Date published 
May 2013

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Companion Diagnostics and Other Aspects of Personalized Medicine - Table of Contents

 

Introduction 

Executive Summary 

Chapter 1 Introduction

Chapter 2 Overview of Personalized Medicine 
2.1. What is Personalized Medicine?
2.2. Selected Terms Used in Personalized Medicine
 
• Pharmacogenomics
• Pharmacogenetics
• Companion Diagnostics
• Other Terms Used in Personalized Medicine
 
2.3. Disease Applications Where Personalized Medicine May Be Used
2.4. Diagnostic Technologies Used in Personalized Medicine
 
Chapter 3 Selected Examples of Personalized Medicine (Drug/Diagnostic Combinations and Prevention of Adverse Effects) in Use Today  
3.1. Estrogen Receptor and Progesterone Receptor Status: Breast Cancer
3.2. HER2 Overexpression in Breast Cancer
3.3. Multigene Tests for Determining Breast Cancer Prognosis and Treatment 
 
• Agendia’s Symphony: MammaPrint, TargetPrint, BluePrint, TheraPrint
• bioTheranostics’ Breast Cancer Index
• Clarient’s Mammostrat Breast Cancer Test
• Genomic Health’s Oncotype DX Breast Cancer Assay 
 
3.4. Multigene Tests for Determining Diagnosis, Prognosis, and Treatment of Other Cancers  
• Agendia’s ColoPrint
• bioTheranostics’ CancerTYPE ID
• Clarient’s Genomics’ Pulmotype Lung Cancer Test
• Genomic Health’s Oncotype DX Colon Cancer Assay
• Pathwork Diagnostics’ Pathwork Tissue of Origin Test 
 
3.5. Epidermal Growth Factor Receptor (EGFR)  
• Testing for Expression of EGFR
• Testing for EGFR Mutations 
 
3.6. KRAS Mutations and Anti-EGFR Therapy for Colorectal Cancer
3.7. BRAF Mutations 
 
• BRAF Mutations and Melanoma
• BRAF Mutations and Anti-EGFR Therapy for Colorectal Cancer 
 
3.8. ALK Gene Rearrangements and Non–Small-Cell Lung Cancer
3.9. DPYD and TYMS Variants and 5-Flurouracil Therapy
3.10. Biomarkers in Hematological Cancers 
 
• Gleevec and Other Tyrosine Kinase Inhibitors for Treatment of Philadelphia Chromosome-Positive CML
• Philadelphia Chromosome and Busulfan
• PML/RARalpha and Vesanoid (tretinoin)/Trisenox (arsenic trioxide)
• Rituxan and Other Antibodies That Target CD20 Antigen for Treatment of Lymphoma or Leukemia
• Many Additional Biomarkers for Leukemia and Lymphoma
• Biomarkers for Myelodysplastic Syndromes (MDS) and Myeloproliferative Diseases 
 
3.11. Thiopurine Methyltransferase and Metabolism of Thiopurine Drugs
3.12. Cytochrome P450 
 
• CYP2D6 Phenotype and Response to Tamoxifen
• CYP2C19 Phenotype and Plavix (clopidogrel bisulfate)
• Cytochrome P450 Enzymes and Other Drugs 
 
3.13. UGT1A1 Genetic Variants and Treatment with Camptosar (irinotecan)
3.14. CYP2C9 and VKORC1 Variants and Warfarin Dosing
3.15. Personalized Medicine and HIV Therapy: Moving Beyond HIV Viral Load and Drug Resistance Testing 
 
• HLA-B*5701 Testing and Hypersensitivity to Abacavir
• CCR5-Tropic HIV and Selzentry (maraviroc) 
 
3.16. Selected CNS Applications of Personalized Medicine
3.17. Selected Other Personalized Medicine Tests 
 
Chapter 4 Selected Examples of Emerging Drug/Diagnostic Combinations and Other Personalized Medicine Tests in Development  
4.1. Personalized Medicine Tests in Development  
• 20/20 GeneSystems
• Abbott Molecular
• BD
• Biocartis
• Biodesix
• bioMérieux
• Dako (An Agilent Technologies Company)
• Genomic Health
• Ignyta
• Insight Genetics
• Myriad Genetics
• Qiagen
• Roche (Including Roche Molecular Diagnostics and Ventana Medical Systems)
• Other Personalized Medicine Tests in Development 
 
