Molecular Diagnostics in Infectious Disease Testing
TriMark Publications, December 2012, Pages: 379
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 infectious disease. In the current medical diagnostics market, molecular diagnostics for infectious disease 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 infectious disease.
Continuing new advancements in the ability to detect and diagnose infectious diseases are being made. Whereas before, detection and identification of many clinically important infectious agents was slow and expensive, and relied upon traditional culturing methods, and where there once were limited solutions offered by diagnostics, researchers and diagnostic companies are now at the cusp of overcoming such limitations by the use of nucleic acid mediated molecular diagnostics testing. Now, the area of molecular diagnostic medicine promises to revolutionize the ability to detect, diagnose and treat a wide variety of infectious diseases. The infectious disease space is the most dominant and profitable sector of molecular diagnostics, and is expected to be throughout the forecast period.
As such, the purpose of this report is to describe the emerging field of molecular diagnostics for infectious disease. The areas covered in this study include: available and emerging technologies in the field, the United States and global market size for molecular diagnostic products, and the profiles of companies that are focusing on the molecular diagnostic sector. This review analyzes the size and growth of the molecular diagnostics infectious disease market, including the factors that influence the various market segments within it, the dollar volume of sales, both in the U.S. and worldwide.
Also examined are:
- PCR technology platforms.
- Clinical applications of nucleic acid based testing.
- The market for molecular diagnostic tests associated with infectious disease diagnosis.
- Companies participating in this sector.
- New technology platforms and diagnostic test kits.
- Trends in the molecular diagnostics industry sector.
- The internal structure of the molecular diagnostics clinical testing sector.
This market report analyzes the size and growth of the molecular diagnostics market in its applications for infectious disease detection and therapy, examining the factors that influence the various market segments and the dollar volume of sales, both in the U.S. and worldwide. The infectious disease market has been divided into the following parts for examination:
- Hepatitis infectious B and C disease molecular diagnostics markets.
- Human immunodeficiency virus (HIV) infectious disease molecular diagnostics market.
- Human papillomavirus (HPV) infectious disease molecular diagnostics market.
- Influenza infectious disease molecular diagnostics market.
- Tuberculosis infectious disease molecular diagnostics market.
- Sexually transmitted diseases (STDs) infectious disease molecular diagnostics market.
- Chlamydia and gonorrhea blood screening market.
- Methicillin-resistant Staphylococcus aureus(MRSA) market.
- Vancomycin-resistant enterococci (VRE) market.
- Other infectious disease molecular diagnostic market segments.
This segregation is based upon the available technology platform advances and the number of companies interested in that segment of the infectious disease market.
This report includes the following features for each major infectious disease market using molecular diagnostics
techniques:
- It examines the generally accepted clinical analytical activities in use today in the molecular diagnostics (MD) sector for diagnosis and management of infectious disease. It includes the prevalent clinicalmeasurement devices and the accompanying reagents and supplies as utilized in hospitals and large reference and specialty Clinical Laboratory Improvements Act (CLIA) licensed laboratories.
- It discusses the potential benefits of the molecular diagnostics technique for various sectors of the medical and scientific communities, and it assesses the market drivers and bottlenecks for MD tests from the perspective of these communities.
- It establishes the current total MD market size and future growth of the molecular diagnostics market for infectious disease management, and analyzes the current size and growth of key segments.
- It assesses various business models in molecular diagnostics for infectious disease, including CLIA licensed specialty labs, general reference labs and reagent kit marketing, and provides strategic recommendations for near-term business opportunities.
- It examines the products offered and roles played by companies that have invested significantly in this market, and it provides current and forecasted market shares by these companies.
- It discusses new collaborative business models that bring together diagnostics and therapeutics.
- It evaluates the role that infectious disease prognostic assays can play in partnership opportunities in personalized medicine.
Scope of the Report
The goal of this study is to review the market for molecular diagnostics infectious disease testing equipment and supplies using reagents and instruments for analysis of individual components in body tissues and fluids. Toward this goal, this review answers the following key questions:
- Which companies are utilizing new, cutting-edge technologies to develop, validate and market molecular diagnostics tests for clinical use in infectious disease management?
- What are the current impediments to incorporating promising molecular tests into clinical practice?
- Which new molecular diagnostics tests show the most promise for regulatory approval?
- What are the economic challenges to gaining approval? And what kind is best?
- How does regulatory oversight drive approval and adoption of new technologies?
- Which strategic alliances show the greatest synergy in bringing molecular diagnostics tests to market?
- Which shared technologies are driving the most encouraging development of new infectious disease testing methods?
- Estimate the current and future U.S. and global markets for molecular diagnostics for infectious disease.
- Examine market drivers that have resulted in the global race for new infectious disease diagnostics.
- Assess market opportunities and the potential market pertaining to the disease indications.
- Discuss product development challenges in relation to regulatory constraints, legislative constraints and technical challenges.
- Analyze the need for molecular diagnostics for the different infectious disease indications.
- Understand the impact of current products and the future of molecular diagnostics industry.
- Provide insight into the molecular diagnostics products in the pipeline and the companies that strive to bring these products to the market in the immediate future.
- Evaluate global activity in molecular diagnostics with specific contributions from the top-ranking five countries: U.S., Japan, Germany, U.K. and China.
