Molecular Diagnostics: Effective Tools for Disease Management, 3rd Edition

Table of Contents

CHAPTER 1: EXECUTIVE SUMMARY

CHAPTER 2: INTRODUCTION

• Molecular Diagnostics
• The IVD Industry and Molecular Diagnostics
• Uses of Molecular Diagnostics in Clinical Settings
• Regulation of Molecular Diagnostics
  • FDA' s New Pharmacogenomic Guidelines
• Scope of this Report

CHAPTER 3: TECHNOLOGY DEVELOPMENTS

• Overview of Technology Platforms
• Immunoassay Technology
  • Introduction
  • Immunoassay Formats
    • Basic Assay Designs
    • Automation and Miniaturization
    • Rapid Immunochromatographic Assays
    • Chromatographic Lateral Flow Devices
• Proteomics Technology
  • Introduction
  • Mass Spectrometry
  • Protein Arrays
  • SELDI ProteinChip Technology
• Nucleic Acid Testing Technology
  • Introduction
    • Isolation of Nucleic Acids
  • DNA Sequencing
  • Probe-based NAT
    • PCR-based Amplification Technologies
    • Alternative Amplification Technologies
    • Automation
    • DNA Microarrays
• Gene Activity Analysis
  • Transcriptional Profiling
  • Methylation Analysis

CHAPTER 4: MOLECULAR DIAGNOSTICS IN INFECTIOUS DISEASES

• Introduction
  • Role of Molecular Diagnostics
• Viral Infections
  • HIV
  • Hepatitis Viruses
  • Influenza and RSV
  • Severe Acute Respiratory Syndrome (SARS)
  • West Nile Virus (WNV)
  • Human Papillomavirus (HPV)
• Bacterial Infections
  • Chlamydia and Gonorrhea
  • Mycobacteria
  • Methicillin-resistent Staphylococcus Aureus (MRSA)
  • Anthrax
  • Sepsis Screening
• Fungal and Parasitic Infections
• Screening of Blood and Blood Products

CHAPTER 5: CARDIOVASCULAR DISEASES

• Overview of Cardiovascular Diseases
  • Role of Molecular Diagnostics
• Biochemical Risk Factors for Coronary Disease
  • Lipoprotein-related Markers
  • CRP
  • Lp-PLA2
  • Homocysteine
  • Myeloperoxidase (MPO)
  • Other Markers
• Acute Chest Pain
  • Markers of Necrosis
  • Markers of Ischemia
• Heart Failure
• Multi Marker Strategies in Acute Coronary Syndromes (ACS)
• Stroke
• Susceptibility to Cardiovascular Disease
  • Monogenic Cardiovascular Diseases
  • Non-monogenic Diseases
• Prediction of Drug Efficacy

CHAPTER 6: CANCER

• Overview of Cancer
• Role of mMolecular Diagnostics
  • Protein Analysis
  • Gene Expression Analysis
  • DNA Analysis
• Breast Cancer
  • Diagnostic Markers
  • Prognostic Markers
  • Markers of Disease Susceptibility
  • Markers of Drug Response
• Prostate Cancer
  • Diagnostic Markers
  • Prognostic Markers
  • Markers of Disease Susceptibility
  • Markers of Drug Response
• Colorectal Cancer
  • Diagnostic Markers
  • Prognostic Markers
  • Markers of Disease Susceptibility
  • Markers of Dug Response
• Lung Cancer
  • Diagnostic Markers
  • Markers of Drug Response
• Ovarian Cancer
  • Diagnostic Markers

CHAPTER 7: MISCELLANEOUS DISEASES AND CONDITIONS

• Introduction
• Genetic Disorders
  • Chromosomal Abnormalities
    • Down Syndrome
  • Monogenic Diseases
    • Cystic Fibrosis
• Neurodegenerative/neuropsychiatric Diseases
  • Alzheimer' s Disease
  • Other Diseases
• Metabolic Diseases
  • Diabetes and Its Complications
  • Osteoporosis
  • Preeclampsia
• Other Conditions
• Predictions of Drug Adverse Effects
  • Cytochrome P450 Gene Family

CHAPTER 8: PATENTS FOR DIAGNOSTIC USE OF BIOMARKERS

• Introduction
• Overview of Patents
• Role of Patents in the Biomedical Industry
• Patenting of Genes and Antibodies
• The Biomarkers Patent Data Set
• Biomarker Patent Activities
• Forward Citations
• Patent Assignees

