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Molecular Diagnostics in Cancer Testing

  • ID: 1195430
  • June 2016
  • Region: Global
  • 201 Pages
  • TriMark Publications
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FEATURED COMPANIES

  • AccuGenomics, Inc.
  • bioMérieux
  • Epigenomics
  • Genoptix, Inc. (Novartis)
  • LabCorp
  • Orion Genomics
  • MORE

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 vitro diagnostics (IVD) market known as molecular diagnostics (MD), with a specialization in the MD tests for cancer. In the current medical diagnostics market, molecular diagnostics for cancer testing offers one of the brightest areas for growth and innovation. The confluence of breakthroughs in genomics, proteomics, and the development of microarray devices to measure analytes in the blood and various body tissues, has led to this revolutionary market segment offering the power of advanced analytical techniques to the diagnosis and treatment of cancer.

This report analyzes the size and growth of the molecular diagnostics market in its applications for cancer detection and therapy, examining the factors that influence the various market segments and the dollar volume of sales, both in the United States and worldwide.

Note: Product cover images may vary from those shown
2 of 4

FEATURED COMPANIES

  • AccuGenomics, Inc.
  • bioMérieux
  • Epigenomics
  • Genoptix, Inc. (Novartis)
  • LabCorp
  • Orion Genomics
  • 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
2.1 Opening 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
2.5.1 Molecular Methods to Detect Genetic Variants in Cancer
2.5.1.1 Allele-Specific PCR
2.5.1.2 Sanger Dideoxy Sequencing
2.5.1.3 Pyrosequencing
2.5.1.4 Mass Spectrometry
2.5.1.5 Single Base Extension Assay
2.5.1.6 Multiplex Ligation-Dependent Probe Amplification (MLPA)
2.5.1.7 Fluorescence In Situ Hybridization (FISH)
2.5.1.8 Next Generation Sequencing
2.5.1.8.1 Next-Generation Sequencing—Custom Panels, Amplicon Capture
2.5.1.8.2 Next-Generation Sequencing—Custom Panels, Hybridization Capture
2.5.1.8.3 Next-Generation Sequencing—Whole Exome Sequencing
2.5.1.8.4 Next-Generation Sequencing—Whole Genome Sequencing
2.5.1.9 Digital Droplet PCR (ddPCR)
2.5.2 Clinical Applications of Next-generation Sequencing
2.6 Oligonucleotide Array Platforms
2.7 Emerging Cancer Personalized Medicine Market
2.7.1 Predictive Cancer Molecular Diagnostics
2.8 Companion Diagnostics
2.9 Opportunities for Molecular Diagnostic Companies
2.10 Liquid Biopsies
2.11 Data Analysis
2.12 In-house vs. Commercial Testing
2.13 Multi-Gene Cancer Panels

3. Cancer Diagnostics Molecular Testing Market
3.1 Market Description
3.1.1 Market Overview for Molecular Diagnostics in Cancer Testing
3.1.2 Laboratories Performing Molecular Diagnostics for Cancer Testing
3.1.3 Competitive Landscape
3.1.3.1 Pure Play Specialty Companies Performing Tumor MDx Analysis
3.1.3.2 Mixed Specialty Cancer Diagnostic Labs
3.1.3.3 General Clinical Reference Laboratories
3.1.3.4 Diagnostic Device and Reagent Developers
3.1.3.5 Companion Diagnostics Development in Partnership with a Pharmaceutical Company
3.1.4 Sales and Marketing Strategies for Cancer Tests
3.1.4.1 North American Market
3.1.4.2 International Markets

