Cytogenetic Testing 115
3.9.1 Hereditary Hemochromatosis 117
3.9.2 Apolipoprotein E (ApoE) Genotyping 117
3.9.3 Fragile X Syndrome 118
3.9.4 Methylenetetrahydrofolate Reductase (MTHFR) Carrier Testing 119
3.10 Developments in Biochips for Clinical Applications 120
3.10.1 Roche AmpliChip Microarray 120
3.10.2 Breast Cancer DNA Chips 120
3.10.3 eSensor DNA Detection System 121
3.11 Pharmacogenomics 122
3.11.1 Coumadin 123
3.12 Thrombic Disorders 125

4. Trends in Molecular Diagnostics 126
4.1 Pharmacogenomics 126
4.1.1 The Market 126
4.1.1.1 Oncology 126
4.1.1.2 Toxicogenomics 126
4.1.2 Market Influences and Forecast 127
4.2 DNA Microarrays 127
4.2.1 Techniques 132
4.2.2 The Market 132
4.2.3 Identification of Sequence SNPs 132
4.2.4 Determining Gene Expression Levels 133
4.2.4.1 Hybridization Tests 133
4.2.4.2 Oligonucleotide Probes 134
4.2.5 Molecular Diagnostics Entry into Point-of-Care Testing 134
4.3 Emerging Markets of DNA Arrays 134
4.3.1 Pharmacogenomics 136
4.3.2 Adoption of Amplified Screening Technology 136
4.3.3 Advances in Automated Testing 136
4.3.4 Increased Focus on Safety of Blood Supply 137
4.3.5 Development of Emerging Markets for NAT Technology 137
4.3.6 Cancer 137
4.3.7 Human Leukocyte Antigen Typing 137
4.3.8 Neonatal Screening 138
4.4 Drivers and Restraints 139
4.5 Market Forecast 140
4.6 Business Trends in the Industry 140
4.6.1 Molecular Diagnostics Industry Trends 140
4.6.1.1 Adoption of Amplified Screening Technology 140
4.6.1.2 Advances in Automated Testing 140
4.6.1.3 Responsiveness to Newly Emerging Threats 141
4.6.1.4 Increased Focus on Safety of Blood Supply 141
4.6.1.5 Growth in Viral Load Testing 141
4.6.1.6 Development of Emerging Markets for NAT Technology 141
4.6.1.7 Improvements in Detection Technologies 142
4.6.2 Pharmaceutical Industry Trends 142
4.6.3 Acquisitions, License Agreements and Partnerships 144
4.6.4 Ethical, Legal and Social Issues Related to the Use of Genetic Information 147
4.6.5 Regulatory Issues 147
4.6.6 Reimbursement Issues 148
4.6.6.1 Cystic Fibrosis 148
4.6.6.2 Viral Load Testing 148
4.6.6.3 NMP22 148

5. Molecular Diagnostics Automated Instrumentation Approved for Market by the FDA 149
5.1 Gene Expression Profiling 150
5.2 Proteomic Multiplex Assays 150
5.3 Solution-Phase Multiplexing 150
5.4 RNA Interference (RNAi) 151
5.4.1 Role of RNAi in Drug Target Validation 152
5.4.2 Other Companies Involved in the RNAi Market 152
5.5 DNA Tags 153

6. Market Trends and Forecasts 154
6.1 Market Dynamics 154
6.1.1 Technological Perspective on Molecular Diagnostics 154
6.1.2 Molecular Diagnostics Market Opportunities 154
6.1.3 Market Forces 155
6.1.3.1 Adoption of Amplified Screening Technology 156
6.1.3.2 Advances in Automated Testing 156
6.1.3.3 Responsiveness to Newly Emerging Threats 156
6.1.3.4 Increased Focus on Safety of Blood Supply 157
6.1.3.5 Growth in Viral Load Testing 157
6.1.3.6 Development of Emerging Markets for NAT Technology 157
6.1.3.7 Improvements in Detection Technologies 158
6.2 Future Considerations for Molecular Diagnosis 158
6.3 Role of Genomics in Transforming Pharmaceutical R&D 159
6.4 Cancer Markers 159
6.5 Cytology Markers 160
6.6 RNA Detection 160
6.7 Diagnosis of Inherited Disease 160
6.8 Ethical Considerations 160

For more information, please visit :

http://www.aarkstore.com/reports/Molecular-Diagnostics-Markets-1336.html

Contact :Sanaa

Aarkstore Enterprise

Tel : +912227453309

Mobile No: +919272852585

Email : contact@aarkstore.com
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