分子診斷﹕技術˙市場˙企業 是由出版商Jain Pharmabiotech在2012年01月所出版的。
這份英文市場調查報告書價格從美金5500起跳。
報告書內容包括﹕醫療活動、公眾衛生、醫藥品產業、法醫學等擔任重要使命的分子診斷技術相關調查。另外，各種複製連鎖反應(PCR)基礎的技術、螢光ISH、縮氨酸核酸(PNA)、DNA的電氣化學檢出、生物晶片、毫微工程和進行蛋白質體技術相關分析。概要內容如下﹕
部分1﹕技術˙倫理˙管制
- 分子診斷的基礎
- 分子診斷技術
- 生物晶片˙生物感知器˙分子標籤
- 依據分子診斷的蛋白質體技術
- 基因性疾病的分子診斷
- 感染症的分子診斷
- 癌症分子診斷
- 生物醫藥品產業和醫療
- 法醫學和細菌戰爭的分子診斷
- 參考
部分2﹕市場˙企業
- 倫理˙特許˙管制上的課題
- 分子診斷的市場
- 分子診斷企業
Abstract
Benefits of this report
- This report has evolved during the past 15 years, profiting from feedback
by numerous readers and experts.
- The most comprehensive and up-to-date one-stop source of information on
technical and commercial aspects of molecular diagnostics.
- Includes profiles of 312 companies, the largest number in any report on
this topic.
- 500 references, cited in the report are included in the bibliography.
- The text is supplemented by 97 tables and 15 figures.
Who should read this report?
- Chief executive officers of molecular diagnostic companies.
- Business development executives of pharmaceutical and biotechnology
companies.
- Executives of companies involved in developing integration of diagnosis
and treatment as well as those interested in personalized medicine.
- Officers of genomic and proteomic companies interested in diagnostic
technologies.
- Research scientists involved in application of molecular diagnostic
technologies.
- " Planners of healthcare services.
Summary
This report describes and evaluates the molecular diagnostics technologies
that will play an important role in practice of medicine, public health,
pharmaceutical industry, forensics and biological warfare in the 21st century.
This includes several polymerase chain reaction (PCR)-based technologies,
fluorescent in situ hybridization (FISH), peptide nucleic acids (PNA),
electrochemical detection of DNA, biochips, nanotechnology and proteomic
technologies.
Initial applications of molecular diagnostics were mostly for infections but
are now increasing in the areas of genetic disorders, preimplantation
screening and cancer. Genetic screening tests, despite some restrictions is a
promising area for future expansion of in vitro diagnostic market. Molecular
diagnostics is being combined with therapeutics and forms an important
component of integrated healthcare. Molecular diagnostic technologies are also
involved in development of personalized medicine based on pharmacogenetics and
pharmacogenomics. Currently, there has been a considerable interest in
developing rapid diagnostic methods for for point-of-care and biowarfare
agents such as anthrax.
The number of companies involved in molecular diagnostics has increased
remarkably during the past few years. More than 500 companies have been
identified to be involved in developing molecular diagnostics and 312 of these
are profiled in the report along with tabulation of 704 collaborations.
Despite the strict regulation, most of the development in molecular
diagnostics has taken place in the United States, which has the largest number
of companies.
The markets for molecular diagnostics technologies are difficult to estimate.
Molecular diagnostics markets overlap with markets for non-molecular
diagnostic technologies in the in vitro diagnostic market and are less well
defined than those for pharmaceuticals. Molecular diagnostic markets are
analyzed for 2010 according to technologies, applications and geographical
regions. Forecasts are made up to 2020. A major portion of the molecular
diagnostic market can be attributed to advances in genomics and proteomics.
Biochip and nanobiotechnology are expected to make a significant contribution
to the growth of molecular diagnostics.
This report was first published as DNA Diagnostics in 1995 by PJB
Publications, UK. It was updated in 1997 as Molecular Diagnostics and the next
edition, Molecular Diagnostics II, was published by Decision Resources Inc in
1999. All the three versions of the reports were well accepted and sold
widely.The report has been rewritten several times since then.