4. Molecular Diagnostic Tests for Cancer
4.1 Overview of Molecular Diagnostics for Cancer
4.1.1 Cancer Statistics
4.1.2 Treating Cancers
4.1.3 Use of Genomics to Understand Cancer
4.1.4 Molecular Diagnostic Tools Solutions
4.1.5 Technology of Gene Expression Analysis
4.1.5.1 Amplify and Detect Diminished Amounts of RNA Consistently
4.1.5.2 Analyze Hundreds of Genes
4.1.5.3 Employ Advanced Information Technology
4.2 Breast Cancer Molecular Diagnostics
4.2.1 Overview of Breast Cancer
4.2.2 Breast Cancer Molecular Diagnostic Assays
4.2.2.1 Ambry Genetics
4.2.2.2 Agendia
4.2.2.2.1 MammaPrint
4.2.2.3 BGI
4.2.2.4 Bioreference Labs
4.2.2.5 BioTheronostics (part of BioMérieux)
4.2.2.5.1 Breast Cancer Index
4.2.2.6 Cancer Genetics, Inc. (CGI)
4.2.2.7 Dako (part of Agilent Technologies)
4.2.2.8 DiaSorin
4.2.2.9 Fulgent Diagnostics
4.2.2.10 Genetic Technologies Ltd.
4.2.2.11 Genomic Health
4.2.2.11.1 Oncotype DX
4.2.2.12 Genoptix (part of Novartis)
4.2.2.13 Invitae
4.2.2.14 LabCorp
4.2.2.14.1 BRCAssure® Tests
4.2.2.15 Multiplicom
4.2.2.16 Myriad Genetics
4.2.2.16.1 BRACAnalysis®
4.2.2.16.2 BART®
4.2.2.17 Nanostring Technologies
4.2.2.17.1 Prosigna
4.2.2.18 Neogenomics
4.2.2.19 Pathway Genomics
4.2.2.20 Sophia Genetics
4.2.2.21 Quest Diagnostics
4.2.2.21.1 BRCAvantage Plus
4.2.2.22 Ventana Medical Systems (Roche)
4.2.2.22.1 HER2 Dual ISH DNA Probe Cocktail, INFORM
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
4.2.4 Market Drivers and Restraints
4.2.4.1 Market Drivers
4.2.4.2 Market Restraints
4.2.5 Breast Cancer Molecular Diagnostic Testing Assay Market and Technology Trends
4.2.5.1 Breast Cancer Molecular Diagnostic Testing Assay Market Trends
4.2.5.2 Breast Cancer Molecular Diagnostic Testing Assay Technology Trends
4.2.5.3 Breast Cancer Testing Assay Strategic Recommendations
4.3 Colorectal Cancer Molecular Diagnostics Market
4.3.1 Overview of Colorectal Cancer
4.3.2 Colon Cancer Molecular Diagnostic Assays
4.3.2.1 BRAF
4.3.2.2 KRAS
4.3.2.3 mSEPT9
4.3.2.4 Screening Assays
4.3.2.4.1 Overview of Stool-based DNA Assays
4.3.2.5 Abbott
4.3.2.5.1 Abbott RealTime KRAS Amplification Reagent Kit
4.3.2.5.2 RealTime mS9 Colorectal Cancer
4.3.2.6 Agendia
4.3.2.6.1 ColoPrint
4.3.2.7 Ambry Genetics
4.3.2.7.1 ColoNext
4.3.2.8 Bioreference Labs
4.3.2.9 Cancer Genetics, Inc.
4.3.2.10 Epigenomics
4.3.2.10.1 Epi proColon
4.3.2.11 Exact Sciences
4.3.2.11.1 Cologuard
4.3.2.12 Fulgent Diagnostics
4.3.2.13 Genomic Health
4.3.2.13.1 Oncotype DX colon
4.3.2.14 Genomictree
4.3.2.15 Genoptix (part of Novartis)
4.3.2.16 Invitae
4.3.2.17 LabCorp
4.3.2.18 Myriad Genetics
4.3.2.18.1 COLARIS
4.3.2.18.2 COLARIS AP
4.3.2.19 Neogenomics
4.3.2.20 Novigenix
4.3.2.20.1 Colox
4.3.2.21 Pathway Genomics
4.3.2.21.1 ColoTrue
4.3.2.22 Qiagen
4.3.2.22.1 therascreen KRAS RGQ PCR Kit
4.3.2.23 Quest Diagnostics
4.3.2.23.1 ColoVantage
4.3.2.24 Roche
4.3.2.24.1 cobas® KRAS Mutation Test
4.3.2.25 Trovagene
4.3.2.25.1 PCM KRAS Mutation Detection Test
4.3.3 Competitive Structure and Market Share Analysis
4.3.3.1 Colorectal Cancer Molecular Diagnostic Testing Market Size
4.3.3.2 Market Drivers and Restraints
4.3.3.2.1 Market Drivers
4.3.3.2.2 Market Restraints
4.3.3.3 Colon Cancer Molecular Diagnostic Testing Assay Market and Technology Trends
4.3.3.3.1 Colon Cancer Molecular Diagnostic Testing Assay Market Trends
4.3.3.3.2 Colon Cancer Molecular Diagnostic Testing Assay Technology Trends