- Analyze the segments in molecular diagnostics in major diseases like hepatitis, HIV and HPV.
- Gain insight into the current applications of molecular diagnostics in a wide variety of infectious diseases.
- Explore drug discovery efforts in relation to molecular diagnostics methods.
- Analyze the usual hurdles new MD diagnostic methods are encountering to reach the market and the right path to the market for these products.
- Review the current licensing, investing and partnering activities in molecular diagnostics sector.
- Assess business models and requirements for a successful molecular diagnostics industry.
- Examine funding scenario for the molecular diagnostics sector.
- Identify the key players in the molecular diagnostics industry and their contribution to this emerging therapy.
Key questions answered in this study are:
- What are the products that come under the phrase “molecular diagnostics”?
- What disease conditions offer the greatest potential for molecular diagnostics technology platforms?
- What is the current global market for molecular diagnostics?
- How much of clinical development activities are taking place globally in molecular diagnostics sector?
- How many companies are involved in the development of molecular diagnostics products?
- How many patents have been issued for molecular diagnostics products in infectious disease?
- What market drivers are responsible for the global growth in diagnosis of infectious disease?
- What regulatory and technical challenges are being confronted by the molecular diagnostics industry?
- What are the current promising developments in molecular diagnostics infectious disease sector?
- What is the latest position of the clinical studies and product pipe line in molecular diagnostics infectious disease sector?
- How long it will take for the molecular diagnostics technology platforms to become the standard of clinical laboratory practice to replace old and slow culture techniques?
- How much of venture capital funding was invested into the molecular diagnostics sector?
- What is the potential population in the U.S. for infectious disease diagnosis?
- Do the developing countries offer growth for the molecular diagnostics products related to infectious disease?
- What are the top-ten molecular diagnostics infectious products available in the market place?
- What are the molecular diagnostics infectious products available in the market?
- How many companies are involved in the development of molecular diagnostics infectious products?
- How many firms concentrate on hepatitis products?
- Which firms are involved in the development of HIV products?
- Which companies are focused on the development of HPV products?
- Which companies are focusing on STD molecular diagnostics infectious products?
- Which companies are associated with developing molecular diagnostics infectious products for diagnosis of bacterial infections?
- What are the different business models suitable for the different types of molecular diagnostics products?
- What are the requirements for the commercial manufacturing of molecular diagnostics products?
- What are the different funding sources in the U.S. for the development of molecular diagnostics products?
This report contains:
- Current market opportunities for molecular diagnostics products for infectious disease.
- Product development challenges confronted by the molecular diagnostics industry.
- A brief discussion on the need for molecular diagnostics and the advantages over the conventional microbiology approaches.
- The future direction of the emerging molecular diagnostics infectious products.
- The overall picture of pipeline products in molecular diagnostics sector and the companies involved.
- A note on the projected time-line for molecular diagnostics infectious products.
- A market projection for global molecular diagnostics products.
- A short note on the potential number of U.S. patients requiring molecular diagnostics infectious products.
- Listing and explaining the most popular molecular diagnostics infectious products in the market.
- Presentation of the global picture of the molecular diagnostics infectious products market with particular reference to the leading countries, such as U.S., Japan, Germany, U.K. and China.
- Number of firms engaged in molecular diagnostics infectious products.
This examination surveys most of the biotech companies known to be currently marketing, manufacturing or developing instruments and reagents for the molecular diagnostics market for infectious disease management, in both the U.S. and the world. Each company is discussed in depth, with sections on its history, product line, business and marketing analysis, and a subjective commentary of the company’s market position. The U.S. is the focus of this report. Primary attention is paid to the specialty and reference lab market segment and, separately, to the instruments, reagents and supplies marketed by the leading companies in this segment. Market size, growth rates and market components for instruments, reagents, controls and consumables used in this area are also analyzed.
Objectives
The main objectives of this analysis are:
- Identifying viable technology drivers through a comprehensive look at platform technologies for molecular diagnostics in infectious disease management, including probe-based nucleic acid assays, microarrays and sequencing.
- Obtaining a complete understanding of the chief characteristics of molecular diagnostics tests as they are used in infectious disease testing—viz., predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic tests—from their basic principles to their applications.
- Discovering feasible market opportunities by identifying high-growth applications in different clinical infectious disease diagnostic areas.
- Focusing on global industry development through an in-depth analysis of the major world markets for molecular diagnostics for infectious disease management, including growth forecasts.
The emphasis in this report is on the clinical use of molecular diagnostics tests for infectious disease diagnosis and management.
