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Molecular Diagnostics Markets - Product Image

Molecular Diagnostics Markets

  • ID: 38984
  • November 2013
  • Region: Global
  • 403 Pages
  • TriMark Publications

FEATURED COMPANIES

  • Abbott Laboratories
  • Biodesix
  • Enzo Biochem
  • Illumina
  • Neogenomics
  • Seegene
  • MORE

The technologies that constitute molecular diagnostics - like first-generation amplification, DNA probes, fluorescent in situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors, and molecular labels - are influencing the discovery of therapeutic molecules, the screening and diagnosis of patients, and the optimization of drug therapy. In the past few years, this rapidly evolving field has seen several fascinating developments.

This report describes the specific market segment of the in vitro diagnostics market known as molecular diagnostics and includes all of the generally accepted clinical analytical activities in use today. It examines the prevalent clinical-measurement devices, as well as their reagents and supplies as utilized in hospitals, clinics, large reference laboratories and doctor’s offices. Diagnostic tests marketed primarily as over-the-counter are generally not included in this report, although there is inevitably some overlap.

Main Objectives of Report

1) Identifying viable technology drivers through a comprehensive look at platform technologies for molecular diagnostics, including READ MORE >

FEATURED COMPANIES

  • Abbott Laboratories
  • Biodesix
  • Enzo Biochem
  • Illumina
  • Neogenomics
  • Seegene
  • MORE

1. Overview
1.1 Statement of Report
1.2 About This Report
1.3 Scope of the Report
1.4 Objectives
1.5 Methodology
1.6 Executive Summary

2. Introduction to Molecular Diagnostics and PCR Technology
2.1 Introduction to Genomics and Its Opportunity
2.2 Genetic Variability and Disease
2.3 Impact of the Human Genome Project on Molecular Diagnostics
2.4 Key Considerations for Molecular Diagnostics
2.5 Molecular Diagnostics in the Post-Genomic Era
2.6 Advances in Molecular Diagnostics Technologies
2.7 Molecular Diagnostics Testing Technologies and Platforms
2.7.1 Amplification Technologies
2.7.1.1 PCR and PCR Derivative Platforms
2.7.1.2 Multiple Displacement Amplification
2.7.1.3 Multiple Annealing and Looping-based Amplification Cycles
2.7.1.4 Whole Genome Amplification
2.7.1.5 Nucleic Acid Sequence-based Amplification
2.7.1.6 Ligase Chain Reaction
2.7.1.7 Branched DNA
2.7.1.8 Bio-Barcode Amplification Assay
2.7.2 Detection of Amplified Gene Products
2.7.2.1 High Resolution Melting Analysis
2.7.2.2 Microparticle-based Flow Cytometry
2.7.3 DNA and Oligonucleotide Microarrays and Chips
2.7.3.1 Array Comparative Genomic Hybridization
2.7.4 Gene Sequencing
2.7.4.1 Sanger Sequencing
2.7.4.2 Next Generation Sequencing
2.7.5 Fluorescence in situ Hybridization
2.8 PCR Reagents
2.9 Basic Molecular Testing Work Flow
2.10 Techniques
2.11 Advances in Automated Testing

3. Business Landscape for the Molecular Diagnostics Market Sectors
3.1 Market Overview
3.2 Molecular Diagnostics Market: Size, Growth, Share, and Competitors
3.2.1 Global Molecular Diagnostics Market
3.2.2 U.S. Molecular Diagnostics Market
3.2.3 Market Share
3.2.4 Competitive Environment
3.2.5 Marketing Strategies
3.3 Snapshot of Molecular Diagnostics Industry Structure
3.4 Commercialization and Market Penetration Strategies
3.4.1 Partnerships
3.5 Market Drivers and Restraints
3.6 Market and Technology Trends
3.6.1 Market Trends
3.6.2 Technology Trends
3.7 Strategic Recommendations
3.8 What are the Challenges for the Future?
3.9 What New Trends are in the Future?
3.10 Recent Industry Activity
3.10.1 M&A Activity
3.10.2 License Agreements and Partnerships
3.11 Key Areas Impacting Future of Molecular Diagnostics
3.11.1 Pharmacogenetics and Pharmacogenomics
3.11.1.1 Current Applications for Pharmacogenetics and Pharmacogenomics
3.11.1.2 Pharmacogenomics and Personalized Medicine in MDx Infectious Disease Testing
3.11.1.3 Companion Diagnostics and Personalized Medicine in the Oncology Sector
3.11.2 Toxicogenomics
3.11.3 Multiplex Molecular Diagnostics
3.11.4 Point of Care Readers and Assays
3.11.5 Next Generation Sequencing
3.12 Intellectual Property Rights
3.12.1 New Patents
3.12.2 Current Patent Disputes

