NUCLEIC ACID TESTING: TECHNOLOGIES AND MARKETS
a report prepared for Clinica World Medical Device and
Diagnostics News (PJB Publications, 2001)
TABLE OF CONTENTS
LIST OF TABLES
EXECUTIVE SUMMARY
CHAPTER 1 INTRODUCTION TO NUCLEIC ACID TESTING
1.1 Scope of this report
1.1.1 Background research
1.1.2 Methodology of market calculations
1.2 Introduction to nucleic acids
1.3 Introduction to probe-based NAT
1.3.1 Probes used in NAT
1.4 Probe-based NAT and immunoassays
1.5 Probe-based NAT protocols
1.5.1 Sample preparation
1.5.2 Nucleic acid amplification
1.5.3 Nucleic acid detection
1.5.4 Qualitative vs quantitative tests
1.5.5 Automation
1.6 Individualised medicine and NAT
1.6.1 Genotyping
1.6.1.1 Drug resistance tests
1.6.1.2 Predisposition tests
1.6.1.3 Theranostic tests
1.6.2 Genotyping technologies
1.6.2.1 Probe-based technologies
1.6.2.2 Sequencing technologies
1.7 NAT costs and the drive towards miniaturization
1.8 Regulation and use of commercial NAT products
CHAPTER 2 PRODUCT DEVELOPMENTS AND CLINICAL APPLICATIONS
2.1 Target amplification technologies
2.1.1 Thermocycling-dependent amplification
2.1.1.1 Polymerase chain reaction (PCR)
2.1.1.2 Ligase chain reaction (LCR)
2.1.2 Isothermal amplification
2.1.2.1 Strand displacement amplification (SDA)
2.1.2.2 Transcription-mediated amplification (TMA)
2.1.2.3 Nucleic acid sequence based amplification (NASBA)
2.1.2.4 Cycling probe technology (CPT)
2.2 Signal amplification technologies
2.2.1 Branched DNA (bDNA)
2.2.2 Hybrid Capture
2.2.3 Multiple triplex reporter formation (MTRF)
2.3 Target and signal amplification
2.3.1 Rolling circle amplification technology (RCAT)
2.4 Some alternatives to amplification
2.4.1 Tessera array technology (TAT)
2.4.2 Target protection assay (TPA)
2.4.3 ORIGEN technology
2.4.4 Zinc finger DNA binding proteins (ZFPs)
2.5 Multiprobe assays and biochips
2.5.1 Multiprobe assays
2.5.2 Biochips
2.5.2.1 Microarrays
2.5.2.2 Microfluidics (lab-on-a-chip)
2.6 High-throughput screening
2.6.1 Traditional amplification-based systems
2.6.2 Microarrays and microfluidics
2.6.3 Automation of sample preparation
2.7 FISH and comparative genomic hybridization
2.8 Diagnosis of infectious diseases
2.8.1 Sexually transmitted bacterial diseases
2.8.2 HIV
2.8.2.1 HIV viral load
2.8.2.2 HIV drug resistance
2.8.3 Hepatitis viral load and drug resistance
2.8.4 Other viruses
2.8.5 Blood testing for viruses
2.8.6 HPV and cervical cancer
2.8.7 Tuberculosis
2.8.8 Other pathogenic organisms
2.8.8.1 Bacteria, fungi and protozoa
2.8.8.2 Bacterial drug resistance
2.9 Genetic testing
2.9.1 Molecular diagnostics
2.9.2 FISH and comparative genomic hybridization
2.10 Forensic and identity testing
2.11 Transplant organ rejection prediction
2.12 Cancer
2.12.1 Diagnostic tests
2.12.1.1 FISH-based tests
2.12.1.2 Colorectal cancer
2.12.1.3 Lung cancer
2.12.2 Predisposition tests
2.12.2.1 Hereditary breast cancer
2.12.2.2 Hereditary colorectal cancer
2.12.2.3 Hereditary kidney cancer
2.12.3 Theranostic tests
2.13 Predictive tests (diseases other than cancer)
2.13.1 Cardiovascular disease
2.13.2 Alzheimer's disease
2.13.3 Other diseases and conditions
2.14 Prediction of drug toxicity
2.15 Evolution of rapid NAT formats
CHAPTER 3 THE WORLD MARKET FOR NAT-BASED DIAGNOSTICS
3.1 Introduction
3.2 Overview of NAT trends
3.2.1 Diverse approaches to target amplification
3.2.2 Development of novel NA detection methods
3.2.3 Appearance of multiprobe assay formats
3.2.4 Evolution of biochip-based diagnostics
3.2.5 Exploration of POC formats
3.2.6 Simplification of sequencing technology
3.2.7 Development of automated systems