4.3.3.3.3 Colon Cancer Molecular Diagnostic Testing Assay Strategic Recommendations
4.3.4 New Guidelines for Colorectal Cancer Molecular Testing
4.4 Prostate Cancer Molecular Diagnostics Market
4.4.1 Molecular Screening Assays for Prostate Cancer
4.4.1.1 Hologic
4.4.1.1.1 PROGENSA PCA3 Assay
4.4.1.2 Bostwick Laboratories
4.4.1.2.1 PCA3Plus
4.4.1.3 Overview of PCA3
4.4.1.4 MDx Health
4.4.1.4.1 SelectMDx for Prostate Cancer
4.4.1.5 Invitae
4.4.1.5.1 Invitae Prostate Cancer Panel
4.4.1.6 Neogenomics
4.4.1.6.1 NeoLAB Prostate
4.4.2 Molecular Assays Performed After Colorectal Biopsy
4.4.2.1 Myriad Genetics
4.4.2.1.1 Prolaris
4.4.2.2 Genomic Health
4.4.2.2.1 Oncotype DX Genomic Prostrate Score
4.4.2.3 MDxHealth (ConfirmMDx)
4.4.2.4 Bostwick Laboratories (ProstaVysion)
4.4.3.5 MDNA Life Sciences
4.4.3.5.1 Prostate Core Mitomic Test
4.4.2.6 GenomeDx
4.4.2.6.1 Decipher
4.4.3 Competitive Structure and Market Share Analysis
4.4.4 Market Drivers and Restraints
4.4.4.1 Market Drivers
4.4.4.2 Market Restraints
4.4.5 Prostate Cancer Molecular Diagnostic Testing Assay Market and Technology Trends
4.4.5.1 Prostate Cancer Molecular Diagnostic Testing Assay Market Trends
4.4.5.2 Prostate Cancer Molecular Diagnostic Testing Assay Technology Trends
4.5 Ovarian Cancer
4.5.1 Incidence of Ovarian Cancer
4.5.2 Key Players in Ovarian Testing Market
4.5.2.1 Ambry Genetics
4.5.2.2 Myriad Genetics
4.5.2.3 Market Drivers and Restraints
4.5.2.3.1 Market Drivers
4.5.2.3.2 Market Restraints
4.6 Lung Cancer
4.6.1 Incidence of Lung Cancer
4.6.2 Pharmacogenomics and Cancer
4.6.3 Lung Cancer Molecular Diagnostics Assays
4.6.3.1 Genoptix (a Novartis company)
4.6.3.1.1 NexCourse NSCLC
4.6.3.2 Qiagen
4.6.3.2.1 therascreen EGFR RGQ PCR Kit
4.6.3.3 Roche
4.6.3.3.1 cobas® EGFR Mutation Test v2
4.6.3.4 Epigenomics
4.6.3.4.1 Epi proLung® BL Reflex Assay
4.6.3.5 Myriad Genetics
4.6.3.5.1 myPlan™ Lung Cancer
4.6.3.6 Quest Diagnostics
4.6.3.6.1 Lung Cancer Mutation Panel
4.6.3.7 Rosetta Genomics
4.6.3.7.1 OncoGxLung
4.6.3.8 Trovagene
4.6.3.8.1 PCM EGFR Mutation Detection Test
4.6.3.9 Veracyte, Inc.
4.6.3.9.1 Percepta
4.6.3.10 Accugenomics
4.6.3.10.1 Lung Cancer Risk Test (LCRT-AGX) 14 Gene Test
4.6.4 Competitive Space
4.7 Melanoma
4.7.1 bioMérieux
4.7.1.1 THxID™ BRAF
4.7.2 Roche
4.7.2.1 cobas® 4800 BRAF V600 Mutation Test
4.7.3 Myriad
4.7.3.1 myPath™ Melanoma
4.7.4 Trovagene
4.7.4.1 PCM BRAF Mutation Detection Test
4.8 Molecular Diagnostic Assays for Other Types of Cancers
4.8.1 Accugenomics
4.8.1.1 Standardized BCR-ABL Molecular Diagnostics Test
4.8.2 Ambry Genetics
4.8.2.1 PancNext
4.8.2.2 PGLNext
4.8.2.3 RenalNext
4.8.3 Asuragen
4.8.3.1 QuantideX® qPCR BCR-ABL IS Kit
4.8.4 DiaSorin
4.8.4.1 PML-RARA Detection bcr1,3 and Discrimination bcr2
4.9 Panels Testing Multiple Cancers
4.9.1 Ambry Genetics
4.9.1.1 CancerNext
4.9.1.2 CancerNext-Expanded
4.9.2 Biotheranostics
4.9.2.1 CancerTYPE ID
4.9.3 Cancer Genetics, Inc. (CGI)
4.9.4 Color Genomics
4.9.4.1 Color Test
4.9.5 Counsyl Labs
4.9.6 Guardant Health
4.9.7 Multiplicom
4.9.7.1 SOMATIC 1 MASTR™ Plus Dx
4.9.8 Myriad Genetics
4.9.8.1 myRisk™ Hereditary Cancer
4.9.9 Pathway Genomics
4.9.9.1 CancerIntercept™ Detect
4.9.10 Quest Diagnostics
4.9.10.1 OncoVantage® Solid Tumor Mutation Analysis
4.9.11 Rosetta Genomics
4.9.11.1 OncoGxOne™
4.10 Potential new Entrants to the Market
4.10.1 Illumina
4.10.2 Metabiomics
4.10.3 Orion Genomics
4.10.4 Siemens
4.10.5 VolitionRx