4. Overview of Clinical Molecular Diagnostic Platforms on the Market
4.1 Abbott
4.1.1 m2000 RealTime System
4.2 Affymetrix Gene Profiling Solutions
4.2.1 GeneChip System 3000Dx v.2
4.2.2 Gene Profiling Array cGMP U133 P2
4.2.3 Affymetrix Gene Profiling Reagents
4.3 AutoGenomics
4.3.1 INFINITI Plus Analyzer
4.4 Becton Dickinson
4.4.1 BD MAX System
4.4.2 BD Viper System
4.4.3 BD Affirm VPIII Microbial Identification System
4.4.4 BD ProbeTec ET System
4.5 Biomerieux
4.5.1 NucliSENS EasyQ
4.5.2 NucliSENS easyMAG
4.6 Cepheid
4.6.1 GeneXpert System
4.6.2 SmartCycler System
4.7 GenMark Dx
4.7.1 eSensor XT-8 System
4.8 Hologic Gen-Probe
4.8.1 PANTHER System
4.8.2 TIGRIS DTS System
4.9 Illumina
4.9.1 MiSeqDx Instrument
4.10 Life Technologies/Applied Biosystems
4.10.1 QuantStudio Dx Real-Time PCR
4.10.2 Veriti Dx PCR Thermal Cycler
4.10.3 3500 Dx Genetic Analyzers CS2
4.10.4 7500 Fast Dx Real-Time PCR System
4.11 Meridian Bioscience
4.11.1 Illumipro-10
4.12 Nanosphere
4.12.1 Verigene System
4.13 Qiagen
4.13.1 Rotor-Gene Q MDx
4.13.2 Rapid Capture System & Hybrid Capture 2 Modular System
4.14 Roche
4.14.1 COBAS 4800 System
4.14.2 COBAS AmpliPrep / COBAS TaqMan System
4.14.3 COBAS AMPLICOR Analyzer
4.14.4 LightCycler 2.0 Instrument
4.15 Siemens
4.15.1 VERSANT 440 Molecular System

5. Molecular Diagnostic Testing and Infectious Diseases
5.1 Molecular Testing of Infectious Disease Market
5.2 HIV Molecular Testing
5.2.1 Summary of Assays and Platforms
5.2.2 HIV Molecular Diagnostics Market and Technology Trends
5.2.2.1 Market Trends
5.2.2.2 Technology Trends
5.2.2.3 Strategic Recommendations
5.3 Hepatitis Molecular Testing
5.3.1 Hepatitis B Virus
5.3.1.1 HBV Molecular Assays and Platforms
5.3.1.2 Hepatitis B Market
5.3.2 Hepatitis C Virus
5.3.2.1 HCV Molecular Assays
5.3.2.2 Hepatitis C Market
5.4 Influenza Virus Molecular Testing
5.4.1 Assays for Influenza Detection
5.4.2 Influenza Molecular Diagnostic Market
5.4.2.1 Market Trends
5.4.2.2 Technology Trends
5.4.2.3 Strategic Recommendations
5.5 STD Testing (Chlamydia/Gonorrhea Molecular Diagnostic Testing)
5.5.1 CT/NG Testing Competitive Structure and Market Share Analysis
5.5.1.1 CT/NG Testing Market Trends
5.5.1.2 Technology Trends
5.5.1.3 Strategic Recommendations
5.5.2 Chlamydia Molecular Diagnostic Testing
5.5.2.1 Product Analysis: Instruments and Reagents for Testing Chlamydia
5.5.3 Gonorrhea Molecular Diagnostic Testing
5.5.4 Product Analysis: Instruments and Reagents
5.6 Tuberculosis
5.6.1 Product Analysis: Instruments and Reagents
5.6.2 Tuberculosis Market
5.6.2.1 Market Trends
5.6.2.2 Technology Trends
5.6.2.3 Strategic Recommendations
5.7 Methicillin-Resistant Staphylococcus aureus
5.7.1 Product Analysis: Instruments and Reagents
5.7.2 MRSA Molecular Diagnostics Market
5.7.2.1 Market Trends
5.7.2.2 Technology Trends
5.7.2.3 Strategic Recommendations
5.8 Vancomycin-resistant Enterococci
5.8.1 Product Analysis: Instruments and Reagents
5.8.2 VRE Molecular Testing Market
5.8.2.1 Market Trends
5.8.2.2 Technology Trends
5.8.2.3 Strategic Recommendations
5.9 Herpes Simplex Virus
5.10 C. difficile
5.11 Cytomegalovirus
5.12 Blood Screening
5.12.1 Product Analysis: Instruments and Reagents
5.12.2 Blood Screening Market
5.12.2.1 Market Trends
5.12.2.2 Technology Trends
5.12.2.3 Strategic Recommendations
5.13 Human Papillomavirus
5.13.1 Molecular Instruments and Reagents for HPV Detection
5.13.2 HPV Market
5.13.2.1 North American Market
5.13.2.2 European Market
5.13.2.3 Market Trends
5.13.2.4 Technology Trends
5.13.2.5 Strategic Recommendations

