Molecular Diagnostics: A Dynamic and Rapidly Broadening Market

  • January 2009
  • -
  • CHI Insight Pharma Reports


Molecular diagnostic applications in the areas of oncology, personalized medicine, inherited disorders, prediction of genetic disease risk, and many others are rapidly increasing in number as this burgeoning field expands beyond infectious disease testing. This report focuses on these newer applications of molecular diagnostics, analyzing:
  • Established and up-and-coming technologies
  • The activities of more than 35 companies
  • More than 300 current and emerging molecular diagnostic tests for disease applications and genetic testing
  • Business considerations associated with product development, commercialization, and marketing
  • Regulatory issues
  • Challenges facing companies developing molecular diagnostics and/or companion diagnostics and targeted therapies
  • Major trends in the molecular diagnostics market, such as the increasing number of tests that are commercially available
 
 

Table Of Contents

Chapter 1
BACKGROUND AND SCOPE
1.1. Background
1.2. Focus of This Report
Chapter 2
CURRENT AND EMERGING TECHNOLOGIES
2.1. Nonamplified Probe-Based Assays
2.2. Cytogenetics and Fluorescent In Situ Hybridization (FISH)
2.3. Polymerase Chain Reaction (PCR) and Other Amplification Technologies
2.4. Microarrays and Other Multiplex Technologies
2.5. DNA Methylation Assays
Epigenomics
OncoMethylome Sciences
Orion Genomics
Rubicon Genomics
2.6. Other Current and Emerging Technologies
Chapter 3
CURRENT AND EMERGING APPLICATIONS OF MOLECULAR DIAGNOSTICS: MOVING BEYOND INFECTIOUS DISEASE TESTING
3.1. Oncology: Diagnostic, Prognostic, and Personalized Medicine Tests
Testing for HER2/neu Overexpression in Breast Cancer
Testing for Epidermal Growth Factor Receptor
Analysis of the Expression of Multiple Genes for Breast Cancer
Prognosis and Treatment Decisions: Current and Emerging Tests
Agendia
bioTheranostics
Genomic Health
Ipsogen
Tests in Development for Prediction of Breast Cancer Metastases
Analysis of the Expression of Multiple Genes for Other Cancer Applications: Current
and Emerging Tests
Agendia
bioTheranostics
Genomic Health
Pathwork Diagnostics
Analysis of Lymph Nodes to Detect Metastasis of Breast Cancer
Other Molecular Tests for Breast Cancer
Abbott Molecular
AdnaGen
Celera
ExonHit Therapeutics and bioMandeacute;rieux
Screening for Colorectal Cancer: Stool-Based DNA Screening
Exact Sciences
OncoMethylome Sciences
NorDiag
Colorectal Cancer and K-RAS Mutations
DxS
Qiagen
Other Molecular Tests for Colorectal Cancer
AdnaGen
DiagnoCure
Epigenomics
ExonHit Therapeutics and bioMandeacute;rieux
OncoMethylome Sciences
Molecular Tests for Prostate Cancer
AdnaGen
CombiMatrix
Epigenomics
ExonHit Therapeutics and bioMandeacute;rieux
Gen-Probe
Leukemias and Lymphomas
Abbott Molecular
Asuragen
Cepheid
CombiMatrix
InVivoScribe Technologies
Roche Molecular Diagnostics
Selected Other Companies with Molecular Tests for Leukemia and Lymphoma
Outside the United States
UGT1A1 Genetic Variants
Third Wave Technologies
AutoGenomics
DNA Methylation Tests and Cancer
Epigenomics
OncoMethylome Sciences
Orion Genomics
Rubicon Genomics
Human Papillomavirus and Cervical Cancer Screening
Other Current and Emerging Molecular Tests for Oncology
Abbott Molecular
Asuragen
Dako
DxS
Myriad Genetics
Roche Molecular Diagnostics
