This market insight report on Prions gives an insight into the global market for Prion Deactivation technologies, Post Mortem Testing for BSE and Prion Reduction Filters. The Prion related products include BSE detection test Kits, Deactivation/Inactivation technologies, Reagents and Services. The study includes estimations and predictions for the global BSE Post Mortem Testing Market. The market is also analyzed by geographic regions encompassing North America, Europe, Japan and Rest of World. Business profiles of 25 major companies are discussed in the report. The report serves as a complete guide to global Prion Detection, Reduction and Inactivation Market covering more than 120 companies that are engaged in research for development of antemortem BSE and CJD test kits, development and supply of BSE Test kits and development of prion Reduction Filters. Information related to recent product releases, product developments, partnerships, collaborations, and mergers and acquisitions is also covered in the report.
Table of Content I. SCOPE AND METHODOLOGY 1 2. REPORT SYNOPSIS 3 2.1 Prions 3 Introduction 3 Exhibit 1. Mammalian Agents of Spongiform Encephalopathies, ICTVdb Code, Disease Name, Natural Host, Prion Name and PrP Iso Form 4 Special Characteristics of Prions 4 Structure and Organization of Prions 5 Hypothesis 5 Prion Replication 5 Prion Diseases 6 Transmissible Spongiform Encephalopathy 6 Characteristics of Transmissible Spongiform Encephalopathy (TSE) 8 Bovine Spongiform Encephalopathy (BSE) 8 Exhibit 2. History of BSE 8 CJD 10 Major Types of CJD 10 Sporadic CJD 10 Hereditary CJD 11 Iatrogenic CJD 11 Variant CJD 11 Relationship between CJD and BSE 11 Scrapie 11 Kuru 12 Transmissible Mink Encephalopathy (TME) 12 Feline Spongiform Encephalopathy (FSE) 12 Chronic Wasting Disease (CWD) 12 Gerstmann-Sträussler-Scheinker Syndrome (GSS) 12 Control of prion Disease 13 Animal Feed 13 Animal Feed Regulations 14 Concern for Quality of Feed Ingredients with Increase in BSE around the World 14 Eurofins Forms Strategic Alliance with VLA in UK to Maintain Feed Safety 14 Plan on Ban of certain Cattle Material from Medical Products to Protect Against BSE 14 Role of WHO in TSE Control 15 Role of OIE 15 Prion Inactivation 16 Prion Disease Testing 17 2.2 Prions - Global Market Analysis 20 Exhibit 3. Prion Deactivation Technologies - Global Market Estimations & Predictions (2005 - 2020) in US$ Million 20 Exhibit 4. Prion Reduction Filters - Global Market Estimations & Predictions (2005 - 2020) in US$ Million 21 Exhibit 5. BSE Post Mortem Testing - Global Market Estimations & Predictions (2005 - 2020) in US$ Million 22 Exhibit 6. List of Global Major Prions Companies 23 3. MARKET DYNAMICS 24 3.1 World Cattle Demographics 24 Exhibit 7. World Cattle Population (2000-2012) – By Geographic Regions for North America, Europe, Japan and Rest of World in Million Head 24 3.2 Market Overview 25 3.3 Global Prion Deactivation Technologies Market 26 Prion Deactivation Technologies - Global Market Analysis 26 Exhibit 8. Prion Deactivation Technologies - Global Market Estimations & Predictions (2005 - 2020) by Geographic Regions for North America, Europe, Japan and Rest of World in US$ Million 26 Exhibit 9. Prion Deactivation Technologies - Global Market Shares (2010, 2015 & 2020) by Geographic Regions for North America, Europe, Japan and Rest of World 27 3.4 North American Prion Deactivation Technologies Market 28 Exhibit 10. Prion Deactivation Technologies - North American Market Estimations & Predictions (2005 - 2020) by Geographic Region for Canada and United States in US$ Million 28 Exhibit 11. Prion Deactivation Technologies - North American Market Shares (2010, 2015 & 2020) by Geographic Region for Canada and United States 29 3.4 (I) United States Prion Deactivation Technologies Market 29 3.4 (II) Canadian Prion Deactivation Technologies Market 29 Exhibit 12. List of Major Companies in North America 29 3.5 European Prion Deactivation Technologies Market 31 Exhibit 13. Prion Deactivation Technologies - European Market Estimations & Predictions (2005 - 2020) by Geographic Region for United Kingdom, France, Ireland, Portugal, Switzerland, Germany, Russia and Rest of Europe in US$ Million 31 Exhibit 14. Prion Deactivation Technologies - European Market Shares (2010, 2015 & 2020) by Geographic Region for United Kingdom, France, Ireland, Portugal, Switzerland, Germany, Russia and Rest of Europe 32 3.5 (I) United Kingdom Prion Deactivation Technologies Market 32 3.5 (II) French Prion Deactivation Technologies Market 32 3.5 (III) Irish Prion Deactivation Technologies Market 32 3.5 (IV) Portuguese