6. Cancer Detection Using Molecular Diagnostics
6.1 Breast Cancer
6.1.2 Breast Cancer Prognostic Assays
6.1.2.1 Myriad Genetics (BRACA1 and BRACA2)
6.1.2.2 Genomic Health (Oncotype DX)
6.1.2.3 InterGenetics, Inc.
6.1.2.4 LabCorp (HER-2)
6.1.2.5 Clarient, Inc. (GE Healthcare)
6.1.2.6 BioTheronostics (AviaraDx)
6.1.2.7 Agendia B.V. (MammaPrint)
6.1.2.8 Oncogene Science (Wilex)
6.1.2.9 Ventana Medical Systems
6.1.3 Competition and Comparison of Methods
6.1.4 Competitive Structure and Market Share Analysis
6.1.4.1 Breast Cancer Molecular Diagnostic Testing Market Size
6.1.4.2 Market Forecasts
6.1.4.3 Market Drivers and Restraints
6.1.4.4 Breast Cancer Molecular Diagnostic Testing Assay Market and Technology Trends
6.2 Colorectal Cancer Molecular Diagnostics Market
6.2.1 Colon Cancer Testing Platforms
6.2.1.1 Genomic Testing
6.2.1.2 Screening Test
6.2.2 Players in the Colorectal Cancer Space
6.2.3 Competitive Structure and Market Share Analysis
6.2.3.1 Colon Cancer Molecular Diagnostic Testing Market Size
6.2.3.2 Market Forecasts
6.2.3.4 Market Drivers and Restraints
6.2.3.5 Colon Cancer Molecular Diagnostic Testing Assay Market and Technology Trends
6.3 Prostate Cancer Molecular Diagnostics Market
6.3.1 Screening for Prostate Cancer
6.3.1.1 PSA Screening Test for Prostate Cancer
6.3.1.2 PCA3 Screening Test for Prostate Cancer
6.3.1.3 Gen-Probe
6.3.1.4 Beckman Coulter (Danaher) Prostate Health Index
6.3.1.5 Opko Health 4KScore
6.3.1.6 Metabolon Prostarix DRE Urine Test
6.3.2 Tests after Positive Biopsy
6.3.2.1 Myriad Genetics (Prolaris)
6.3.2.2 Genomic Health (Genomic Prostate Score)
6.3.2.3 Bostwick Laboratories (ProstaVysion)
6.3.2.4 Metamark Genetics (Biopsy Test)
6.3.3 Tests After Negative Biopsy
6.3.3.1 Mitomics (Prostate Core Test)
6.3.3.2 MDxHealth (Confirm MDx)
6.3.4 Tests After Surgery
6.3.4.1 GenomeDx Sciences (Decipher)
6.3.4.2 Iris International (Nadia ProsVue)
6.3.5 Competition and Comparison of Methods
6.3.6 Competitive Structure and Market Share Analysis
6.3.7 Market Drivers and Restraints
6.3.7.1 Market Drivers
6.3.7.2 Market Restraints
6.3.8 Prostate Cancer Molecular Diagnostic Testing Assay Market and Technology Trends
6.3.8.1 Prostate Cancer Molecular Diagnostic Testing Assay Market Trends
6.3.8.2 Prostate Cancer Molecular Diagnostic Testing Assay Technology Trends
6.3.8.3 Prostate Cancer Testing Assay Strategic Recommendations
6.4 Other Cancer Molecular Diagnostic Markets
6.4.1 Bladder Cancer
6.4.2 Lung Cancer
6.4.3 Melanoma
6.5 Molecular Diagnostic Screening Test for Cancer
6.6 Companion Diagnostic Tests for Cancer Therapeutics

