Molecular Diagnostics in Cancer Testing - BioMarket Group · 3.1.1 Market Overview for Molecular Diagnostics in Cancer Testing 54 ... 4.5.2.2 Myriad Genetics 129 4.5.2.3 Market Drivers

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Published: 2016-JUN-01Pages: 201Format: PDFPrice: 5500 USD (Single User License)

DescriptionMolecular diagnostics is a rapidly-advancing area of research and medicine, with new technologies and applications beingcontinually 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 andclassification of cancer patients, and the optimization of drug therapy.

This TriMark Publications report describes the specific segment of the in vitro diagnostics (IVD) market known as moleculardiagnostics (MD), with a specialization in the MD tests for cancer. In the current medical diagnostics market, moleculardiagnostics 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 analytesin the blood and various body tissues, has led to this revolutionary market segment offering the power of advancedanalytical 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 andtherapy, examining the factors that influence the various market segments and the dollar volume of sales, both in the UnitedStates and worldwide.

TABLE OF CONTENTS

1. Overview 101.1 Statement of Report 101.2 About This Report 101.3 Scope of the Report 111.4 Objectives 111.5 Methodology 111.6 Executive Summary 13

2. Introduction to Molecular Diagnostics 202.1 Opening of Opportunities in Molecular Diagnostics 202.2 Impact of the Human Genome Project on Molecular Diagnostics 222.3 Considerations for Molecular and Clinical Diagnostics 232.4 Molecular Diagnostics in the Post-Genomic Era 252.5 Advances in Molecular Diagnostics Technologies 262.5.1 Molecular Methods to Detect Genetic Variants in Cancer 27 2.5.1.1 Allele-Specific PCR 292.5.1.2 Sanger Dideoxy Sequencing 29

Molecular Diagnostics in Cancer Testing

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BioMarket Group - A Global Online Aggregator of Life Science Market Research2.5.1.3 Pyrosequencing 302.5.1.4 Mass Spectrometry 302.5.1.5 Single Base Extension Assay 302.5.1.6 Multiplex Ligation-Dependent Probe Amplification (MLPA) 312.5.1.7 Fluorescence In Situ Hybridization (FISH) 312.5.1.8 Next Generation Sequencing 312.5.1.8.1 Next-Generation Sequencing—Custom Panels, Amplicon Capture 322.5.1.8.2 Next-Generation Sequencing—Custom Panels, Hybridization Capture 322.5.1.8.3 Next-Generation Sequencing—Whole Exome Sequencing 332.5.1.8.4 Next-Generation Sequencing—Whole Genome Sequencing 332.5.1.9 Digital Droplet PCR (ddPCR) 332.5.2 Clinical Applications of Next-generation Sequencing 352.6 Oligonucleotide Array Platforms 362.7 Emerging Cancer Personalized Medicine Market 372.7.1 Predictive Cancer Molecular Diagnostics 402.8 Companion Diagnostics 412.9 Opportunities for Molecular Diagnostic Companies 502.10 Liquid Biopsies 512.11 Data Analysis 512.12 In-house vs. Commercial Testing 522.13 Multi-Gene Cancer Panels 53

3. Cancer Diagnostics Molecular Testing Market 54 3.1 Market Description 543.1.1 Market Overview for Molecular Diagnostics in Cancer Testing 543.1.2 Laboratories Performing Molecular Diagnostics for Cancer Testing 573.1.3 Competitive Landscape 593.1.3.1 Pure Play Specialty Companies Performing Tumor MDx Analysis 593.1.3.2 Mixed Specialty Cancer Diagnostic Labs 603.1.3.3 General Clinical Reference Laboratories 603.1.3.4 Diagnostic Device and Reagent Developers 613.1.3.5 Companion Diagnostics Development in Partnership with a Pharmaceutical Company 613.1.4 Sales and Marketing Strategies for Cancer Tests 623.1.4.1 North American Market 633.1.4.2 International Markets 64

