癌のオーダーメイド医療を可能とするコンパニオン診断

Abstract

Introduction

Companion diagnostics will play an increasing role in cancer care. Pharmaceutical companies developing targeted therapies for cancer must consider the potential benefits of developing a companion diagnostic. As they join the rush to identify critical biomarkers, however, they also need to consider technology options, potential diagnostics partners, and regulatory hurdles.

Get the Answers You Need to Shape Your Strategy

Companion diagnostics are becoming an integral part of the design and development of targeted cancer therapies. How can pharmaceutical companies identify which agents need to be developed in concert with a companion diagnostic and which do not? Is the inevitable stratifi cation of disease markets a reason to shy away from targeted therapies and companion diagnostics? Developing targeted therapies and companion diagnostics is all about discovering and validating clinical biomarkers. Which diagnostics companies are developing biomarkers that might be potential targets for licensing or acquisition? PCR, microarrays, and expression profiling are being used to improve the sensitivity and selectivity of companion diagnostics. Which companies are developing key technologies? What are the latest developments in this field? Many companies forego FDA approval and instead develop companion diagnostics for use in CLIA-certifi ed laboratories. What are the advantages of going the CLIA route? Are all companion diagnostics likely to need FDA approval in the near term?

Scope

• Regulatory issues: CLIA regulations, FDA guidance on pharmacogenetic tests, and the Health and Human Services Secretary' s Advisory Committee on Genetics, Health, and Society.
• Companion diagnostics available for current products: Herceptin, Gleevec, EGFR,metabolizing enzymes.
• Companion diagnostics for CLIA labs: leading companies and products.
• Emerging technologies and products: review of technologies used for design of companion diagnostics, epigenetics, blood-based technologies, oncology biomarkers.
• Leading companies: profi les of select companies developing companion diagnostics.
• Outlook: a look ahead to the role companion diagnostics may play in drug development.
• Spectrum Expert Commentary: the view from an executive at an industry-leading company.

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