7. Genetics Testing in Molecular Diagnostics
7.1 Key Functions of Molecular Genetic Testing
7.1.1 Diagnostic Testing of Genetic Disorders
7.1.1.1 Common Genetic Disorders
7.1.2 Carrier Testing for Genetic Disorders
7.1.3 Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening
7.1.4 Prenatal/In utero Genetic Testing
7.1.5 Newborn Genetic Screening Tests
7.1.6 Presymptomatic and Predictive Testing for Adult Onset Disorders
7.1.7 Pharmacogenomics
7.1.8 Tissue and Blood Typing
7.1.8.1 Human Leukocyte Antigen Determination
7.1.8.2 Rhesus D Factor Determination
7.1.9 Parentage/Relationship Testing (Paternity Testing)
7.1.10 Genealogical DNA Testing
7.1.11 Criminal and Forensics Testing
7.2 Market Structure and Competitive Situation
7.2.1 Primary Competitors
7.2.2 Commercialization Strategies for Molecular Diagnostic Products
7.2.3 Market Penetration Strategies for Genetic Testing
7.3 Growing Genetic Testing Market Segments
7.3.1 Personalized Medicine and Companion Diagnostics Market
7.3.2 Predictive Molecular Diagnostics Market
7.3.3 Parallel Genetic Tests for Drug Development
7.3.4 Direct-to-Consumer Genetic Testing Market
7.3.5 Detecting Genetic Disorders
7.3.6 Pre-natal Screening
7.3.7 Neonatal Screening
7.3.8 Forensic Testing
7.3.9 Parentage Testing
7.3.10 Blood and Tissue Typing
7.3.11 DNA Sequencing
7.4 Select Diagnostic and Carrier Tests for Genetic Disorders
7.4.1 CombiMatrix Diagnostics’ DNAarray™ Pediatric Microarray Oligo 105K
7.4.2 GeneDx’s Genetic Testing for Hereditary Disorders
7.4.3 Hologic’s Factor V Reagents
7.4.4 Progenika’s FH Test
7.4.5 Abbott Molecular’s Cystic Fibrosis Genotyping Assay
7.4.6 Counsyl’s Universal Genetic Test
7.4.7 Hologic’s InPlex® CF Molecular Test
7.4.8 Integrated Genetic’s Inheritest Carrier Screen
7.4.9 Luminex’s xTAG Cystic Fibrosis (CFTR) v2 Assays
7.4.10 Natera’s Natera One Multi-Disease Genetic Carrier Screening Panel
7.4.11 Sequenom’s Heredi-T Cystic Fibrosis Carrier Screen Test
7.4.12 Summary of Cystic Fibrosis Tests
7.5 Pre-implantation Genetic Tests
7.5.1 Natera’s Preimplantation Genetic Diagnosis Test
7.6 Prenatal/In Utero Molecular Genetic Screening Tests
7.6.1 Cell-Free Fetal DNA Testing
7.6.1.1 Ariosa Diagnostics’ Harmony Prenatal Test
7.6.1.2 Natera’s Panorama
7.6.1.3 Sequenom’s MaterniT21 PLUS Test
7.6.1.4 Verinata Health’s verifi Prenatal Test
7.6.2 Molecular Cytogenetic Tests
7.6.2.1 Abbott Molecular’s AneuVysion Multicolor DNA Probe Panel
7.6.2.2 CombiMatrix Diagnostics’ DNAarray Prenatal Microarrays
7.6.2.3 Signature Genomics’ Signature Precision Panel I Prenatal
7.6.2.4 Signature Genomics’ Signature PrenatalChip TE (Targeted Enhanced) Microarray
7.6.2.5 Signature Genomics’ Signature PrenatalChip OS Microarray
7.7 Newborn Genetic Screening Tests
7.7.1 Screening for Cystic Fibrosis with Molecular Diagnostic Assays
7.7.2 Screening for SCID with the TREC Assay
7.7.2.1 PerkinElmer Genetics

8. Molecular Diagnostics Uses in Industrial Testing and Food Diagnostics
8.1 The Market
8.1.1 Detection of Helicobacter pylori by PCR
8.1.2 Detection of Escherichia coli 0157
8.1.3 Detection of Enteric Viruses
8.1.4 Industrial Microorganisms
8.2 Molecular Diagnostics Forensics Testing Market
8.2.1 Analysis by PCR-based DNA Typing
8.2.2 Rapid Isolation of DNA for Restriction Fragment Length Polymorphism (RFLP) and PCR
8.2.3 DNA for PCR-STR Typing

9. Bioterrorism and Molecular Diagnostics
9.1 Introduction
9.2 Current Biological Threat Detection Systems
9.2.1 Use of DNA Microarrays and Biochips for Gene Expression Profiles in BWAs
9.2.2 Advantages and Disadvantages of Host Gene Expression Profiling as a Biothreat Detection
9.2.3 Biological Warfare Agents
9.2.4 Anthrax
9.2.5 Botulinum Toxin
9.2.6 Ricin
9.2.7 IVD Industry and Bioterrorism Preparedness
9.2.8 Brucellosis
9.2.9 Cholera
9.3 Rapid Lateral Flow Immunoassays
9.4 Biosensors
9.5 Anthrax in Clinical Samples
9.5.1 Rapid Tests