4. Molecular Diagnostic Tests for Cancer 664.1 Overview of Molecular Diagnostics for Cancer 664.1.1 Cancer Statistics 664.1.2 Treating Cancers 674.1.3 Use of Genomics to Understand Cancer 684.1.4 Molecular Diagnostic Tools Solutions 704.1.5 Technology of Gene Expression Analysis 724.1.5.1 Amplify and Detect Diminished Amounts of RNA Consistently 724.1.5.2 Analyze Hundreds of Genes 724.1.5.3 Employ Advanced Information Technology 734.2 Breast Cancer Molecular Diagnostics 734.2.1 Overview of Breast Cancer 734.2.2 Breast Cancer Molecular Diagnostic Assays 764.2.2.1 Ambry Genetics 774.2.2.2 Agendia 784.2.2.2.1 MammaPrint 784.2.2.3 BGI 804.2.2.4 Bioreference Labs 804.2.2.5 BioTheronostics (part of BioMérieux) 81


BioMarket Group - A Global Online Aggregator of Life Science Market Research4.2.2.5.1 Breast Cancer Index 814.2.2.6 Cancer Genetics, Inc. (CGI) 814.2.2.7 Dako (part of Agilent Technologies) 824.2.2.8 DiaSorin 824.2.2.9 Fulgent Diagnostics 824.2.2.10 Genetic Technologies Ltd. 824.2.2.11 Genomic Health 834.2.2.11.1 Oncotype DX 834.2.2.12 Genoptix (part of Novartis) 844.2.2.13 Invitae 854.2.2.14 LabCorp 854.2.2.14.1 BRCAssure® Tests 864.2.2.15 Multiplicom 864.2.2.16 Myriad Genetics 864.2.2.16.1 BRACAnalysis® 874.2.2.16.2 BART® 874.2.2.17 Nanostring Technologies 874.2.2.17.1 Prosigna 874.2.2.18 Neogenomics 884.2.2.19 Pathway Genomics 884.2.2.20 Sophia Genetics 884.2.2.21 Quest Diagnostics 88 4.2.2.21.1 BRCAvantage Plus 884.2.2.22 Ventana Medical Systems (Roche) 894.2.2.22.1 HER2 Dual ISH DNA Probe Cocktail, INFORM 894.2.3 Competitive Structure and Market Share Analysis 894.2.3.1 Breast Cancer Molecular Diagnostic Testing Market Size 914.2.3.1.1 Global Market 914.2.3.1.2 U.S. Market 914.2.3.1.3 European Market 914.2.4 Market Drivers and Restraints 924.2.4.1 Market Drivers 924.2.4.2 Market Restraints 924.2.5 Breast Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 93 4.2.5.1 Breast Cancer Molecular Diagnostic Testing Assay Market Trends 934.2.5.2 Breast Cancer Molecular Diagnostic Testing Assay Technology Trends 934.2.5.3 Breast Cancer Testing Assay Strategic Recommendations 934.3 Colorectal Cancer Molecular Diagnostics Market 944.3.1 Overview of Colorectal Cancer 944.3.2 Colon Cancer Molecular Diagnostic Assays 954.3.2.1 BRAF 964.3.2.2 KRAS 964.3.2.3 mSEPT9 984.3.2.4 Screening Assays 994.3.2.4.1 Overview of Stool-based DNA Assays 994.3.2.5 Abbott 1014.3.2.5.1 Abbott RealTime KRAS Amplification Reagent Kit 1014.3.2.5.2 RealTime mS9 Colorectal Cancer 1014.3.2.6 Agendia 1014.3.2.6.1 ColoPrint 1014.3.2.7 Ambry Genetics 1024.3.2.7.1 ColoNext 1024.3.2.8 Bioreference Labs 1024.3.2.9 Cancer Genetics, Inc. 1024.3.2.10 Epigenomics 103


