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Molecular Diagnostics Reports Bundle - Product Image

Molecular Diagnostics Reports Bundle

  • ID: 2671596
  • November 2013
  • Region: Global
  • 1139 Pages
  • TriMark Publications

FEATURED COMPANIES

  • Abbott Laboratories
  • Biocartis
  • Enzo Biochem
  • Genoptix, Inc.
  • Nanogen
  • Seegene
  • MORE

The Molecular Diagnostics Reports Bundle includes the following publications at a 15% discount off the individual reports being purchased separately:

- Molecular Diagnostics in Cancer Testing
- Molecular Diagnostics in Genetic Testing
- Molecular Diagnostics in Infectious Disease Testing
- Molecular Diagnostics Markets

Below are summaries of each report as well as links to purchase the individual titles.

'Molecular Diagnostics in Cancer Testing'

Molecular diagnostics is a rapidly-advancing area of research and medicine, with new technologies and applications being continually added. The technologies that come under the umbrella of molecular diagnostics include first-generation amplification, DNA probes, fluorescent in-situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors and molecular labels, and gene expression profiling using microarrays. These technologies are improving the discovery of therapeutic molecules for cancer, the screening, diagnosis and classification of cancer patients, and the optimization of drug therapy.

This report describes the specific segment of the in READ MORE >

FEATURED COMPANIES

  • Abbott Laboratories
  • Biocartis
  • Enzo Biochem
  • Genoptix, Inc.
  • Nanogen
  • Seegene
  • MORE

Table of Contents - Molecular Diagnostics in Cancer Testing

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
2.1 Opening-up of Opportunities in Molecular Diagnostics
2.2 Impact of the Human Genome Project on Molecular Diagnostics
2.3 Considerations for Molecular and Clinical Diagnostics
2.4 Molecular Diagnostics in the Post-Genomic Era
2.5 Advances in Molecular Diagnostics Technologies
2.6 Oligonucleotide Array Platforms
2.7 Emerging Cancer Personalized Medicine Market
2.7.1 Predictive Cancer Molecular Diagnostics
2.8 Companion Tests for Drug Development
2.9 Opportunities for IVDMIA Companies

3. Cancer Diagnostics Molecular Testing Market
3.1 Market Description
3.1.1 Market Overview
3.1.2 Tumor Markers
3.1.3 Molecular Diagnostic Markers
3.1.4 Competitive Landscape
3.1.5 Sales and Marketing Strategies for Cancer Tests
3.1.5.1 North American Market
3.1.5.2 International Markets
3.1.5.3 Europe
3.1.5.4 Asia-Pacific

4. Molecular Diagnostic Tests for Cancer
4.1 Cancer Diagnostic Tests
4.1.1 Use of Genomics to Understand Cancer
4.1.2 Molecular Diagnostic Tools Solutions
4.1.3 Technology of Gene Expression Analysis
4.1.3.1 Amplify and Detect Diminished Amounts of RNA Consistently
4.1.3.2 Analyze Hundreds of Genes
4.1.3.3 Employ Advanced Information Technology
4.2 Breast Cancer
4.2.1 Cancer Prognostic Assays
4.2.1.1 Myriad Genetics (BRACA1 and BRACA2)
4.2.1.2 Genomic Health (Oncotype DX)
4.2.1.2.1 Single Gene Reporting (ER, PR, HER2)
4.2.1.2.2 Node Positive (N+)
4.2.1.2.3 Aromatase Inhibitors
4.2.1.2.4 Product Development
4.2.1.2.5 Product Development Opportunities in Breast Cancer
4.2.1.3 InterGenetics, Inc.
4.2.1.4 LabCorp (HER-2)
4.2.1.5 Clarient, Inc.
4.2.1.6 BioTheronostics (AviaraDx)
4.2.1.7 Agendia B.V. (MammaPrint)
4.2.1.8 Oncogene Science (Wilex)
4.2.2 Competition and Comparison of Methods
4.2.3 Competitive Structure and Market Share Analysis
4.2.3.1 Breast Cancer Molecular Diagnostic Testing Market Size
4.2.3.1.1 Global Market
4.2.3.1.2 U.S. Market
4.2.3.1.3 European Market
4.2.3.2 Market Forecasts
4.2.3.2.1 Revenue Forecasts
4.2.3.3 Market Drivers and Restraints
4.2.3.3.1 Market Drivers
4.2.3.3.2 Market Restraints
4.2.3.4 Breast Cancer Molecular Diagnostic Testing Assay Market and Technology Trends
4.2.3.4.1 Breast Cancer Molecular Diagnostic Testing Assay Market Trends
4.2.3.4.2 Breast Cancer Molecular Diagnostic Testing Assay Technology Trends
4.2.3.4.3 Breast Cancer Testing Assay Strategic Recommendations
4.3 Colorectal Cancer Molecular Diagnostics Market
4.3.1 Colon Cancer Testing Platforms
4.3.1.1 Genomic Testing
4.3.1.1.1 IVD Multiplex Index Analysis (MIA)
4.3.1.1.2 The BRAF Test
4.3.1.1.3 KRAS
4.3.1.1.3.1 Background on KRAS Mutation
4.3.1.1.4 mSEPT9
4.3.1.2 Screening Test
4.3.2 Players in the Colorectal Cancer Space
4.3.3 Competitive Structure and Market Share Analysis
4.3.3.1 Colon Cancer Molecular Diagnostic Testing Market Size
4.3.3.1.1 Global Colon Cancer testing Market
4.3.3.1.2 U.S. Colon Cancer testing Market
4.3.3.1.3 European Colon Cancer testing Market
4.3.3.2 Market Forecasts
4.3.3.2.1 Revenue Forecasts
4.3.3.3 Market Drivers and Restraints
4.3.3.3.1 Market Drivers
4.3.3.3.2 Market Restraints
4.3.3.4 Colon Cancer Molecular Diagnostic Testing Assay Market and Technology Trends
4.3.3.4.1 Colon Cancer Molecular Diagnostic Testing Assay Market Trends
4.3.3.4.2 Colon Cancer Molecular Diagnostic Testing Assay Technology Trends
4.3.3.4.3 Colon Cancer Molecular Diagnostic Testing Assay Strategic Recommendations
4.4 Prostate Cancer Molecular Diagnostics Market
4.5 Other Cancer Molecular Diagnostic Markets
4.5.1 Bladder Cancer
4.5.2 Ovarian Cancer
4.5.2.1 Incidence of Ovarian Cancer
4.5.2.2 Key Players in Ovarian Testing market
4.5.2.3 Ovarian Cancer Market Size
4.5.2.4 Ovarian Cancer Molecular Diagnostic Testing Market Size
4.5.2.4.1 Global Ovarian Cancer testing Market
4.5.2.4.2 U.S. Ovarian Cancer testing Market
4.5.2.4.3 European Ovarian Cancer testing Market
4.5.2.5 Market Forecasts
4.5.2.5.1 Revenue Forecasts
4.5.2.6 Market Drivers and Restraints
4.5.2.6.1 Market Drivers
4.5.2.6.2 Market Restraints
4.5.2.7 Ovarian Cancer Molecular Diagnostic Testing Assay Market and Technology Trends
4.5.2.7.1 Ovarian Cancer Molecular Diagnostic Testing Assay Market Trends
4.5.2.7.2 Ovarian Cancer Molecular Diagnostic Testing Assay Technology Trends
4.5.2.7.3 Ovarian Cancer Molecular Diagnostic Testing Assay Strategic Recommendations
4.5.3 Lung Cancer
4.5.4 Melanoma
4.6 Molecular Diagnostic Screening Test for Cancer
4.6.1 Extreme Drug Resistance assay (Oncotech EDR Assay)
4.6.2 Multidrug Resistance Protein (MRP)
4.7 Companion Diagnostic Tests for Cancer Therapeutics

5. Business
5.1 Technology and Market Trends
5.1.1 Technology Trends
5.1.2 Market Trends
5.2 M&A Activity
5.3 Partnerships
5.4 Competitive Analysis
5.4.1 Primary Competitors
5.4.1.1 Summary of Market Strengths, Weaknesses, Opportunities and Threats
5.4.2 Industry Challenges and Strategic Recommendations
5.4.3 Commercialization of Molecular Diagnostic Products
5.5 SWOT Comparison of Business Models for Cancer Diagnostic Testing
5.6 Intellectual Property Rights
5.6.1 BRCA1 and BRCA2 Gene Patents
5.6.2 Current Patent Disputes