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 Summary of Market Strengths, Weaknesses, Opportunities and Threats
5.4.1 Industry Challenges and Strategic Recommendations
5.4.2 Commercialization of Molecular Diagnostic Products
5.5 Intellectual Property Rights
5.5.1 BRCA1 and BRCA2 Gene Patents
5.5.2 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 MDx Tests for Cancer Using Medicare Reimbursement Rules
6.3 Trends in Patient Care and Reimbursement
6.4 Revenue Threats
6.4.1 Three Areas for Denial of Claims by Biomarkers
6.5 Billing
6.5.1 Medicare Billing Procedures
6.5.2 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
7.4 State Licensing for Service Laboratories
7.5 510(k) Clearance
7.6 Pre-Market Approval
7.7 ASRs
7.8 What Regulatory Guidance is Needed for Companion Biomarkers?
7.9 U.S. Patent and Trademark Office
7.10 IRB Approval in Clinical Trials
7.11 Microarray Quality Control
7.12 ER and PR Proficiency Testing

8. Company Profiles
8.1 Abbott Molecular Diagnostics
8.2 AccuGenomics, Inc.
8.3 Agendia
8.4 Ambry Genetics
8.5 Asuragen
8.6 BGI
8.7 Biodesix
8.8 bioMérieux
8.9 Bioreference Labs
8.10 bioTheranostics
8.11 Cancer Genetics, Inc.
8.12 Counsyl
8.13 Dako (an Agilent Technologies company)
8.14 DiaSorin
8.15 Epigenomics
8.16 Exact Sciences Corporation
8.17 Exiqon
8.18 Flatiron Health
8.19 Fulgent Diagnostics
8.20 Genomic Health, Inc.
8.21 Genomictree
8.22 Genoptix, Inc. (Novartis)
8.23 HTG Molecular Diagnostics
8.24 Guardant Health
8.25 Hologic
8.26 Illumina
8.27 Invitae
9.28 LabCorp
8.29 MDxHealth
8.30 Myriad Genetics, Inc.
8.31 Nanostring
8.32 Neogenomics
8.33 Nuvera Biosciences
8.34 Orion Genomics
8.35 Pathway Genomics
8.36 Qiagen
8.37 Quest Diagnostics
8.38 Roche Molecular Systems
8.39 Rosetta Genomics Ltd.
8.40 Sophia Genetics
8.41 Trovagene

Appendix 1: Definition of Terms for Molecular Diagnostics
Appendix 2: Standard Cancer Therapeutic Panels