BioMarket Group - A Global Online Aggregator of Life Science Market Research4.3.2.10.1 Epi proColon 1034.3.2.11 Exact Sciences 1044.3.2.11.1 Cologuard 1044.3.2.12 Fulgent Diagnostics 1044.3.2.13 Genomic Health 1054.3.2.13.1 Oncotype DX colon 1054.3.2.14 Genomictree 1054.3.2.15 Genoptix (part of Novartis) 1054.3.2.16 Invitae 1064.3.2.17 LabCorp 1064.3.2.18 Myriad Genetics 1074.3.2.18.1 COLARIS 1074.3.2.18.2 COLARIS AP 1074.3.2.19 Neogenomics 1094.3.2.20 Novigenix 1094.3.2.20.1 Colox 1094.3.2.21 Pathway Genomics 1094.3.2.21.1 ColoTrue 1094.3.2.22 Qiagen 1094.3.2.22.1 therascreen KRAS RGQ PCR Kit 1094.3.2.23 Quest Diagnostics 1104.3.2.23.1 ColoVantage 1104.3.2.24 Roche 1104.3.2.24.1 cobas® KRAS Mutation Test 1104.3.2.25 Trovagene 1104.3.2.25.1 PCM KRAS Mutation Detection Test 1104.3.3 Competitive Structure and Market Share Analysis 1114.3.3.1 Colorectal Cancer Molecular Diagnostic Testing Market Size 1114.3.3.2 Market Drivers and Restraints 1124.3.3.2.1 Market Drivers 1124.3.3.2.2 Market Restraints 1134.3.3.3 Colon Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 1134.3.3.3.1 Colon Cancer Molecular Diagnostic Testing Assay Market Trends 1134.3.3.3.2 Colon Cancer Molecular Diagnostic Testing Assay Technology Trends 1134.3.3.3.3 Colon Cancer Molecular Diagnostic Testing Assay Strategic Recommendations 1144.3.4 New Guidelines for Colorectal Cancer Molecular Testing 1154.4 Prostate Cancer Molecular Diagnostics Market 1154.4.1 Molecular Screening Assays for Prostate Cancer 1164.4.1.1 Hologic 1174.4.1.1.1 PROGENSA PCA3 Assay 1174.4.1.2 Bostwick Laboratories 118 4.4.1.2.1 PCA3Plus 1184.4.1.3 Overview of PCA3 1184.4.1.4 MDx Health 1204.4.1.4.1 SelectMDx for Prostate Cancer 1204.4.1.5 Invitae 1204.4.1.5.1 Invitae Prostate Cancer Panel 1204.4.1.6 Neogenomics 1204.4.1.6.1 NeoLAB Prostate 1204.4.2 Molecular Assays Performed After Colorectal Biopsy 1214.4.2.1 Myriad Genetics 1214.4.2.1.1 Prolaris 1214.4.2.2 Genomic Health 1214.4.2.2.1 Oncotype DX Genomic Prostrate Score 1214.4.2.3 MDxHealth (ConfirmMDx) 122