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 (PCR)
2.6.2 Real-time PCR (RT-PCR)
2.6.3 Nucleic Acid Sequence-based Amplification (NASBA)
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
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
3.3.1.8.3 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 (HCV) 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
3.3.2.2.5.2 Market Restraints
3.3.2.2.6 Market and Technology Trends
3.3.2.2.6.1 Market Trends
3.3.2.2.6.2 Technology Trends
3.3.2.2.7 Strategic Recommendations
3.3.3 Human Papillomavirus (HPV)
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
3.3.3.6 Market and Technology Trends
3.3.3.6.1 Market Trends
3.3.3.6.2 Technology Trends
3.3.3.6.3 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
3.3.4.6 Market and Technology Trends
3.3.4.6.1 Market Trends
3.3.4.6.2 Technology Trends
3.3.4.7 Strategic Recommendations
3.3.5 STD Testing
3.3.5.1 Chlamydia
3.3.5.1.1 Disease Background and Description
3.3.5.1.2 Product Analysis: Instruments and Reagents for Testing Chlamydia
3.3.5.1.3 Method Comparison
3.3.5.1.4 Chlamydia/Gonorrhea Molecular Diagnostic Testing Market Size
3.3.5.1.5 Competitive Structure and Market Share Analysis
3.3.5.1.6 Market Forecasts
3.3.5.1.6.1 Revenue Forecasts
3.3.5.1.7 Market Forecasts
3.3.5.1.7.1 Revenue Forecasts
3.3.5.1.8 Market Challenges
3.3.5.1.8.1 Market Drivers
3.3.5.1.8.2 Market Restraints
3.3.5.1.9 Market and Technology Trends
3.3.5.1.9.1 Market Trends
3.3.5.1.9.2 Technology Trends
3.3.5.1.9.3 Strategic Recommendations
3.3.6 Gonorrhea
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 Competitive Structure and Market Share Analysis
3.3.6.5 Market Forecasts
3.3.6.5.1 Revenue Forecasts
3.3.6.6 Market Challenges
3.3.6.6.1 Market Drivers
3.3.6.6.2 Market Restraints
3.3.6.7 Market and Technology Trends
3.3.6.7.1 Market Trends
3.3.6.7.2 Technology Trends
3.3.6.8 Strategic Recommendations
3.3.7 Tuberculosis (TB)
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 Tuberculosis 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 Methicillin-resistant Staphylococcus Aureus (MRSA)
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 MRSA Market Size
3.3.8.5 Competitive Structure and Market Share Analysis
3.3.8.6 Market Forecasts
3.3.8.6.1 Revenue Forecasts
3.3.8.7 Market Challenges
3.3.8.7.1 Market Drivers
3.3.8.7.2 Market Restraints
3.3.8.8 Market and Technology Trends
3.3.8.8.1 Market Trends
3.3.8.8.2 Technology Trends
3.3.8.9 Strategic Recommendations
3.3.9 Vancomycin-resistant Enterococci (VRE)
3.3.9.1 Disease Background and Description
3.3.9.2 Product Analysis: Instruments and Reagents
3.3.9.3 Method Comparison
3.3.9.4 Competitive Structure and Market Share Analysis
3.3.9.5 Market Forecasts
3.3.9.5.1 Revenue Forecasts
3.3.9.6 Market Challenges
3.3.9.6.1 Market Drivers
3.3.9.6.2 Market Restraints
3.3.9.7 Market and Technology Trends
3.3.9.7.1 Market Trends
3.3.9.7.2 Technology Trends
3.3.9.8 Strategic Recommendations
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
3.4.6 Market and Technology Trends
3.4.6.1 Market Trends
3.4.6.2 Technology Trends
3.4.7 Strategic Recommendations
4. Molecular Diagnostic Testing Technology for Infectious Disease Testing
4.1 Infectious Disease Diagnostic Tests
4.1.2 Molecular Diagnostic Tools Solutions
4.1.3 Technology of Gene Expression Analysis
4.1.3.1 Amplification and Detection of RNA
4.1.3.2 Analysis of Multiple Genes
4.1.3.3 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 Pharmacogemomics 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
4.5 Next Generation Sequencing
4.6 Patient Flow Software
4.7 Digital PCR
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 240
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
6.2 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 (CLIA)
7.4 State Licensing for Service Laboratories
7.5 IVDMIAs
7.6 510(k) Clearance
7.7 Pre-Market Approval (PMA)
7.7.1 Premarket Approval Application
7.8 Analyte Specific Reagents (ASRs)
7.8.1 Laboratory Developed Tests
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 CE Marking and the IVDD (European In Vitro Diagnostic Device Directive)
7.13 De Novo Classification
7.14 Research Use Only Reagents
8. Business Decisions using Molecular Diagnostic Tests in Infectious Disease Testing 8.1 What are Key Opportunities in Infectious Disease Testing Development and Commercialization
8.2 What are the Current Obstacles for MD Infectious Disease Testing Implementation?
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 Regs 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?