Table of Contents
Part I
0. Executive Summary
1. Introduction
- Definitions and scope of the subject
- Historical evolution of molecular diagnostics
- Molecular biology relevant to molecular diagnostics
- DNA
- DNA polymerases
- Restriction endonucleases
- DNA methylation
- RNA
- RNA polymerases
- Non-coding RNAs
- DNA transcription
- Chromosomes
- Telomeres
- Mitochondrial DNA
- Genes
- The genetic code
- Gene expression
- The human genome
- Variations in the human genome
- Variations in DNA sequences
- Single nucleotide polymorphisms
- Haplotyping
- Copy number variations in the human genome
- Genotype and haplotypes
- Insertions and deletions in the human genome
- Complex chromosomal rearrangements
- Large scale variation in human genome
- Structural variations in the human genome
- Replication of the DNA helix
- Transposons
- Proteins
- Proteomics
- Monoclonal antibodies
- Aptamers
- Basics of molecular diagnostics
- Tracking DNA: the Southern blot
- Pulsed-field gel electrophoresis
- DNA Probes
- The polymerase chain reaction
- Basic Principles of PCR
- Target selection
- Detection of amplified DNA
- Impact of human genome project on molecular diagnostics
- Mapping and sequencing of structural variation from human genomes
- 1000 Genomes Project
- Human Variome Project
- Role of bioinformatics in molecular diagnostics
- Systems biology approach to molecular diagnostics
- Biomarkers
- Applications of molecular diagnostics
2. Molecular Diagnostic Technologies
- Introduction
- DNA sample collection and extraction
- Blood samples
- Dried blood spots
- Buccal swabs and saliva
- Urine samples for transrenal DNA
- Manual vs automated DNA extraction
- Sample preparation
- Pressure Cycling Technology
- Membrane immobilization of nucleic acids
- Automation of sample preparation in molecular diagnostics
- ABI PRISM 6700 Automated Nucleic Acid Workstation
- BioRobot technology
- COBAS AmpliPrep System
- GENESIS FE500 Workcell
- GeneMole
- PCR BioCube
- QIAsymphony
- Tigris instrument system
- Techniques for sample preparation that are suitable for automation
- Xtra Amp Genomic DNA Extraction
- Extraction of DNA from paraffin sections
- Dynabead technology
- Pressure Cycling Technology
- SamPrep
- Use of magnetic particles for automation in genome analysis
- Companies involved in nucleic acid isolation
- Labeling and detection of nucleic acids
- Novel PCR methods
- Addressing limitations of PCR
- CAST-PCR
- Combined PCR-ELISA
- Convection PCR
- Digital PCR
- Emulsion PCR
- ExCyto PCR
- Long and accurate PCR
- Multiplex PCR
- Real-time PCR systems
- Dyes used in real-time PCR
- Commercially available real-time PCR systems
- LightCycler PCR system
- LightUp probes based on real-time PCR
- READ"! real-time PCR method
- StellARray"! technology
- 7500 Fast Dx Real-Time PCR Instrument
- Applications of real-time PCR
- Limitations of real-time PCR
- Quantitative PCR for accurate low level DNA analysis
- qPCR for quantification of circulating mtDNA
- Guidelines for real-time qPCR
- Future applications of real-time qPCR
- Reverse transcriptase (RT)-PCR
- Standardized reverse transcriptase PCR
- Single cell PCR
- LATE-PCR
- COLD-PCR
- AmpliGrid-System
- DNA melt analysis
- High-resolution DNA melt analysis for genotyping
- PCR device for DNA melt analysis in space
- Monitoring of gene amplification in molecular diagnostics
- Non-PCR nucleic acid amplification methods
- DNA probes with conjugated minor groove binder
- Dynamic Flux Amplification
- Isothermal reaction for amplification of oligonucleotides
- ICAN (Isothermal and Chimeric primer-initiated Amplification of Nucleic
Acids)
- Linked Linear Amplification
- Multiplex Ligation-Dependent Probe Amplification
- Rapid analysis of gene expression
- Rolling circle amplification technology
- Gene-based diagnostics through RCAT
- RCAT-immunodiagnostics
- RCAT-pharmacogenomics
- Circle-to-circle amplification
- Ramification amplification method
- Single Primer Isothermal Amplification
- Transcription mediated amplification
- WAVE nucleic acid fragment analysis system
- Technologies for signal amplification
- 3 DNA dendrimer signal amplification
- Hybridization signal amplification method
- Signal mediated amplification of RNA technology
- Invader assays
- Hybrid Capture technology
- Branched DNA test
- Tyramide signal amplification
- Non-enzymatic signal amplification technologies
- Direct molecular analysis without amplification
- Trilogy"! Platform
- Direct detection of dsDNA
- Multiplex assays
- Fluorescent in situ hybridization
- FISH technique