BioMarket Group - A Global Online Aggregator of Life Science Market Research4.4.2.4 Bostwick Laboratories (ProstaVysion) 1224.4.3.5 MDNA Life Sciences 1234.4.3.5.1 Prostate Core Mitomic Test 1234.4.2.6 GenomeDx 1244.4.2.6.1 Decipher 1244.4.3 Competitive Structure and Market Share Analysis 1244.4.4 Market Drivers and Restraints 1254.4.4.1 Market Drivers 1254.4.4.2 Market Restraints 1254.4.5 Prostate Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 1264.4.5.1 Prostate Cancer Molecular Diagnostic Testing Assay Market Trends 1264.4.5.2 Prostate Cancer Molecular Diagnostic Testing Assay Technology Trends 1274.5 Ovarian Cancer 1274.5.1 Incidence of Ovarian Cancer 1274.5.2 Key Players in Ovarian Testing Market 1284.5.2.1 Ambry Genetics 1284.5.2.2 Myriad Genetics 1294.5.2.3 Market Drivers and Restraints 1294.5.2.3.1 Market Drivers 1294.5.2.3.2 Market Restraints 1304.6 Lung Cancer 1304.6.1 Incidence of Lung Cancer 1304.6.2 Pharmacogenomics and Cancer 1324.6.3 Lung Cancer Molecular Diagnostics Assays 1344.6.3.1 Genoptix (a Novartis company) 1344.6.3.1.1 NexCourse NSCLC 1344.6.3.2 Qiagen 1344.6.3.2.1 therascreen EGFR RGQ PCR Kit 134 4.6.3.3 Roche 1354.6.3.3.1 cobas® EGFR Mutation Test v2 1354.6.3.4 Epigenomics 1364.6.3.4.1 Epi proLung® BL Reflex Assay 1364.6.3.5 Myriad Genetics 1364.6.3.5.1 myPlan™ Lung Cancer 1364.6.3.6 Quest Diagnostics 137 4.6.3.6.1 Lung Cancer Mutation Panel 1374.6.3.7 Rosetta Genomics 1374.6.3.7.1 OncoGxLung 1374.6.3.8 Trovagene 1374.6.3.8.1 PCM EGFR Mutation Detection Test 1374.6.3.9 Veracyte, Inc. 1384.6.3.9.1 Percepta 1384.6.3.10 Accugenomics 1384.6.3.10.1 Lung Cancer Risk Test (LCRT-AGX) 14 Gene Test 1384.6.4 Competitive Space 1394.7 Melanoma 1394.7.1 bioMérieux 1404.7.1.1 THxID™ BRAF 1404.7.2 Roche 1414.7.2.1 cobas® 4800 BRAF V600 Mutation Test 1414.7.3 Myriad 1414.7.3.1 myPath™ Melanoma 1414.7.4 Trovagene 1414.7.4.1 PCM BRAF Mutation Detection Test 1414.8 Molecular Diagnostic Assays for Other Types of Cancers 142


BioMarket Group - A Global Online Aggregator of Life Science Market Research4.8.1 Accugenomics 1424.8.1.1 Standardized BCR-ABL Molecular Diagnostics Test 1424.8.2 Ambry Genetics 1424.8.2.1 PancNext 1424.8.2.2 PGLNext 1424.8.2.3 RenalNext 1434.8.3 Asuragen 1434.8.3.1 QuantideX® qPCR BCR-ABL IS Kit 1434.8.4 DiaSorin 1434.8.4.1 PML-RARA Detection bcr1,3 and Discrimination bcr2 1434.9 Panels Testing Multiple Cancers 1444.9.1 Ambry Genetics 1444.9.1.1 CancerNext 1444.9.1.2 CancerNext-Expanded 1444.9.2 Biotheranostics 1444.9.2.1 CancerTYPE ID 1444.9.3 Cancer Genetics, Inc. (CGI) 1444.9.4 Color Genomics 1464.9.4.1 Color Test 1464.9.5 Counsyl Labs 1464.9.6 Guardant Health 1464.9.7 Multiplicom 1474.9.7.1 SOMATIC 1 MASTR™ Plus Dx 1474.9.8 Myriad Genetics 1474.9.8.1 myRisk™ Hereditary Cancer 1474.9.9 Pathway Genomics 1474.9.9.1 CancerIntercept™ Detect 1474.9.10 Quest Diagnostics 1484.9.10.1 OncoVantage® Solid Tumor Mutation Analysis 1484.9.11 Rosetta Genomics 1484.9.11.1 OncoGxOne™ 1484.10 Potential new Entrants to the Market 1484.10.1 Illumina 1484.10.2 Metabiomics 1484.10.3 Orion Genomics 1494.10.4 Siemens 1494.10.5 VolitionRx 149

