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

Companion Diagnostics: Enabling Personalized Medicines in Cancer

発行	Decision Resources, Inc.
出版日	2006年10月	商品コード	45807
ページ情報	英文 30 pages
価格	こちらの商品の販売は終了いたしました。

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当商品の販売は、2011年12月21日を持ちまして終了しました。

原文目次

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.

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