Cell-Based Diagnostics: Technology, Applications, and Markets, 2nd Edition

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

• Introduction
• Scope and Methodology
• Size and Growth of the Market
• Market Trends

CHAPTER TWO: INTRODUCTION

• Background: Cell-Based Testing in the 21st Century
• The Cell, Inside and Out
• The Status Quo and Huge Potential of Cell-Based Diagnostics
• Point of View

CHAPTER THREE: MEDICAL TRENDS AND MARKET ISSUES IN THE COMMERCIALIZATION OF CELL BASED DIAGNOSTICS

• Background
• The Molecular Revolution, New Testing Opportunities
• Reimbursement and Commercialization of Novel Tests
• Regulatory Affairs
• Worldwide Opportunities for Cell-Based Tests
• Drug Discovery

CHAPTER FOUR: TECHNOLOGICAL TRENDS THAT ENABLE THE FUTURE OF CELL-BASED DIAGNOSTICS

• Background
• New Assay Designs
• The In Vitro/In Vivo Mix
• Personalized Medicine, Drug Selection, and Cell-Based Assays
• Rare Cell Event Testing
• Cancer Cells: Stem Cell Cousins
• Miniaturization and Multiplexed Biological Assays
• Cell Marker Development
• Histology Automation
• Cell Culture

CHAPTER FIVE: TECHNOLOGY PLATFORMS AT THE FOREFRONT OF CELL-BASED ASSAYS

• Background
• Hematology Analyzers
• Flow Cytometry
• Microscopy and Image-Based Platforms
• Laser Capture Microdissection and Tissue Microarrays
• In Situ Hybridization
• Molecular Techniques

CHAPTER SIX: MARKET ANALYSIS

• Background
• Cell-Based Diagnostics and IVD Markets
• The Market for Cell Assays in Cancer Management
• The Market for Cell Assays in Hematology
• The Market for Cell Assays in Histopathology/Cytology
  • The Future of the Pap Smear & HPV Testing
  • IHC/ISH and Digital Cytometry
• The Market for Cell Assays in Microbiology/Virology
• The Market for Cell Assays in Blood Product Safety
• The Market for Cell Assays in Tissue Transplant Management
• The Market for Cell Assays in Prenatal Testing

CHAPTER SEVEN: CONCLUSIONS AND STRATEGIC IMPLICATIONS

• Conclusion
  • Implication
• Conclusion
  • Implication
• Conclusion
  • Implication
• Conclusion
  • Implication
• Conclusion
  • Implication

CHAPTER EIGHT: COMPANY PROFILES

• Abbott Diagnostics
• Accelr8 Technology Corporation
• Accuri Cytometers
• Acolyte Biomedica
• Advanced Analytical Technologies Inc. (AATI)
• AdvanDx, Inc.
• Advalytix AG
• Agendia B.V.
• Almac Diagnostics (formerly ArraDx)
• Amnis Corporation
• Aperio Technologies, Inc.
• Applied Imaging Corp./Genetix
• Asuragen, Inc.
• AviaraDx (formerly Arcturus Biosciences)
• AVIVA Biosciences Corporation
• Becton Dickinson & Company
• Beckman Coulter, Inc.
• Biocept, Inc.
• BioGenex Laboratories, Inc.
• Biomoda, Inc.
• BioMosaics
• BIOVIEW, Inc.
• Bruker Daltonics
• Cancer Genetics, Inc.
• Celera
• Celerus Diagnostics
• CellaVision AB
• Cellestis Ltd
• Clarient Inc. (formerly ChromaVision)
• Compucyte Corporation
• Cylex Incorporated
• CytoCore, Inc. (formerly Molecular Diagnostics, Inc.)
• Cytyc Corporation
• Dako A/S
• DiaGenic ASA
• Diagnostic Hybrids, Inc. (DHI)
• Diamics, Inc.
• Digene Corporation
• eGene Inc.
• Exagen Diagnostics, Inc.
• Genomic Health
• Greiner Bio-One International AG
• Guava Technologies, Inc.
• GW Medical Technologies, LLC
• Gynecor
• Hemosystem SA
• HistoRx, Inc,
• iCyt Visionary Bioscience
• Ikonisys Inc.
• Immunicon Corporation
• InterGenetics
• IntraCellular Diagnostics, Inc.
• Invirion Diagnostics, LLC
• Invitrogen Corporation
• IPSOGEN
• IRIS International, Inc.
• MDS/Molecular Devices Corporation
• Medion Diagnostics AG
• Micro Imaging Technology (MIT)
• Microgen Bioproducts
• Micronics, Inc.
• Milestone Medical
• Modern Technology Corp.
• MonoGen
• Monogram Biosciences Inc. (formerly Virologic, Inc.)
• MTM Laboratories AG
• Nalge Nunc International Corporation
• NorChip
• Nuvera Biosciences
• One Cell Systems, Inc.
• Orpegen Pharma
• Partec GmbH
• Pathwork Diagnostics (formerly Predicant Biosciences)
• Perceptronix Medical Inc.
• PerkinElmer, Inc.
• PointCare Technologies, Inc.
• Progenika Biopharma S.A.
• QBC Diagnostics Inc.
• QuantomiX Ltd.
• Rational Therapeutics
• Ravgen
• Sakura Finetek USA Inc.
• Sequenom Inc.
• Siemens Medical Solutions Diagnostics
• Signature Genomic Laboratories LLC
• Source MDx
• Sysmex Corporation
• Targeted Diagnostics & Therapeutics, Inc. (TDT)
• Tripath Imaging, Inc.
• Ventana Medical Systems. Inc.
• Verax Biomedical Inc.
• Veridex, LLC
• Vision BioSystems Ltd/Danaher Corp.
• Vitatex Inc.
• WaveSense LLC
• XDx, Inc
• Xytos Inc.
• Zila Inc.