Prion Deactivation Technologies Market 32 3.5 (V) Swiss Prion Deactivation Technologies Market 33 3.5 (VI) German Prion Deactivation Technologies Market 33 3.5 (V) Russian Market for Prion Deactivation Technologies 33 3.6 Japanese Prion Deactivation Technologies Market 34 Exhibit 15. Prion Deactivation Technologies - Japanese Market Estimations & Predictions (2005 - 2020) in US$ Million 34 3.7 Rest of World Prion Deactivation Technologies Market 35 Exhibit 16. Prion Deactivation Technologies – Rest of World Market Estimations & Predictions (2005 - 2020) by Geographic Region for Israel, South Africa, Brazil and Other Countries in US$ Million 35 Exhibit 17. Prion Deactivation Technologies - Rest of World Market Shares (2010, 2015 & 2020) by Geographic Region for Israel, South Africa, Brazil and Other Countries 36 3.6 (I) Israeli Prion Deactivation Technology Market 36 3.6 (II) South African Prion Deactivation Technology Market 36 3.6 (III) Brazilian Prion Deactivation Technology Market 36 3.10 Global Prion Reduction Filters Market 37 Prion Reduction Filters – Global Market Analysis 37 Exhibit 18. Prion Reduction Filters - Global Market Estimations & Predictions (2005 - 2020) by Geographic Regions for Europe, North America, Japan and Rest of World in US$ Million 38 Exhibit 19. Prion Reduction Filters - Global Market Shares (2010, 2015 & 2020) by Geographic Region for Europe, North America, Japan and Rest of World 39 3.11 North American Prion Reduction Filters Market 40 Exhibit 20. Prion Reduction Filters - North American Market Estimations & Predictions (2005 - 2020) by Geographic Region for Canada and United States in US$ Million 40 Exhibit 21. Prion Reduction Filters - North American Market Shares (2010, 2015 & 2020) by Geographic Region for Canada and United States 41 3.11 (I) United States Prion Reduction Filters Market 41 3.11 (II) Canadian Prion Reduction Filters Market 41 3.12 European Prion Reduction Filters Market 42 Exhibit 22. Prion Reduction Filters - European Market Estimations & Predictions (2005 - 2020) by Geographic Regions for United Kingdom, France, Ireland, Portugal, Switzerland, Germany, Russia and Rest of Europe in US$ Million 42 Exhibit 23. Prion Reduction Filters - European Market Shares (2010, 2015 & 2020) by Geographic Region for United Kingdom, France, Ireland, Portugal, Switzerland, Germany, Russia and Rest of Europe 43 3.12 (I) United Kingdom Prion Reduction Filters Market 43 3.12 (II) French Prion Reduction Filters Market 43 3.12 (III) Irish Prion Reduction Filters Market 43 3.12 (IV) Portuguese Prion Reduction Filters Market 43 3.12 (V) Swiss Prion Reduction Filters Market 43 3.12 (VI) German Prion Reduction Filters Market 44 3.12 (VI) Russian Prion Reduction Filters Market 44 3.13 Japanese Prion Reduction Filters Market 45 Exhibit 24. Prion Reduction Filters - Japanese Market Estimations & Predictions (2005 - 2020) in US$ Million 45 3.14 Rest of World Prion Reduction Filters Market 46 Exhibit 25. Prion Reduction Filters - Rest of World Market Estimations & Predictions (2005 - 2020) by Geographic Region for Israel, South Africa, Brazil and Other Countries in US$ Million 46 Exhibit 26. Prion Reduction Filters – Rest of World Market Shares (2010, 2015 & 2020) by Geographic Region for by Geographic Region for Israel, South Africa, Brazil and Other Countries 47 126.96.36.199 (II) Israel Prion Reduction Filters Market 47 188.8.131.52 (II) South Africa Prion Reduction Filters Market 47 184.108.40.206 (II) Brazil Prion Reduction Filters Market 47 3.15 Global BSE Post Mortem Testing Market 48 BSE Post Mortem Testing – Global Market Analysis 48 Exhibit 27. BSE Post Mortem Testing - Global Market Estimations & Predictions (2005 - 2020) by Geographic Regions for Europe, North America, Japan and Rest of World in US$ Million 49 Exhibit 28. BSE Post Mortem Testing - Global Market Shares (2010, 2015 & 2020) by Geographic Region for Europe, North America, Japan and Rest of World 50 Exhibit 29. List of Countries with BSE Risk Status 50 3.16 North American BSE Post Mortem Testing Market 52 Exhibit 30. BSE Post Mortem Testing - North American Market Estimations & Predictions (2005 - 2020) by Geographic Region for Canada and United States in US$ Million 52 Exhibit 31. BSE Post Mortem Testing - North American Market Shares (2010, 2015 & 2020) by Geographic Region for Canada and United States 53 Exhibit 32. Number of Confirmed BSE cases in North America (2000 and before – 2013) 53 3.16 (I) United States BSE Post Mortem Testing Market 54 US Allocation of Funds for Food Safety and BSE Research 54 Harmonization of BSE Management Policies by United States, Canada, and