10. Regulatory Requirements
10.1 U.S. Food and Drug Administration
10.1.1 FDA Labeling Requirements
10.1.2 U.S. Government Regulation of Medical Devices
10.1.3 FDA’s Qualification of Biomarkers
10.1.4 FDA’s Voluntary Genomic Data Submission
10.2 Clinical Laboratory Improvement Act
10.3 CLIA Regulations
10.4 State Licensing for Service Laboratories
10.5 Multivariate Index Assays
10.6 FDA Draft Guidance on In Vitro Companion Diagnostic Devices
10.7 FDA Draft Guidance on Molecular Diagnostic Instruments with Combined Functions
10.8 510(k) Clearance
10.9 Pre-Market Approval
10.10 Pre-market Approval Application
10.11 Laboratory Developed Tests
10.12 Analyte Specific Reagents
10.13 What Regulatory Guidance is needed for Companion Biomarkers?
10.14 IRB Approval in Clinical Trials
10.15 CE marking and the European In Vitro Diagnostic Device Directive
10.16 De Novo Classification
10.17 Research Use Only Reagents
10.18 Ethical, Legal and Social Issues Related to the Use of Genetic Information
10.19 Regulatory Issues for Direct to the Consumer Genetic Tests
10.20 The Genetic Information Nondiscrimination Act of 2008
10.21 Genetic Tests and Medical Records
10.22 Recommendations by the American College of Medical Genetics and Genomics

11. Reimbursement Issues and Billing Landscape for Molecular Diagnostics Testing
11.1 Overview
11.1.1 Gap Filling
11.2 Trends in Healthcare Reimbursement Practices
11.2.1 Molecular Genetics Testing Reimbursement
11.3 Medicare Reimbursement Program
11.4 Medicare Billing Procedure
11.5 CPT Coding Rules for Molecular Diagnostics
11.5.1 Former Coding Rules for Molecular Diagnostics
11.5.2 Current Coding Rules for Molecular Diagnostics
11.5.2.1 Gapfilling
11.5.2.2 Reimbursement Delays for Molecular Diagnostics
11.6 Revenue Threats
11.6.1 Medicare Payment Exceptions
11.6.2 Three Areas for Denial of Claims
11.7 Bundled Payments for Care Improvement Initiative
11.8 Infectious Disease Billing Strategies
11.9 Analysis of ROI for MDx Tests for Cancer Using Medicare Reimbursement Rules
11.9.1 Reimbursement for Insight Dx, MammaPrint and Oncotype Dx
11.9.2 Reimbursement for JAK2 Mutation Testing for Myeloproliferative Neoplasms

12. Company Profiles
12.1 Abbott Laboratories
12.2 AdvanDx
12.3 Agendia
12.4 Arcxis Biotechnologies
12.5 Agilent Technologies
12.6 Ambry Genetics
12.7 Atlas Genetics
12.8 AutoGenomics, Inc.
12.9 Beckman Coulter
12.10 Becton, Dickinson and Company
12.11 Biodesix
12.12 Biohelix Corporation
12.13 bioMérieux
12.14 Bio-Rad Laboratories
12.15 Cancer Genetics, Inc.
12.16 Celera (acquired by Quest Diagnostics)
12.17 Cepheid
12.18 Clarient, Inc. (GE Healthcare)
12.19 CombiMatrix Corporation
12.20 Cytocell Technologies Ltd.
12.21 DiagnoCure, Inc.
12.22 Enzo Biochem
12.23 Epigenomics
12.24 Exact Sciences Corporation
12.25 Exagen Diagnostics, Inc.
12.26 Exiqon
12.27 Genera Biosystems
12.28 GenMark Diagnostics, Inc.
12.29 Genomic Health
12.30 Great Basin Corporation
12.31 Hologic
12.32 Illumina
12.33 IntegenX
12.34 InterGenetics, Inc.
12.35 LabCorp
12.36 Life Technologies Corporation
12.37 Luminex
12.38 Myriad Genetics, Inc.
12.39 Nanosphere
12.40 Nanostring
12.41 Natera
12.42 NetBio
12.43 Neogenomics
12.44 Nuvera Biosciences
12.45 Orion Genomics
12.46 PerkinElmer Genetics
12.47 Progenika
12.48 QIAGEN N.V.
12.49 Roche Diagnostics
12.50 Rosetta Genomics Ltd.
12.51 Seegene
12.52 Sequenom, Inc.
12.53 Siemens Healthcare Diagnostics (Siemens)
12.54 Spartan Bioscience
12.55 Thorne Diagnostics
12.56 Transgenomic
12.57 TrimGen
12.58 Trovagene, Inc.
12.59 Veredus Laboratories
12.60 Veridex