9. Economics of Anti-microbial Drug Resistance: The Persistent need for Anti-bacterials
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 Genetics
10.5 AutoGenomics, Inc.
10.6 Becton, Dickinson and Company
10.7 BioGenex Laboratories, Inc.
10.8 BioHelix Corporation
10.9 bioMérieux
10.10 Biocartis
10.11 bioTheranostics
10.12 Celera
10.13 Cepheid
10.14 EraGen Biosciences
10.15 Exiqon A/S
10.16 Genera Biosystems
10.17 GenMark Diagnostics, Inc.
10.18 Genomix Biotech
10.19 Gen-Probe
10.20 PANTHER System
10.21 Gene Express
10.22 Genomica
10.23 Great Basin Scientific
10.24 Hologic
10.25 Illumina, Inc.
10.26 Innogenetics NV
10.27 Life Technologies
10.28 Mobidiag
10.29 Myconostica
10.30 Nanosphere
10.31 NorDiag ASA
10.32 Qiagen NV
10.33 Roche Ltd.
10.34 Seegene
10.35 SIRS-Lab
10.36 Source MDx
10.37 TrimGen
10.38 TrovaGene
10.39 Veredus Laboratories
10.40 Veridex
Appendix 1: Draft Guidance for Industry and Food and Drug Administration Staff—Establishing the Performance Characteristics of Nucleic Acid-based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA)
INDEX OF FIGURES
Figure 2.1: Relationship of DNA Testing to Key Areas of Clinical Diagnosis
Figure 2.2: Finding Genes with Microassays
Figure 2.3: The Use of Microassays for Studying Gene Expression
Figure 2.4: Overall Structure of Nucleic Acid Testing Market
Figure 2.5: Global Market for Molecular Diagnostics, 2002-2016
Figure 3.1: Global Market for Molecular Diagnostics Testing, 2010
Figure 3.2: Share of Molecular Diagnostics Testing by Testing Type, 2009
Figure 3.3: Key Players Market Share in Global Molecular Diagnostics Testing Markets
Figure 3.4: Global Market for Infectious Disease Treatments, 2007-2014
Figure 3.5: Global Revenue Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2016
Figure 3.6: Global Market Revenue Share Forecasts for Molecular Diagnostics Infectious Disease Testing Markets by Region, 2009 and 2015
Figure 3.7: Infectious Disease Testing Revenue Market Share of Total U.S. MD Market, 2009 and 2015
Figure 3.8: European Market Revenue Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2015
Figure 3.9: Infectious Disease Testing Revenue Market Share of Total European MD Market, 2009 and 2015
Figure 3.10: Japanese Market Revenue Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2016
Figure 3.11: Infectious Disease Testing Revenue Market Share of Total Japanese MD Market, 2009 and 2015
Figure 3.12: Total Global Infectious Disease Molecular Diagnostics Markets, 2010
Figure 3.13: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2010
Figure 3.14: Total Global Infectious Disease Molecular Diagnostics Markets, 2016
Figure 3.15: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2016
Figure 3.16: Global Trend of HIV Infection, 1991-2007
Figure 3.17: Number of People Living with HIV, Newly Infected with HIV and Number of AIDS Deaths in the World, 1990-2008
Figure 3.18: Worldwide Rate of New HIV Cases, 1990-2007
Figure 3.19: Percentage of Adult Population in African Countries with HIV, 2007
Figure 3.20: Global View of HIV Infection, 2008
Figure 3.21: Ethnic Distribution of AIDS Patients in the U.S., 2007
Figure 3.22: Ten Best Selling AIDS Drugs in the U.S., 2008
Figure 3.23: U.S. Rates for New HIV Cases, 2008
Figure 3.24: U.S. Rates for New HIV Cases in Men, 2008
Figure 3.25: U.S. Rates for New HIV Cases in Women, 2008
Figure 3.26: Global Trend of HIV Infections, 1991-2007
Figure 3.27: Proposed HIV Testing Algorithm*
Figure 3.28: Distribution of HIV Molecular Diagnostic Testing by Purpose
Figure 3.29: Estimated Market Forecast for Global HIV Molecular Diagnostic Testing, 2011-2016
Figure 3.30: Estimated Market Forecast for U.S. HIV Molecular Diagnostic Testing, 2011-2016
Figure 3.31: Market Share Viral Load HIV MD Diagnostic Testing
Figure 3.32: Geographic Distribution of Chronic HBV Infection
Figure 3.33: Rate of New Hepatitis A, B and C Infections in the U.S., 1982-2006
Figure 3.34: Global Prevalence of Hepatitis C
Figure 3.35: Primary Causes of Chronic Liver Disease
Figure 3.36: HCV Infection Prevalence
Figure 3.37: Hepatitis C Infection by Source
Figure 3.38: Growth and Projections of HCV Therapies by Drug Class, 2008 and 2013
Figure 3.39: U.S. Market Size and Share of HCV Molecular Diagnostic Market, 2010 Figure 3.40: Ex-U.S. Market Size and Share of HCV Molecular Diagnostic Market, 2010
Figure 3.41: Rate of New Cases and Deaths of Cervical Cancer by Age Group Worldwide, 2008
Figure 3.42: U.S. Market Size and Share of HPV Molecular Diagnostic Market, 2010 Figure 3.43: Ex-U.S. Market Size and Share of HPV Molecular Diagnostic Market, 2010
Figure 3.44: Market Share Estimates for Molecular Diagnostic HPV Testing, 2009 Figure 3.45: Number of Reported and Confirmed Cases of Influenza H1N1 Strain Worldwide, 2009
Figure 3.46: Distribution of H1N1 Flu in the U.S., 2009
Figure 3.47: H1N1 Confirmed and Probable Case Rate in the U.S., By Age Group
Figure 3:48: U.S. Rates of Sexually-transmitted Diseases, 1940-2007
Figure 3.49: Chlamydia Infection Rates: Total and by Gender: U.S., 1989-2008
