Molecular Diagnostics: Technological Advances Fueling Market Expansion

TABLE OF CONTENTS

Chapter 1. Introduction

1.1. Clinical Applications for Molecular Diagnostics

1.2. Clinical Importance of Molecular Diagnostics

1.3. Business Implications

1.4. Key Issues and Challenges

1.5. Technology Trends

1.6. Competition

Chapter 2. Current Technologies

2.1. Non-Amplified Probe-Based Assays

2.2. Polymerase Chain Reaction and Other Amplification Technologies

2.3. Cytogenetics and Fluorescence In Situ Hybridization (FISH)

2.4. Microarrays

2.5. Technologies for Genotyping and SNP Analysis

2.6. Whole Genome Analysis

454 Life Sciences

OpGen

Solexa

U.S. Genomics

2.7. Proteomics

Chapter 3. Examples of Current and Emerging Applications of Molecular Diagnostics

3.1. Detection/Diagnosis of Infectious Disease

Detection of Infections

Viral Load Testing

Bioterrorism Testing

3.2. Viral Genotyping

HIV Genotyping/Drug Resistance Testing

HCV Genotyping

3.3. Cancer Diagnostics

HER-2/neu and Breast Cancer: Determining Prognosis and Optimal Therapeutic Regimen

Screening for Colorectal Cancer

Other Applications of Molecular Diagnostics in Cancer Testing

3.4. Predicting Risk of Disease/Disease Susceptibility

Cancer

Cardiovascular Disease

Alzheimer' s Disease

Predicting Genetic Risk for Other Diseases

3.5. Predicting Response to Drugs

Drug Metabolism and the Cytochrome P450 Family of Enzymes

Thiopurine Methyltransferase and Metabolism of Thiopurine Drugs

Other Activities to Predict Drug Response

3.6. Genetic Testing: Inherited Diseases

3.7. Identity and Forensics Testing

Chapter 4. Business Considerations: Molecular Diagnostics

4.1. Regulatory Environment

4.2. Molecular Diagnostics Market

"Home Brew" Testing

Market Segmentation

Market Drivers

Key Barriers

Competition

4.3. Impact of Molecular Diagnostics and Predictive Medicine on Pharmaceutical Companies

Impact on the Treatment of Infectious Diseases

Impact on Preventive (Prophylactic) Therapies

Impact on Cancer Therapeutic Agents

Impact of Predicting Response to Therapy

4.4. Deal-Making Trends in Molecular Diagnostics

Chapter 5. Expert Commentaries

Bernice Allitto, Genzyme Genetics

Carl Borrebaeck, Lund University

Colin Dykes, OpGen

Lance Fors, Third Wave Technologies

Bruce Huebner & Graham Lidgard, Nanogen

Steven Lehrer, DNA Sciences

Jorge A. Leon, Leomics Consulting

Stephen Little, DxS, Ltd.

Krishnan Nandabalan, Genaissance Pharmaceuticals

Gary Schweikhardt, Epigenomics AG

Thomas J. White, Celera Diagnostics

Appendix

Selected Company Profiles

Abbott Laboratories

Affymetrix

Bayer

BD (Becton, Dickinson and Company)

bioMérieux

Celera Diagnostics

Cepheid

deCODE genetics

DiagnoCure

Digene

DNAPrint genomics

DNA Sciences

Epigenomics AG

Genaissance Pharmaceuticals

Gen-Probe

Gentris

Genzyme Genetics (Part of Genzyme Corp.)

Innogenetics

Interleukin Genetics

Myriad Genetics Inc./Myriad Genetic Laboratories Inc.

Nanogen

Nuvelo (Formerly Hyseq and Variagenics)

Orchid BioSciences

Roche Diagnostics (A Division of F. Hoffmann-La Roche Ltd.)

Third Wave Technologies

Tm Bioscience

Virco (Part of Tibotec-Virco, which is part of Johnson & Johnson)

Glossary

Company Index

Tables and Figures

Table 1: Selected Nucleic Acid-Amplification Technologies

Table 2: Selected Examples of Companies Commercializing Microarrays for Genotyping and/or Diagnostic Applications

Table 3: Features of SNP-Genotyping Methods

Table 4: Selected Companies with SNP/Genotyping Technologies and Tools (Products)

Table 5: Selected Examples of Molecular Diagnostic Tests on the Market for Infectious Disease Diagnostics

Table 6: Selected Examples of Molecular Diagnostic Tests in Development for Infectious Disease Diagnostics

Table 7: Selected Companies Developing and/or Marketing Viral Genotyping Tests or Services (or Tests/Services for Viral Drug Resistance)

Table 8: Selected Companies Developing or Marketing Molecular Tests or Services for Cancer Diagnostics

Table 9: Selected Companies Developing or Marketing Molecular Tests or Services for Predicting Risk of Disease or Disease Susceptibility

Table 10: Selected Companies Developing or Marketing Molecular Tests or Services for Predicting Response to Drugs/Therapy

Table 11: Selected Companies Developing or Marketing Molecular Tests or Services for Genetic Testing/Inherited Diseases

Table 12: Selected Companies Developing or Marketing Molecular-Based Services for Identity or Forensics Testing

Table 13: World Molecular Diagnostics Market: 2002–2008 (millions of dollars)

Table 14: Sales of Molecular Diagnostics Products by Market Segment: 2002

Table 15: Market Shares of Leading Competitors in Molecular Diagnostics

Table 16: Selected Deals in Molecular Diagnostics, 1/1/02–5/1/03

Figure 1: SNP Genotyping Methods