6. Reimbursement and Billing
6.1 Overview
6.2 Trends in Reimbursement Practice
6.2.1 Medicare Reimbursement
6.2.2 Analysis of ROI for MD Tests for Cancer Using Medicare Reimbursement Rules
6.2.3 Reimbursement for Insight Dx, MammaPrint and Oncotype Dx
6.2.4 Reimbursement for JAK2 Mutation Testing for Myeloproliferative Neoplasms
6.3 Breast Cancer Tests
6.4 Colon Cancer Tests
6.5 Trends in Patient Care and Reimbursement
6.6 Revenue Threats
6.6.1 Medicare Exceptions
6.6.2 Three Areas for Denial of Claims by Biomarkers
6.7 Billing
6.7.1 Medicare Billing Procedures
6.7.2 Medicare CPT Coding Rules for Cancer Biomarkers

7. Government Regulation
7.1 U.S. Food and Drug Administration
7.2 CLIA Regulations
7.3 Clinical Laboratory Improvement Act (CLIA)
7.4 State Licensing for Service Laboratories
7.5 FDA Treatment of Multivariate Index Assays (IVDMIAs)
7.6 510(k) Clearance
7.7 Pre-Market Approval (PMA)
7.8 ASRs
7.9 What Regulatory Guidance is Needed for Companion Biomarkers?
7.10 U.S. Patent and Trademark Office (USPTO)
7.11 IRB Approval in Clinical Trials
7.12 Oncology Biomarkers Qualification Initiative Project
7.13 FDA Clearance Picture for Insight Dx, MammaPrint, and Oncotype DX
7.14 FDA Packaging Requirements for Erbitux
7.15 Micoarray Quality Control (MAQC)
7.16 CAP Evidence-based Recommendations to Improve the Accuracy of ER and PR Testing
7.17 ER and PR Proficiency Testing

8. Business Decisions Using Molecular Diagnostic Tests in Drug Development
8.1 Advantages of a Pharmacogenomic Assessment of Genetic Biomarkers to Determine Clinical Dose
8.2 What are Key Opportunities in Biomarker Discovery, Development and Commercialization?
8.3 What are the Current Obstacles in Biomarker Implementation?
8.4 How do Business Strategies, such as those Relating to Acquisition, Drive Biomarker Strategies?
8.5 What is the Right Balance between External Partnerships and Internal Infrastructure?
8.6 How might Novel Biomarker Development Lead to Acquisition Strategies?
8.7 Which Types of Genetic Biomarkers should be Developed by Diagnostic Companies?
8.8 What Strategies Help Translate Genetic biomarkers from Preclinical to Clinical Development?
8.9 In what Class of Drugs is the Value of Using Genetic biomarkers in Decision making the Highest?
8.10 How can Regulatory Oversight Drive Approval and Adoption of New Technologies?
8.11 How can Big Pharma Co-develop Genetic Biomarkers for Regulatory Acceptance?
8.12 How are Genetic Biomarkers being Used to reduce the Attrition Rate in Drug Development?
8.13 How is ROI Measured Using Genetic Biomarkers in Drug Development?
8.14 How might Organizational Structures Limit the Use of Genetic Biomarkers in Drug Development and How Should R&D Organizations Address This Problem?
8.15 How to Maximize Business Development through Biomarker Strategies?
8.16 What is the Best Type of Business Model for Developing Genetic Biomarkers? 8.17 What are Organizational Impediments in Genetic Biomarkers in Drug Development?
8.18 What are Internal Capabilities for Novel Biomarker Development and Application?
8.19 How can Key Biomarker Technical Expertise be Applied across a Complex and Highly-Stratified R&D Value Chain?
8.20 At what Stage of Drug Development have Genetic Biomarkers Provided the Most Benefit?
8.21 What Companies are the most Innovative in Development of Genetic Biomarkers?
8.22 Best Values for Genetic Biomarkers in Drug Development and in Diagnostics 8.23 Molecular Diagnostic Tests can Increase Value in an Associated Drug

9. Company Profiles
9.1 Agendia
9.2 ArcticDx, Inc.
9.3 Arcxis Biotechnologies
9.4 Aureon Laboratories
9.5 bioTheranostics (AviaraDx)
9.6 Clarient, Inc.
9.7 CombiMatrix Corporation
9.8 DiagnoCure
9.9 Epigenomics
9.10 Exact Sciences Corporation
9.11 Exagen Diagnostics, Inc.
9.12 Exiqon
9.13 Ferrer inCode
9.14 Genomic Health, Inc.
9.15 Genoptix, Inc.
9.16 Gen-Probe
9.17 InterGenetics, Inc.
9.18 LabCorp
9.19 Myriad Genetics, Inc.
9.20 Nuvera Biosciences
9.21 Orion Genomics
9.22 QIAGEN NV
9.23 Rosetta Genomics Ltd.
9.24 Seegene
9.25 Sequenom, Inc.
9.26 SABiosciences Corporation
9.27 Source MDx
9.28 Targeted Molecular Diagnostics
9.29 Xenomics, Inc.

Appendix 1: Definition of Terms for Molecular Diagnostics
Appendix 2: Standard Cancer Therapeutic Panels
Appendix 3: Menu of Specialized Technologies Used to Assess and Characterize Cancer
Appendix 4: Technical Assessment of the KRAS Mutation Test by Several Methodologies and Specialty Oncology Laboratories
Appendix 5: Overview of Microarrays

Table of Contents - Molecular Diagnostics in Genetic Testing

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. Role of Molecular Diagnostics and Opportunities in the Genetic Testing Sector
2.1 Introduction to Molecular Diagnostics for Genetic Testing
2.1.1 Definition and Scope of Molecular Genetic Testing within this Report
2.1.2 Key Functions of Molecular Genetic Testing
2.1.3 Overview of Molecular Genetic Testing Laboratories
2.2 Diagnostic Testing of Genetic Disorders
2.2.1 Review of Genetic Disorders: Characterizations of Abnormalities and Patterns of Inheritance
2.2.2 Common Genetic Disorders
2.3 Carrier Testing for Genetic Disorders
2.4 Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening
2.5 Prenatal/In utero Genetic Testing
2.6 Newborn Genetic Screening Tests
2.6.1 Molecular Diagnostics for Newborn Genetic Testing
2.7 Pre-symptomatic and Predictive Testing for Adult Onset Disorders
2.8 Pharmacogenetics and Pharmacogenomics
2.8.1 Current Applications for Pharmacogenetics and Pharmacogenomics
2.8.1.1 Warfarin and VKORC1 and CYP2C9 Testing
2.8.1.2 Trastuzumab and Lapatinib and HER2 Overexpression Testing
2.8.1.3 Clopidogrel and CYP2C19 Testing
2.8.1.4 Thiopurines and TPMT Testing
2.8.1.5 Cetuximab and EGFR Expression and KRAS Mutation Testing
2.8.1.6 Irinotecan and UGT1A1*28 Testing
2.8.1.7 Abacavir and HLA-B*5701 Testing
2.8.1.8 Carbamazepine and HLA-B*1502 Testing
2.9 Tissue and Blood Typing
2.9.1 HLA Determination
2.9.2 Rhesus D Factor Determination
2.10 Parentage/Relationship Testing (Paternity Testing)
2.11 Genealogical DNA Testing
2.12 Criminal and Forensics Testing