INDEX OF FIGURES

Figure 2.1: Finding Genes with Microassays
Figure 2.2: Use of Microassays for Studying Gene Expression
Figure 2.3: Finding New Drugs with Microarrays
Figure 2.4: Using DNA Microarrays to Compare Cancer and Normal Cells
Figure 2.5: Microarrays for Prediction of Survival in Cancer
Figure 2.6: ddPCR Using a Single Color Probe
Figure 2.7: ddPCR Using Two Probe Colors
Figure 2.8: BEAMing Method of ctDNA Detection
Figure 2.9: Using Gene Expression Patterns to Chose Treatment
Figure 3.1: Molecular Diagnostic Markets for Cancer Testing Globally, 2015
Figure 3.2: Molecular Diagnostic Markets for Cancer Testing in the U.S., 2015
Figure 3.3: Market Share for Key Companies in the Global Molecular Diagnostics Cancer Testing Market
Figure 3.4: Market Growth and Evolution of MDx Cancer Biomarkers
Figure 4.1: Using DNA Microassays to Measure Gene Expression
Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients
Figure 4.3: Action of Herceptin in Breast Cancer Patients
Figure 4.4: Analysis of Cancer Tissue by Microarray
Figure 4.5: HNPCC Mutation Increases Risk of Cancer
Figure 4.6: APC Mutation Increases Risk of Cancer
Figure 4.7: Prostate-Specific Membrane Antigen
Figure 4.8: PCA3 Score Nomogram
Figure 4.9: Ovarian Cancer Types
Figure 4.10: Targets for Therapy—Mutations Associated with Lung Cancer
Figure 4.11: Molecular Subsets of Lung Cancer
Figure 5.1: FDA Co-Developed Products as a Model for Collaboration