5. Business 1515.1 Technology and Market Trends 1515.1.1 Technology Trends 1525.1.2 Market Trends 1525.2 M&A Activity 1545.3 Partnerships 1565.4 Summary of Market Strengths, Weaknesses, Opportunities and Threats 1585.4.1 Industry Challenges and Strategic Recommendations 1595.4.2 Commercialization of Molecular Diagnostic Products 1595.5 Intellectual Property Rights 1605.5.1 BRCA1 and BRCA2 Gene Patents 1615.5.2 Current Patent Disputes 161

6. Reimbursement and Billing 1636.1 Overview 1636.2 Trends in Reimbursement Practice 1636.2.1 Medicare Reimbursement 163


BioMarket Group - A Global Online Aggregator of Life Science Market Research6.2.2 Analysis of ROI for MDx Tests for Cancer Using Medicare Reimbursement Rules 1666.3 Trends in Patient Care and Reimbursement 1666.4 Revenue Threats 1676.4.1 Three Areas for Denial of Claims by Biomarkers 1696.5 Billing 1696.5.1 Medicare Billing Procedures 1706.5.2 Medicare CPT Coding Rules for Cancer Biomarkers 170

7. Government Regulation 1727.1 U.S. Food and Drug Administration 1727.2 CLIA Regulations 1737.3 Clinical Laboratory Improvement Act 1737.4 State Licensing for Service Laboratories 1757.5 510(k) Clearance 1757.6 Pre-Market Approval 1757.7 ASRs 1757.8 What Regulatory Guidance is Needed for Companion Biomarkers? 1767.9 U.S. Patent and Trademark Office 1777.10 IRB Approval in Clinical Trials 1777.11 Microarray Quality Control 1777.12 ER and PR Proficiency Testing 178

8. Company Profiles 1798.1 Abbott Molecular Diagnostics 1798.2 AccuGenomics, Inc. 1798.3 Agendia 1798.4 Ambry Genetics 1808.5 Asuragen 1808.6 BGI 1808.7 Biodesix 1818.8 bioMérieux 1818.9 Bioreference Labs 1828.10 bioTheranostics 1828.11 Cancer Genetics, Inc. 1828.12 Counsyl 1858.13 Dako (an Agilent Technologies company) 1858.14 DiaSorin 1858.15 Epigenomics 1858.16 Exact Sciences Corporation 1868.17 Exiqon 1868.18 Flatiron Health 1878.19 Fulgent Diagnostics 1878.20 Genomic Health, Inc. 1878.21 Genomictree 1888.22 Genoptix, Inc. (Novartis) 1898.23 HTG Molecular Diagnostics 1898.24 Guardant Health 1898.25 Hologic 1898.26 Illumina 1898.27 Invitae 1909.28 LabCorp 1908.29 MDxHealth 1918.30 Myriad Genetics, Inc. 1928.31 Nanostring 1938.32 Neogenomics 193


BioMarket Group - A Global Online Aggregator of Life Science Market Research8.33 Nuvera Biosciences 1948.34 Orion Genomics 1948.35 Pathway Genomics 1948.36 Qiagen 1958.37 Quest Diagnostics 1958.38 Roche Molecular Systems 1968.39 Rosetta Genomics Ltd. 1978.40 Sophia Genetics 1978.41 Trovagene 197

Appendix 1: Definition of Terms for Molecular Diagnostics 198Appendix 2: Standard Cancer Therapeutic Panels 200