Mexico 54 Upgrading of BSE Risk Status 55 3.16 (II) Canadian BSE Post Mortem Testing Market 55 3.17 European BSE Post Mortem Testing Market 56 Exhibit 33. BSE Post Mortem Testing - European Market Estimations & Predictions (2005 - 2020) by Geographic Regions for United Kingdom, France, Ireland, Portugal, Switzerland, Germany, Russia and Rest of Europe in US$ Million 56 Exhibit 34. BSE Post Mortem Testing - European Market Shares (2010, 2015 & 2020) by Geographic Region for United Kingdom, France, Ireland, Portugal, Switzerland, Germany, Russia and Rest of Europe 57 Exhibit 35. Number of Confirmed BSE cases in European Countries (2000 and before – 2013) 58 3.17 (I) European Cattle Demographics 59 Exhibit 36. Cattle – European Population (2000-2010) by Countries for UK, France, Ireland, Portugal, Switzerland, Germany and Rest of Europe in Million Head 59 European Policies on BSE 60 EU Commission’s Latest Proposal Reduces BSE Testing Costs 61 3.17 (II) United Kingdom BSE Post Mortem Testing Market 61 BSE Cases in the United Kingdom 61 Measures Taken by United Kingdom to Control BSE 62 3.17 (III) French BSE Post Mortem Testing Market 62 3.17 (IV) Irish BSE Post Mortem Testing Market 63 3.17 (V) Portuguese BSE Post Mortem Testing Market 63 3.17 (VI) Swiss BSE Post Mortem Testing Market 63 Swiss market for BSE Post Mortem Testing was estimated at US$24.59 million in 2012. The market is projected to reach US$108.79 million by 2020, growing at a CAGR of 21.29% during 2005-2020. 63 Swiss Beef Industry Awarded for Managing BSE 63 3.17 (VII) German BSE Post Mortem Testing Market 63 Germany to Modify BSE Testing Regulations 64 The Netherlands 64 New Case of Mad Cow Disease Reported in the Netherlands 64 Slovenia 64 Slovenian Authorities Confirm BSE Case Findings 64 Austria 65 August 2005, Third Case of Mad Cow Reported in Austria 65 Exhibit 37. List of Major Companies in Europe 65 3.18 Japanese BSE Post Mortem Testing Market 66 Exhibit 38. BSE Post Mortem Testing - Japanese Market Estimations & Predictions (2005 - 2020) in US$ Million 66 Exhibit 39. Number of Confirmed BSE Cases in Japan (2000 and before – 2013) 67 37th BSE Case Reported in Japan 67 BSE Cases Reported in Japan 67 Health Ministry Bans Blood Donations in Japan 68 A New Amendment Proposed by USDA on Import of Boneless Beef from Japan 68 Japan Re-enforces US Beef Ban 70 3.19 Rest of World BSE Post Mortem Testing Market 71 Exhibit 40. BSE Post Mortem Testing - Rest of World Market Estimations & Predictions (2005 - 2020) Geographic Region for Israel, South Africa, Brazil and Other Countries in US$ Million 71 Exhibit 41. BSE Post Mortem Testing - Rest of World Market Shares (2010, 2015 & 2020) by Geographic Region for Israel, South Africa, Brazil and Other Countries in US$ Million 72 Exhibit 42. Number of Confirmed BSE Cases in Rest of World (2000 and before – 2013) 73 220.127.116.11 (I) Israeli BSE Post Mortem Testing Market 73 18.104.22.168 (II) South African BSE Post Mortem Testing Market 73 22.214.171.124 (II) Brazilian BSE Post Mortem Testing Market 73 3.20 Major Companies in Prions Market 74 Analytik Jena AG (Germany) 74 Beckman Coulter, Inc. (USA) 76 Bio-Rad Laboratories, Inc. (USA) 76 Cayman Chemical Company (USA) 78 Covance, Inc. (USA) 78 Enfer Scientific (Ireland) 79 Eurofins Scientific SA (France) 81 Eurogentec SA (Belgium) 81 Gene Thera, Inc (USA) 82 GenWay Biotech, Inc. (USA) 82 IdentiGEN Ltd. (Ireland) 83 IDEXX Laboratories, Inc. (USA) 84 Meridian Life Science, Inc. (USA) 84 Microsens Biotechnologies (UK) 85 EMD Millipore (USA) 87 Neogen Corporation 88 Pall Corporation (UK) 89 Prionics AG (Switzerland) 89 ProMetic Life Sciences, Inc. (Canada) 90 Proteome Sciences plc (UK) 91 R-Biopharm AG (Germany) 92 ScheBo® • Biotech AG (Germany) 92 VMRD, Inc. (Veterinary Medical Research & Development) (USA) 92 3.21 Major Activities in Prions Industry 94 Bayer HealthCare Expands Animal Health Research Capacity 94 IDEXX Laboratories Acquires Madasa do Brasil Ltda. 94 Bayer HealthCare Acquires Teva’s U.S Animal Health Business 94 Macopharma Successfully Completes P-Capt Prion Studies 94 ProMetic Life Sciences in Association with Nantpharma Develops and Commercializes Plasma-Derived Biopharmaceuticals 95 Amorfix Collaborates with Global Leader in Prion Diagnostic Research 95 US$13.5 million Neurodegenerative Biomarker Consortium to be Lead by Karolinska 96 Scripps Scientists Discover Single Prion Protein Responsible for Neuronal Death 96 University of Alberta Researchers Discover Additional Link between Alzheimer's and Prion Diseases 97 IDEXX Laboratories Completes the Acquisition of RADIL Reference Laboratory