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A Review of the Growth Opportunities and Challenges That Are Being Faced By Clinical Genomics

Posted on: Tuesday, 31 January 2006, 12:00 CST

Research and Markets (http://www.researchandmarkets.com/reports/c31841) has announced the addition of The Impact of Genomics on Clinical Trials to their offering.

The Impact of Genomics on Clinical Trials and Medical Practice evaluates the potential of clinical genomics to transform drug development and the practice of medicine. The report projects significant growth opportunities in this field, balanced with a realistic assessment of the challenges and hurdles to bringing clinical genomics to mainstream medicine.

Clinical genomics is the application of large-scale, high-throughput genomics technologies in clinical settings, such as clinical trials or primary care of patients. Clinical genomics promises to allow a molecular understanding of disease and drug response, with benefits in all areas of medicine.

Contributing to the growth of genomics, in 2005 the FDA issued guidelines for applications of genomics in drug development, with the stated hope that genomics will improve the safety and effectiveness of medicines. Given this mandate, clinical genomics applications appear to have crossed a threshold with the recent approval of several clinical genomics products. These approvals are expected to provide important precedents for other product approvals in the near future.

Examples reviewed in the report include the following:

-- Affymetrix's AmpliChip Cytochrome P450 Genotyping Test: In 2004 this test, a DNA chip that identifies variations in two genes affecting response to a wide variety of drugs, became the first microarray approved for treatment decisions by the FDA.

-- Third Wave Technologies' Invader UGT1A1 Test: This test for detecting heightened risk of adverse reaction to the chemotherapy drug irinotecan was FDA-approved in 2005 as the first pharmacogenetic companion diagnostic paired with a specific drug therapy.

Genomics applications in clinical trials are also dramatically rising. It is now estimated that about 20% of U.S. clinical trials use some sort of genomics approach, with the highest percentage in oncology trials. While this trend is expected to accelerate during the next few years, the field still faces considerable regulatory, technical, economic, and sociological hurdles. The full promise of clinical genomics applications may not be fully realized for at least another ten to fifteen years. However, as genomics transitions away from primarily research to more clinical applications, the field will be ripe with business opportunities and the report examines some of the business and strategic factors relevant to the further adoption of genomics technologies in clinical trials and medical practice.

Topics Covered

Chapter 1. Introduction

1.1. Overview

1.2. The Impact of Genomics in the Clinic

1.3. Impact of Data from the Human Genome

1.4. The Promise of Clinical Genomics

1.5. Challenges in the Field

Chapter 2. Applications of Genomics in Clinical Trials and Medicine

2.1. Prediction, Detection, and Diagnosis of Disease

2.2. Predicting Response to Drugs

2.3. Factors Influencing Response to Drugs

2.4. Personalized Medicine

2.5. Toxicogenomics

2.6. Determining Risk of Disease

2.7. Gene Therapy

2.8. Identifying Individuals

2.9. Proteomics

Chapter 3. Genomic Technologies for the Clinic

3.1. Overview

3.2. Detecting DNA Variation

3.3. SNP Genotyping Methods

3.4. Gene Expression Detection

3.5. RNA Interference

3.6. Other Technologies

Chapter 4. Advances in Clinical Genomics Applications

4.1. Overview

4.2. Toxicogenomics

4.3. Clinical Trials

4.4. Clinical Oncology

4.5. Infectious Diseases

4.6. Newborn Screening

4.7. Genomics and Race

4.8. Genomics and Drug Labeling

Chapter 5. Business and Strategic Factors

5.1. Overview

5.2. Patient Stratification

5.3. Scientific Issues

5.4. Standardization and Quality Control

5.5. Physician and Payer Response

5.6. Drug-Diagnostic Codevelopment: Theranostics

5.7. The Regulatory Environment

5.8. Cost-Benefit Analysis

5.9. Niche Markets for Clinical Genomics

References

Index

List of Tables and Figures

For more information visit http://www.researchandmarkets.com/reports/c31841

Source: Business Wire

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