3. Introduction to Molecular Diagnostics Technology for Genetic Testing
3.1 Introduction to Genomics and Its Opportunity
3.1.1 Science Background: Structures and Functions of Nucleic Acids and Proteins
3.1.2 The Human Genome
3.1.3 Genomics: Opening up of Opportunities in Molecular Diagnostics
3.2 Genetic Variability and Disease
3.3 Impact of the Human Genome Project on Molecular Diagnostics
3.4 Key Considerations for Molecular Diagnostics
3.5 Molecular Diagnostics in the Post-Genomic Era
3.6 Advances in Molecular Diagnostics Technologies
3.7 Molecular Diagnostics Testing Technologies and Platforms
3.7.1 Amplification Technologies
3.7.1.1 PCR and PCR Derivative Platforms
3.7.1.2 Multiple Displacement Amplification (MDA)
3.7.1.3 Multiple Annealing and Looping-based Amplification Cycles (MALBAC)
3.7.1.4 Whole Genome Amplification
3.7.1.5 Nucleic Acid Sequence-based Amplification (NASBA)
3.7.2 Detection of Amplified Gene Products
3.7.2.1 High Resolution Melting Analysis
3.7.2.2 Microparticle-based Flow Cytometry
3.7.3 DNA and Oligonucleotide Microarrays and Chips
3.7.3.1 Array Comparative Genomic Hybridization (aCGH)
3.7.4 Gene Sequencing
3.7.4.1 Sanger Sequencing
3.7.4.2 Next Generation Sequencing
3.7.5 Fluorescence In situ Hybridization (FISH)

4. Business Landscape for Molecular Diagnostics in Genetic Testing
4.1 Market Analysis: Size, Growth, Share and Competitors
4.1.1 Worldwide Genetic Testing Markets
4.1.2 Market Structure and Competitive Situation
4.1.3 Primary Competitors
4.1.4 Commercialization Strategies for Molecular Diagnostic Products
4.1.5 Market Penetration Strategies for Genetic Testing
4.2 Growing Genetic Testing Market Segments
4.2.1 Personalized Medicine and Companion Diagnostics Market
4.2.2 Predictive Molecular Diagnostics Market
4.2.3 Parallel Genetic Tests for Drug Development
4.2.4 Direct-to-Consumer Genetic Testing Market
4.2.5 Detecting Genetic Disorders
4.2.6 Pre-natal Screening
4.2.7 Neonatal Screening
4.2.8 Forensic Testing
4.2.9 Blood and Tissue Typing
4.2.10 Parentage Testing
4.2.11 DNA Sequencing
4.3 Market Drivers and Restraints
4.3.1 Market Drivers
4.3.2 Market Restraints
4.4 Market and Technology Trends
4.4.1 Market Trends
4.4.2 Technology Trends
4.5 Industry Challenges and Strategic Recommendations
4.6 Recent Industry Activity
4.6.1 M&A Activity
4.6.2 License Agreements and Partnerships
4.7 Business Models and Requirements for Successful Products in the Genetic Testing Industry
4.7.1 Commercial Manufacturing of Genetic Testing Products: Requirements
4.7.1.1 Regulatory Requirements
4.7.1.2 Manufacturing Process Scale
4.7.1.3 In-House Manufacturing
4.7.1.4 Contract Manufacturing: Commercial and Academic

5. Molecular Diagnostic Assays and Select Laboratories for Genetic Testing on the Market
5.1 Select Diagnostic Tests for Genetic Disorders
5.1.1 CombiMatrix DiagnosticsÕ DNAarrayª Pediatric Microarray Oligo 105K
5.1.2 GeneDxÕs Genetic Testing for Hereditary Disorders
5.1.3 HologicÕs Factor V Reagents
5.1.4 ProgenikaÕs FH Test
5.2 Carrier Tests for Genetic Disorders
5.2.1 Abbott MolecularÕs Cystic Fibrosis Genotyping Assay
5.2.2 CounsylÕs Universal Genetic Test
5.2.3 GenPathÕs InheriGen and InheriGen Plus
5.2.4 Good Start GeneticsÕ Good Start Select
5.2.5 HologicÕs InPlex¨ CF Molecular Test
5.2.6 Integrated GeneticÕs InheritestSM Carrier Screen
5.2.7 LuminexÕs xTAG Cystic Fibrosis (CFTR) v2 Assays
5.2.8 NateraÕs Natera Oneª Multi-Disease Genetic Carrier Screening Panel
5.2.9 SequenomÕs Heredi-Tª Cystic Fibrosis Carrier Screen Test
5.3 Pre-implantation Genetic Tests
5.3.1 NateraÕs Preimplantation Genetic Diagnosis (PGD) Test
5.4 Prenatal/In utero Molecular Genetic Screening Tests
5.4.1 Cell-free Fetal DNA Testing
5.4.1.1 Ariosa DiagnosticsÕ Harmonyª Prenatal Test
5.4.1.2 NateraÕs Panorama
5.4.1.3 SequenomÕs MaterniT21 PLUS Test
5.4.1.4 Verinata HealthÕs verifi¨ Prenatal Test
5.4.2 Molecular Cytogenetic Tests
5.4.2.1 Abbott MolecularÕs AneuVysion (Vysis CEP 18/X/Y-alpha satellite/LSI 13/21) Multicolor
DNA Probe Panel
5.4.2.2 CombiMatrix DiagnosticsÕ DNAarrayª Prenatal Microarrays
5.4.2.3 Signature GenomicsÕ Signature Precision Panelª I Prenatal
5.4.2.4 Signature GenomicsÕ Signature PrenatalChip¨TE (Targeted Enhanced) Microarray
5.4.2.5 Signature GenomicsÕ Signature PrenatalChip¨OS Microarray
5.5 Newborn Genetic Screening Tests
5.5.1 Screening for Cystic Fibrosis with Molecular Diagnostic Assays
5.5.2 Screening for SCID with the TREC Assay
5.5.2.1 PerkinElmer Genetics
5.6 Predictive and Presymptomatic Tests for Adult Onset Disorders
5.6.1 SequenomÕs RetnaGeneª AMD Test for Age-Related Macular Degeneration
5.7 Pharmacogenomics and Pharmacogenetics
5.7.1 Warfarin Sensitivity
5.7.2 EntroGenÕs Mutation Analysis and Genotyping Kits
5.7.3 QiagenÕs therascreen¨ KRAS RGQ PCR Kit
5.7.4 RocheÕs COBAS¨ AmpliPrep/COBAS¨ TaqMan¨ HLA-B*5701 Screening Test
5.7.5 Genomic Health Oncotype Tests
5.7.6 Life Technologies
5.7.6.1 Life TechnologiesÕ Pervenioª Lung RS Test
5.7.7 NanosphereÕs Veragene¨ Human Genetic Tests
5.7.8 AgendiaÕs SYMPHONYª Personalized Breast Cancer Profile
5.7.9 CardioDxÕs Corus CAD
5.7.10 VeracyteÕs Afirma Thyroid FNA Analysis
5.8 Tissue and Blood Typing Tests
5.8.1 ImmunocorÕs LIFECODES HLA Typing Kits
5.8.1.1 LIFECODES HLA SSO Typing Kits
5.8.1.2 LIFECODES HLA SSP Typing
5.8.2 Life Technology/InvitrogenÕs AllSet+ª Gold HLA Typing Kits
5.8.3 Life Technology/InvitrogenÕs SeCore¨ HLA Sequence-Based Typing Kits
5.8.4 One LambdaÕs LABType¨ SSO
5.8.5 ProgenikaÕs BLOODchipª
5.8.6 SequenomÕs SensiGene¨ Fetal RHD Genotyping Test
5.9 Paternity Tests
5.9.1 NateraÕs Non-Invasive Prenatal Paternity Test
5.10 Criminal and Forensics Tests
5.10.1 IntengenXÕs RapidHITª 200 Human DNA Identification System
5.10.2 NetBioÕs and GE Healthcare Life SciencesÕ DNAscan Rapid DNA Analysis System
5.10.3 Sorenson Forensics
5.11 Direct to Consumer Genetic Tests
5.11.1 23andMe
5.11.2 Lumigenix
5.11.3 DNA DTC
5.11.4 Family Tree DNA
5.11.5 Gene by Gene
5.11.6 AncestryDNA Test
5.12 Select Laboratories Providing Genetic Testing Services
5.12.1 Ambry Genetics
5.12.2 ARUP Laboratories
5.12.3 GeneDx
5.12.4 LabCorp and Integrated Genetics
5.12.5 Mayo Medical Laboratories
5.12.6 Medical Genetics Laboratory at Baylor College of Medicine
5.12.7 Pathway Genomics
5.12.8 Quest Diagnostics
5.13 Major Technology Platforms for Genetic Testing on the Market
5.14 Product Launches and Introductions
5.14.1 Ariosa Diagnostics Introduces Y-Chromosome Analysis Test Option
5.14.2 Ariosa Diagnostics Expands Harmony Prenatal Test to Twin Pregnancies and Launches New X,Y
Analysis Test
5.14.3 Natera Launches Panoramaª
5.14.4 Rubicon Genomics Launched Its New ThruPlex Technology and Partners with Agendia
5.14.5 Sequenom Center for Molecular Medicine Launches New Cystic Fibrosis Carrier Screen Test
5.14.6 Sequenom Launches the MaterniT21 PLUS
5.14.7 Next Generation Sequencing with RocheÕs GS Junior System Approved for Tissue Typing