CHAPTER 9: MARKET CONSIDERATIONS AND FORECASTS

• Introduction
• Overview of the Total Pharmaceuticals Market
• Overview of the Total In Vitro Diagnostics Market
• Outlook for the Total Immunoassay Market
  • General Immunoassays
  • Infectious Disease Immunoassays
  • Cancer Immunoassays
  • Specialty (e.g. Cardiovascular) Immunoassays
• Outlook for the Total NAT Market
  • Infectious Diseases
    • Bacterial tests
    • Viral Detection and Load
    • Viral and Bacterial Genotyping
    • Blood Screening
• Cancer
  • Cervical Cancer (HPV) Screening
  • Chromosomal Aberrations and Shed Nucleic Acids
  • Gene Expression Profiling
  • Genetic Testing and Hereditary Cancers
  • Predisposition and Pharmacogenomic Tests
  • Human Identity Testing
• Outlook for the Proteomic Assay Market
• Forecasts by Geographical Region
• Leading Companies and Analytes

CHAPTER 10: COMPANY PROFILES

• Abbott
• Bayer
• Becton Dickinson
• Chiron
• Genaissance Pharmaceuticals
• Innogenetics
• Johnson & Johnson
• Myriad Genetics
• Nuvelo
• Nymox
• OXIS
• Proteome Sciences
• Sequenom

CHAPTER 11: TRENDS AND OPPORTUNITIES

• Next Generation of Molecular Diagnostics
• Exploiting Protein Biomarkers
• Exploiting Gene Expression Profiling
• Exploiting DNA Biomarkers
• The Rise of Companion Diagnostics

TABLE OF EXHIBITS

• Exhibit 4.1 Immunoassays and Nucleic Acid Tests for Viruses
• Exhibit 4.2 Immunoassays and Nucleic Acid Tests for Bacteria
• Exhibit 4.3 Immunoassays and Nucleic Acid Tests for Fungi, Parasites, and Protozoa
• Exhibit 5.1 Marker Tests for Cardiovascular Disease Management
• Exhibit 5.2 Human Genes Associated with Cardiovascular Disorders
• Exhibit 5.3 Human Genes Associated with Diabetes and Obesity
• Exhibit 6.1 Marker Tests for Cancer Management
• Exhibit 6.2 Human Genes Associated with Cancer
• Exhibit 7.1 Human Genes Associated with Mental Disorders
• Exhibit 8.1 Biomarker Patents: Filing and Publication Dates
• Exhibit 8.2 Activity Analysis for US Biomarker Patents, 2000-2006
• Exhibit 8.3 Top Cited Biomarker Patents (US Filings 2000 - 2006)
• Exhibit 8.4 Top 20 Biomarker Patent Assignees
• Exhibit 8.5 Biomarker Methodology Patents (US Filings 2000 - 2006)
• Exhibit 8.6 Cancer Related Biomarker Patents (US Filings 2000 - 2006)
• Exhibit 8.7 Cardiovascular-related Biomarker Patents (US Filings 2000 - 2006)
• Exhibit 8.8 Pharmacogenomic Biomarker Patents (US Filings 2000 - 2006)
• Exhibit 8.9 Infection-related Biomarker Patents (US Filings 2000 - 2006)
• Exhibit 8.10 Other Clinical Biomarker Patents (US Filings 2000 - 2006)
• Exhibit 9.1 World Pharma Market by Region in 2005 and 2010 (in $US millions)
• Exhibit 9.2 World Pharma Market by Indication in 2005 and 2010 (in $US millions)
• Exhibit 9.3 Worldwide In Vitro Diagnostic Sales by Country, 2005 - 2010 ($US M)
• Exhibit 9.4 Worldwide In Vitro Diagnostic Sales by Application, 2005-2010 ($M)
• Exhibit 9.5 Immunoassay and NAT Markets by Application, 2005-2010
• Exhibit 9.6 Immunoassay and NAT Markets by Geographical Region, 2005-2010
• Exhibit 9.7 Immunoassay Markets by Geographical Region, 2005-2010
• Exhibit 9.8 NAT Markets by Geographical Region, 2005-2010
• Exhibit 9.9 CLIA Kits by Application, 2000 - 2006
• Exhibit 9.10 Leading CLIA Analytes by Application Group
• Exhibit 9.11 FDA IVD Approvals 2000-2006 by Test Complexity
• Exhibit 9.12 CLIA Applications by Test Complexity
• Exhibit 9.13 Leading CLIA Analytes, 2000-2006
• Exhibit 9.14 Leading CLIA Kit Manufacturers, 2000-2006