- Applications of FISH
- Modifications of FISH
- Direct visual in situ hybridization
- Direct labeled Satellite FISH probes
- Comparative genomic hybridization
- Primed in situ labeling
- Interphase FISH
- FISH with telomere-specific probes
- Multicolor FISH
- Simultaneous Ultrasensitive Subpopulation staining/Hybridization In situ
- Automation of FISH
- Companies involved in FISH diagnostics
- RNA diagnostics
- RNA isolation from tissue samples
- Commercially available tests for mRNA detection and quantitation
- Branched-chain DNA assay for measurement of RNA
- Cycling probe technology
- Invader RNA assays
- Linear RNA amplification
- Non-isotopic RNase cleavage assay
- Nucleic acid sequence-based amplification
- Q Beta replicase system
- RNAScope
- RNA expression profiling
- Visualization of mRNA expression in vivo
- Solid Phase Transcription Chain Reaction
- Transcriptome analysis
- MicroRNA diagnostics
- Real-time PCR for expression profiling of miRNAs
- Microarray vs quantitative PCR for measuring miRNAs
- Use of LNA to explore miRNA
- Nuclease Protection Assay to measure miRNA expression
- Microarrays for analysis of miRNA gene expression
- Modification of in situ hybridization for detection of miRNAs
- Whole genome amplification
- Companies that provide technologies for whole genome amplification
- QIAGEN's Repli-G system
- GenomePlex™ Whole Genome Amplification
- DNA sequencing
- Companies involved in sequencing
- Applications of next generation sequencing in molecular diagnostics
- Companies developing sequencing for molecular diagnostics
- Genome-wide approach for chromatin mapping
- Mitochondrial sequencing
- Identification of unknown DNA sequences
- Optical mapping
- Gene expression analysis
- Gene expression profiling on whole blood samples
- Gene expression patterns of white blood cells
- Gene expression profiling based on alternative RNA splicing
- MAUI (MicroArray User Interface) hybridization
- Monitoring in vivo gene expression by molecular imaging
- Serial analysis of gene expression (SAGE)
- Single-cell gene expression analysis
- T cell receptor expression analysis
- Tangerine"! expression profiling
- Whole genome expression array
- Ziplex"! system
- Companies involved in gene expression analysis
- Peptide nucleic acid technology
- Use of PNA with fluorescence in situ hybridization
- PNA and PCR
- Use of PNA with biosensors
- PNA-based PD-loop technology
- PNA-DNA hybrid quadruplexes
- Companies involved in PNA diagnostics
- Locked nucleic acids
- Zip Nucleic Acids
- Electrochemical detection of DNA
- Mediated nucleic acid oxidation
- Detection of hybridized nucleic acid with cyclic voltametry
- Electrochemical detection based on Toshiba's CMOS technology
- Concluding remarks on electrochemical DNA detection
- Bead-based assay platforms
- Scorpions"! technology
- The Scorpions reaction
- Applications of Scorpions
- Nucleic acid lateral flow molecular diagnostics
3. Biochips, Biosensors, and Molecular Labels
- Introduction to biochip technology
- Applications of biochips in diagnostics
- GeneChip
- GeneChip Human Genome Arrays
- AmpliChip CYP450
- Electronic detection of nucleic acids on microarrays
- Microchip capillary electrophoresis
- Strand displacement amplification on a biochip
- Rolling circle amplification on microarrays
- LiquiChip-RCAT
- Fast PCR biochip
- Multiplex microarray-enhanced PCR for DNA analysis
- Multiplexed Molecular Profiling
- Universal DNA microarray combining PCR and ligase detection reaction
- Genomewide association scans
- Whole genome chips/microarrays
- Transposon insertion site profiling chip
- Standardizing the microarrays
- Companies involved in developing biochip technology for diagnostics
- Future of biochip technology for molecular diagnostics
- Microfluidic chips
- Fish-on-chip
- Lab-on-a-chip
- LabCD
- Micronics' microfluidic technology
- Microfluidic chips/arrays using PCR
- Microfluidic automated DNA analysis using PCR
- Digital PCR Array
- Digital PCR on a SlipChip
- Microfluidic chips integrated with RCAT
- Microfluidic chips integrated with PET
- Companies developing microfluidic technologies
- Biosensor technologies
- Classification of biosensor technologies
- DNA-based biosensors
- DNA hybridization biosensor chips
- PCR-free DNA biosensor
- DNA based biosensor to detects metallic ions
- Genetically engineered B lymphocytes
- Biosensors immunoassays
- PNA (peptide nucleic acid)-based biosensors
- Protein-based biosensors
- Antibody biosensors
- Cell-based biosensors (cytosensors)
- Multicell biosensors