Index of Figures

Figure 2.1: Segment of Double-Stranded DNA Showing the Base-Pair Relationship
Figure 2.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients
Figure 2.3: The PCR Cycle
Figure 2.4: Multiple Displacement Amplification
Figure 2.5: Using DNA Microassays to Measure Gene Expression
Figure 3.1: Overall Structure of Nucleic Acid Testing Market
Figure 3.2: Global Market for Molecular Diagnostics Testing, 2012
Figure 3.3: Molecular Diagnostics Market Segmentation by Technology
Figure 3.4: Share of Molecular Diagnostics Testing by Application, 2012
Figure 3.5: Key Players Market Share in Global Molecular Diagnostics Testing Markets
Figure 3.6: FDA Co-developed Products as a Model for Collaboration
Figure 5.1: Global Market for Infectious Disease Treatments, 2008-2014
Figure 5.2: Global Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018
Figure 5.3: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018
Figure 5.4: Infectious Disease Testing Revenue Market Share of Total U.S. MDx Market, 2012 and 2018
Figure 5.5: Infectious Disease Testing Revenue Market Share by Region, 2012 and 2018
Figure 5.6: Markers of Acute HCV Infection as a Function of Time after Exposure to Infection
Figure 5.7: Pipeline for TB Diagnostics, 2005-2015
Figure 5.8: The Development Pipeline for New TB Drugs, July 2012
Figure 5.9: U.S. Market Share of MRSA Molecular Diagnostic Market, 2012
Figure 5.10: Global Market Share (Excluding U.S.) of MRSA Molecular Diagnostic Market, 2012
Figure 5.11: U.S. Market Share of VRE Molecular Diagnostic Market, 2012
Figure 5.12: Hybrid Capture 2 (HC2) versus PCR - Analytical Sensitivity and Clinical Sensitivity
Figure 5.13: Basic Steps in Hybrid Capture 2 Technology
Figure 5.14: U.S. Market Share of HPV Molecular Diagnostic Market, 2012
Figure 5.15: Global Market Share (Excluding U.S.) of HPV Molecular Diagnostic Market, 2012
Figure 5.16: Market Share Estimates for Molecular Diagnostic HPV Testing, 2012
Figure 6.1: HER-2/NEU Protein as a Target in Cancer Therapy
Figure 6.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC
Figure 6.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH
Figure 6.4: Action of Herceptin in Breast Cancer Patients
Figure 6.5: Analysis of Cancer Tissue by Microarray
Figure 6.6: Global Market Size and Share of Breast Cancer Molecular Diagnostic Market, 2012
Figure 6.7: HNPCC Mutation Increases Risk of Cancer
Figure 6.8: APC Mutation Increases the Risk of Cancer
Figure 6.9: Prostate-Specific Membrane Antigen
Figure 6.10: PCA3 Score Nomogram
Figure 6.11: Estimates for PCA3 Test Volume in the U.S., 2005-2012
Figure 7.1: Segmentation of the Biomarker Development Market
Figure 10.1: Current Regulations for Laboratory Testing
Figure 10.2: Existing Regulatory Framework for LDTs
Figure 11.1: Reimbursement for Diagnostics in Healthcare Decision Making
Figure 11.2: MAC Jurisdiction Map, 2012

