Molecular Diagnostics: A Rapidly Shifting Commercial and Technology Landscape

By Lucy Sannes, PhD, MBA

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

Chapter 6
SELECTED COMPANY PROFILES
Abbott Molecular (aka Vysis)
Agendia
AutoGenomics
BD and BD GeneOhm
Cepheid
Digene
Genomic Health
Gen-Probe
Luminex
Nanogen
Osmetech and Osmetech Molecular Diagnostics
Prodesse
Qiagen
Roche Molecular Systems
Third Wave Technologies

Appendix
CHI INSIGHT PHARMA REPORTS - MOLECULAR DIAGNOSTICS SURVEY ANALYSIS