from UoM (University of Missouri) 97 ProMetic Secures Binding Forecast from Octapharma for over US$ 2 million of Prion Capture Resin 98 PREVENT employs Amorfix Life Sciences’ ProMIS Technology 98 LGC Takes Over KBioscience 99 Drug Targets Discovered for Prion Diseases 99 High Affinity Antibodies to Cancer Specific Epitopes Successfully Produced by Amorfix 99 Prometric & MacoPharma Urges the DoH of UK to adopt P-Capt® filter for Safer (vCJD prion free) Blood Transfusion 100 Neogen Acquires GeneSeek 100 Chronix Biomedical Enters into Agreement with University of Calgary for Commercialization of Serum DNA based Blood Test BSE detection 101 ASP’s Sterrad Technology Receives AFSSAPS Approval for Complete Inactivation of Prions 101 New Blood Filter by Pall Corporation 102 ProMetic and Abraxis in Prion Capture Technology Commercialization Agreement 102 SaBTO Advises P-Capt® Prion Reduction Filter as Protection against vCJD Blood Transmission in Children 103 ProMetic Acquires ARC’s Stake in Pathogen Removal and Diagnostic Technologies Inc. 103 Evolutionary Origin of Prion Disease Gene Discovered 103 Beckman Coulter Acquires Cogenics 104 Bio-Rad TeSeE® SAP Test Gets USDA Approval 104 Alberta Building up Considerable Funds for Prion Research 105 Accelerated Method for the Detection of Infectious Prion Strains Developed by Scripps Florida 105 Sophisticated Techniques for Testing of Transmissible Spongiform Encephalopathies 106 BSE Testing Laboratory in Exeter by LGC 106 HemoBioTech’s Orth Technology Eradicates 100% Prions 107 BTG plc Acquires Protherics PLC 107 HPA Awarded Patent for Detection and Inactivation of Prions that Cause Variant Creutzfeldt - Jakob disease (vCJD) 108 INRA Establishes Animal House for Prion Research 108 Mysteries of Neurodegenerative Diseases Uncovered by the Royal Veterinary College. 109 British Blinded Panel of Spiked Human Blood Samples Results Released by Amorfix. 109 Resin for Prion Elimination in Plasma product for Biopharmaceutical Application Upgraded by ProMetic 110 Human Clinical Trials for P-Capt® Prion Filter Successfully Completed 110 The Concentration Technology of PRDT Magnifies Sensitivity of Diagnostic Tests for BSE 110 ProMetic BioTherapeutics Signs Agreement with Kedrion to Develop Multiple Hyperimmunes 111 Prionics Lelystad Launched in Netherlands 111 Eurofins Acquires Analycen 111 GeneThera and IZSLER in Collaboration Agreement 112 ProMetic Announces New Filter Product to Detect BSE in Cattle 112 Expanded Marketing of Mad Cow Disease Testing Kits by GeneThera 112 Private Testing for Mad Cow Disease Permitted by Court 113 Vita-Tech Acquired by IDEXX 113 IDEXX Acquires Critical Care Division of Osmetech 113 Covance now Becomes the Only Provider of Neuroscience Gold Standard Antibodies to Treat Alzheimer’s and Prions Diseases 113 Rapid BSE Diagnosis Facility of IdentiGEN Awarded ISO Certification 114 Abbott to Provide Blood Screening Facility Along with Four Important Tests to American Red Cross 114 Newly Developed Prion Capture Filter Receives CE Mark 115 IDEXX Acquires Golden Veterinary Laboratory in South Africa 115 New Acquisition Results in Comprehensive Antibody Products and Services 115 Prionics Buys CEDI Diagnostics, Creates New Strategic Alliance with World Class Science Innovation Center 115 Prionics Buys Pfizer Animal Health’s Diagnostic Products 116 IDEXX Acquires ITS Innovative Technologies and Systems 116 Covance Acquires GFI Research Center; Phase I Clinical Capacity Now Increased 117 Pall Corporation in Collaboration with Fresenius Kabi for Speedy Implementation of Prion Reduction Technology 117 CFIA Endorses New BSE Test 118 Strategic Alliance between ProMetic and Top Meadow to Develop New Diagnostics for the Easy Detection of BSE 118 Pall Launches Filter System to Eliminate Prions from Blood 118 Pall Corporation in Global Supply Agreement with Gambro BCT for Leukoreduction Filters 119 HerdChek® BSE Antigen EIA Test Kit from IDEXX Approved by European Commission 119 Euroflow Acquired by Pall Corporation 119 3.22 Beef Market – An Overview 120 US Beef Consumption 120 Exhibit 43. Beef Consumption – United States (2002-2012) in Billion Pounds 120 US Beef Production 121 Exhibit 44. Beef Production – United States Commercial Carcass Weight (2002-2012) in Billion Pounds 121 US Beef Exports 122 Exhibit 45. Beef Exports – United States Commercial Carcass Weight (2002-2012) in Million Pounds 122 Exhibit 46. Beef Exports – United States (2002-2012) in US$ Million 123 Canadian Beef Markets 124 Exhibit 47. Beef Products - Canadian Exports (2002-2012) for Live Animal and Beef CAN$ Million 124 Exhibit 48. United States Cattle – Imports from Canada and Other Countries (2002-2012) in Heads 125 Exhibit 49. United States Beef and Veal –Imports from Canada and Other Countries (2002-2012) in Billion Pounds 126 Bison in Demand after BSE Crisis 127 Confirmed BSE Cases in North America 127 1997 Canada Feed Ban 127 Prevalence of BSE in Canada 128 U$39.8 Million to Alberta for New Feed Regulation Implementation 129 New Regulations for Animal Feed in Canada 129 Beef Industry in Canada Granted Class Action Suit of Compensation 129 Safer Designation for Canadian Cattle from World Organization for Animal Health 130 New Network of Excellence Centers to Study Prion Diseases 130 Control Measures to Prevent Spread of BSE 130 Control Measures to Prevent Transmission of BSE to Human 132 Canada Amends BSE Infection Control Regulations for US Imports 132 Exhibit 50. BSE Cases Diagnosed in North America (1993-2012) 133 3.23 Prions – Market Outlook 134 4. PRODUCT /TECHNOLOGY RESEARCH 135 4.1 Introduction 135 Introduction 135 History 135 Prions 137 Prions Formation 137 Structure and Properties of Prion Proteins 138 Prion Protein Diversity 138 Isoforms 139 PrPC 139 PrPSc 140 PrP’s Role in Long-Term Memory 140 Characteristics of Prions 140 Exhibit 51. Comparison of General Characteristics of Classic Virus and Prions 141 Prion Biosynthesis 141 Prions Replication 141 Prion Strains 142 Species Barrier 142 Cancer and Prions 143 Prion Vaccines 143 Prion Disease Prevention through Vaccine in Mice 143 Vaccination 144 Promising Vaccines against Prion Disease 145 Toxic clumps 145 Gut Reaction 146 Approach to Prevent and Control the Spread of Prion Diseases in Human Beings 146 Methods to Control the Cause of BSE and Scrapies 147 Methods for Controlling the Transmission of Prions via Human Plasma Derivatives 148 Diseases Caused by Prions 149 Exhibit 52. Diseases caused by Prions in Animals 149 Transmissible Spongiform Encephalopathy (TSE) 150 Exhibit 53. List of Prion Diseases and Pathogenesis in Humans 150 Exhibit 54. List of Prion Disease and Pathogenesis in Animals 151 Characteristics of TSE 152 Genetics 153 Epidemiology 153 Research to Treat Prion Diseases 153 Mechanism of Conversion of PrPC to PrPSc 154 Transmission and Causes of Prion Diseases 155 Prion Transmission and Propagation Modes 155 Metallic Poisoning 156 Viral Possibilities 157 Sterilization 157 Prions in Yeast and Other Fungi 157 Mechanism of the Prion Diseases 158 Unsolved Puzzle 158 Effectiveness of Quinacrine for Treating Creutzfeldt-Jakob Disease 159 Analysis of Pentosan Polysulphate for Treating Prion Diseases 159 Difficulty Posed by Blood Brain Barrier 160 Risks Associated with PPS 160 Efficacy Evaluation of Intraventricular PPS Administration 160 Species Barriers for Prions 161 Efforts to Control TSE Related Diseases 162 Effect of TSE Related Diseases on Biopharmaceutical Industry 162 Development of In Vitro Diagnostics Polyclonals Free from Pathogen of Scrapie and BSE 163 Genotype 164 Extensive Monitoring of Disease Pathogens 164 Isolation of the countries based on the extent of cases reported: 164 Approved Monitoring Programme: 164 Conclusion 164 Bovine Spongiform Encephalopathy (BSE) 164 Source of the Epidemic 166 Causes 166 Cases of BSE 166 Measures to Prevent the Spread of BSE 167 BSE Testing 167 Ante-Mortem Assays 168 Regulations 168 BSE/TSEs Testing Regulations Imposed by European Union 169 Transmissible Mink Encephalopathy (TME) 170 TME Related Diseases 170 Clinical Characteristics of TME Infected Animals 171 Diagnosis 171 Prevalence of the Disease 171 Stetson Ville Outbreak 172 Scrapie 172 History 172 Introduction 173 Epidemiology and Transmission 173 Signs & Symptoms 174 Wool Manufacturing Process – An Effective Route of BSE Propagation 174 Research 175 Diagnosis of Scrapie 176 Immunohistochemical (IHC) Detection 177 Procedures and Techniques of Immunoblotting 179 Capillary Electrophoresis Immunoassay 179 Evaluation of tests for TSEs by European Union (EU) 180 Eradication Program 180 Exhibit 55. Number of Confirmed Scrapie Cases Reported in Great Britain (1993-2014) 180 Scrapie Cases Reported 181 Feline Spongiform Encephalopathy (FSE) 182 Cause 182 Common Breeding Age and Occurrence 182 Common Symptoms 182 Diagnosis 183 Treatment 183 Prognosis 183 Research 183 Chronic Wasting Disease (CWD) 183 History 184 Major Consequences of CWD Prevalence 184 Causative Agent 185 Clinical Duration 185 Characteristics of Chronic Wasting Disease 185 Diagnosis 186 Development of Aptamer Beacons for Ante-Mortem Diagnosis of Chronic Wasting Disease 186 Epidemiology 187 Distribution 188 Prevention & Control Strategies 188 Kuru 189 Introduction 189 Transmission 190 