6. Reimbursement and Billing Landscape for Molecular Diagnostic Genetic Testing
6.1 Overview
6.2 Trends in Healthcare Reimbursement Practices
6.2.1 Molecular Genetics Testing Reimbursement
6.3 Medicare Reimbursement Program
6.4 Medicare Billing Procedure
6.5 CPT Coding Rules for Molecular Diagnostics
6.5.1 Former Coding Rules for Molecular Diagnostics
6.5.2 Current Coding Rules for Molecular Diagnostics
6.5.2.1 Gapfilling
6.5.2.2 Reimbursement Delays for Molecular Diagnostics
6.6 Revenue Threats
6.6.1 Medicare Payment Exceptions
6.6.2 Three Areas for Denial of Claims
6.7 Bundled Payments for Care Improvement (BPCI) Initiative

7. Regulatory Issues for Genetic Testing
7.1 U.S. Food and Drug Administration
7.1.1 FDA Labeling Requirements
7.1.2 U.S. Government Regulation of Medical Devices
7.1.3 FDAÕs Qualification of Biomarkers
7.1.4 FDAÕs Voluntary Genomic Data Submission
7.2 Clinical Laboratory Improvement Act (CLIA)
7.3 CLIA Regulations
7.4 State Licensing for Service Laboratories
7.5 Multivariate Index Assays (IVDMIAs)
7.6 FDA Draft Guidance on In Vitro Companion Diagnostic Devices
7.7 Pre-Market Approval (PMA)
7.7.1 510(k) Clearance
7.8 De Novo Classification
7.9 Laboratory Developed Tests
7.9.1 Analyte Specific Reagents (ASRs)
7.10 U.S. Patent and Trademark Office (USPTO)
7.11 IRB Approval in Clinical Trials
7.12 CE marking and IVDD (European In Vitro Diagnostic Device Directive)
7.13 Research Use Only Reagents
7.14 Regulatory Issues for Direct to the Consumer Genetic Tests (DTC)
7.15 The Genetic Information Nondiscrimination Act of 2008
7.16 Genetic Tests and Medical Records
7.17 Recommendations by the American College of Medical Genetics and Genomics (ACMG)

8. Business Decisions, Strategic Outlook and Recommendations Using Molecular Diagnostic Tests in
Genetic Testing
8.1 Key Opportunities in Genetic Testing Development and Commercialization
8.2 What are the Current Obstacles in Molecular Diagnostic Genetic Testing Implementation?
8.3 How are Genetic Testing Products Driven by Business Strategies?
8.4 How might Novel Genetic Test Development Lead to Acquisition Strategies?
8.5 How can Genetic Tests Increase Value in Associated Drug Marketing Plans?
8.6 What Steps can be Taken in the Clinical Phases to Improve the Success Rate of Genetic Tests in Development?
8.7 How can Regulatory Oversight Drive Approval and Adoption of New Technologies?
8.8 What are the Noteworthy Deals?
8.9 How will Platform Technology Companies Enter the Space and Position Themselves for Diagnostic Development?
8.10 Will Pharma Integrate with Diagnostics?
8.11 How will Partnering and M&As Alter the Competitive Landscape?
8.12 How will FDA Regulations Impact New Diagnostic Tests?
8.13 What is Necessary for Incorporating Promising Molecular Tests into Clinical Practice
8.14 What is the Best Type of Business Model for Developing Genetic Testing Biomarkers?
8.15 How have Genetic Biomarkers Provided the Most Benefit in Genetic Testing?
8.16 What are the Most Innovative Methods in Development of Molecular Diagnostic Biomarkers?

9. Company Profiles
9.1 Abbott Laboratories
9.2 Beckman Coulter
9.3 CombiMatrix
9.4 EntroGen, Inc.
9.5 Genmark Diagnostics, Inc.
9.6 Genomic Health
9.7 Hologic, Inc.
9.8 Illumina, Inc.
9.9 IntegenX
9.10 Laboratory Corporation of America Holdings
9.11 Life Technologies Corporation
9.12 Luminex Corporation
9.13 Myriad Genetics, Inc.
9.14 Natera
9.15 NetBio
9.16 PerkinElmer Genetics
9.17 Progenika, Inc.
9.18 Roche Diagnostics
9.19 Sequenom, Inc.
9.20 Signature Genomics
9.21 Spartan Bioscience, Inc.
9.22 Transgenomic, Inc.

Table of Contents - Molecular Diagnostics in Infectious Disease Testing

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 for Infectious Disease Testing
2.1 Molecular Diagnostics Testing and Opportunities in the Infectious Disease Sector
2.2 The Infectious Disease Problem
2.3 Impact of the Human Genome Project on Molecular Diagnostics
2.4 Opportunities for Molecular and Clinical Diagnostics
2.4.1 Companion Diagnostics
2.5 Development of Molecular Diagnostics Testing Markets
2.6 Target-Based Gene Amplification
2.6.1 Polymerase Chain Reaction
2.6.2 Real-Time PCR
2.6.3 Nucleic Acid Sequence-Based Amplification
2.6.4 Market Drivers and Restraints
2.6.4.1 Market Drivers
2.6.4.2 Market Restraints
2.6.5 Market and Technology Trends
2.6.5.1 Market Trends
2.6.5 2 Technology Trends
2.6.6 Strategic Recommendations
2.7 PCR Reagents for Clinical Diagnostics