4.2. Next-Generation Sequencing and Personalized Medicine
4.3. Pharmaceutical/Diagnostic Company Agreements
4.4. Other Diagnostic Company Agreements in Personalized Medicine 
 
Chapter 5 Development of Drug/Diagnostic Combinations: Personalized Medicine Products  
5.1. Identification of Personalized Medicine Biomarkers
5.2. Validation of Biomarkers and Diagnostic Tests for Personalized Medicine
5.3. Development and Regulatory Issues Facing Diagnostic Companies in Personalized Medicine 
 

• Regulatory Issues and Considerations for Diagnostic Companies with CLIA-Certified Laboratories and Clinical Laboratories with Laboratory-Developed
• Tests for Personalized Medicine
• Regulatory Issues and Considerations for Diagnostics Companies in Personalized Medicine
• The FDA Review Processes and Classifications for Diagnostic Tests 
 

5.4. Development and Regulatory Issues Facing Therapeutic Companies in Personalized Medicine
5.5. Selected Personalized Medicine Examples: What Tests Are Used by Physicians? 
 

• Why Isn’t Warfarin Sensitivity Testing Routinely Performed?
• Screening for HLA-B*5701 Hypersensitivity to Abacavir
• Genomic Health and Validation of Oncotype DX Breast Cancer Assay
 
Chapter 6 Business Considerations for Pharmaceutical and Diagnostic Companies Developing Personalized Medicine Products  
6.1. Need for More Research and Understanding 
• Biomarkers and Other Factors Influencing Response to Therapy
• Validation Studies and Outcome Studies
• Other Research and Information Needs 
 

6.2. Models/Options for Pharmaceutical Companies Developing Drug/Diagnostic Combinations
6.3. Models/Options for Diagnostic Companies Developing Personalized Medicine Tests
6.4. Delivery of New Diagnostic Tests: IVD vs. CLIA Laboratory
6.5. Health Economics, Reimbursement, and the Payers’ Perspective 
 
• Health Economic Studies for Personalized Medicine Tests
• Perspectives Expressed in Expert Interviews
• Payer Perspectives and Policies
• Companies Providing Services to Diagnostic Companies, Payers, and Providers in Personalized Medicine
• Changes in Reimbursement for Molecular Diagnostic Tests 
 

6.6. Intellectual Property Issues
6.7. Penetrating the Market
 
• Does the Test Affect Physicians’ Decisions?
• Does The Test Improve Patient Outcomes?
• Acceptance by Experts; Incorporation into Guidelines
• Education of Physicians, Other Health Professionals, and Other Stakeholders
• Current Barriers and Growing Use of Personalized Medicine Tests
 
Chapter 7 Company Perspectives on Personalized Medicine 
7.1. Potential Benefits, Risks, and Challenges for Biopharmaceutical and Pharmaceutical Companies 
7.2. Potential Benefits, Risks, and Challenges for Diagnostic Companies  
Chapter 8 Results of Insight Pharma Reports’ Personalized Medicine Survey Chapter 9 Expert Interviews  
9.1. Stephen Eck, MD, PhD, Vice President, Oncology, Astellas Global Pharma Development 
9.2. Paul Beresford, PhD, Vice President, Business Development & Strategic Planning, Biodesix 
9.3. Richard Ding, CEO, bioTheranostics (A bioMérieux Company) 
9.4. Mark J. Ahn, PhD, President & Chief Executive Officer Rosemary Mazanet, MD, PhD, Executive Vice President & Chief Medical Officer, Galena Biopharma 
9.5. Howard Coleman, Chairman and Chief Executive Officer, Genelex 
9.6. Stephen Little, PhD, Vice President, Personalized Healthcare, Qiagen 
9.7. Felix Frueh, PhD, Entrepreneur-in-Residence, Third Rock Ventures 
9.8. Joshua P. Cohen, PhD, Senior Research Fellow, Tufts Center for the Study of Drug Development 
9.9. Michael Laposata, MD, PhD, Edward and Nancy Fody Professor and Executive Vice Chair of Pathology, Professor of Medicine, Pathologist-in-Chief, Vanderbilt University Hospital