Figure 3.50: Chlamydia U.S. Prevalence by Age Group and Race/Ethnicity
Figure 3.51: U.S. Market Size and Share of CT/NG Molecular Diagnostic Market, 2010
Figure 3.52: Ex-U.S. Market Size and Share of CT/NG Molecular Diagnostic Market, 2010
Figure 3.53: U.S. Gonorrhea Infection Rates, 1941-2006
Figure 3.54: U.S. Gonorrhea Infection Rates by Race/Ethnicity, 1999-2008
Figure 3.55: Pipeline for TB Diagnostics
Figure 3.56: Number of Tuberculosis Cases Among U.S. and Foreign-born Persons in the U.S., 1993-2008
Figure 3.57: Rate of Tuberculosis Cases Among U.S. and Foreign-born Persons, in the U.S., 1993-2008
Figure 3.58: Rate of Tuberculosis (TB) Cases by State/Area in the U.S., 2008
Figure 3.59: U.S.-born TB Cases by Ethnicity, 2008
Figure 3.60: Reported TB Cases in the U.S., 1983-2007
Figure 3.61: Global Market Share of MD TB Testing
Figure 3.62: Global Market Share of MD TB Testing by Region
Figure 3.63: Incidence Rates of Invasive MRSA Infections by Age
Figure 3.64: MRSA Trends According to Patient Location, 1998-2005
Figure 3.65: Incidence of Healthcare-associated MRSA Infections, 2005-2008
Figure 3.66: U.S. Market Size and Share of MRSA Molecular Diagnostic Market, 2010
Figure 3.67: Ex-U.S. Market Size and Share of MRSA Molecular Diagnostic Market, 2010
Figure 3.68 Global Frequency of Vancomycin-resistant Enterococci, 2006
Figure 3.69: U.S. Market Size and Share of VRE Molecular Diagnostic Market, 2010 Figure 3.70: Estimated Market for Global Blood Screening Product Sales, 2007-2016 Figure 3.71: Gen-Probe Blood Screening Product Market Share, 2005-2009
Figure 3.72: Blood Screening Product Market Share by Company, 2010
Figure 4.1: Using DNA Microassays to Measure Gene Expression
Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients
Figure 5.1: FDA Co-developed Products as a Model for Collaboration
Figure 5.2: Market Growth of MD Infectious Disease Tests
Figure 5.3: Segmentation of the Biomarker Development Market
Figure 5.4: Global Distribution of Anti-infective Agent Sales by Geography
Figure 5.5: Leading Companies in Anti-infectives Market Share, 2008
Figure 6.1: Reimbursement for Diagnostics in Healthcare Decision Making
Figure 9.1: Global Multidrug Susceptibility in Pseudomonas aeruginosa
Figure 9.2: Global Frequency of Vancomycin-resistant Enterococci, 2006
Figure 10.1: Gen-Probe Key Acquisitions
Figure 10.2: Gen-Probe Projected R&D Expenditures
INDEX OF TABLES
Table 1.1: Market Trends in Infectious Disease DNA Testing
Table 1.2: Molecular Diagnostics Infectious Disease Market: Market Drivers Ranked in Order of Impact
Table 1.3: Molecular Diagnostics Infectious Disease Market: Market Restraints Ranked in Order of Impact
Table 1.4: Strategic Recommendations on Molecular Diagnostic Sector Business Functions
Table 2.1: Nucleic Acid-based Tests for Clinically Important Viral and Bacterial Pathogens
Table 2.2: Top Ten Causes of Death Worldwide
Table 2.3: The Most Prevalent Infectious Diseases Worldwide
Table 2.4: Annual Rates of Global Infectious Diseases
Table 2.5: Emerging Molecular Diagnostic Technologies
Table 2.6: Global Market for Molecular Diagnostics Testing, 2000-2016
Table 2.7: U.S. Market for Molecular Diagnostics Testing, 2004-2016
Table 2.8: Automated Molecular Diagnostics Platforms for Infectious Disease Testing Table 2.9: Companies Marketing Products Using DNA Probes
Table 2.10: Companies Marketing Multiple Products in Molecular Diagnostics Sector Table 2.11: FDA-approved Molecular Diagnostic Commercial Kits for the Detection of Infectious Agents
Table 2.12: Global and U.S. Major Infectious Disease Market Size
Table 2.13: Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
Table 2.14: Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
Table 2.15: Attractive Growth Areas for Molecular Diagnostic Testing
Table 2.16: NAT Labs in U.S. and Five European Markets
Table 3.1: European Market for Molecular Diagnostics Testing, 2005-2015
Table 3.2: Japanese Market for Molecular Diagnostics Testing, 2009-2016
Table 3.3: Summary of Molecular Diagnostics Testing Sectors
Table 3.4: Share of Molecular Diagnostics Testing by Testing Type, 2009
Table 3.5: Key Players and Market Share in Global Molecular Diagnostics Testing Market
Table 3.6: Revenue Model for Molecular Diagnostics Testing
Table 3.7: Molecular Infectious Disease Diagnostics Market: Market Drivers Ranked in Order of Impact
Table 3.8: Molecular Infectious Disease Diagnostics Market: Market Restraints Ranked in Order of Impact
Table 3.9: Global Revenue Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2016
Table 3.10: U.S. Market Revenue Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2016
Table 3.11: European Market Revenue Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2015
Table 3.12: Japanese Market Revenue Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2016
Table 3.13: Molecular Diagnostic Markets for Infectious Disease Testing, 2010
Table 3.14: Molecular Diagnostic Markets for Infectious Disease Testing, 2016
Table 3.15: Business Factors Influencing Advanced Infectious Disease MD Testing Services