3.2. Personalized Medicine; Pharmacogenomics and Companion Diagnostics:Moving Beyond Oncology
Cytochrome P450 and Drug Metabolism
Pharmacogenomic Test for Warfarin Response
Thiopurine Methyltransferase and Metabolism of Thiopurine Drugs
Pharmacogenetics and Response to Antiretroviral Therapy (Anti-HIV Therapy)
Other Molecular Diagnostics Personalized Medicine Tests
AutoGenomics
PGx Health (Part of Clinical Data)
XDx
3.3. Genetic Testing: For Inherited Disorders and Prenatal Diagnostics
Cystic Fibrosis
Prenatal Diagnosis
Abbott Molecular
CombiMatrix
Sequenom
Signature Genomic Laboratories
Tepnel
Ashkenazi Jewish Genetic Panel
Comparative Genomic Hybridization Microarrays
Other Current and Emerging Molecular Tests for Inherited Disorders
3.4. Genetic Testing: Predicting Risk of Disease
Risk of Venous Thromboembolism
Predicting Risk of Developing Cancer
Myriad Genetics
deCODE Genetics
Risk of Developing Alzheimerandrsquo;s Disease
Athena Diagnostics
Innogenetics
Celera
Risk of Cardiovascular Diseases
Celera
deCODE Genetics
Other Emerging Molecular Tests for Predicting Risk of Disease
Celera
CombiMatrix
deCODE Genetics
3.5. Tables
Chapter 4
BUSINESS CONSIDERATIONS IN MOLECULAR DIAGNOSTICS
4.1. Molecular Diagnostics Market Overview
4.2. Major Trends in the Molecular Diagnostics Market
Automation, Ease of Use
Moving Selected Molecular Diagnostic Tests Nearer to the Patient
Growth in Number of New Biomarkers
Increasing Efforts on Clinical Validation of Tests
Increasing Number of Tests Commercially Available
Launching New Tests Through CLIA-Certified Laboratories
Impact of FDA Regulations
Growing Number of FDA-Cleared and Approved Tests
Consolidation (Acquisitions)
Competition
Increasing Role of Personalized Medicine
4.3. Personalized Medicine and Molecular Diagnostics
Treatment of Infectious Diseases
Companion Diagnostics and Targeted Therapies
Other Personalized Medicine Tests
4.4. Major Challenges Facing Molecular Diagnostic Companies
Challenges Associated with Personalized Medicine Market Segment
Regulatory Issues and Considerations
Regulatory Issues and Considerations for Molecular Diagnostics Clinical Laboratories
Regulatory Issues and Considerations for Molecular Diagnostic Companies
Regulatory Issues and Consideration for Pharmaceutical Companies Developing Pharmacogenomic Therapies
Reimbursement of Molecular Diagnostics
Patient and Physician Education
Identification of New Biomarkers; Validation of Biomarkers and Diagnostic Tests
Chapter 5
EXPERT INTERVIEWS
Jeremy Bridge-Cook, PhD, Vice President, Luminex Molecular Diagnostics, Luminex Corporation, Austin, TX
David Craford, Vice President, Commercial Operations, Pathwork Diagnostics, Sunnyvale, CA
Amit Kumar, PhD, CEO and President, CombiMatrix Corporation, Mukilteo, WA
Fareed Kureshy, Founder, Chairman, President, and CEO, AutoGenomics, Carlsbad, CA
Jeffrey E. Miller, PhD, CSO, CEO, and Chairman, InVivoScribe Board of Directors,
InVivoScribe Technologies, San Diego, CA
Mansoor Mohammed, PhD, President and CEO, CombiMatrix Molecular Diagnostics (CMDX) (subsidiary of CombiMatrix Corporation), Irvine, CA
Oliver Schacht, PhD, CFO and CEO, Epigenomics Inc., Epigenomics AG, Berlin, Germany
John C. Schafer, President and CEO, DiagnoCure, Quebec, Canada
James White, CEO, Osmetech plc, Pasadena, CA
Matt Winkler, PhD, CEO and CSO, Asuragen, Austin, TX
References
Company Index with Web Addresses

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