3. Infectious Disease Diagnostics Molecular Testing Market
3.1 Market Overview
3.1.1 Overall Infectious Disease Market Analysis
3.2 NAT Molecular Diagnostics Market
3.3 Infectious Disease Molecular Diagnostic Testing Markets
3.3.1 HIV
3.3.1.1 Disease Background and Statistics
3.3.1.2 Measuring Viral Loads
3.3.1.3 Instruments and MD Reagents
3.3.1.4 Method Comparisons
3.3.1.5 Market Size
3.3.1.5.1 HIV Diagnostic Testing
3.3.1.6 HIV Market Challenges and Strategic Recommendations
3.3.1.6.1 HIV Molecular Diagnostic Market History
3.3.1.7 Market Drivers and Restraints
3.3.1.7.1 Market Drivers
3.3.1.7.2 Market Restraints
3.3.1.8 Market and Technology Trends
3.3.1.8.1 Market Trends
3.3.1.8.2 Technology Trends
3.3.1.9 Strategic Recommendations
3.3.2 Hepatitis
3.3.2.1 Hepatitis B Virus
3.3.2.1.1 Hepatitis B Disease Background and Statistics
3.3.2.1.2 Instruments and Reagents for Hepatitis B Detection
3.3.2.1.3 Method Comparisons
3.3.2.1.4 Hepatitis B Market Size
3.3.2.1.5 HBV Market Challenges and Strategic Recommendations
3.3.2.1.5.1 Market Drivers and Restraints
3.3.2.1.5.1.1 Market Drivers
3.3.2.1.5.1.2 Market Restraints
3.3.2.1.6 Market and Technology Trends
3.3.2.1.6.1 Market Trends
3.3.2.1.6.2 Technology Trends
3.3.2.1.7 Strategic Recommendations
3.3.2.2 Hepatitis C Virus Testing
3.3.2.2.1 Disease Background and Statistics
3.3.2.2.2 Instruments and Reagents for Hepatitis C Detection
3.3.2.2.3 Method Comparisons for HCV Tests
3.3.2.2.4 Hepatitis C Market Size
3.3.2.2.4.1 HCV Market Share
3.3.2.2.5 HCV Market Challenges and Strategic Recommendations
3.3.2.2.5.1 Market Drivers and Restraints
3.3.2.2.5.1.1 Market Drivers
3.3.2.2.5.1.2 Market Restraints
3.3.2.2.5.2 Market and Technology Trends
3.3.2.2.5.2.1 Market Trends
3.3.2.2.5.2.2 Technology Trends
3.3.2.2.6 Strategic Recommendations
3.3.3 Human Papillomavirus
3.3.3.1 Disease Background and Statistics
3.3.3.2 Instruments and Reagents for HPV Detection
3.3.3.3 Method Comparison
3.3.3.4 HPV Market Size
3.3.3.4.1 North American Market
3.3.3.4.2 European Market
3.3.3.5 Market Challenges and Strategic Recommendations
3.3.3.5.1 Market Drivers and Restraints
3.3.3.5.1.1 Market Drivers
3.3.3.5.1.2 Market Restraints
3.3.3.5.2 Market and Technology Trends
3.3.3.5.2.1 Market Trends
3.3.3.5.2.2 Technology Trends
3.3.3.5.3 Strategic Recommendations
3.3.4 Influenza Viruses
3.3.4.1 Disease Background and Statistics
3.3.4.2 Instruments and Reagents for Influenza Detection
3.3.4.3 Method Comparisons
3.3.4.4 Influenza Market Size
3.3.4.5 Influenza Market Challenges and Strategic Recommendations
3.3.4.5.1 Market Drivers and Restraints
3.3.4.5.1.1 Market Drivers
3.3.4.5.1.2 Market Restraints
3.3.4.5.2 Market and Technology Trends
3.3.4.5.2.1 Market Trends
3.3.4.5.2.2 Technology Trends
3.3.4.5.3 Strategic Recommendations
3.3.5 STD Testing (Chlamydia/Gonorrhea Molecular Diagnostic Testing)
3.3.5.1 Chlamydia/Gonorrhea Molecular Diagnostic Testing Market Size
3.3.5.2 Competitive Structure and Market Share Analysis
3.3.5.2.1 Market Forecasts
3.3.5.2.1.1 Revenue Forecasts
3.3.5.3 Chlamydia Molecular Diagnostic Testing
3.3.5.3.1 Disease Background and Description
3.3.5.3.2 Product Analysis: Instruments and Reagents for Testing Chlamydia
3.3.5.3.3 Method Comparison
3.3.5.3.4 Chlamydia Molecular Diagnostic Testing
3.3.5.3.4.1 Revenue Forecasts
3.3.5.3.4.2 Market Challenges
3.3.5.3.4.2.1 Market Drivers
3.3.5.3.4.2.2 Market Restraints
3.3.5.3.5 Market and Technology Trends
3.3.5.3.5.1 Market Trends
3.3.5.3.5.2 Technology Trends
3.3.5.3.5.3 Strategic Recommendations
3.3.5.4 Gonorrhea Molecular Diagnostic Testing
3.3.5.4.1 Disease Background and Description
3.3.5.4.2 Product Analysis: Instruments and Reagents
3.3.5.4.3 Method Comparison
3.3.5.4.4 Competitive Structure and Market Share Analysis
3.3.5.4.5 Market Forecasts
3.3.5.4.5.1 Revenue Forecasts
3.3.5.4.6 Market Challenges
3.3.5.4.6.1 Market Drivers
3.3.5.4.6.2 Market Restraints
3.3.5.4.7 Market and Technology Trends
3.3.5.4.7.1 Market Trends
3.3.5.4.7.2 Technology Trends
3.3.5.4.8 Strategic Recommendations
3.3.6 Tuberculosis
3.3.6.1 Disease Background and Description
3.3.6.2 Product Analysis: Instruments and Reagents
3.3.6.3 Method Comparison
3.3.6.4 Tuberculosis Market Size
3.3.6.5 Competitive Structure and Market Share Analysis
3.3.6.6 Market Forecasts
3.3.6.6.1 Revenue Forecasts
3.3.6.7 Market Challenges
3.3.6.7.1 Market Drivers
3.3.6.7.2 Market Restraints
3.3.6.8 Market and Technology Trends
3.3.6.8.1 Market Trends
3.3.6.8.2 Technology Trends
3.3.6.9 Strategic Recommendations
3.3.7 Methicillin-Resistant Staphylococcus aureus (MRSA)
3.3.7.1 Disease Background and Description
3.3.7.2 Product Analysis: Instruments and Reagents
3.3.7.3 Method Comparison
3.3.7.4 MRSA Market Size
3.3.7.5 Competitive Structure and Market Share Analysis
3.3.7.6 Market Forecasts
3.3.7.6.1 Revenue Forecasts
3.3.7.7 Market Challenges
3.3.7.7.1 Market Drivers
3.3.7.7.2 Market Restraints
3.3.7.8 Market and Technology Trends
3.3.7.8.1 Market Trends
3.3.7.8.2 Technology Trends
3.3.7.9 Strategic Recommendations
3.3.8 Vancomycin-resistant Enterococci
3.3.8.1 Disease Background and Description
3.3.8.2 Product Analysis: Instruments and Reagents
3.3.8.3 Method Comparison
3.3.8.4 Competitive Structure and Market Share Analysis
3.3.8.5 Market Forecasts
3.3.8.5.1 Revenue Forecasts
3.3.8.6 Market Challenges
3.3.8.6.1 Market Drivers
3.3.8.6.2 Market Restraints
3.3.8.7 Market and Technology Trends
3.3.8.7.1 Market Trends
3.3.8.7.2 Technology Trends
3.3.8.8 Strategic Recommendations
3.3.9 Herpes Simplex Virus
3.3.10 C. difficile
3.3.11 Cytomegalovirus
3.4 Blood Screening
3.4.1 Product Analysis: Instruments and Reagents
3.4.2 Method Comparison
3.4.3 Blood Screening Market Size
3.4.4 Competitive Positions
3.4.5 Market Challenges and Strategic Recommendations
3.4.5.1 Market Drivers and Restraints
3.4.5.1.1 Market Drivers
3.4.5.1.2 Market Restraints
3.4.5.2 Market and Technology Trends
3.4.5.2.1 Market Trends
3.4.5.2.2 Technology Trends
3.4.5.3 Strategic Recommendations

4. Molecular Diagnostic Testing Technology for Infectious Disease Testing
4.1 Infectious Disease Diagnostic Tests
4.1.1 Molecular Diagnostic Tools Solutions
4.1.2 Technology of Gene Expression Analysis
4.1.2.1 Amplification and Detection of RNA
4.1.2.2 Analysis of Multiple Genes
4.1.2.3 Advanced Information Technology
4.2 Use of Molecular Tests in Infectious Disease
4.2.1 Molecular Screening
4.2.2 Early Detection
4.2.3 Detection of Specific Resistance Genes and Viral Loading Tests
4.2.4 Pharmacogenomics and Personalized Medicine in MD Infectious Disease Testing
4.2.5 Molecular Strain Typing
4.3 Cost of Molecular Diagnostic Testing
4.4 Use of Multiplex PCR Tests
4.4.1 Advantages of Multiplex PCR
4.4.2 Applications of Multiplex PCR
4.5 Next-Generation Sequencing
4.6 Patient Flow Software
4.7 Digital PCR
4.8 LAMP
4.9 Ion Proton System for Gene Sequencing

5. Business
5.1 Technology and Market Trends
5.1.1 Technology Trends
5.2 M&A Activity
5.3 Partnerships
5.4 Competitive Analysis
5.4.1 Primary Competitors
5.4.2 Industry Challenges and Strategic Recommendations
5.4.3 Commercialization of Molecular Diagnostic Products
5.5 Intellectual Property Rights
5.5.1 New Patents
5.5.2 Current Patent Disputes
5.6 Opportunities and Strategic Recommendations
5.6.1 The Key Technical Opportunities with Significant Market Appeal in the Molecular Diagnostic Space in the Next Five Years
5.6.2 Developments for Molecular Diagnostic Instrumentation Products
5.6.3 Market Penetration Strategies for Infectious Disease Testing
5.7 Business Models and Requirements for a Successful Molecular Diagnostics Infectious Disease Products Industry
5.7.1 Scope of This Section
5.7.2 The Success Achieved by the Molecular Diagnostics Infectious Disease Products
5.7.3 Business Models in Molecular Diagnostics Infectious Disease Products
5.7.4 SWOT Comparison of Business Models for MD Infectious Disease Diagnostic Testing
5.7.5 Commercial Manufacturing of Molecular Diagnostics Infectious Disease Products: Requirements
5.7.5.1 Elements of Commercial Manufacturing
5.7.5.1.1 Regulatory Requirements
5.7.5.1.2 Manufacturing Process Scale
5.7.5.1.3 In-House Manufacturing
5.7.5.2 Contract Manufacturing: Commercial and Academic
5.7.6 Sales and Marketing Strategies for Infectious Disease Tests
5.8 Companion Diagnostics Development in Partnership with a Pharmaceutical Company
5.8.1 Description of Business Model
5.8.2 Anti-Infective Pharmaceutical Market