Table 3.16: Global Summary of the HIV/AIDS Epidemic, 2008
Table 3.17: Global HIV Statistics, 2008
Table 3.18: HIV Resistance Testing Recommendations
Table 3.19: Summary of Assays for HIV Viral Load Testing
Table 3.20: Commercially Available Molecular Diagnostic Products for HIV Assay Table 3.21: Global Market for Molecular Diagnostic HIV Testing, 2007-2010
Table 3.22: U.S. Market for HIV Molecular Diagnostic Testing, 2007-2010
Table 3.23: Global Market Forecast for Molecular Diagnostic HIV Diagnostic Testing, 2011-2016
Table 3.24: U.S. Market Forecast for Molecular Diagnostic HIV Diagnostic Testing, 2011-2016
Table 3.25: Global Market for HIV Viral Load Diagnostic Testing, 2007-2010
Table 3.26: U.S. Market for HIV Viral Load Diagnostic Testing, 2007-2010
Table 3.27: Global Market Forecast for HIV Viral Load Diagnostic Testing, 2011-2016
Table 3.28: U.S. Market Forecast for HIV Viral Load Diagnostic Testing, 2011-2016 Table 3.29: Global Market for HIV Genotyping Testing, 2007-2010
Table 3.30: U.S. Market for HIV Genotype Testing, 2007-2010
Table 3.31: Global Market Forecast for HIV Genotyping Testing 2011-2015
Table 3.32: U.S. Market Forecast for HIV Genotyping Testing, 2011-2016
Table 3.33: HIV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
Table 3.34: HIV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
Table 3.35: Clinical Application of Quantitative HBV DNA Testing
Table 3.36: Lower Detection Limits of HBV DNA Assays
Table 3.37: Summary of Molecular Diagnostic Assays for Testing HBV
Table 3.38: Global Market for HBV Diagnostic Testing, 2000-2010
Table 3.39: U.S. Market for HBV Diagnostic Testing, 2000-2010
Table 3.40: Global Market Forecast for HBV Diagnostic Testing, 2011-2016
Table 3.41: U.S. Market Forecast for HBV Diagnostic Testing, 2011-2016
Table 3.42: HBV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
Table 3.43: HBV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
Table 3.44: Hepatitis B Facts
Table 3.45: U.S. HCV Statistics
Table 3.46: Worldwide Rate of HCV Cases
Table 3.47: Efficiency of Available HCV Screening Tests
Table 3.48: Commercially Available Molecular Diagnostic Products for HCV Assay Table 3.49: Global Market for DNA HCV Diagnostic Testing, 2005-2010
Table 3.50: U.S. Market for DNA HCV Diagnostic Testing, 2005-2010
Table 3.51: Global Market Forecast for NAT HCV Diagnostic Testing, 2011-2016 Table 3.52: U.S. Market Forecast for NAT HCV Diagnostic Testing, 2011-2016
Table 3.53: Major Companies Marketing HCV Molecular Diagnostic Tests: Market Size and Share, 2010
Table 3.54: HCV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
Table 3.55: HCV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
Table 3.56: Recommendations for HCV Diagnostic Testing
Table 3.57: Number of Pap Smears Performed by Country, 2009
Table 3.58: Qiagen's Digene HC2 High-risk HPV DNA Test
Table 3.59: Commercially Available Molecular Diagnostic Products for HPV Assay Table 3.60: Major Companies Marketing HPV Molecular Diagnostic Tests: Market Size and Share, 2010
Table 3.61: Global Market for HPV Molecular Diagnostic Testing, 2007-2010
Table 3.62: U.S. Market for HPV Molecular Diagnostic Testing, 2007-2010
Table 3.63: Global Market Forecast for HPV Molecular Diagnostic Testing, 2011-2016
Table 3.64: U.S. Market Forecast for HPV Molecular Diagnostic Testing, 2011-2016 Table 3.65: HPV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
Table 3.66: HPV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
Table 3.67: Commercially Available Molecular Diagnostic Products for Influenza Assay
Table 3.68: Global Market for Molecular Influenza Diagnostic Testing, 2007-2010 Table 3.69: U.S. Market for DNA Influenza Diagnostic Testing, 2007-2010
Table 3.70: Global Market Forecast for Influenza Molecular Diagnostic Testing, 2010-2016
Table 3.71: U.S. Market Forecast for Influenza Molecular Diagnostic Testing, 2010-2016
Table 3.72: INFLUENZA Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
Table 3.73: INFLUENZA Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
Table 3.74: U.S. Chlamydia Infection Rates, 1985-2008
Table 3.75: U.S. Chlamydia Statistics
Table 3.76: Commercially Available Molecular Diagnostic Products for Chlamydia Assay
Table 3.77: Global Market for Molecular Diagnostic Chlamydia/NG Diagnostic Testing, 2000-2010
Table 3.78: U.S. Market for Molecular Diagnostic Chlamydia/NG Diagnostic Testing, 2000-2010
Table 3.79: Major Companies Market Share of Chlamydia/Gonorrhea Molecular Diagnostic Tests, 2010
Table 3.80: Global Market Forecast for Chlamydia/Gonorrhea Diagnostic Testing, 2011-2016
Table 3.81: U.S. Market Forecast for Chlamydia/Gonorrhea Diagnostic Testing, 2010-2016
Table 3.82: Global Market Forecast for Chlamydia Molecular Diagnostic Testing, 2011-2016
Table 3.83: U.S. Market Forecast for Chlamydia Molecular Diagnostic Testing, 2011-2016
Table 3.84: Chlamydia Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
Table 3.85: Chlamydia Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