Diagnosis 190 Treatment 190 Gerstmann-Sträussler-Scheinker Syndrome (GSS) 190 Cause 191 Symptoms 191 Prognosis 191 Creutzfeldt - Jakob Disease 191 Symptoms of CJD 193 Transmission of CJD 193 Precautions to Control Spreading of the Disease 194 Research 195 CJD-Types and Characteristics 195 Sporadic CJD 195 Diagnosis 195 EEG (Electroencephalography) 196 Cerebrospinal Fluid 14-3-3 Analysis 196 Magnetic Resonance Imaging 197 Variant CJD (vCJD) 197 Definition 198 Origin of vCJD 198 Differences between spCJD and vCJD 198 Differences between Classic and Variant CJD 199 Prevalence of vCJD 200 Diagnosis 201 Magnetic Resonance Imaging 201 Tonsil Biopsy 202 CSF 14-3-3 202 Molecular Diagnosis of vCJD through Ante-Mortem Tonsil Biopsy 202 Genetic CJD 203 Diagnosis 203 Iatrogenic CJD 203 Diagnosis 203 EEG (Electroencephalography) 205 Biomarkers 205 14-3-3 Protein 205 Sensitivity and Specificity of 14-3-3 Protein Vary with the form of CJD 205 Metallothionein 206 Laminin Receptor Protein / Laminin 206 Exhibit 56. Worldwide Number of Reported Cases of vCJD by Country (2012) 206 Exhibit 57. Referrals of Suspect CJD, Deaths of Definite and Probable CJD in United Kingdom 207 CJD Control Measures in United Kingdom and United States 208 Centers for Disease Control and Prevention 208 Treatment 208 Fatal Familial Insomnia (FFI) 209 History 209 Pathophysiology of Disease 209 Disease Progression 209 Treatment 210 Common Symptoms and Time Duration Observed in FFI 210 Diagnosis 210 Prions Detection Technologies 210 Immunocapillary Electrophoresis 211 Principle of ICE 211 Sample Source 211 ICE Methodology 211 Parameters 212 Sensitivity of ICE (Immunocapillary Electrophoresis) 212 Limitations and the Present Status 212 Heartbeat Clue to Diagnosing vCJD 214 Conformation Dependent Immunoassay (CDI) 215 Merits of CDI 215 Sensitivity 215 Quantification 215 Rapid Screening 216 Early Diagnosis 216 Other Benefits 216 Immunoblot (IB) 217 Immunoblot Analysis 217 Histopathology and Immunohistochemistry (IHC) 218 Immunohistochemistry 218 Protein Misfolding Cyclic Amplification (PMCA) 219 The PMCA Assay 220 Amplification of rPrPC to rPrPSc in vitro 220 Amplification Technique Improves Prospects for Diagnostic Tests 220 Western Blot Assay for TSE 221 Electrophoretic Pattern of PrP 222 Western Blot Assay for PrP 222 Synthetic Ligands 223 A Protein-Binding Ligand System for Prion Disease Detection 223 Blood Testing for the Prion Disease Agent 224 Immuno-PCR 225 Biomarkers for Detection of Prions (Surrogate Markers) 226 Prion Infection 226 Surrogate Markers 227 Other Assays for Diagnosis of Prion Diseases 228 Platelia Test (ELISA, BioRad) 228 Detection 228 Enfer test (ELISA, Enfer) 228 Prionics-Check LIA (ELISA, Prionics AG) 228 CDI (Inpro) 228 Histoblot 229 Paraffin-Embedded Tissue (PET) Blot 229 Genotyping PrP 229 ELISA and DELFIA 230 Rapid Assay 230 Advantages of this method 230 RNA Aptamers and Prion Proteins 230 Prion Protein Binding RNA Aptamer 230 Interaction of RNA Aptamers with PrPc 231 RNA Aptamer as a Diagnostic and Therapeutic Agent 231 Aptamer and Mutations 231 Animal Bioassays and Cell Culture Assays 232 Mechanism of Prion Formation 232 Animal Bioassays 233 Cell Culture Bioassays 233 Genetic Engineering Tools 233 Prion Decontamination and Inactivation Techniques 234 General Methods of Decontamination 235 Facility Issues 235 Device Issues 236 Novel Methods to Restrict Decontamination of Surgical Instruments 237 Enzyme-Detergent Method to Sterilize Prions 237 Latest Methodologies Restricting the Infections Caused by Prion-Contaminated Medical Appliances 237 Available Alternatives or Methodologies 238 Conditions Normally Used for Inactivating Prions 238 Conclusion 238 Analysis 238 Clearance Studies 238 Prion Clearance Studies 239 Prion Inactivation and Removal 240 Creutzfeldt - Jakob Disease 240 Bovine Components 240 Sanitization of Prion 240 EMEA Clearance 241 Effective Mode Prion Clearance 241 The Regulatory Environment 241 The Nature of the Agent 242 Spiking Agents 242 Yardsticks for Clearance 242 Investigative Steps 243 Inactivation Techniques 243 Exhibit 58. Ineffective or Unreliable Methods of Eradicating Prions 244 Conventional Methods for Inactivation of Prions 245 Use of NaOH and NaOCl for Chemical Disinfection 246 Techniques for Inactivation of Prions in Reusable Instruments and Surfaces 247 Application of Maillard Reaction to Minimize Prion Activation 248 ViruSure 248 Evaluation Protocol 248 Evaluation Process 250 Criteria for Submission of Dossier 250 Pre-Evaluation Assessment 251 Criteria for Admission to Full Evaluation 252 Prion Reduction Filters 252 Core Concerns 252 TSE Transmission