- Microbial biosensors
- Optical biosensors
- Surface plasmon resonance technology
- Label-free optical biosensor
- Microsensors using with nano/microelectronic communications technology
- Electrochemical sensors
- Enzyme electrodes for biosensing
- Conductometric sensors
- Electrochemical genosensors
- Electrochemical nanobiosensor
- Bioelectronic sensors
- Phototransistor biochip biosensor
- Ribozyme-based sensors
- RiboReporters
- Concluding remarks and future prospects of biosensor technology
- Companies developing biosensors for molecular diagnostics
- Molecular labels and detection
- Detection technologies for molecular labels
- Fluorescence and chemiluminescence
- Fluorescence technologies for label detection
- Companies with fluorescence and chemiluminescence products
- Molecular beacons
- The Green fluorescent protein
- Multiophoton detection radioimmunoassay
- Multi-pixel photon counter
- Enzyme labels and detection by fluorescence
- Phase-sensitive flow cytometry
- Microtransponder-based DNA diagnostics
- Laboratory Multiple Analyte Profile
- Multiple labels
- Protein-DNA chimeras for detection of small numbers of molecules
- Single molecule detection
- Atomic force microscopy
- Capillary electrophoresis
- Confocal laser scanning
- nCounter Analysis System
- Spectrally resolved fluorescence lifetime imaging microscopy
- Molecular imaging
- Basic research in molecular imaging
- Devices for molecular imaging
- Molecular imaging in clinical practice
- Challenges and future prospects of molecular imaging
- Companies involved in molecular imaging
- Nanobiotechnology for molecular diagnostics
- Magnetic nanoparticles
- Gold nanoparticles
- Quantum dot technology
- Nanotechnology on a chip
- Nanogen's NanoChip
- Fullerene photodetectors for chemiluminescence detection on microfluidic
chip
- Diagnostics based on nanopore technology
- Nanosensors
- Detection of cocaine molecules by nanoparticle-labeled aptasensors
- Nanosensors for glucose monitoring
- PEBBLE nanosensors
- Quartz nanobalance biosensor
- Cantilever arrays
- Resonance Light Scattering technology
- DNA nanomachines for molecular diagnostics
- Nanobarcodes technology for molecular diagnostics
- Qdot nanobarcode for multiplexed gene expression profiling
- Role of nanobiotechnology in improving molecular diagnostics
- Companies involved in nanomolecular diagnostics
- Concluding remarks about nanodiagnostics
- Future prospects of nanodiagnostics
4. Proteomic Technologies for Molecular Diagnostics
- Introduction
- Proteomic technologies
- Biomarkers of disease
- Proteomic tools for biomarkers
- Search for biomarkers in body fluids
- Captamers with proximity extension assay for proteins
- Cyclical amplification of proteins
- Detection of misfolded proteins by ELISA with exponential signal
amplification
- Diagnostics based on designed repeat proteins
- Differential Peptide Display
- Light-switching excimer probes
- MALDI-TOF MS
- Molecular beacon aptamer
- Molecular beacon assay
- Proteomic patterns
- Real-time PCR for protein quantification
- Protein biochip technologies
- ProteinChip
- LabChip for protein analysis
- TRINECTIN proteome chip
- Protein chips for antigen-antibody interactions molecular diagnostics
- Microfluidic devices for proteomics-based diagnostics
- Nanotechnology-based protein biochips/microarrays
- Nanoparticle protein chip
- Protein nanobiochip
- Protein biochips based on fluorescence planar wave guide technology
- New developments in protein chips/microarrays
- Antibody microarrays
- Aptamer-based protein biochip
- Multiplexed Protein Profiling on Microarrays
- Proteomic pattern analysis
- Single molecule array
- Viral protein chip
- Commercial development of protein chips for molecular diagnostics
- Proteome Identification Kit
- Laser capture microdissection (LCM)
- LCM technology
- Applications of LCM in molecular diagnostics
- Proteomic diagnosis of CNS disorders
- Cerebrospinal fluids tests based on proteomics
- Urine tests for CNS disorders based on proteins in urine
- Diagnosis of CNS disorders by examination of proteins in the blood
- Diagnosis of CNS disorders by examination of proteins in tears
- Role of proteomics in the diagnosis of Alzheimer's disease
- Role of proteomics in the diagnosis of Creutzfeldt-Jakob disease
- Future prospects of use of proteomics for diagnosis of CNS disorders
- Concluding remarks on the use of proteomics in diagnostics
5. Molecular Diagnosis of Genetic Disorders
- Introduction
- Cytogenetics
- FISH with probes to the telomeres
- Single copy FISH probes
