Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Targeted Therapies and Companion Diagnostics
- Regulatory Quagmire
- Scope of Clinical Laboratory Improvement Amendments Regulations
- FDA Guidance for Pharmacogenetic Tests and Genetic Tests for Heritable
Markers
- Secretary' s Advisory Committee on Genetics, Health, and Society
- Spectrum Expert Commentary: Regulatory Approaches to Companion Diagnostics
- Companion Diagnostics on the Market
- Herceptin (Trastuzumab) Companions
- Gleevec (Imatinib) Companions
- Epidermal Growth Factor Receptor Companions
- Companion Diagnostics Involving Metabolizing Enzymes
- Companions for TMPT, CYP2C9, and UGT1A1 Enzymes
- Companions for Aromatase Inhibitors
- Companion Diagnostics Used by Clinical Service Laboratories
- New Technologies and Products Under Development
- Epigenetic-Based Companion Diagnostics
- Epigenomics
- Oncomethylome
- Orion Genomics
- Rubicon Genetics
- Blood-Based Technologies
- Oncology Biomarkers Throughout a Drug' s Life Cycle
- Select Companies Developing Companion Diagnostics
- Molecular Profiling Institute
- Monogram Biosciences
- Oxford Genome Sciences
- Target Discovery
- Outlook
Tables
- 1. Select FDA-Approved Companion Diagnostics, 1998-2005
- 2. Drugs That Target the EGFR Family
- 3. Genzyme Genetics' Companion Diagnostics for Use in CLIA-Certified
Laboratories
- 4. Select Companion Diagnostics Under Development, 2006
- 5. Select Alliances with Epigenomics, 2006
- 6. Select Alliances for New Companion Diagnostics, 2005-2006
Figures
- 1. Companion Diagnostics, Targeted Therapies, and Molecular Diagnostics
- 2. EGFR Family
- 3. Estrogen Synthesis and Aromatase Inhibition in Postmenopausal Women
- 4. Select Technologies Used in the Development of Companion Diagnostics
- 5. Origins of 1 Million Human Protein Isoforms
- 6. When to Develop a Companion Diagnostic
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