via Blood 252 Filters to Facilitate Reduction in Prion Proteins 253 The Effectiveness of the Pall Corporation Filter 253 UKBS Approach to Filters 253 Experimental Models for Endogenous Infectivity in Blood 255 Donor Species 255 Prion Strain 255 Method to Detect Infectivity/PrPSc 256 Advice Sought From the Committee 256 Post Mortem BSE Testing 256 IDEXX HerdChek® Bovine Spongiform Encephalopathy Antigen Test Kit EIA 257 Description and Principles 257 Parts of the Kit 258 Sampling and Preparation 258 Step 1 258 Step 2 259 Step 3 259 Step 4 259 Preparation of Reagents 259 Wash Solutions 1 and 2 259 Plate Diluent Component 2 259 Working Plate Diluent 259 Negative and Positive Controls 260 HRPO-Conjugated Anti-PrP Antibody Solution 260 Acid Stop Solution 260 Test Procedure 260 Assay Protocols 260 Sample Dilution in Working Plate Diluent 260 Use of Plate Shaker for Sample Incubation Protocols – Short and Ultra-short 261 Results 261 Precautions 261 Safety Information 262 Enfer TSE assay 262 Principle 262 Buffers 262 Merits 263 Prionics®-Check WESTERN 263 Method 263 Merits 263 Prionics®-Check LIA 263 Method 263 Merits 264 Prionics®-Check PrioSTRIP 264 Method 264 Merits 264 Post Mortem CWD Diagnosis 265 Antigen-Capture Enzyme-Linked Immunoassay 265 Principle 265 Protocol of EIA 265 Merits of EIA 266 Efficacy of EIA 266 Prions Risk Assessment 268 Measuring Risks Related to Prions 268 Prion Diseases Management Policies 269 Health Control Policies in UK 269 European Union and BSE controls 269 Exhibit 59. EU Preventing the Introduction and Spread of BSE 270 Japan and BSE 270 FDA’s Qualitative Risk Assessment 271 Modes for Transmission of Prions through Cosmetics 271 Identification of Hazard 272 Dose-Response Assessment 273 Characterization of Risk 274 Inferences 274 Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathies via Human and Veterinary Medicinal Products 275 Regulatory Compliance 275 Risk Assessment 275 Legal Aspects 275 Clarification 276 Scope of the Note for Guidance 276 Relevant Animal Species 276 Materials 276 Seed lots, Cell Banks and Routine Fermentation/Production 277 General Considerations 278 Scientific Principles for Minimizing Risk 278 Source Animals 278 Geographical Sourcing 278 Bovine Materials 278 European Commission Scientific Steering Committee Classification 279 Sheep and Goats (Small Ruminants) 279 BSE Negligible Risk (Closed) Bovine Herds 280 Parts of Animal Bodies, Body Fluids and Secretions as Starting Materials 280 Age of Animals 282 Manufacturing Process 282 Cleaning Process 282 Validation 283 Risk/Benefit Evaluation 283 Specific Considerations 284 Collagen 284 Structural Protein 284 Function of Collagen in the Human Body 284 Safety Measures Offered by Collagen 285 Clinical Perseverance of Collagen Product 285 Enhanced Performance 285 Superior Flexibility 285 Products Derived from Collagen and its Multiple Biomedical Applications 285 Procedure Followed in the Extraction of Collagen 286 Properties and Characteristics of Atelocollagen 286 Additional Characteristics of Atelocollagen 286 Processing of Atelocollagen to Desired Configurations 286 Mutable Characteristics of Available Atelocollagen 287 Superior Quality of KOKEN Atelocollagen 287 KOKEN Atelocollagen is Absolutely Safe 287 Application of Collagen in Various Biomedical Applications 287 Application in Clinical Medicine 287 Tissue Culture Research 287 Cosmetics 287 KOKEN Special-Purpose Atelocollagen Design 288 Gelatin 288 The source material that has been used. 288 Manufacturing methods 288 Bovine Blood Derivatives 289 Traceability 289 Geographical origin 289 Stunning Methods 290 Tallow Derivatives 290 Animal Charcoal 290 Milk and Milk Derivatives 291 Wool Derivatives 291 Amino Acids 292 Product Trends 292 A New Fluorescent Molecule Effective in Diagnosing Prion Disease 292 New Test to Detect Bovine Spongiform Encephalopathy 292 Hematech – Company Develops New BSE Resistant Cow 293 Recent Progress in Prion Research 294 Blood Test to Find Fatal variant Creutzfeldt–Jakob disease 294 Prion like Proteins Helps to Create Long-Term Memories 294 Understanding the Life of Prion Molecules 295 Shape of Infectious Prions 296 Creutzfeldt–Jakob Disease can be Transmitted by Blood 297 1 in 2,000 People in UK Carry Variant CJD Proteins 298 Recombinant Human Prion Protein 299 Prion like Proteins Dispel many Diseases of Aging 299 New Models developed to further the study of Human Prion Diseases 300 Role of HSPG Receptors in the Spread of Misfolded Proteins 301 Ribosomes New Target for Antiprion Medicines 301 New Method to Protect Prion Protein from Changing Shape and Becoming Infectious 302 Flexible