INDEX OF FIGURES

Figure 2.1: Finding Genes with Microassays 21Figure 2.2: Use of Microassays for Studying Gene Expression 21Figure 2.3: Finding New Drugs with Microarrays 22Figure 2.4: Using DNA Microarrays to Compare Cancer and Normal Cells 22 Figure 2.5: Microarrays for Prediction of Survival in Cancer 24Figure 2.6: ddPCR Using a Single Color Probe 34Figure 2.7: ddPCR Using Two Probe Colors 34Figure 2.8: BEAMing Method of ctDNA Detection 35Figure 2.9: Using Gene Expression Patterns to Chose Treatment 37Figure 3.1: Molecular Diagnostic Markets for Cancer Testing Globally, 2015 55Figure 3.2: Molecular Diagnostic Markets for Cancer Testing in the U.S., 2015 56Figure 3.3: Market Share for Key Companies in the Global Molecular Diagnostics Cancer Testing Market 56Figure 3.4: Market Growth and Evolution of MDx Cancer Biomarkers 62Figure 4.1: Using DNA Microassays to Measure Gene Expression 69Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients 69Figure 4.3: Action of Herceptin in Breast Cancer Patients 75Figure 4.4: Analysis of Cancer Tissue by Microarray 79Figure 4.5: HNPCC Mutation Increases Risk of Cancer 108Figure 4.6: APC Mutation Increases Risk of Cancer 108Figure 4.7: Prostate-Specific Membrane Antigen 116Figure 4.8: PCA3 Score Nomogram 119Figure 4.9: Ovarian Cancer Types 128Figure 4.10: Targets for Therapy—Mutations Associated with Lung Cancer 133Figure 4.11: Molecular Subsets of Lung Cancer 133Figure 5.1: FDA Co-Developed Products as a Model for Collaboration 157

INDEX OF TABLES

Table 2.1: Types of Molecular Tests and Types of Genetic Variants Detected 28Table 2.2: Use of Cancer Biomarkers to Enhance Patient Care 37Table 2.3: Targeted Drug Therapies for Cancers 38Table 2.4: Select Genes and Cancer Risk 40Table 2.5: Use of Cancer Biomarkers in Drug Development 42Table 2.6: Utility of Biomarkers as Companion Diagnostics to Drug Development 42Table 2.7: FDA Approved Companion Diagnostics 43Table 2.8: Recommended Databases for Interpreting Somatic Mutation Results in Cancer 52 Table 3.1: Specific Diagnostic Products Categories Comprising the Cancer Diagnostic Market 54Table 3.2: Global Market for Molecular Diagnostics Cancer Testing, 2012-2021 54