- Comparative genomic hybridization
- Use of biochips in genetic disorders
- Representational oligonucleotide microarray analysis
- SignatureChipR-based diagnostics for cytogenetic abnormalities
- Diagnosis of genomic rearrangements by multiplex PCR
- Quantitative fluorescent PCR
- Mutation detection technologies
- PCR-based methods for mutation detection
- Cleavase Fragment Length Polymorphism
- Direct dideoxy DNA sequencing
- Digital Genetic Analysis (DGA)
- Fluorescence-based directed termination PCR
- Fluorescence melting curve analysis for multiplex mutation detection
- Heteroduplex analysis
- Restriction fragment length polymorphism
- Single-stranded conformation polymorphism (SSCP) analysis
- TaqMan real-time PCR
- Non-PCR methods for mutation detection
- Arrayed primer extension
- BEAMing (beads, emulsion, amplification, and magnetics)
- ELISA-protein truncation test
- Enzymatic mutation detection
- Specific anchor nucleotide incorporation
- Conversion analysis for mutation detection
- Biochip technologies for mutation detection
- Combination of FISH and gene chips
- Haplotype Specific Extraction
- Use of biosensors for detection of mutations
- Technologies for SNP analysis
- DNA sequencing
- Electrochemical DNA probes
- Use of NanoChip for detection of SNPs
- Single base extension-tag array
- Laboratory Multiple Analyte Profile
- SNP genotyping with gold nanoparticle probes
- PCR-CTPP (confronting two-pair primers)
- Peptide nucleic acid probes for SNP detection
- SNP genotyping on a genome-wide amplified DOP-PCR template
- Pyrosequencing
- Reversed enzyme activity DNA interrogation test
- Smart amplification process version 2
- Zinc finger proteins
- UCAN method (Takara Biomedical)
- Biochip and microarray-based detection of SNPs
- SNP genotyping by MassARRAY
- Electronic dot blot assay
- Biochip combining BeadArray and ZipCode technologies
- SNP-IT primer-extension technology
- OmniScan SNP genotyping
- Affymetrix SNP genotyping array
- Concluding remarks on SNP genotyping
- Limitations of SNP in genetic testing
- Haplotyping versus SNP genotyping
- Nanofluidics technology for high throughput SNP genotyping
- Companies involved in developing technologies/products for SNP analysis
- Role of copy number variations in genetic diagnostic testing
- CNVs in various diseases
- CNVs in genetic epilepsy syndromes
- CNVs associated with schizophrenia
- Methods for determination of CNVs
- Digital array for CNV detection
- Wellcome Trust Case Control Consortium CNV typing array
- CNVer algorithm for CNV detection
- Study of rare variants in pinpointing disease-causing genes
- Prenatal DNA diagnosis
- Amniocentesis
- Chorionic villus sampling
- Separating fetal cells in maternal blood for genetic diagnosis
- Antenatal screening for Down's syndrome
- Fetal DNA in maternal blood
- Molecular methods for prenatal diagnosis
- aCGH for prenatal diagnosis
- BAC HD Scan test
- FISH for prenatal diagnosis
- PCR for prenatal diagnosis
- Plasma DNA sequencing to detect fetal chromosomal aneuploidies
- In vivo gene expression analysis of the living human fetus
- Noninvasive prenatal diagnosis of monogenic diseases
- Digital relative mutation dosage
- Massively parallel plasma DNA sequencing
- Applications of prenatal diagnosis
- Diagnosis of congenital infections
- Diagnosis of congenital CMV
- Diagnosis of eclampsia
- Use of transrenal DNA for prenatal testing
- Preimplantation genetic diagnosis
- Technologies for preimplantation genetic diagnosis (PGD)
- PCR for preimplantation genetic diagnosis
- FISH for preimplantation genetic diagnosis
- Microarrays for preimplantation genetic diagnosis
- Conditions detected by preimplantation genetic diagnosis
- The future of preimplantation genetic diagnosis
- Companies involved in prenatal/preimplantation diagnosis
- Cystic fibrosis
- Detection of CFTR gene mutations
- CFTR technologies of various companies
- Genzyme's CF gene sequencing
- CF Plus™ Tag-It Cystic Fibrosis Kit
- Asuragen's bead array test
- The Ambry CF Test
- Biochip for CF diagnosis
- Identification of CF variants by PCR/Oligonucleotide Ligation Assay
- SensiGene (SEQUENOM) CF carrier screening test
- Serum proteomic signature for CF using antibody microarrays
- Guidelines for genetic screening for CF
- Congenital adrenal hyperplasia
- Primary immunodeficiencies
- Hematological disorders
- Hemoglobinopathies
- Sickle cell anemia
- Thalassemia
- Paroxysmal nocturnal hemoglobinuria
- Hemophilia
- Hereditary hemochromatosis
- Polycystic kidney disease
- Hereditary metabolic disorders
