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Diagnostics for Emerging Infectious Disease Threats Volume I: Prion Disease

Diagnostic testing for prion diseases has become more important as countries increase the number of tests to battle the potential public health problem. Academic, government, and industry organizations continue to develop diagnostic testing technologies and policies as preventative measures. The number of prion diagnostic technologies being used and developed for prion diseases primarily reflects the scientific and technical challenges of detecting prion proteins.

Growth of prion testing will depend on these technology breakthroughs and the future prevalence of prion disease. Post-mortem TSE testing is widespread, but growth will vary with disease prevalence and outbreaks in the next five years. Ante-mortem TSE testing seems to be the holy grail. An ante-mortem test does not currently exist. The sensitivity and specificity of detection technology are the main forces driving post-mortem and ante-mortem technology development. While the technology is developing, cost is considered.

This report focuses on the prion diagnostic technologies that are being used worldwide, developing technologies, the different types of prion testing, and the policies that affect testing in this area.

For this discussion, prion testing is divided into segments based on the disease application, technology, and geography. There are more than 20 countries with at least one type of TSE testing program. Although the report addresses developments applicable to all prion disease, the five segments specifically pegged for market analysis in this volume are:

  • Bovine Spongiform Encephalopathy (BSE) [cattle]
  • Creutzfeldt-Jakob Disease (CJD) [humans]
  • Chronic Wasting Disease [deer/elk]
  • Ovine Spongiform Encephalopathy [sheep]
  • Caprine Spongiform Encephalopathy [goat]

This study is the first volume in a series of reports on diagnostics for emerging infectious disease threats. Subsequent volumes discuss Viral Disease (Volume II; KLI895748; December 1, 2003) and Bacteria, Yeast, and Protozoa (Volume III; KLI895749; January 1, 2004).


Chapter One: Executive Summary

  • Introductions
  • Scope and Methodology
  • Summary of Major Findings

Chapter Two: Prion Disease Primer

  • Introduction
  • Human Prion Diseases
  • Variant Creutzfeldt-Jakob disease (vCJD)
  • Gertsmann-Straussler-Scheinker (GSS) Syndrome
  • Fatal Familial Insomnia (FFI)
  • Kuru
  • Animal Prion Disease
  • Scrapie
  • Bovine Spongiform Encephalopathy (BSE)
  • Chronic Wasting Disease (CWD)
  • Feline Spongiform Encephalopathy (FSE)
  • Tranmissible Mink Encephalopathy (TME)
  • Exotic Ungulate Encephalopathy

Chapter Three: The Technologies

  • Prion Diagnostic Technology Definitions
  • Polymerase Chain Reaction
  • Synthetic Ligands
  • Electrocardiogram (ECG)
  • Immunoassays
  • Nucleic Acid Hybridization
  • Protein Misfolding Cyclic Amplifications (PMCA)
  • Aptamer
  • Capillary Electrophoresis and Chromatography
  • Membrane-Based Preparative Electrophoresis
  • Biomarkers
  • Transgenic Mice
  • Prion Diagnostic Competitors and Products
  • Post-Mortem BSE Testing
  • Post-Mortem Scrapie Prion Diagnostics
  • Post-Mortem CWD Prion Diagnostics
  • Ante-Mortem Prion Diagnostic Technology
  • Ante-Mortem BSE Prion Diagnostic Technologies
  • Ante-Mortem Scrapie Prion Diagnostics
  • Ante-Mortem vCJD Prion
  • Ante-Mortem CWD Prion Diagnostic Technologies

Chapter Four: The Markets

  • Total TSE Post-Mortem Diagnostic Testing
  • Post-Mortem BSE Cattle Testing
  • Post-Mortem Scrapie Sheep (Ovine) Testing
  • Post-Mortem Scrapie Caprine (Goat) Testing
  • Post-Mortem CWD Testing
  • Total Market
  • CWD Testing in Wild and Captive Deer
  • Ante-Mortem TSE Diagnostic Testing
  • Emerging Markets
  • Worldwide Sheep Genotyping
  • Species Identification
  • Prion Removal Techniques

Chapter Five: Conclusions and Strategic Implications

  • First Conclusion
  • Second Conclusion
  • Third Conclusion
  • Fourth Conclusion

Chapter Six: Company Profiles

  • Abbott Laboratories
  • Altegen, Inc.
  • BIORAD
  • Biotraces, Inc.
  • Caprion Pharmaceuticals, Inc.
  • Chronix Biomedical
  • Gene Thera
  • Gradipore Inc.
  • Idexx Laboratories
  • InPro Biotechnology
  • InPro Biotechnology
  • Microsens Biotechnologies
  • Ortho-Clinical Diagnostics/Johnson & Johnson
  • Prion Developmental Laboratories
  • Prionics AG
  • PrioSense Ltd.
  • ProMetic Life Sciences
  • Proteome Sciences plc
  • Serono Pharmaceutical Research Institute
  • TSEnse Diagnostics Ltd
  • VMRD, Inc.