Index of Tables

Table 2.1: Key Assay Technologies for Molecular Diagnostics
Table 2.2: Emerging Molecular Diagnostic Technologies
Table 2.3: DNA Microarray Applications
Table 2.4: Companies Involved in Next Generation Sequencing Platforms
Table 2.5: Desired Characteristics for Clinical Versus Discovery Next Generation Sequencing
Table 3.1: Applications of Molecular Diagnostics Technology Platforms
Table 3.2: Global Market for Molecular Diagnostics Testing, 2010-2018
Table 3.3: U.S. Market for Molecular Diagnostics Testing, 2010-2018
Table 3.4: Share of Molecular Diagnostics Testing by Application, 2012
Table 3.5: Key Players and Market Share in the Global Molecular Diagnostics Testing Market
Table 3.6: Revenue Model for Molecular Diagnostics Testing
Table 3.7: Companies Marketing Multiple Products in Molecular Diagnostics Sector
Table 3.8: Companies Marketing Clinical Genotyping Technologies
Table 3.9: Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
Table 3.10: Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
Table 3.11: Molecular Diagnostic Testing Market Trends
Table 3.12: Molecular Diagnostic Testing Technology Trends
Table 3.13: Attractive Growth Areas for Molecular Diagnostic Testing
Table 3.14: Molecular Diagnostics Market: Strategic Recommendations on MDx Sector Business Functions
Table 3.15: Potential Benefits of Pharmacogenetics
Table 3.16: Select Drugs with Commercially Available Pharmacogenetic Tests
Table 3.17: Examples of Personalized Medicine in Treatment of Infectious Disease
Table 3.18: Documents for Protecting Intellectual Property Rights
Table 3.19: Recent Patents Related to PCR, Nucleic Acid Amplification and Sample Prep
Table 4.1: Molecular Diagnostic High-Throughput Automated Testing Systems
Table 5.1: Global Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018
Table 5.2: Molecular Infectious Disease Diagnostics Market: Market Restraints Ranked in Order of Impact
Table 5.3: Molecular Infectious Disease Diagnostics Market: Market Drivers Ranked in Order of Impact
Table 5.4: U.S. Market Revenue for Molecular Diagnostics Testing for Infectious Disease, 2009-2018
Table 5.5: Molecular Diagnostic Markets for Infectious Disease Testing, 2012
Table 5.6: Molecular Diagnostic Markets for Infectious Disease Testing, 2018
Table 5.7: Business Factors Influencing Advanced Infectious Disease MDx Testing Services
Table 5.8: Key Players in Global Molecular Diagnostics Infectious Disease Testing Market
Table 5.9: Summary of Assays for HIV Viral Load Testing
Table 5.10: HIV Resistance Testing Recommendations
Table 5.11: Commercially Available Molecular Diagnostic Products for HIV Assay
Table 5.12: Lower Detection Limits of HBV DNA Assays
Table 5.13: Summary of Molecular Diagnostic Assays for Testing HBV
Table 5.14: Recommendations for HCV Diagnostic Testing
Table 5.15: Commercially Available Molecular Diagnostic Products for HCV Assay
Table 5.16: Major Companies Marketing HCV Molecular Diagnostic Tests: Market Size and Share, 2012
Table 5.17: Commercially Available Molecular Diagnostic Products for Influenza Assay
Table 5.18: Major Companies Marketing Chlamydia/Gonorrhea Molecular Diagnostic Tests: Market Size and Share, 2012
Table 5.19: Commercially Available Molecular Diagnostic Products for Chlamydia Assay
Table 5.20: Commercially Available Molecular Diagnostic Products for Gonorrhea Assay
Table 5.21: Commercially Available Molecular Diagnostic Assays for Testing TB
Table 5.22: Comparative U.S. Claim Charges for TB Testing by Type, 2012
Table 5.23: Global Testing for TB by Testing Type, 2012
Table 5.24: Global Testing for TB by Testing Reason, 2012
Table 5.25: Commercially Available Molecular Diagnostic Products for MRSA Assay
Table 5.26: Major Companies Marketing MRSA Molecular Diagnostic Tests: Market Size and Share, 2012
Table 5.27: Commercially Available Molecular Diagnostic Products for VRE Assay
Table 5.28 Major Companies Marketing VRE Molecular Diagnostic Tests: Market Size and Share, 2012
Table 5.29: Transmission-related Disease Screening from Blood Donor Pools
Table 5.30: Principal Blood Screening Products of Hologic Gen-Probe for HIV Assay
Table 5.31: Major Companies Marketing Blood Screening Molecular Diagnostic Tests: Market Size and Share, 2012
Table 5.32: Qiagen’s Digene HC2 High-risk HPV DNA Test
Table 5.33: Commercially Available Molecular Diagnostic Products for HPV Assay
Table 5.34: Major Companies Marketing HPV Molecular Diagnostic Tests: Market Size and Share, 2012
Table 6.1: Companies Marketing Products in the Cancer Molecular Diagnostics Sector
Table 6.2: Key Elements for Business Competition in Gene Expression Profiling for Cancer
Table 6.3: Key Elements for Future Success in the Gene Profiling for Cancer Segment
Table 6.4: Breast Cancer Overview
Table 6.5: Overview of ER/PR Testing and Response to Therapy
Table 6.6: Key Players in the Breast Cancer Molecular Diagnostic Space
Table 6.7: Commercially Available Molecular Diagnostic Products for Breast Cancer Assay
Table 6.8: Summary of Strengths, Weaknesses, Opportunities and Threats of the Breast Cancer Molecular Diagnostic Market
Table 6.9: Clinical Utility and Health Economic Benefits of Oncotype DX
Table 6.10: Oncotype DX Overview
Table 6.11: Comparison of Agendia vs. Genomic Health Breast Cancer Tests
Table 6.12: Overview of HER2/neu and Herceptin
Table 6.13: MammaPrint: Key Features
Table 6.14: Oncogene Science Biomarker Group Reagents
Table 6.15: Major Laboratory Testing Companies Marketing Breast Cancer Molecular Diagnostic Tests, 2012
Table 6.16: Global Market for Breast Cancer Molecular Diagnostic Testing, 2005-2012
Table 6.17: U.S. Market for Breast Cancer Molecular Diagnostic Testing, 2005-2012
Table 6.18: Global Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2013-2018
Table 6.19: U.S. Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2013-2018
Table 6.20: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact
Table 6.21: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact
Table 6.22: Colorectal Cancer Overview
Table 6.23: KRAS Mutation Assay
Table 6.24: KRAS Assays by Analytical Type
Table 6.25: KRAS Mutation Analysis Summary
Table 6.26: DxS KRAS Mutation Test Summary
Table 6.27: KRAS and BRAF in Clinical Use
Table 6.28: Product Development Opportunities in Cancer Tumor Types, 2008
Table 6.29: Key Players in the Colorectal Cancer Molecular Diagnostic Space
Table 6.30: ArcticDx Genetic Test, Colo Risk
Table 6.31: NexCourse CRC Test Offering and Treatment Direction
Table 6.32: Global Market for Molecular Diagnostic Colon Cancer Testing, 2005-2012
Table 6.33: U.S. Market for Molecular Diagnostic Colon Cancer Testing, 2005-2012
Table 6.34: Global Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2013-2018
Table 6.35: U.S. Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2010-2018
Table 6.36: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact
Table 6.37: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact
Table 6.38: Summary of Strengths, Weaknesses, Opportunities and Threats of the Colon Cancer Market
Table 6.39: Stages in Prostate Cancer Discovery and Diagnosis
Table 6.40: Corporate Players Entering the Prostate Cancer Molecular Diagnostic Space
Table 6.41: Gen-Probe Genetic Testing Product Line
Table 6.42: Prostate Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact
Table 6.43: Prostate Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact
Table 6.44: Summary of Strengths, Weaknesses, Opportunities and Threats of the Prostate Cancer Molecular Diagnostic Market
Table 6.45: Players in the Bladder Cancer Molecular Diagnostic Space
Table 6.46: Lung Cancer Survival Rates
Table 6.47: Lung Cancer Facts
Table 6.48: Lung Cancer Predictive and Prognostic Markers
Table 6.49: Potential of Cancer Biomarkers in Drug Delivery and Development
Table 6.50: Barriers to Adoption of Biomarkers in Clinical Use
Table 7.1: Common Genetic Disorders
Table 7.2: HLA Allele Nomenclature
Table 7.3: Comparison of HLA Typing Methods
Table 7.4: Diagnostic Companies with Existing Pharma Relationships (market caps under $5 Billion)
Table 7.5: Use of Cancer Biomarkers in Drug Development
Table 7.6: Utility of Biomarkers as Companion Diagnostics to Drug Development
Table 7.7: Competitors in the Field of Forensic Testing
Table 7.8: Competitors in the Field of Identity, Family and Paternity Testing
Table 7.9: Comparison of Current Genetic Testing Protocols and Potential Use of Whole Genome Sequencing
Table 7.10: Commercial CF-Screening Products
Table 7.11: CF Screening Technology Summary
Table 8.1: Molecular Diagnostics Methods for Detection of Salmonella in Food
Table 9.1: Barriers for Biologics Warfare Monitoring Systems
Table 9.2: Technical Problems for PCR Assays for Pathogen Genotyping and Detection
Table 9.3: Biological Warfare Agents Identified by PCR Methods
Table 9.4: Companies Developing Detection Devices for Biological Warfare Agents
Table 10.1: Regulatory Rules that Affect the Ability of a Diagnostic Testing Reagent Company to Conduct Business
Table 10.2: Strengths of the 510k Process
Table 10.3: Drawbacks of the 510k Process
Table 10.4: Focus Areas for the FDA Critical Path Initiative
Table 11.1: Factors Determining Third-Party Payment for Molecular Diagnostic Tests
Table 11.2: CPT Codes for Molecular Diagnostic Infectious Disease Testing
Table 11.3: New CPT Codes for Respiratory Virus Detection