- Lesch-Nyhan Syndrome
- Gaucher's Disease
- Acute Intermittent Porphyria
- Phenylketonuria
- Hereditary periodic fever
- Achondroplasia
- Molecular diagnosis of cardiovascular disorders
- Coronary heart disease
- Genomics of coronary heart disease
- Cardiomyopathy
- Familial Hypertrophic Cardiomyopathy
- Idiopathic dilated cardiomyopathy
- Cardiac Arrhythmias
- Long Q-T Syndrome
- Familial atrial fibrillation
- Idiopathic ventricular fibrillation
- Congestive heart failure
- Hypertension
- Disturbances of blood lipids
- Familial dyslipoproteinemias
- Hypercholesterolemia
- Thrombotic disorders
- Factor V Leiden mutation
- Pulmonary embolism
- Hereditary thrombophilia
- Companies developing molecular diagnostics for cardiovascular disorders
- Molecular diagnosis of eye diseases
- Molecular diagnosis of retinitis pigmentosa
- Genetic screening for glaucoma
- Role of molecular diagnostics in rheumatoid arthritis
- Molecular diagnosis of neurogenetic disorders
- Alzheimer's disease
- Autism spectrum disorders
- CNVs associated with autism
- Charcot-Marie Tooth disease
- Down syndrome
- Duchenne and Becker muscular dystrophy
- eNOS gene polymorphisms as predictor of cerebral aneurysm rupture
- Fragile X syndrome
- Huntington disease
- Hereditary neuropathy with liability to pressure palsies
- Mitochondrial disorders affecting the nervous system
- Parkinson's disease
- Pompe's disease
- Spinal muscular atrophy
- Triple repeat disorders
- Genetic testing for disease predisposition
- Direct-to-consumer genetic tests
6. Molecular Diagnosis of Infections
- Introduction
- Molecular techniques for the diagnosis of infections
- Antibody-enhanced microplate hybridization assays
- Bacteriophage-based methods for detection of bacteria
- Biosensors for detection of microorganisms
- Ibis T5000"! Biosensor System
- DNA enzyme immunoassay
- DNA biochip/microarray in diagnosis of infections
- DNA-based typing methods
- Restriction fragment length polymorphism analysis
- Ribotyping
- Random amplified polymorphic DNA
- Combinatorial DNA melting assay
- Electrochemical detection of pathogens
- FISH for detection of infections
- Helicase-dependent isothermal amplification for rapid detection of
pathogens
- High resolution melt analysis for diagnosis of infections
- Ligase chain reaction
- Mass spectrometry for microbial identification
- Metagenomic pyrosequencing
- Multiplex PCR for detection of infections
- Dual priming oligonucleotide for multiplex PCR
- LightCyclerR SeptiFast Test
- Multiplex amplified nominal tandem repeat analysis
- VYOOR Sepsis Test
- NASBA for detection of microorganisms
- Nucleic acid probes
- Neutrophil CD11b expression as a diagnostic marker
- Optical Mapping
- PNA-FISH for diagnosis of infections
- QuantiFERONR technology for pre-molecular diagnosis of infections
- Quantitative reverse-transcription PCR for bacterial diagnostics
- Rupture event scanning
- Real-time single-molecule imaging of virus particles
- Single-strand conformational polymorphism
- SmartGene platform for identifying pathogens based on genetic sequences
- Tessera array technology
- Unyvero Solution
- Applications, advantages and limitations of molecular diagnostics
- Molecular diagnostics versus other microbial detection technologies
- Advantages of nucleic acid-based diagnostics in infections
- Drawbacks of nucleic acid-based diagnostics in infections
- Nanotechnology for detection of infectious agents
- Bacterial and fungal infections
- Mycobacterium tuberculosis
- Conventional diagnosis of tuberculosis
- Microscopic Observation Drug Susceptible Assay for tuberculosis
- Molecular diagnostics for tuberculosis
- Combined tuberculin testing and ELISpotPLUS assay
- Biomarkers for tuberculosis
- Diagnosis of drug-resistant M. tuberculosis infection
- Xpert MTB/RIF automated molecular test for MTB
- Diagnosis of other mycobacteria
- Chlamydial infections
- Neisseria gonorrhoeae
- Bacteria associated with bacterial vaginosis
- Streptococcal infections
- Group B Streptococci
- Streptococcus pyogenes and Streptococcus dysgalactiae
- Pseudomonas aeruginosa
- Helicobacter pylori
- Lyme disease
- Mycoplasmas
- Fungal infections
- Aspergillus
- Candida species
- Viral infections
- HIV/AIDS
- Diagnosis of HIV
- Detection of HIV provirus
- Global Surveillance of HIV-1 genetic variations
- Genotyping for drug-resistance in HIV
- Neonatal screening of infants of HIV-positive mothers
- Phenotyping as predictor of drug susceptibility/resistance in HIV
- Point-of-care testing for HIV
- Resolution of indeterminate Western blot