3.2.7.1 Automation of amplification and detection
3.2.7.2 Automation of sample preparation
3.2.7.3 Automation of FISH-based diagnostics
3.2.7.4 Automation of biochip-based diagnostics
3.3 Overview of National Markets
3.3.1 Population trends
3.3.2 Economic climate
3.3.3 Geographical Opportunities
3.3.4 Quantitative breakdown
3.4 NAT Market Segments and Forecasts
3.4.1 Introduction
3.4.2 Total NAT Market
3.4.3 Infectious diseases
3.4.3.1 Bacteria
... Chlamydia and gonorrhea (STDs)
... Mycobacterium tuberculosis (MTB)
3.4.3.4 Viral detection and load
... HIV
... Hepatitis (HBV and HCV)
... CMV
3.4.3.5 Viral genotyping tests
... HIV
... HBV/HCV
3.4.3.5 Screening of blood donations
3.4.4 Cancer
3.4.4.1 Overall incidence
3.4.4.2 Cervical cancer screening
3.4.4.3 Chromosomal aberrations
3.4.5 Genetic testing
3.4.6 Forensic and identity testing
3.4.7 Disease predisposition and theranostics
3.4.8 Forecasts
3.5 Key players in the market and their strategies
3.5.1 Multinationals committed to NAT diagnostics
3.5.2 Established biotechnology companies
3.5.3 Innovative start-ups
CHAPTER 4 THE US MARKET
4.1 Introduction
4.2 Demographic details
4.3 Health services
4.4 Major diseases
4.4.1 Overview
4.4.1 HIV/AIDS
4.4.2 Hepatitis
4.4.3 Cervical cancer
4.5 Screening programs
4.6 Diagnostics regulation
4.7 Diagnostics market
4.8 Imports and exports
CHAPTER 5 THE JAPANESE MARKET
5.1 Introduction
5.2 Demographics
5.3 Health services
5.4 Major diseases
5.4.1 Overview
5.4.2 HIV/AIDS
5.4.3 Hepatitis
5.5 Screening programs
5.6 Diagnostic regulation
5.7 Diagnostic market
5.8 Imports and exports
CHAPTER 6 THE EUROPEAN MARKET
6.1 Prologue
6.1.1 Scope of this Chapter
6.1.2 The EC IVD Medical Devices Directive
6.1.3 EC haemovigilance statement
6.2 United Kingdom
6.2.1 Introduction
6.2.2 Demographics
6.2.3 Health services
6.2.4 Major diseases
6.2.4.1 Overview
6.2.4.2 HIV/AIDS
6.2.4.3 Hepatitis
6.2.4.4 Cervical Cancer
6.2.5 Screening programs
6.2.6 Diagnostics Regulation
6.2.7 Diagnostics Market
6.2.8 Imports and Exports
6.3 France
6.3.1 Introduction
6.3.2 Demographics
6.3.3 Health services
6.3.4 Major diseases
6.3.4.1 Overview
6.3.4.2 HIV/AIDS
6.3.4.3 Hepatitis
6.3.4.4 Cervical cancer
6.3.5 Screening programs
6.3.6 Diagnostics Regulation
6.3.7 Diagnostics market
6.3.8 Imports and Exports
6.4 Germany
6.4.1 Introduction
6.4.2 Demographics
6.4.3 Health services
6.4.4 Major diseases
6.4.4.1 Overview
6.4.4.2 HIV/AIDS
6.4.4.3 Hepatitis
6.4.4.4 Cervical cancer
6.4.5 Screening programs
6.4.6 Diagnostic regulation
6.4.7 Diagnostics market
6.4.8 Imports and exports
6.5 Italy
6.5.1 Introduction
6.5.2 Demographics
6.5.3 Health services
6.5.4 Major diseases
6.5.4.1 Overview
6.5.4.2 HIV/AIDS
6.5.4.3 Hepatitis
6.5.5 Screening programs
6.5.6 Diagnostics regulation
6.5.7 Diagnostics market
6.5.8 Imports and exports
6.6 Spain
6.6.1 Introduction
6.6.2 Demographics
6.6.3 Health services
6.6.4 Major diseases
6.6.4.1 Overview
6.6.4.2 HIV/AIDS
6.6.4.3 Hepatitis
6.6.5 Diagnostic regulation
6.6.6 Diagnostics market
6.6.7 Imports and exports
CHAPTER 7 KEY COMPANIES IN THE NAT MARKET
7.1 Abbott Laboratories Inc
7.2 Affymetrix Inc
7.3 Bayer Corporation
7.4 Chiron Corporation
7.5 CyGene Inc
7.6 Digene Corporation
7.7 Enzo Biochem Inc
7.8 EXACT Sciences Corporation
7.9 SEQUENOM Inc
7.10 Genaissance Pharmaceuticals Inc
7.12 Gen-Probe Inc
7.13 IGEN International Inc
7.14 Innogenetics NV
7.15 Myriad Genetics Inc
7.16 Quest Diagnostics Inc
7.17 Roche Holding Ltd
7.18 Tibotec-Virco NV
7.19 Visible Genetics Inc
7.20 Vysis Inc
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