- Abbott Laboratories
- AdvanDx
- Agendia
- Arcxis Biotechnologies
- Agilent Technologies
- Ambry Genetics
- Atlas Genetics
- AutoGenomics, Inc
- Beckman Coulter
- Becton, Dickinson and Company
- Biodesix
- Biohelix Corporation
- bioMérieux
- Bio-Rad Laboratories
- Cancer Genetics, Inc
- Celera (acquired by Quest Diagnostics)
- Cepheid
- Clarient, Inc (GE Healthcare)
- CombiMatrix Corporation
- Cytocell Technologies Ltd
- DiagnoCure, Inc
- Enzo Biochem
- Epigenomics
- Exact Sciences Corporation
- Exagen Diagnostics, Inc
- Exiqon
- Genera Biosystems
- GenMark Diagnostics, Inc
- Genomic Health
- Great Basin Corporation
- Hologic
- Illumina
- IntegenX
- InterGenetics, Inc
- LabCorp
- Life Technologies Corporation
- Luminex
- Myriad Genetics, Inc
- Nanosphere
- Nanostring
- Natera
- NetBio
- Neogenomics
- Nuvera Biosciences
- Orion Genomics
- PerkinElmer Genetics
- Progenika
- QIAGEN NV
- Roche Diagnostics
- Rosetta Genomics Ltd
- Seegene
- Sequenom, Inc
- Siemens Healthcare Diagnostics (Siemens)
- Spartan Bioscience
- Thorne Diagnostics
- Transgenomic
- TrimGen
- Trovagene, Inc
- Veredus Laboratories
- Veridex

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