6. Reimbursement and Billing Landscape for Molecular Diagnostics Testing for Infectious Disease
6.1 Overview
6.1.1 Gap Filling
6.2 Trends in Reimbursement Practice
6.2.1 Medicare Reimbursement Threats
6.2.2 Analysis of ROI for Molecular Diagnostic Tests for Infectious Disease Using Current Medicare Reimbursement Rules
6.3 Trends in Patient Care and Reimbursement
6.4 Revenue Threats
6.4.1 Medicare Payment Exceptions
6.4.2 Three Areas for Denial of Claims
6.5 Billing Rules
6.5.1 Medicare Billing Procedures
6.5.2 Medicare CPT Coding Rules for MD Infectious Disease Testing
6.5.3 Infectious Disease Billing Strategies

7. Regulatory Requirements
7.1 U.S. Food and Drug Administration
7.2 CLIA Regulations
7.3 Clinical Laboratory Improvement Act
7.4 State Licensing for Service Laboratories
7.5 IVDMIAs
7.6 FDA Draft Guidance on In Vitro Companion Diagnostic Devices
7.7 510(k) Clearance
7.8 Pre-Market Approval (PMA)
7.8.1 Pre-Market Approval Application
7.9 Analyte Specific Reagents (ASRs)
7.9.1 Laboratory Developed Tests (LDT)
7.10 What Regulatory Guidance is Needed for Companion Biomarkers?
7.11 U.S. Patent and Trademark Office (USPTO)
7.12 IRB Approval in Clinical Trials
7.13 CE Marking and the European In Vitro Diagnostic Device Directive
7.14 De Novo Classification
7.15 Research Use Only Reagents
7.16 FDA Recommendations on Methicillin-Resistant Staphylococcus aureus and Staphylococcus aureus Testing

8. Business Decisions using Molecular Diagnostic Tests in Infectious Disease Testing
8.1 What are Key Opportunities in Infectious Disease Testing Development and Commercialization?
8.3 How do Business Strategies, Such as Those Relating to Acquisition, Drive MD Strategies?
8.4 How Might Novel Infectious Disease MD Test Development Lead to Acquisition Strategies and Their Implications for Deal Making?
8.5 How can Molecular Diagnostic Tests Increase Value in an Associated Drug Marketing Plan?
8.6 Which Types of Infectious Disease MD Testing Should be Developed by Diagnostic Companies at Various Stages in the Development Pipeline?
8.7 How can Regulatory Oversight Drive Approval and Adoption of New Technologies?
8.8 What are the Noteworthy Deals?
8.9 Who are the Acquirers?
8.10 Who are the Target Companies?
8.11 How will Platform Technology Companies Enter the Space?
8.12 Will Pharma Integrate with Diagnostics?
8.13 How do Platform Technology Companies Position Themselves for Diagnostics Development?
8.14 Evaluate How Partnering and M&As will Alter the Competitive Landscape
8.15 Predict How FDA Regulations will Impact New Diagnostic Tests
8.16 How can Big Pharma and Diagnostic Companies Co-Develop Biomarkers in a Model for Regulatory Acceptance?
8.17 How to Maximize Business Development Through Biomarker Strategies?
8.18 What is the Best Type of Business Model for Developing Genetic Biomarkers for Infectious Disease?
8.19 How Best have Genetic Biomarkers Provided the Most Benefit in Infectious Disease Testing?
8.20 What are the Most Innovative Methods in Development of Molecular Diagnostic Biomarkers?
8.21 What are the Best Values for Genetic Biomarkers in Drug Development and in Diagnostics?
FDA Clears Gen-Probe's PANTHERÆ System for use with APTIMA Combo 2Æ Assay in May 2012

9. Economics of Anti-Microbial Drug Resistance: The Persistent Need for Antibacterials
9.1 Resistance and Antibiotic Usage
9.2 Infection Control Programs

10. Company Profiles
10.1 Abbott Laboratories
10.2 AdvanDx
10.3 Arcxis Biotechnologies
10.4 Atlas
10.5 AutoGenomics, Inc.
10.6 Becton, Dickinson and Company
10.7 bioMÈrieux
10.8 Biocartis
10.9 bioTheranostics
10.10 Cepheid
10.11 EraGen Biosciences
10.12 GenMark Diagnostics, Inc.
10.13 Genomix Biotech
10.14 Hologic Gen-Probe
10.15 Genomica S.A.U.
10.16 Great Basin Corporation
10.17 Illumina, Inc.
10.18 Innogenetics NV
10.19 Life Technologies
10.20 Mobidiag
10.21 Myconostica
10.22 Myriad Genetics, Inc.
10.23 Nanosphere
10.24 NorDiag ASA (The DiaSorin Group)
10.25 Qiagen NV
10.26 Roche Ltd.
10.27 Seegene
10.28 SIRS-Lab
10.29 TrimGen
10.30 TrovaGene
10.31 Veredus Laboratories
10.32 Veridex

Table of Contents - Molecular Diagnostics Markets

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 Impact of the Human Genome Project on Molecular Diagnostics
2.3 Key Considerations for Molecular Diagnostics
2.4 Molecular Diagnostics in the Post-Genomic Era
2.5 Advances in Molecular Diagnostics Technologies
2.6 Genetic Variability and Disease
2.7 Major Technology Platforms
2.7.1 Gene-based Amplification Technologies
2.7.2 Detection of Amplified Gene Products
2.7.3 Target-based Gene Amplification
2.7.3.1 Polymerase Chain Reaction (PCR)
2.7.3.2 Real-Time PCR
2.7.3.3 Nucleic Acid Sequence-based Amplification (NASBA)
2.7.4 Probe-based Amplification
2.7.4.1 Ligase Chain Reaction (LCR)
2.7.4.2 Strand Displacement Amplification (SDA)
2.7.4.3 QB-Replicase Amplified Probe Assay
2.7.5 Signal-based Amplification
2.7.5.1 Branched DNA (bDNA)
2.7.6 Other Gene Amplification Technologies
2.7.6.1 Immuno-PCR (IPCR)
2.7.6.2 Bio-Barcode Amplification Assay (BCA)
2.7.6.3 Hybrid Capture
2.7.7 Next Generation Sequencing

