Nucleic Acid Testing: A Vehicle for Advancing Personalized Medicine

Published by: Decision Resources

Published: Apr. 17, 2009 - 29 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Introduction to NAT—A Central Technology

Driving the Evolution to Personalized Medicine

Affecting Drug Discovery and Approval

Leading the Molecular Diagnostic Assay Technologies

Scope of the Report

The NAT Toolbox: Technologies for Now and the Future

Therapeutic Focus of the NAT Market

Blood Screening and Infectious Diseases

Testing for Sexually Transmitted Infections

Hospital-Acquired Infections Testing

HIV Drug Resistance Testing

Infectious Respiratory Diseases

Oncology

Hereditary Risk Assays

Early Detection Assays

Targeted Therapy Assays

Assays for Cancer Prognosis

Assays Guiding Treatment Options

Company Leaders in NAT

Future Trends

Applications That Will Drive the NAT Market for the Foreseeable Future

Leading Companies in NAT Will Drive Growth Through Acquisitions and Licensing

NAT Assays Are High Value, but Tests Need to Demonstrate Cost-Effectiveness

Sidebar

Using Discovery Tools to Shape Future NAT Oncology Assays

Tables

1. The Nucleic Acid Testing Toolbox

2. Validated Genomic Biomarkers for Select Approved Agents

3. Select Nucleic Acid Testing Leaders, by Market Segment

4. Select Acquisitions in NAT, November 2007-December 2008

Appendix A. Select Licensing and Collaboration Activities in NAT, November 2007-December 2008

Figures

1. NAT Alliances in 2008, by Therapeutic Area

2. Algorithm for the Diagnosis of Chronic Hepatitis C

3. Cancer Molecular Targets

Abstract

• NAT is a leading molecular diagnostics technology. What are the advantages of NAT over other molecular diagnostics technologies? Which elements of NAT will drive personalized medicine forward?
• Polymerase chain reaction (PCR) is one of the most common methods in the NAT toolbox used to discover new biomarkers and develop diagnostics tests. What other methods are commonly used for NAT? Which of these methods have the most product development activity?
• Roche Diagnostics is the clear leader in molecular diagnostics. How do Roche's sales fi gures compare with those of smaller diagnostics players? What does the competition look like within the smaller segments? How are companies using dealmaking to advance their positions?
• Infectious disease and oncology are the two main therapy areas for use of NAT technologies. What are the growth trends and growth drivers within these therapy areas? What companies are positioned to tap the opportunities?

• Importance of NAT for advancing personalized medicine: Use of and rationale for NAT techniques and products to support the push for personalized medicine.
• Key mergers and acquisitions (M&As), collaboration, and licensing activities in NAT: Two tables featuring 92 alliances that occurred from November 2007 through December 2008.
• Leading NAT markets: Types of assays and tests within infectious disease and oncology that will continue to have a strong presence in the NAT market.
• Future trends: Insight into strategic considerations required to drive the NAT market and NAT companies forward.

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