Table 3.86: U.S. Gonorrhea Statistics
Table 3.87: Commercially Available Molecular Diagnostic Products for Gonorrhea Assay
Table 3.88: Major Companies Marketing Chlamydia/Gonorrhea Molecular Diagnostic Tests: Market Size and Share 2010
Table 3.89: Gonorrhea Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
Table 3.90: Gonorrhea Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
Table 3.91: Commercially Available Molecular Diagnostic Assays for Testing TB Table 3.92: Global Market for MD TB Diagnostic Testing, 2005-2010
Table 3.93:U.S. Market for MD TB Diagnostic Testing, 2005-2010
Table 3.94: Worldwide Market Share of MD TB Testing by Region, 2010
Table 3.95: Worldwide Unit Sales of MD TB Testing by Region, 2010
Table 3.96: Comparative U.S. Claim Charges for TB Testing by Type, 2010
Table 3.97: Global Testing for TB by Testing Type, 2010
Table 3.98: Global Testing for TB by Testing Reason, 2010
Table 3.99: Global Market Forecast for MD TB Diagnostic Testing, 2011-2016
Table 3.100: U.S. Market Forecast for MD TB Diagnostic Testing, 2011-2016
Table 3.101: Tuberculosis Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
Table 3.102: Tuberculosis Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
Table 3.103: Leading Tuberculosis Therapeutic R&D Candidates
Table 3.104: Commercially Available Molecular Diagnostic Products for MRSA Assay
Table 3.105: Global Market for MRSA Diagnostic Testing, 2005-2010
Table 3.106: U.S. Market for MRSA Diagnostic Testing, 2005-2010
Table 3.107: Major Companies Marketing HCV Molecular Diagnostic Tests: Market Size and Share, 2010
Table 3.108: Global Market Forecast for MD MRSA Diagnostic Testing, 2010-2016 Table 3.109: U.S. Market Forecast for MD MRSA Diagnostic Testing, 2010-2016 Table 3.110: MRSA Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
Table 3.111: MRSA Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
Table 3.112: In vitro Susceptibility of Staphylococci to New Agents in Development Table 3.113: Commercially Available Molecular Diagnostic Products for VRE Assay Table 3.114: Global Market for VRE Diagnostic Testing, 2005-2010
Table 3.115: U.S. Market for VRE Diagnostic Testing, 2005-2010
Table 3.116: Major Companies Marketing VRE Molecular Diagnostic Tests: Market Size and Share, 2010
Table 3.117: Global Market Forecast for MD VRE Diagnostic Testing, 2011-2016
Table 3.118: U.S. Market Forecast for MD VRE Diagnostic Testing, 2011-2016
Table 3.119: VRE Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
Table 3.120: VRE Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
Table 3.121: Transmission-related Disease Screening from Blood Donor Pools
Table 3.122: Principal Blood Screening Products of Gen-Probe for HIV Assay
Table 3.123: Global Market for Blood Screening Product Sales, 2007-2016
Table 3.124: Global Revenue and Forecast for Blood-Screening Market, 2000-2016 Table 3.125: U.S. Market and Forecast for Blood-Screening Market, 2000-2016
Table 3.126: Major Companies' Market Share of Blood Screening Molecular Diagnostic Tests
Table 3.127: Blood Screening Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
Table 3.128: Blood Screening Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
Table 4.1: Key Elements for Business Competition in Molecular Diagnostic Testing for Infectious Disease
Table 4.2: Key Elements for Future Success in Molecular Testing for Infectious Disease
Table 4.3: Examples of Personalized Medicine in Treatment of Infectious Disease
Table 4.4: Molecular Methods for Epidemiologic Typing of Microorganisms
Table 4.5: Drivers of Molecular Diagnostic Methods for Infectious Disease Testing in the Clinical Setting
Table 4.6: Barriers to Molecular Diagnostic Methods for Infectious Disease Testing in the Clinical Setting
Table 5.1: Technology Trends in Molecular Diagnostic Infectious Disease Testing Table 5.2: Clinical Testing Trends in Molecular Diagnostic Infectious Disease Testing Table 5.3: Business Market Trends in Molecular Diagnostics Infectious Disease Testing
Table 5.4: Expected Changes in Healthcare
Table 5.5: Customer Feedback for Automated Molecular Diagnostic Instruments
Table 5.6: Molecular Diagnostics Infectious Disease Market: Market Drivers Ranked in Order of Impact
Table 5.7: Molecular Diagnostics Infectious Disease Market: Market Restraints Ranked in Order of Impact
Table 5.8: Advantages of European Markets for Molecular Diagnostic Testing
Table 5.9: European Sales Percentage of Most Common Molecular Diagnostic Tests by Analyte Type
Table 5.10: Disadvantages of European Markets for Molecular Diagnostic Testing Table 5.11: Summary of Recent M&A Activity in the Molecular Diagnostics Sector Table 5.12: High Value Opportunities in Collaborative and Strategic Partnerships
Table 5.13: Principal Competitive Factors in the Molecular Diagnostics Infectious Disease Testing Market
Table 5.14: Molecular Diagnostics Infectious Disease Testing Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions
Table 5.15: Molecular Diagnostics Infectious Disease Market: Impact of Top Industry Challenges in the U.S.