Tail of Prion Protein found to Damage Brain Cells 303 A likely Treatment for Prion Disease in Humans 303 CJD May be Manifested as Rapid Hearing Loss 304 Iron Metabolism Controlled by Normal Prion Protein 305 More Disease Causing Proteins in Brain Disorders 306 Protective Prion Stimulates Transition in Yeast Cells 307 Adaptation of Infectious Prions to Multiple Hosts 308 Extracts from Green Tea and Red Wine can disrupt Alzheimer’s Disease Pathway in Cells 309 Role of Normal Prion Protein in Brain Development 310 Mode of Transmission of Infectious Prion Proteins 310 US$13.5 million Neurodegenerative Biomarker Consortium to be Lead by Karolinska 311 Potential Biomarker for Creutzfeldt-Jakob Disease Discovered by Case Western University 311 Transmission of Prions through Aerosols 311 Early Diagnosis of Prion Diseases: NIH 312 New Prion Discovery Shows Drug Target for Mad Cow Disease and other such Illnesses 313 Role of Aggregate Size in the Spread of Prion based Disease 314 Discovery of Variably Protease-Sensitive Prionopathy (VPSPr) and its Relation with Creutzfeldt-Jakob disease (CJD) 315 Possible Transmission of CJD through Surgery 317 In Normal Brain Tissue Infectious Prions were Found to Come up Unexpectedly 317 Vaccines for Prion Diseases 318 Role of the Sequence and Structure for Prion Disease Transmission to New Hosts 319 Cattle Eye – Indicator of Mad Cow Disease 319 Additional BSE Testing in Cattle by Alberta 320 Prion Proteins and Cellular IPOD 320 Occurrence of a New Form of Prion Disease 321 Synthetic Recombinant Infectious Prion Protein 322 Prion Leaves Sustainable Impression on Memory 323 Prion Protein in Cell Culture 324 Novel, Fast-Acting Disinfectant against Viruses, Bacteria, Fungi and Prions could help Reduce the Spread of Lethal Infections in Hospitals 325 Transformation of Normal Prion Protein into Infectious Form by Misfolding 326 Prions and its Role in Causing Evolutionary Changes, Adaptation and Diseases 327 New Protein that is Vital to Development of Bovine Spongiform Encephalopathy (BSE) Discovered 329 Evolvement of a Brain Disease Resistance Gene in a Community in Papua New Guinea may Provide Insight into CJD 329 Prion Disease and Cholesterol Biosynthesis 330 Molecular Structure of Misfolded Prion Proteins 330 Cell Study explains why Younger People are More Prone to vCJD 331 Detection of vCJD Prions from Non-Human Primates by Amorfix 332 Mutation in Gene-Enough to Cause Contagious Prion Disease 333 Impaired Transport in Neurons Trigger Prion Disease 334 Discovery of the method adopted by prion proteins in Brain Cell Damage could help in Better Comprehending Mad Cow Disease and Related Disorders 335 Socioeconomic Aspects of CWD in Canada 337 Link Between Copper and Functioning of Prions Related to BSE & CJD Discovered…. 338 Prions and Phenotypic Diversity 339 Role of Iron in Prion Disease- Associated Neuronal Demise 340 Treatment of Variant Creutzfeldt-Jakob Disease (vCJD) with Antibody 340 Prions and Adaptive Gene Expression 341 Susceptibility of Prions to Birnessite 342 Presence of Prions in White And Brown Fat Tissues of Mice 342 Role of Mutant Proteins in Infectious Prion Disease in Mice 343 Mouse Model of Prion Disease Mirrors the Symptoms of Human Disorder 343 First Constructed Prion Protein with an Anchor 344 Alternate Pathway not very Useful for Prions 345 Unraveling the Mystery behind Prion Proteins 345 Infectious, Test Tube-Produced Prions Can Jump the ‘Species Barrier’ 346 The Findings on a Research Study on Animals Reveal that a Variation of Mad Cow Disease may be Transmitted through Blood Transfusions. 348 Tracking Prions 349 Prions show their Good Side 350 Scrapie Prions from Asymptomatic Sheep by Amorfix 350 Resistant Prions 350 Transmission of Prion Diseases in Milk 351 Prions Associate with Cholesterol to Cause Neuro-Degeneration…. 352 Glowing Molecules to Detect Prions….. 353 Prions May Activate Retroviruses in Infected Brain Cells 353 Small Clumps of Prion Proteins May be Primary Cause of Neurodegenerative Diseases 354 Newly Discovered Prion Proteins May Offer Insight into Mad Cow Disease 355 Prion Proteins Discovered to Prevent Development of Alzheimer’s Disease 356 Manganese Levels Mount in Scrapie-Infected Sheep Prior to Development of Clinical Symptoms 357 Vaccine Prevents Prion Disease in Mice 357 Safe Disposal of Prion Diseases Infected Animals….. 358 Resin Beads Developed to Seize Mad Cow Disease Agent through Blood 358 Single Prion Molecules’ Structural Dynamics 359 Prion Free Genetically Modified Cattle… 360 V. CORPORATE DIRECTORY 361 VI. PATENTS INFORMATION 377
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