BioMarket Group - A Global Online Aggregator of Life Science Market ResearchTable 3.3: U.S. Market for Molecular Diagnostics Cancer Testing, 2012-2021 55Table 3.4: Molecular Diagnostic Markets for Cancer Testing, 2015 56Table 3.5: Key Companies in the Global Molecular Diagnostics Cancer Testing Market 57 Table 3.6: Highlights of the Cancer Diagnostic Testing Segment 58Table 3.7: Highlights of Certified Clinical Labs Specializing in Cancer Genetics and Molecular DiagnosticServices 58Table 3.8: Business Factors Influencing Advanced Oncology Testing Services 58Table 3.9: Strategies for Marketing Cancer Diagnostic Products 63Table 3.10: Key Elements of MDx Diagnostic Companies Marketing Plan 63Table 4.1: FDA Approved Cancer Tests 66Table 4.2: Estimates for the Leading Sites of New Cancer Cases in the U.S. by Gender, 2016 66Table 4.3: Estimates for the Leading Sites of Cancer Deaths in the U.S. by Gender, 2016 67 Table 4.4: Molecular Diagnostic Technologies 70Table 4.5: Breast Cancer Overview 74Table 4.6: Overview of HER2/neu and Herceptin 75Table 4.7: Key Players in the Breast Cancer Molecular Diagnostic Space 76Table 4.8: FDA-Approved Breast Cancer Molecular Diagnostic Tests on the Market 77Table 4.9: MammaPrint: Key Features 80Table 4.10: Clinical Utility and Health Economic Benefits of Oncotype DX 84Table 4.11: Oncotype DX Overview 84Table 4.12: Major Laboratory Testing Companies Marketing Breast Cancer Molecular DiagnosticTests, 2015 90Table 4.13: Global Market for Breast Cancer Molecular Diagnostic Testing, 2012-2021 91Table 4.14: U.S. Market for Breast Cancer Molecular Diagnostic Testing, 2012-2021 91Table 4.15: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order ofImpact 92Table 4.16: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order ofImpact 92Table 4.17: Summary of Strengths, Weaknesses, Opportunities and Threats of the Breast Cancer Molecular DiagnosticMarket 93Table 4.18: Colorectal Cancer Overview 95Table 4.19: Key Players in the Breast Cancer Molecular Diagnostic Space 95Table 4.20: FDA-Approved and/or CE-marked Colorectal Cancer Molecular Diagnostic Tests on theMarket 96Table 4.21: KRAS Assays by Analytical Type 97Table 4.22: KRAS Mutation Analysis Summary 98Table 4.23: KRAS and BRAF in Clinical Use 98Table 4.24: Key Players in the Colorectal Cancer Molecular Diagnostic Space 100Table 4.25: NexCourse CRC Test Offering and Treatment Direction 106Table 4.26: Global Market for Molecular Diagnostic Colon Cancer Testing, 2012-2021 111 Table 4.27: U.S. Market for Molecular Diagnostic Colon Cancer Testing, 2012-2021 112Table 4.28: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order ofImpact 112Table 4.29: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order ofImpact 113Table 4.30: Summary of Strengths, Weaknesses, Opportunities and Threats of the Colon Cancer Market 114Table 4.31: Stages in Prostate Cancer Discovery and Diagnosis 116Table 4.32: Corporate Players in the Prostate Cancer Molecular Diagnostic Space 117Table 4.33: Prostate Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact 125Table 4.34: Prostate Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order ofImpact 125Table 4.35: Summary of Strengths, Weaknesses, Opportunities and Threats of the Prostate Cancer Molecular DiagnosticMarket 126Table 4.36: Ovarian Cancer Molecular Diagnostic Testing Market: Market Drivers in Order of Impact 129


BioMarket Group - A Global Online Aggregator of Life Science Market ResearchTable 4.37: Ovarian Cancer Molecular Diagnostic Testing Market: Market Restraints in Order of Impact 130Table 4.38: Lung Cancer Survival Rates 130Table 4.39: Lung Cancer Facts 131Table 4.40: Pharmacogenetic Markers for Select Cancer Drugs 132Table 4.41: Potential of Cancer Biomarkers in Drug Delivery and Development 133Table 5.1: Technology Trends in Cancer Testing 152Table 5.2: Trends in Theranostics 152Table 5.3: Market Trends in Cancer Testing 153Table 5.4: Molecular Diagnostics Cancer Market: Market Drivers Ranked in Order of Impact 153Table 5.5: Molecular Diagnostics Cancer Market: Market Restraints Ranked in Order of Impact 154Table 5.6: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of CareMarket 158Table 5.7: Molecular Diagnostics Cancer Market: Strategic Recommendations on Molecular Diagnostic Sector BusinessFunctions 159Table 5.8: Total U.S. Molecular Diagnostics Cancer Market: Impact of Top Industry Challenges 159Table 5.9: Key Elements for Business Competition in Gene Expression Profiling for Cancer 160 Table 6.1: Factors Determining Third-Party Payment for Advanced Cancer Tests 168Table 7.1: Rules that Affect the Ability of a Cancer Diagnostic Service Lab to Conduct Business 172Table 7.2: Focus Areas for the FDA Critical Path Initiative 177

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Molecular Diagnostics in Cancer Testing - BioMarket Group · 3.1.1 Market Overview for Molecular Diagnostics in Cancer Testing 54 ... 4.5.2.2 Myriad Genetics 129 4.5.2.3 Market Drivers