This document provides a summary of a report on companion diagnostics in personalized medicine and cancer therapy. It examines the use of companion diagnostics to personalize cancer treatment. The report provides qualitative and quantitative analysis of the industry, including profiles of leading companies developing companion diagnostic solutions. It also discusses regulatory trends around companion diagnostics and personalized medicine. Companion diagnostics are helping to personalize cancer care by linking diagnostic tests to specific drug therapies.

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Diagnostics in Personalized Medicine and Cancer
Therapy
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Companion diagnostics (CDx) refers to a particular clinical diagnostic test that is under
evaluation and is specifically linked to a known drug therapy. This linkage could be important in
the therapeutic application and clinical outcome of a drug, such as with personalized medicine
for oncology patients. The molecular diagnostics field plays a vital part in personalized medicine
and has greatly expanded over the past twenty years, expanding by more than 20% annually
compared to most other laboratory procedures. Research will continue to produce an increased
understanding of disease processes, and diagnostics manufacturers will continue to expand and
refine the technology and automation needed for clinical testing. Companion diagnostics,
although smaller at present, is one of the fastest growing segments in the in vitro diagnostic
(IVD) market. And while the concept of a drug-diagnostic combination is not new, it has only
recently started to generate interest with the move of healthcare towards pharmacogenomics.
This TriMark Publications report examines the use of companion diagnostics in personalized
medicine and cancer therapy. The study provides a qualitative and quantitative review of the
industry, including cancer biomarker tests, pharmacogenomics tests, recurrence prediction
tests, blood-based technologies, proteomics and regulatory trends. Moreover, this analysis
profiles the leading companies that are developing and manufacturing companion diagnostics
solutions. Each company is discussed in extensive depth with a section on its history, product
line, business and marketing analysis, and a subjective commentary of the company's market
position. Detailed tables and charts with sales forecasts and market share data are also included.
Table of Contents :
1. Overview 9

2. 1.1 Statement of Report 9
1.2 About This Report 9
1.3 Scope of the Report 10
1.4 Objectives 11
1.5 Methodology 11
1.6 Executive Summary 13
2. Companion Diagnostics and Personalized Medicine 17
2.1 Scope of This Section 17
2.2 Introduction to Companion Diagnostics and Personalized Medicine 17
2.3 Drug Metabolism, Companion Diagnostics and Personalized Medicine 22
2.4 Examples of Personalized Medicine and Companion Diagnostic Tests 26
2.5 Personalized Medicine and Companion Diagnostic Testing Product Pipeline 29
2.6 The Personalized Medicine Coalition (PMC) 31
2.7 Regulatory Trends and Guidelines in the Personalized Medicine Space 38
2.7.1 The Changing Regulatory Landscape for Personalized Medicine 40
2.8 Companion Diagnostics Play an Increasing Role in Cancer Care 41
2.9 Specific Examples of Clinical Situations where Companion Diagnostics are being Deployed 42
2.9.1 Epidermal Growth Factor Receptor Assay 42
2.9.2 Individualized Warfarin Therapy 45
2.9.3 UGT1A1 Molecular Assay for Camptosar 46
2.9.4 Response to Gleevec in Gastrointestinal Stromal Tumors (GISTs) 46
2.9.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases 46
2.9.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Enter Companion
Diagnostics 47
2.9.7 Roche’s Metastatic Melanoma Treatment, Zelboraf (vemurafenib) 47

3. 2.9.8 Abbott’s Late-Stage NSCLC Treatment, Xalkori (crizotinib) 47
2.10 Diagnostic Tests for Personalized Analysis of Cancer Therapy Effectiveness 47
2.11 Value Chain 48
2.12 Impact of Companion Diagnostics/Personalized Medicine on Drug Clinical Trials 50
3. Companion Diagnostics: Qualitative and Quantitative Market Analysis 51
3.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics 51
3.2 Costs of Companion Diagnostics in Healthcare Expenditures 52
3.3 Molecular Diagnostic Market 53
3.4 Molecular Diagnostics Technology Platforms and Their Impact on Clinical Medicine 55
3.5 Snapshot of Companion Diagnostics Industry Structure 57
3.6 The Case for Theranostics 58
3.7 Companion Diagnostics Market Analysis—Market Survey Data Characterizing the Qualitative
and Quantitative Industry Parameters 59
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