3. Nucleic Acid Test Applications
3.1 Molecular Diagnostic Testing and Infectious Diseases
3.1.1 Genomics Molecular Diagnostics Market
3.1.1.1 Methods for DNA Detection and Gene Sequencing
3.1.1.2 Products and Applications
3.1.1.3 Oncology
3.1.2 SNPs and Genes: Medical Utility (Clinical Applications)
3.1.2.1 Clinical Application Initiatives
3.1.2.2 Sampling of Affymetrix's Clinical Application Collaborations
3.2 Infectious Disease Testing Using Molecular Diagnostics
3.2.1 HIV
3.2.2 Hepatitis Serologic Markers and Nucleic Acid Testing
3.2.2.1 Hepatitis A Virus (HAV)
3.2.2.2 Hepatitis B Virus (HBV)
3.2.2.2.1 Hepatitis B Market Size
3.2.2.3 Hepatitis C Virus (HCV)
3.2.2.4 Hepatitis D Virus (HDV)
3.2.2.5 Hepatitis E Virus (HEV)
3.2.3 Human Papillomavirus (HPV)
3.2.4 Influenza Viruses
3.2.4.1 H5N1 Influenza Virus
3.2.4.2 H1N1 Influenza Virus
3.2.5 Cancer Detection Using Molecular Diagnostics
3.2.5.1 Lung Cancer
3.2.5.2 Oral Cancer
3.2.5.3 Prostate Cancer
3.2.5.3.1 PCA3
3.2.5.3.2 Companies Active in Molecular Diagnostics and Prostate Cancer Analysis
3.2.5.4 Chronic Myelogenous Leukemia
3.2.5.5 Malignant Gliomas
3.2.5.6 Colorectal Cancer
3.2.5.6.1 Background on KRAS Mutation
3.2.5.7 Breast Cancer
3.2.5.8 Bladder Cancer
3.2.5.9 Ovarian Cancer
3.2.5.10 Molecular Diagnostic Screening Test for Cancer
3.2.5.11 Cervical Cancer
3.2.6 Microbiology Testing Using Molecular Diagnostics
3.2.6.1 Chlamydia
3.2.6.1.1 Revenue Forecasts
3.2.6.2 Gonorrhea
3.2.6.3 Tuberculosis (TB)
3.2.6.4 Group B Streptococcus (GBS)
3.2.6.5 Bordetella pertussis
3.2.6.6 Legionella pneumophilia
3.2.6.7 Periodontal Bacteria
3.2.6.8 Pneumocystis carinii
3.2.6.9 Methicillin-resistant Staphylococcus Aureus (MRSA)
3.2.6.10 Clostridium difficile
3.2.6.11 Vancomycin-resistant Enterococci (VRE)
3.2.6.12 Fungal Infections
3.2.6.13 Herpes
3.2.6.14 Other Infectious Diseases
3.2.7 Blood Screening Using Molecular Diagnostics
3.2.7.1 Blood Screening Competitive Positions
3.3 Genetics Testing in Molecular Diagnostics
3.3.1 Functional Genomics
3.3.2 Genetic and Paternity Testing
3.4 Molecular Diagnostics Uses in Industrial Testing and Food Diagnostics
3.4.1 The Market
3.4.2 Detection of Helicobacter pylori by PCR
3.4.3 Detection of Escherichia coli 0157
3.4.4 Detection of Enteric Viruses
3.4.5 Industrial Microorganisms
3.5 Molecular Diagnostics Forensics Testing Market
3.5.1 Analysis by PCR-based DNA Typing
3.5.2 Rapid Isolation of DNA for Restriction Fragment Length Polymorphism (RFLP) and PCR
3.5.3 DNA for PCR-STR Typing
3.6 Bioterrorism and Molecular Diagnostics
3.6.1 Introduction
3.6.1.1 Current Biological Threat Detection Systems
3.6.1.2 Use of DNA Microarrays and Biochips for Gene Expression Profiles in BWAs
3.6.1.3 Advantages and Disadvantages of Host Gene Expression Profiling as a Biothreat Detection
3.6.2 Biological Warfare Agents (BWAs)
3.6.2.1 Anthrax
3.6.2.2 Botulinum Toxin
3.6.2.3 Ricin
3.6.2.4 IVD Industry and Bioterrorism Preparedness
3.6.2.4.1 Brucellosis
3.6.2.4.2 Cholera
3.6.2.5 Rapid Lateral Flow Immunoassays
3.6.2.6 Biosensors
3.6.3 Anthrax in Clinical Samples
3.6.3.1 Overview of Anthrax and its Infectivity
3.6.3.2 Rapid Tests
3.7 Cystic Fibrosis Testing
3.8 Human Leukocyte Antigen (HLA) Sequencing-based Typing Kits
3.8.1 Transplantation of Tissues
3.9 Molecular Cytogenetic Testing
3.9.1 Hereditary Hemochromatosis
3.9.2 Apolipoprotein E (ApoE) Genotyping
3.9.3 Fragile X Syndrome (FXS)
3.9.4 Methylenetetrahydrofolate Reductase (MTHFR) Carrier Testing
3.9 5 Other Genetic Testing Procedures
3.10 Developments in DNA Biochips for Clinical Applications
3.10.1 Product Analysis
3.10.2 Breast Cancer DNA Arrays
3.10.3 eSensor DNA Detection System
3.11 Personalized Medicine, Pharmacogenomics and Molecular Diagnostics Testing
3.11.1 Coumadin (Warfarin)
3.12 Thrombic Disorders
3.13 Respiratory Virus Panel
3.14 HFE (Hemochromatosis)
3.15 Lupus
3.16 Down's Syndrome and Prenatal Screening
3.17 Molecular Diagnostics Technology Platforms and their Impact on Personalized Medicine

4. Trends in Molecular Diagnostics
4.1 Pharmacogenomics
4.1.1 The Market
4.1.1.1 Oncology
4.1.1.2 Toxicogenomics
4.1.2 Market Influences and Forecast
4.2 DNA Microarrays
4.2.1 Techniques
4.2.2 The Market
4.2.3 Identification of Sequence SNPs
4.2.4 Determining Gene Expression Levels
4.2.4.1 Hybridization Tests
4.2.4.2 Oligonucleotide Probes
4.2.5 Molecular Diagnostics Entry into Point-of-Care (POC) Testing
4.3 Emerging Markets of DNA Arrays
4.3.1 Pharmacogenomics
4.3.2 Adoption of Amplified Screening Technology
4.3.3 Advances in Automated Testing
4.3.4 Increased Focus on Safety of Blood Supply
4.3.5 Development of Emerging Markets for NAT Technology
4.3.6 Cancer
4.3.7 Human Leukocyte Antigen (HLA) Typing
4.3.8 Neonatal Screening
4.4 Drivers and Restraints
4.5 Market Forecast
4.6 Business Trends in the Industry
4.6.1 Molecular Diagnostics Industry Trends
4.6.1.1 Adoption of Amplified Screening Technology
4.6.1.2 Advances in Automated Testing
4.6.1.3 Responsiveness to Newly Emerging Threats
4.6.1.4 Increased Focus on Safety of Blood Supply
4.6.1.5 Growth in Viral Load Testing
4.6.1.6 Development of Emerging Markets for NAT Technology
4.6.1.7 Improvements in Detection Technologies
4.6.1.8 Use of Multiplex PCR Tests
4.6.2 Pharmaceutical Industry Trends
4.6.3 Acquisitions, License Agreements and Partnerships
4.6.4 Ethical, Legal and Social Issues Related to the Use of Genetic Information
4.6.5 Regulatory Issues
4.6.5.1 U.S. Food and Drug Administration
4.6.5.2 CLIA Regulations
4.6.5.3 Clinical Laboratory Improvement Act (CLIA)
4.6.5.4 State Licensing for Service Laboratories
4.6.5.5 Multivariate Index Assays (IVDMIAs)
4.6.5.6 510(k) Clearance
4.6.5.6.1 Pre-Market Approval (PMA)
4.6.5.7 PMAs
4.6.5.8 ASRs
4.6.5.9 Laboratory Developed Tests
4.6.5.10 What Regulatory Guidance is needed for Companion Biomarkers?
4.6.5.11 U.S. Patent and Trademark Office (USPTO)
4.6.5.12 IRB Approval in Clinical Trials
4.6.5.13 CE marking and the IVDD (European In Vitro Diagnostic Device Directive)
4.6.5.14 De Novo Classification
4.6.5.15 Research Use Only Reagents
4.6.6 Reimbursement Issues and Billing Landscape for Molecular Diagnostics Testing
4.6.6.1 Cystic Fibrosis
4.6.6.2 Viral Load Testing
4.6.6.3 NMP22
4.6.6.4 Trends in Reimbursement Practice
4.6.6.5 Medicare Reimbursement Threats
4.7 Patent Protection and Intellectual Property Rights
4.7.1 New Patents
4.7.2 BRCA1 and BRCA2 Gene Patents
4.7.3 Current Patent Disputes
4.8 Micoarray Quality Control (MAQC)

5. Molecular Diagnostics Automated Instrumentation Approved for Market by the FDA
5.1 Gene Expression Profiling
5.2 Proteomic Multiplex Assays
5.3 Solution-Phase Multiplexing
5.4 RNA Interference (RNAi)
5.4.1 Role of RNAi in Drug Target Validation
5.4.2 Other Companies involved in the RNAi Market
5.5 DNA Tags
5.6 Follow-on Optical Technologies