Appendix: Selected Cell-Based Tests and Technologies

LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

• Table 1-1: Worldwide Cell Diagnostics Product Sales by Type 2006-2011

MEDICAL TRENDS AND MARKET ISSUES IN THE COMMERCIALIZATION OF CELL BASED DIAGNOSTICS

• Table 3-1: Selected Cell-Based Molecular Tests
• Table 3-2: Selected Commercial Cell-Based Molecular Tests
• Table 3-3: Selected Cell-Based Tests Used in Drug Discovery

CHAPTER FOUR: TECHNOLOGICAL TRENDS THAT ENABLE THE FUTURE OF CELL-BASED DIAGNOSTICS

• Table 4-1: Selected Tests and Cell Diagnostics Technology Crossovers
• Table 4-2: Selected Cell-Based Lateral Flow Tests
• Table 4-3: Selected Cell-Based Pharmacodiagnostic Tests
• Table 4-4: Selected Rare Cell Event Tests
• Table 4-5: Selected Cell Culture Tests

CHAPTER FIVE: TECHNOLOGY PLATFORMS AT THE FOREFRONT OF CELL-BASED ASSAYS

• Table 5-1: Selected New Hematology Analyzer Tests, 1990s-2007
• Table 5-2: Selected New Immunohematology Research Projects
• Table 5-3: Revenue History of Leading Companies in Flow Cytometry 2001-2006
• Table 5-4: Selected Flow Cytometry Applications
• Table 5-5: Selected Flow Cytometry Product Companies
• Table 5-6: Selected Microscopy and Image Analysis Product Companies
• Table 5-7: Cytometry Imaging Market Revenues by Competitor 2006
• Table 5-8: Selected LCM Systems on the Market, 2007
• Table 5-9: Major Molecular Markers for Tissue Staining
• Table 5-10: Selected In Situ Hybridization Histopathology Tests
• Table 5-11: Selected Cell-Based Molecular Tests
• Table 5-12: Selected DNA Sample Preparation Companies

CHAPTER SIX: MARKET ANALYSIS

• Table 6-1: Selected Acquisitions and Collaborations in Cell Diagnostics
• Table 6-2: Worldwide Cell Diagnostics Product Sales by Testing Area (Hematology, Histology/Cytology without Pap, Flow Cytometry, DNA Microarrays, Pap, Protein Microarrays, Prenatal Testing, Tissue Typing, Tissue Microarrays, Microbiology/Virology, Rare Cell Event Detection, Blood Safety) 2006-2011
• Table 6-3: Selected IVD Cancer Markers
• Table 6-4: Worldwide Market for Cell Diagnostics for Cancer by Testing Area (Histology/Cytology without Pap, Flow Cytometry, Pap, Tissue Microarrays, DNA Microarrays, Protein Microarrays, Rare Cell Event Detection, In Situ Hybridization, Immunohistochemical Staining) 2006
• Table 6-5: Selected New Hematology Analyzer Tests, 1990s-2007
• Table 6-6: Revenue History of the Top 5 Hematology Vendors 2001-2006
• Table 6-7: Selected POC CBC Systems
• Table 6-8: Worldwide Histology/Cytology Sales by Type (Traditional Non-Pap, Pap, IHC, ISH, Image Cytometry, Tissue Microarrays) 2006-2011
• Table 6-9: Selected Vendors of Traditional Histology Stains
• Table 6-10: Selected Automated Pap Systems
• Table 6-11: Selected HPV Test Innovators
• Table 6-12: Selected IHC and ISH Product Companies
• Table 6-13: Major Protein and Molecular Markers Used in Tissue Staining
• Table 6-14: Selected Digital Pathology Systems
• Table 6-15: Selected Cell Diagnostics for Microbiology/Virology
• Table 6-16: Selected Simplified, Inexpensive CD4 Test Systems