- Screening of cadaveric tissue donors
- Tests used for quantification of HIV
- Conclusions about HIV diagnostics
- Hepatitis viruses
- Hepatitis A virus
- Hepatitis B virus
- Hepatitis C virus
- Detection and quantification of HCV RNA
- Quantification of HCV RNA levels as a guide to antiviral therapy
- Electrochemical DNA chip for diagnosis of HCV
- HCV Genotyping as a guide to therapy
- Enteroviruses
- Adenoviruses
- Rhinoviruses
- Herpes viruses
- Herpes simplex virus
- Genital and neonatal herpes simplex
- Human cytomegalovirus infections
- Epstein-Barr virus
- Human papilloma virus
- Molecular diagnostics for HPV
- Detection of encephalitis viruses
- West Nile and St. Louis encephalitis
- Venezuelan equine encephalitis virus
- Detection of noroviruses
- Protozoal infections
- Amebiasis
- Cryptosporidium parvum
- Leishmaniasis
- Malaria
- Neurocysticercosis
- Pneumocystis carinii
- Toxoplasmosis
- Infections of various systems
- CNS infections
- Molecular diagnosis in bacterial meningitis
- Molecular diagnosis in herpes simplex encephalitis
- Diagnosis of transmissible spongiform encephalopathies
- Molecular diagnosis of respiratory viruses
- SARS-associated coronavirus
- Influenza viruses
- Avian influenza
- H1N1 influenza
- Gastrointestinal infections
- Periodontal infections
- Diagnosis of urinary infections by a biosensor
- Role of molecular diagnostics in septicemia
- Limitations and needs of diagnostics for infections
- Differentiation between live and antibiotic-killed bacteria
- Cell-based methods for identifying pathogenic microorganisms
- Cell-based virus assays
- Cell-based detection of host response to infection
- Role of molecular diagnostics in hospital acquired infections
- Detection of hospital-acquired bacterial infections
- Detection of methicillin-resistant S. aureus
- Detection of vancomycin-resistant enterococci
- Detection of hospital-acquired C. difficile
- Bacterial genome sequencing in antimicrobial resistance
- Detection of hospital-acquired viral infections
- Molecular diagnosis of BK virus
- Diagnosis of hospital-acquired rotavirus gastroenteritis
- Molecular diagnostics and the microbiome
- Human Microbiome Project
- Application of metagenomics to study of the microbiome
- MicroBiome Analysis Center
- Concluding remarks and future prospects of diagnosis of infections
- Rapid point-of-care diagnosis of infection
- Diagnosis of viruses using protein fingerprinting
- QIAplex PCR multiplex technology
- Companies involved in molecular diagnosis of infectious diseases
7. Molecular Diagnosis of Cancer
- Introduction
- Cancer genomics
- Cancer genes
- Oncogenes
- Tumor Suppressor Genes
- p53
- p16
- CNVs in cancer
- Allele-specific copy number analysis of tumors
- Viruses and cancer
- Detecting viral agents in cancer
- Conventional cancer diagnosis
- Molecular techniques for cancer diagnosis
- Genome analysis at the molecular level
- Mutation detection at molecular level
- Expression profiling of tumor cells sorted by flow cytometry
- MicroRNA expression profiling for cancer diagnostics
- Biomarkers in cancer
- Circulating nucleosomes in serum of cancer patients
- Detection of DNA methylation
- eTag assay system for cancer biomarkers
- HAAH as a biomarker for cancer
- LigAmp for detection of gene mutations in cancer
- Mitochondrial DNA as a cancer biomarker
- Oncoproteins as biomarkers for cancer
- Sequencing-based approaches for detection of cancer biomarkers
- Molecular fingerprinting of cancer
- Fluorescent in situ hybridization
- Genetic analysis of cancer
- Comparative genomic hybridization in cancer diagnostics
- Loss of heterozygosity
- Digital karyotyping
- Gene expression profiles predict chromosomal instability in tumors
- PCR Techniques
- Realtime quantitative PCR for diagnosis of cancer
- Cold-PCR
- Antibody-based diagnosis of cancer
- Monoclonal antibodies for diagnosis of cancer
- Recombinant antibodies as a novel approach to cancer diagnosis
- Combined immunological and nucleic acid tests
- Combination of MAbs and RT-PCR
- Immunobead RT-PCR
- Assays for determining susceptibility to cancer
- Gene expression profiling in cancer
- Microarrays for gene expression profiling in cancer
- Serial analysis of gene expression (SAGE)
- DNA tags for finding genes expressed in cancer
- Suppression subtractive hybridization
- Measurement of telomerase activity
- Detection of circulating tumor cells in blood
- Biochips/microfluidics for detection of CTCs
- CellSearch
- CellTracksR AutoPrepR System
- CTCscope system for detection of CTCs
- CTChip"!
