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TABLE OF CONTENTS
1. Overview 12
1.1 Statement of Report 12
1.2 About This Report 12
1.3 Scope of the Report 13
1.4 Objectives 13
1.5 Methodology 14
1.6 Executive Summary 15
2. Introduction to Molecular Diagnostics and PCR Technology 19
2.1 Introduction to Genomics and Its Opportunity 19
2.2 Impact of the Human Genome Project on Molecular Diagnostics 21
2.3 Key Considerations for Molecular Diagnostics 21
2.4 Molecular Diagnostics in the Post-Genomic Era 23
2.5 Advances in Molecular Diagnostics Technologies 24
2.6 Genetic Variability and Disease 25
2.7 Major Technology Platforms 25
2.7.1 Gene-based Amplification Technologies 28
2.7.2 Detection of Amplified Gene Products 28
2.7.3 Target-based Gene Amplification 29
2.7.3.1 Polymerase Chain Reaction (PCR) 29
2.7.3.2 Real-Time PCR 29
2.7.3.3 Nucleic Acid Sequence-based Amplification (NASBA) 30
2.7.4 Probe-based Amplification 30
2.7.4.1 Ligase Chain Reaction (LCR) 30
2.7.4.2 Strand Displacement Amplification (SDA) 31
2.7.4.3 QB-Replicase Amplified Probe Assay 31
2.7.5 Signal-based Amplification 31
2.7.5.1 Branched DNA (bDNA) 31
2.7.6 Other Gene Amplification Technologies 32
2.7.6.1 Immuno-PCR (IPCR) 32
2.7.6.2 Bio-Barcode Amplification Assay (BCA) 32
2.7.6.3 Hybrid Capture 33
2.7.7 Next Generation Sequencing 33
3. Nucleic Acid Test Applications 35
3.1 Molecular Diagnostic Testing and Infectious Diseases 36
3.1.1
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