APPENDIX: Company Directory
List of Exhibits
Chapter Two: Prion Disease PrimeR

  • Table 2-1: Number of Confirmed BSE Cases in Countries around the World
  • Table 2-2: Number of CWD Affected Herds in North America by
  • State or Province 2003
  • Table 2-3: Summary of Prion Diseases, Hosts and Mechanism

Chapter Three: The Technologies

  • Table 3-1: Number of Current Prion Diagnostic Competitors by Country
  • Ante- and Post-Mortem 2003
  • Table 3-2: Ante-Mortem & Post-Mortem Prion Diagnostic Companies
  • Table 3-3: Ante- & Post-Mortem Prion Diagnostic Test by Technology and
  • Number of Companies
  • Table 3-4: Post-Mortem Prion Diagnostics by Companies and Technologies
  • Table 3-5: Post-Mortem BSE Prion Diagnostic Test Technologies
  • Table 3-6: Summary of Post-Mortem BSE Diagnostics on the Market or in Development
  • Table 3-7: Post-Mortem Scrapie Prion Diagnostic Technologies
  • Table 3-8: Summary of Post-Mortem Scrapie Diagnostics on the Market or in Development
  • Table 3-9: Post-Mortem CWD Prion Diagnostic Technologies
  • Table 3-10: Summary of Post-Mortem CWD Diagnostics on the Market or in Development
  • Table 3-11: Ante-Mortem Prion Diagnostic Companies and Technologies
  • Table 3-12: Ante-Mortem BSE Prion Diagnostic Technologies
  • Table 3-13: Summary of Ante-Mortem BSE Diagnostics on the Market or in Development
  • Table 3-14: Ante-Mortem Scrapie Prion Diagnostic Technologies
  • Table 3-15: Summary of Ante-Mortem Scrapie Diagnostics on the Market or in Development
  • Table 3-16: Ante-Mortem vCJD Prion Diagnostic Technologies
  • Table 3-17: Summary of Ante-Mortem vCJD Diagnostics on the Market or in Development
  • Table 3-18: Ante-Mortem CWD Prion Diagnostic Technologies

Chapter Four: The Markets

  • Table 4-1: Worldwide TSE Post-Mortem Diagnostic Testing Revenue 2001-2008
  • Table 4-2: Worldwide TSE Post-Mortem Diagnostic Testing Volume 2001-2008
  • Table 4-3: Worldwide BSE Cattle Testing Revenue by Geographic Regions 2001-2008
  • Table 4-4: Worldwide Post-Mortem BSE Cattle Testing Volume by Geographic Regions 2001-2008
  • Figure 4-2: Distribution of Post-Mortem BSE Tests by Geography 2003
  • Table 4-5: European Union & Acceding/EEA Countries Passive BSE Testing Revenues 2001, 2002, and First Four Months of 2003
  • Table 4-6: European Union & Acceding/EEA Countries Passive BSE Testing Volume 2001, 2002, and First Four Months of 2003
  • Figure 4-3: Total European Passive BSE Testing Revenue Distribution by Country 2002
  • Table 4-7: European Union & Acceding/EEA Total Active BSE Screening Revenues by Country 2001-2003
  • Table 4-8: European Union & Acceding/EEA Total Active BSE Screening Testing Volumes by Country 2001-2003
  • Figure 4-4: Total Active European Passive BSE Testing Revenue Distribution by Country 2003
  • Table 4-9: European Union & Acceding/EEA Healthy Slaughter Active BSE Screening Revenues by Country 2001-2003
  • Table 4-10: European Union & Acceding/EEA Healthy Slaughter Active BSE Screening Testing Volume by Country 2001-2003
  • Figure 4-5: Total European Healthy Slaughter Active BSE Screening Revenue Distribution by Country 2003
  • Table 4-11: European Union & Acceding/EEA Other Active BSE Screening Revenue by Country 2001-2003
  • Table 4-12: European Union & Acceding/EEA Other Active BSE Screening Testing Volume by Country 2001-2003
  • Figure 4-6: Total European Other Active BSE Screening Distribution of Revenues by Country 2003
  • Table 4-13: Worldwide Scrapie Sheep Testing Revenues by Geographic Region 2001-2008
  • Table 4-14: Worldwide Scrapie Sheep Testing Volume by Geographic Region 2001-2008
  • Table 4-15: Worldwide Scrapie Goat Post-Mortem Testing Revenue 2001-2008
  • Table 4-16: Worldwide Scrapie Goat Post-Mortem Testing Volume 2001-2008
  • Table 4-17: Worldwide CWD Post-Mortem Testing Revenues by Geographic Region 2001-2008
  • Table 4-18: Worldwide CWD Post-Mortem Testing Volume by Geographic Region 2001-2008
  • Table 4-19: CWD Post-Mortem Tests in the United States Revenues by Wild vs. Captive Deer 2001-2008
  • Table 4-20: CWD Post-Mortem Tests in the United States Testing Volume by Wild vs. Captive Deer 2001-2008
  • Table 4-21: CWD Post-Mortem Tests in Canada Revenues by Wild vs. Captive Deer 2001-2008
  • Table 4-21: CWD Post-Mortem Tests in Canada Testing Volume by Wild vs. Captive Deer 2001-2008
  • Table 4-25: Sheep Genotyping Testing Volume by Country

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