6. Market Trends and Forecasts
6.1 Market Dynamics
6.1.1 Molecular Diagnostics Market Opportunities
6.1.2 Market Forces
6.2 Future Considerations for Molecular Diagnosis
6.3 Role of Genomics in Transforming Pharmaceutical R&D
6.4 Cancer Markers
6.5 Cytology Markers
6.6 RNA Detection
6.7 Diagnosis of Inherited Disease
6.8 Ethical Considerations
6.9 NAT and Personalized Medicine
6.10 Five Molecular Diagnostics Growth Areas
6.11 Specific Commercial Nucleic Acid Probes
6.12 Novel Amplification Techniques in the Market
6.13 Ramification Amplification Method (RAM)
6.14 Invader Assays/Third Wave Technologies (Hologic)
6.15 Molecular Beacons
6.16 Human Leukocyte Antigen (HLA) Sequencing-based Typing Kits
6.17 Prenatal Diagnosis
6.18 Newborn Screening
6.19 NAT and Preventive Medicine: NAT-based Assays
6.20 Prenatal and Pre-Implantation Diagnosis
6.21 FISH-based Tests on Fetal Cells
6.22 Companion Therapeutic/Diagnostic Approach
6.23 Sample Preparation Market
6.24 Emerging Amplification Techniques
6.24.1 Gold Nanoparticle Molecular Probes
6.24.2 Real-Time Microfluidic PCR Using Magnetic Affinity Beads
6.25 ASRs (Analyte-Specific Reagents)

7. Company Profiles
7.1 Abbott Laboratories
7.2 Adnavance Technologies, Inc.
7.3 AdvanDx
7.4 Agendia
7.5 Agilent Technologies
7.6 Asuragen
7.7 Ambry Genetics
7.8 American Diagnostica
7.9 Applied Biosystems, Inc. (now Life Technologies)
7.10 ARCA biopharma
7.11 ArcticDx, Inc.
7.12 Arcxis Biotechnologies
7.13 Atlas Genetics
7.14 Aureon Laboratories
7.15 AutoGenomics, Inc.
7.16 Beckman Coulter, Inc.
7.17 Becton, Dickinson and Company
7.18 BG Medicine
7.19 Biocartis
7.20 BioGenex Laboratories, Inc.
7.21 Biohelix Corporation
7.22 bioMerieux
7.23 Bio-Rad Laboratories
7.24 Biotage AB
7.25 Biotest AG
7.26 Caliper Life Sciences, Inc.
7.27 Celera
7.28 Cepheid
7.29 CombiMatrix Corporation
7.30 Cytocell Technologies Ltd.
7.31 CytoCore, Inc.
7.32 DiagnoCure, Inc.
7.33 DxS
7.34 Enzo Biochem
7.35 Epigenomics
7.36 EraGen Biosciences
7.37 Eurogentec
7.38 EXACT Sciences Corporation
7.39 Exiqon A/S
7.40 GeneOhm Sciences
7.41 Genera Biosystems
7.42 Genzyme Corporation
7.43 GenMark Diagnostics, Inc.
7.44 Genomix Biotech
7.45 Gen-Probe
7.46 Gene Express
7.47 Genomica
7.48 Hologic
7.49 Illumina, Inc.
7.50 Innogenetics NV
7.51 Invitrogen (Life Technologies)
7.52 Life Technologies
7.53 Luminex
7.54 Inverness Medical Innovations
7.55 Monogram Biosciences, Inc.
7.56 Myconostica
7.57 Nanogen
7.58 Nanosphere
7.59 NorDiag ASA
7.60 PharMingen
7.61 Qiagen N.V.
7.62 Roche Diagnostics
7.63 SABiosciences Corporation
7.64 Seegene
7.65 Siemens Healthcare Diagnostics (Siemens)
7.66 SIRS-Lab
7.67 Source MDx
7.68 Targeted Molecular Diagnostics
7.69 Thermo Fisher Scientific
7.70 Thorne Diagnostics
7.71 TrimGen
7.72 TrovaGene
7.73 U.S. Genetics, Inc.
7.74 Veredus Laboratories
7.75 Veridex

8. Market Overview
8.1 Snapshot of Molecular Diagnostics Industry Structure
8.2 Global Molecular Diagnostics Testing Market
8.3 U.S. Molecular Diagnostics Testing Market
8.4 European Molecular Diagnostics Market
8.5 Japanese Molecular Diagnostics Testing Market
8.6 Overview of the European Molecular Diagnostics Country Markets
8.6.1 France
8.6.2 Germany
8.6.3 U.K.
8.6.4 Italy
8.6.5 Spain
8.7 Strategic Assessment and Business Development in the Molecular Diagnostics Sector
8.7.1 Industry Background
8.7.2 Competition
8.7.3 Business Strategy
8.7.4 Corporate Examples
8.7.4.1 Gen-Probe
8.7.4.2 Osmetech
8.7.4.3 Combimatrix
8.7.4.4 Sekisui Chemical Co. Ltd.
8.7.4.5 Myriad Genetics
8.7.4.6 Luminex
8.7.5 IVD Manufacturers' Goals in Detection Technology Development
8.7.5.1 New Developments in Molecular Diagnostic Markers are driven by Corporate Joint Ventures
8.7.5.2 Factors for Growth in Molecular Diagnostics
8.7.5.3 How has the IVD Industry Changed?
8.7.5.4 What are the Challenges for the Future?
8.7.5.5 What New Trends are in the Future?
8.7.5.5.1 Market and Technology Trends
8.7.5.5.1.1 Market Trends
8.7.5.5.1.2 Technology Trends
8.7.5.5.1.3 Strategic Recommendations

- ARCA biopharma
- Abbott Laboratories
- Adnavance Technologies, Inc.
- AdvanDx
- Agendia
- Agilent Technologies
- Ambry Genetics
- American Diagnostica
- Applied Biosystems, Inc. (now Life Technologies)
- ArcticDx, Inc.
- Arcxis Biotechnologies
- Asuragen
- Atlas Genetics
- Aureon Laboratories
- AutoGenomics, Inc
- BG Medicine
- Beckman Coulter
- Becton, Dickinson and Company
- bioMerieux
- bioTheranostics
- Bio-Rad Laboratories
- BioGenex Laboratories, Inc
- BioHelix Corporation
- Biocartis
- Biotage AB
- Biotest AG
- Caliper Life Sciences, Inc.
- Celera
- Cepheid
- Clarient, Inc.
- CombiMatrix Corporation
- CytoCore, Inc.
- Cytocell Technologies Ltd.
- DiagnoCure, Inc.
- DxS
- EXACT Sciences Corporation
- EntroGen, Inc
- Enzo Biochem
- Epigenomics
- EraGen Biosciences
- Eurogentec
- Exact Sciences Corporation
- Exagen Diagnostics, Inc.
- Exiqon A/S
- Ferrer inCode
- Gen-Probe
- GenMark Diagnostics, Inc.
- Gene Express
- GeneOhm Sciences
- Genera Biosystems
- Genmark Diagnostics, Inc
- Genomic Health, Inc.
- Genomica
- Genomix Biotech
- Genoptix, Inc.
- Genzyme Corporation
- Great Basin Scientific
- Hologic, Inc
- Illumina, Inc
- Innogenetics NV
- IntegenX
- InterGenetics, Inc.
- Inverness Medical Innovations
- Invitrogen (Life Technologies)
- LabCorp
- Laboratory Corporation of America Holdings
- Life Technologies Corporation
- Luminex
- Luminex Corporation
- Mobidiag
- Monogram Biosciences, Inc.
- Myconostica
- Myriad Genetics, Inc
- Nanogen
- Nanosphere
- Natera
- NetBio
- NorDiag ASA
- Nuvera Biosciences
- Orion Genomics
- PANTHER System
- PerkinElmer Genetics
- PharMingen
- Progenika, Inc
- QIAGEN NV
- Roche Ltd
- Rosetta Genomics Ltd.
- SABiosciences Corporation
- SIRS-Lab
- Seegene
- Sequenom, Inc.
- Siemens Healthcare Diagnostics (Siemens)
- Signature Genomics
- Source MDx
- Spartan Bioscience, Inc
- Targeted Molecular Diagnostics
- Thermo Fisher Scientific
- Thorne Diagnostics
- Transgenomic, Inc
- TrimGen
- TrovaGene
- U.S. Genomics, Inc.
- Veredus Laboratories
- Veridex
- Xenomics, Inc.

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