INDEX OF TABLES

Table 2.1: Types of Molecular Tests and Types of Genetic Variants Detected
Table 2.2: Use of Cancer Biomarkers to Enhance Patient Care
Table 2.3: Targeted Drug Therapies for Cancers
Table 2.4: Select Genes and Cancer Risk
Table 2.5: Use of Cancer Biomarkers in Drug Development
Table 2.6: Utility of Biomarkers as Companion Diagnostics to Drug Development
Table 2.7: FDA Approved Companion Diagnostics
Table 2.8: Recommended Databases for Interpreting Somatic Mutation Results in Cancer
Table 3.1: Specific Diagnostic Products Categories Comprising the Cancer Diagnostic Market
Table 3.2: Global Market for Molecular Diagnostics Cancer Testing, 2012-2021
Table 3.3: U.S. Market for Molecular Diagnostics Cancer Testing, 2012-2021
Table 3.4: Molecular Diagnostic Markets for Cancer Testing, 2015
Table 3.5: Key Companies in the Global Molecular Diagnostics Cancer Testing Market
Table 3.6: Highlights of the Cancer Diagnostic Testing Segment
Table 3.7: Highlights of Certified Clinical Labs Specializing in Cancer Genetics and Molecular Diagnostic Services
Table 3.8: Business Factors Influencing Advanced Oncology Testing Services
Table 3.9: Strategies for Marketing Cancer Diagnostic Products
Table 3.10: Key Elements of MDx Diagnostic Companies Marketing Plan
Table 4.1: FDA Approved Cancer Tests
Table 4.2: Estimates for the Leading Sites of New Cancer Cases in the U.S. by Gender, 2016
Table 4.3: Estimates for the Leading Sites of Cancer Deaths in the U.S. by Gender, 2016
Table 4.4: Molecular Diagnostic Technologies
Table 4.5: Breast Cancer Overview
Table 4.6: Overview of HER2/neu and Herceptin
Table 4.7: Key Players in the Breast Cancer Molecular Diagnostic Space
Table 4.8: FDA-Approved Breast Cancer Molecular Diagnostic Tests on the Market
Table 4.9: MammaPrint: Key Features
Table 4.10: Clinical Utility and Health Economic Benefits of Oncotype DX
Table 4.11: Oncotype DX Overview
Table 4.12: Major Laboratory Testing Companies Marketing Breast Cancer Molecular Diagnostic Tests, 2015
Table 4.13: Global Market for Breast Cancer Molecular Diagnostic Testing, 2012-2021
Table 4.14: U.S. Market for Breast Cancer Molecular Diagnostic Testing, 2012-2021
Table 4.15: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact
Table 4.16: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact
Table 4.17: Summary of Strengths, Weaknesses, Opportunities and Threats of the Breast Cancer Molecular Diagnostic Market
Table 4.18: Colorectal Cancer Overview
Table 4.19: Key Players in the Breast Cancer Molecular Diagnostic Space
Table 4.20: FDA-Approved and/or CE-marked Colorectal Cancer Molecular Diagnostic Tests on the Market
Table 4.21: KRAS Assays by Analytical Type
Table 4.22: KRAS Mutation Analysis Summary
Table 4.23: KRAS and BRAF in Clinical Use
Table 4.24: Key Players in the Colorectal Cancer Molecular Diagnostic Space
Table 4.25: NexCourse CRC Test Offering and Treatment Direction
Table 4.26: Global Market for Molecular Diagnostic Colon Cancer Testing, 2012-2021
Table 4.27: U.S. Market for Molecular Diagnostic Colon Cancer Testing, 2012-2021
Table 4.28: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact
Table 4.29: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact
Table 4.30: Summary of Strengths, Weaknesses, Opportunities and Threats of the Colon Cancer Market
Table 4.31: Stages in Prostate Cancer Discovery and Diagnosis
Table 4.32: Corporate Players in the Prostate Cancer Molecular Diagnostic Space
Table 4.33: Prostate Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact
Table 4.34: Prostate Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact
Table 4.35: Summary of Strengths, Weaknesses, Opportunities and Threats of the Prostate Cancer Molecular Diagnostic Market
Table 4.36: Ovarian Cancer Molecular Diagnostic Testing Market: Market Drivers in Order of Impact
Table 4.37: Ovarian Cancer Molecular Diagnostic Testing Market: Market Restraints in Order of Impact
Table 4.38: Lung Cancer Survival Rates
Table 4.39: Lung Cancer Facts
Table 4.40: Pharmacogenetic Markers for Select Cancer Drugs
Table 4.41: Potential of Cancer Biomarkers in Drug Delivery and Development
Table 5.1: Technology Trends in Cancer Testing
Table 5.2: Trends in Theranostics
Table 5.3: Market Trends in Cancer Testing
Table 5.4: Molecular Diagnostics Cancer Market: Market Drivers Ranked in Order of Impact
Table 5.5: Molecular Diagnostics Cancer Market: Market Restraints Ranked in Order of Impact
Table 5.6: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care Market
Table 5.7: Molecular Diagnostics Cancer Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions
Table 5.8: Total U.S. Molecular Diagnostics Cancer Market: Impact of Top Industry Challenges
Table 5.9: Key Elements for Business Competition in Gene Expression Profiling for Cancer
Table 6.1: Factors Determining Third-Party Payment for Advanced Cancer Tests
Table 7.1: Rules that Affect the Ability of a Cancer Diagnostic Service Lab to Conduct Business
Table 7.2: Focus Areas for the FDA Critical Path Initiative

Note: Product cover images may vary from those shown
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- Abbott Molecular Diagnostics
- AccuGenomics, Inc.
- Agendia
- Ambry Genetics
- Asuragen
- BGI
- Biodesix
- bioMérieux
- Bioreference Labs
- bioTheranostics
- Cancer Genetics, Inc.
- Counsyl
- Dako (an Agilent Technologies company)
- DiaSorin
- Epigenomics
- Exact Sciences Corporation
- Exiqon
- Flatiron Health
- Fulgent Diagnostics
- Genomic Health, Inc.
- Genomictree
- Genoptix, Inc. (Novartis)
- HTG Molecular Diagnostics
- Guardant Health
- Hologic
- Illumina
- Invitae
- LabCorp
- MDxHealth
- Myriad Genetics, Inc.
- Nanostring
- Neogenomics
- Nuvera Biosciences
- Orion Genomics
- Pathway Genomics
- Qiagen
- Quest Diagnostics
- Roche Molecular Systems
- Rosetta Genomics Ltd.
- Sophia Genetics
- Trovagene

Note: Product cover images may vary from those shown
4 of 4
Note: Product cover images may vary from those shown

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