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Reportlinker Adds Molecular Diagnostics: A Dynamic and Rapidly Broadening Market

NEW YORK, Oct. 29 /PRNewswire/ -- announces that a new market research report is available in its catalogue.

Molecular Diagnostics: A Dynamic and Rapidly Broadening Market

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

Chapter 1


1.1. Background

1.2. Focus of This Report

Chapter 2


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


OncoMethylome Sciences

Orion Genomics

Rubicon Genomics

2.6. Other Current and Emerging Technologies

Chapter 3


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


Genomic Health

Tests in Development for Prediction of Breast Cancer Metastases

Analysis of the Expression of Multiple Genes for Other Cancer Applications: Current

and Emerging Tests


Genomic Health

Pathwork Diagnostics

Analysis of Lymph Nodes to Detect Metastasis of Breast Cancer

Other Molecular Tests for Breast Cancer

Abbott Molecular

ExonHit Therapeutics and bioMerieux

Screening for Colorectal Cancer: Stool-Based DNA Screening

Exact Sciences

OncoMethylome Sciences

Colorectal Cancer and K-RAS Mutations

Other Molecular Tests for Colorectal Cancer



ExonHit Therapeutics and bioMérieux

OncoMethylome Sciences

Molecular Tests for Prostate Cancer



ExonHit Therapeutics and bioMerieux


Leukemias and Lymphomas

Abbott Molecular



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


DNA Methylation Tests and Cancer


OncoMethylome Sciences

Orion Genomics

Rubicon Genomics

Human Papillomavirus and Cervical Cancer Screening

Other Current and Emerging Molecular Tests for Oncology

Abbott Molecular


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


PGx Health (Part of Clinical Data)

3.3. Genetic Testing: For Inherited Disorders and Prenatal Diagnostics

Cystic Fibrosis

Prenatal Diagnosis

Abbott Molecular



Signature Genomic Laboratories

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 Alzheimer's Disease

Athena Diagnostics


Risk of Cardiovascular Diseases

deCODE Genetics

Other Emerging Molecular Tests for Predicting Risk of Disease


deCODE Genetics

3.5. Tables

Chapter 4


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)


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


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


Company Index with Web Addresses

To order this report:

Molecular Diagnostics: A Dynamic and Rapidly Broadening Market

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    Nicolas Bombourg
    US: (805)652-2626
    Intl: +1 805-652-2626

SOURCE Reportlinker

SOURCE Reportlinker
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