Table 5.16: Documents for Protecting Intellectual Property Rights
Table 5.17: Recent Patents Related to PCR, Nucleic Acid Amplification, and Sample Prep
Table 5.18: Specific Opportunities for Automated Instrumentation and Reagent Systems in Molecular Diagnostics for Infectious Disease Testing
Table 3.19: Roche PCR Licenses
Table 5.20: Global Sales of Gen-Probe by Geographic Area, 2008-2010
Table 5.21: The Required Elements of a Manufacturing Facility
Table 5.22: CMO Qualification Audit: Points to Investigate
Table 5.23: Strategies and POA for Marketing Infectious disease Diagnostic Products Table 5.24: Key Elements of Molecular Diagnostic Companies Marketing Plan
Table 5.25: Utility of Biomarkers as Companion Diagnostics to Drug Development Table 5.26: Leading Pharmaceutical Companies in the Anti-infective Market—Total Global Sales, 2008
Table 6.1: Factors Determining Third Party Payment for Molecular Diagnostic Tests for Infectious Disease
Table 6.2: CPT Codes for Molecular Diagnostic Infectious Disease Testing
Table 7.1: Regulatory Rules Affecting a Diagnostic Testing Reagent Company to Conduct Business
Table 7.2: Strengths of the 510k Process
Table 7.3: Drawbacks of the 510k Process
Table 7.4: Focus Areas for the FDA Critical Path Initiative
Table 8.1: Effect of Regulation on MD Infectious Disease Market Technology Platforms, 2007 and 2015
Table 8.2: Companies Utilizing New, Cutting-edge Technologies to Develop, Validate and Market Molecular Tests for Clinical Use in Infectious Disease Management
Table 8.3: Impediments to Incorporating Promising Molecular Tests into Clinical Practice
Table 8.4: New Molecular Diagnostics Tests Showing the Most Promise for Approval Table 8.5: Alliances Showing the Greatest Synergy in bringing Molecular Diagnostics Tests to Market
Table 8.6: Shared Technologies Driving the Most Encouraging MD Development 300
Table 10.1: Gen-Probe Key Acquisitions
Table A1: MRSA/SA Strains for Analytical Sensitivity (LoD) and Inclusivity Studies obtained from the CDC
Table A2: MRSA Strains (known Clinical Associated Strains) obtained from the Network on Antimicrobial Resistance in Staphylococcus aureus (NARSA) for Analytical Sensitivity (LoD) and Inclusivity Studies
Table A3: MRSA Strains (Clinical Isolates and Isolates obtained from Public and Private Collections) for analytical sensitivity (LoD) and Inclusivity Studies
Table A4: Examples of Microorganisms (Non-Staphylococci Strains of Various Bacterial and Yeast Species and Viruses) Recommended for Analytical Specificity (Cross-reactivity) Studies for Devices that are Indicated for Testing Nasal Swab Specimens Collected from Patients at Risk for MRSA Colonization
Table A5: Examples of coagulase negative Staphylococci (CNS) from Public and Private Collections (including Methicillin-resistant Staphylococcus epidermidis (MRSE), Methicillin-resistant Coagulase Negative Staphylococci (MRCoNS) and Methicillin-sensitive Coagulase Negative Staphylococci (MSCoNS) Recommended for Analytical Specificity (Cross-reactivity) Studies for Devices that are Indicated for Testing Nasal Swab Specimens Collected from Patients at Risk for MRSA Colonization
Table A6: Examples of Substances Recommended for an Interference Study for Nasal Swab Specimens
Table A7: Examples of Substances Recommended for an Interference Study for Skin and Soft Tissue Infection Swab Specimens
Table A8: FDA-approved Molecular Diagnostic Tests for Infectious Diseasesa
Table A9: Noncommercial Nucleic Acid-based Tests for Clinically Important Viral and Bacterial Pathogensa
Table A10: Molecular Methods for Detecting Antimicrobial Resistancea
Table A11: Genotypic Methods for Epidemiologic Typing of Microorganismsa,b
Table A12: Reduction in Number and Cost of Nosocomial Infections through Collaborative Efforts of Infection Control, Clinical Microbiology, and Molecular Typing Laboratoriesa
- Abbott Laboratories
- AdvanDx
- Arcxis Biotechnologies
- Atlas Genetics
- AutoGenomics, Inc
- Becton, Dickinson and Company
- BioGenex Laboratories, Inc
- BioHelix Corporation
- bioMérieux
- Biocartis
- bioTheranostics
- Celera
- Cepheid
- EraGen Biosciences
- Exiqon A/S
- Genera Biosystems
- GenMark Diagnostics, Inc
- Genomix Biotech
- Gen-Probe
- PANTHER System
- Gene Express
- Genomica
- Great Basin Scientific
- Hologic
- Illumina, Inc
- Innogenetics NV
- Life Technologies
- Mobidiag
- Myconostica
- Nanosphere
- NorDiag ASA
- Qiagen NV
- Roche Ltd
- Seegene
- SIRS-Lab
- Source MDx
- TrimGen
- TrovaGene
- Veredus Laboratories
- Veridex
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