Molecular Diagnostics: A Rapidly Shifting Commercial and Technology Landscape

Published by	Insight Pharma Reports
Published	November, 2007	Product code	58120
Content info	232 pages
Price	US $ 1498 PDF by E-mail ( Single User License) US $ 1875 PDF by E-mail (Single Site License)

Introduction
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Molecular Diagnostics: A Rapidly Shifting Commercial and Technology Landscape published by Insight Pharma Reports in November, 2007. This report consists of 232 pages and the price starts from US $ 1498.

Introduction

Abstract

Molecular diagnostic tests are now used for a wide range of applications, including:

Human clinical molecular diagnostic testing
Veterinary molecular diagnostic testing
Identity testing
Forensic testing
Histocompatibility testing

Within these broad disease areas, molecular diagnostics tests have a wide range of applications, including:

Identification of individuals who are at increased risk of developing certain disorders
Screening apparently healthy populations
Diagnosis
Determining prognosis, such as with cancer
Personalized medicine applications, including pharmacogenetic tests such as drug metabolism tests to avoid adverse drug effects and companion diagnostics to identify patients who will respond to a specific drug
Monitoring response to therapy

Molecular Diagnostics: A Rapidly Shifting Commercial and Technology Landscape focuses on human clinical molecular diagnostics. Even within this field, molecular diagnostics is being applied to a wide range of diseases and applications. The first molecular diagnostics tests to reach the market were for infectious diseases, and this remains the largest segment of the molecular diagnostics market. Molecular oncology tests have been emerging as a second significant-and rapidly growing-market segment. Molecular diagnostics is also starting to emerge as an important tool for inherited disorders, cardiovascular disorders, and other disease areas.

This report provides a thorough discussion of the many companies involved in molecular diagnostics and their commercial products either on the market or in development for these applications. Molecular diagnostics has emerged as a significant segment of the overall clinical diagnostics market. Overall, the molecular diagnostics market is growing rapidly, although some segments are growing more rapidly than others. This report provides an overview of the molecular diagnostics market, and discusses many of the trends in this market-including factors that are driving the growth.

This report also includes results from a Web survey of individuals involved in molecular diagnostics research, development, and use. More than 250 people responded to the survey, pointing out in a question what they think will be the biggest growth areas over the next 5 years:

As molecular diagnostics moves into the future, companies in this market will face a number of challenges. Selected examples of the challenges are discussed. The molecular diagnostics market is changing rapidly and is becoming highly competitive. The market shows considerable promise for new tests to improve the diagnosis and treatment of a wide range of diseases and disorders.

Chapter 1 BACKGROUND AND SCOPE

Chapter 2 CURRENT AND EMERGING TECHNOLOGIES

2.1. Nonamplified Probe-Based Assays
2.2. Cytogenetics and FISH
2.3. PCR and Other Amplification Technologies
2.4. Microarrays
2.5. DNA Methylation Assays
- Companies Focusing on Methylation and Cancer Diagnostics
  - Epigenomics
  - OncoMethylome Sciences
  - Orion Genomics
  - Rubicon Genomics
2.6. Other Current and Emerging Technologies

Chapter 3 CURRENT AND EMERGING APPLICATIONS OF MOLECULAR DIAGNOSTICS

3.1. Infectious Disease Diagnostics
- Human Immunodeficiency Virus
- Hepatitis C Virus
- Hepatitis B Virus
- Molecular Tests for Blood Screening
- Chlamydia and Gonorrhea
- Human Papillomavirus and Cervical Cancer
- Methicillin-Resistant Staphylococcus aureus
- Other Current and Emerging Infectious Disease Diagnostics Tests
3.2. Molecular Oncology Tests
- Analysis of the Expression of Multiple Genes and Cancer Prognosis
- Analysis of Lymph Nodes to Detect Metastasis of Breast Cancer
- Screening for Colorectal Cancer: Stool-Based DNA Screening
- Leukemias and Lymphomas
- DNA Methylation Tests and Cancer
- Other Emerging Molecular Diagnostics Tests for Oncology
  - Abbott Molecular
  - DiagnoCure
  - ExonHit Therapeutics
  - Gen-Probe
  - Roche Diagnostics
3.3. Genetic Testing: Tests for Inherited Disorders and Prenatal Diagnostics
- Cystic Fibrosis
- Prenatal Diagnosis
- Ashkenazi Jewish Genetic Panel
- Other Current and Emerging Molecular Tests - Inherited Disorders
3.4. Genetic Testing: Predicting Risk of Disease
- Risk of Venous Thromboembolism
- Predicting Risk of Developing Cancer
- Other Emerging Molecular Tests for Predicting Risk of Disease
3.5. Personalized Medicine: Pharmacogenomics and Companion Diagnostics
- Cytochrome P450 and Drug Metabolism
- Targeted Cancer Therapies and Companion Diagnostics Tests
- Testing for HER2/neu Overexpression in Breast Cancer
- Testing for Epidermal Growth Factor Receptor (EGFR)
- UGT1A1 Genetic Variants
- Pharmacogenetics and Response to Antiretroviral Therapy
- Thiopurine Methyltransferase and Metabolism of Thiopurine Drugs
- Other Molecular Diagnostics Personalized Medicine Tests
  - AutoGenomics
  - DxS
  - Myriad Genetics
  - OncoMethylome Sciences
  - PGxHealth (part of Clinical Data)

Chapter 4 BUSINESS CONSIDERATIONS IN MOLECULAR DIAGNOSTICS

4.1. Molecular Diagnostics Market
4.2. Major Trends in the Molecular Diagnostics Market
- Rapidly Growing Market; Growth Rates Vary by Segment
- Automation, Ease of Use
- Moving Molecular Diagnostics Tests Nearer to the Patient
- Growth in Number of New Biomarkers; Efforts to Demonstrate Clinical Utility
- Increasing Number of Tests Commercially Available
- Growing Number of FDA-Cleared and FDA-Approved Tests
- Consolidation in IVD
4.3. Personalized Medicine and Molecular Diagnostics: Impact on the Pharmaceutical Industry
- Treatment of Infectious Diseases
- Companion Diagnostics and Targeted Therapies
- Prevention of Adverse Drug Reactions
4.4. Major Challenges Facing Molecular Diagnostics Companies
- Regulatory Issues and Considerations
  - Regulatory Issues and Considerations for Molecular Diagnostics Clinical
  - Laboratories
  - Regulatory Issues and Considerations for Molecular Diagnostics
  - Companies
  - Regulatory Issues and Considerations for Pharmaceutical Companies
  - Developing Pharmacogenomic Therapies
- Reimbursement of Molecular Diagnostics
- Patient and Physician Education
- Identification of New Biomarkers; Validation of Biomarkers and Diagnostics Tests

Chapter 5 EXPERT INTERVIEWS

Fareed Kureshy, MBA
- Chairman, President and CEO
- AutoGenomics, Carlsbad, CA
David H. Persing, MD, PhD
- Executive Vice President, Chief Medical and Technical Officer
- Cepheid, Sunnyvale, CA
Geert Walther Nygaard
- CEO
- Epigenomics AG, Berlin, Germany and Oliver Schacht
- CFO and CEO
- Epigenomics, Seattle, WA
Shuqi Chen, PhD
- President, CEO, and Chairman
- IQuum, Marlborough, MA
Jorge Leon, PhD
- President, Leomics Associates
- Former Acting Chief Scientific Officer
- Orion Genomics, St. Louis, MO
James White
- Chief Executive Officer
- Osmetech, Pasadena, CA