- Fiber-optic array scanning technology
- Lab-on-chip for the isolation and detection of CTCs
- MagSweeper
- Future prospects of detection of cancer cells in blood
- Epithelial aggregate separation and isolation
- Proteomic technologies for the molecular diagnosis of cancer
- Proteomic technologies for tumor biomarkers
- Affibodies as contrast agents for imaging in cancer
- Aptamer-based technology for protein signatures of cancer cells
- Aptamer probes for in vivo diagnosis of cancer
- Aptamers for combined diagnosis and therapeutics of cancer
- Automated image analysis of nuclear protein distribution
- Laser capture microdissection in oncology
- Layered expression scanning
- Membrane-type serine protease-1
- Survivin and molecular diagnosis of cancer
- Biochip/microarrays for cancer diagnosis
- Role of DNA microarrays in gene expression profiling
- Biochip detection of FHIT gene
- Nanobiotechnology for early detection of cancer
- Detection of nanoparticle self assembly in tumors by MRI
- Differentiation between normal and cancer cells by nanosensors
- Magnetic nanoparticle probes
- Quantum dots for early detection of cancer
- Molecular imaging of cancer
- In vivo tumor illumination by adenoviral-GFP
- PET for in vivo molecular diagnosis of cancer
- Radiolabeled peptide-based targeting probes for cancer imaging
- Xenon-enhanced MRI
- Optical systems for in vivo molecular imaging of cancer
- Detection of micrometastases
- Molecular diagnosis of cancers of various organs
- Brain tumors
- Molecular diagnostic methods for brain tumors
- Glioblastoma multiforme
- Circulating microvesicles as biomarkers of glioblastoma
- Combination of neuroimaging and DNA microarray analysis in GBM
- Medulloblastoma
- Multigene predictor of outcome in GBM
- Oligodendroglioma
- Advantages and limitations of molecular diagnosis of brain tumors
- Breast cancer
- Breast cancer genes
- Circulating nucleic acid biomarkers of breast cancer
- Molecular diagnostic tests for breast cancer
- Mouse ESC-based assays to evaluate mutations in BRCA2
- Genomic profiles of breast cancer
- Role of molecular diagnostics in management of breast cancer
- Tests for prognosis of breast cancer
- Prediction of recurrence in breast cancer for personalizing therapy
- Cervical cancer
- Colorectal cancer
- ColoVantage CRC test
- Detection of familial adenomatous polyposis coli
- Detection of CRC at precancerous state
- Detection of circulating tumor cells in colorectal cancer
- Diagnosis of hereditary nonpolyposis colorectal cancer
- Diagnosis of colorectal cancer from DNA in stools
- Early diagnosis of colorectal cancer from blood samples
- Guanylyl cyclase C tests for colorectal cancer
- Minimally invasive screening for colorectal cancer
- Gastric cancer
- Head and neck cancer
- Nanobiochip sensor technique for analysis of oral cancer biomarkers
- ProteinChip for diagnosis of head and neck cancer
- Hematological malignancies
- Chromosome translocations
- Flow cytometry in diagnosis of leukemia
- Gene chip technology
- Hairy-cell leukemia
- Laboratory assessment of leukemia
- Molecular probes
- Minimal residual disease
- Screening of gene mutations in chronic myeloproliferative diseases
- Lung cancer
- Melanoma
- Ovarian cancer
- Mutation of genes
- Relevance of genetic testing to management of ovarian cancer
- Serum biomarkers for early detection of ovarian cancer
- Biomarkers of ovarian cancer
- Concluding remarks on testing for ovarian cancer
- Pancreatic cancer
- Prostate cancer
- Early detection of prostate cancer recurrence by nanotechnology
- Gene expression analysis of prostate cancer
- Huntingtin Interacting Protein 1
- Integrative genomic and proteomic profiling of prostate cancer
- LCM for diagnosis of prostate cancer
- PCA3 gene detection in urine
- PCR assay for assessing silencing of protein cadherin 13 gene
- Prostate biopsy for detection of prostatic intraepithelial neoplasia
- Screening of multiple SNPs for risk of prostate cancer
- Semen testing for prostate cancer biomarkers
- Serum-protein fingerprinting in prostate cancer
- Thyroid cancer
- Gene expression biomarkers of thyroid cancer
- Multiple endocrine neoplasia type 2B as risk factor for thyroid cancer
- miRNA expression profiling in thyroid cancer
- Urinary bladder cancer
- Role of molecular diagnostics in the management of cancer
- Risk assessment and prevention of cancer
- Role of molecular diagnosis in the design of future cancer therapies
- Molecular classification of cancer
- Determination of cancer prognosis
- Prognosis by tumor classification
- Prognosis by cancer gene expression
- Selection of anticancer drugs based on molecular diagnosis
- Integrated genome-wide analysis of cancer for diagnosis and therapy
- Personalized therapy for cancer patients
- Pharmacogenetics and cancer therapy
- Molecular diagnostics as an aid to selection of cancer therapy
- Drug resistance in cancer
- Role of organizatons in molecular diagnosis of cancer
- Role of NCI in molecular diagnosis of cancer
- Molecular profiling of cancer
- Cancer Genome Atlas
- Cancer Genetic Markers of Susceptibility Project
- Support for future research in molecular diagnosis of cancer
- Role of the International Cancer Genome Consortium
- Future prospects of molecular diagnosis of cancer
- Companies involved in molecular diagnosis of cancer
8. Molecular Diagnostics in Biopharmaceutical Industry & Healthcare
- Introduction
- Molecular diagnostics in biopharmaceutical industry
- Molecular diagnostic technologies and drug discovery
- Molecular diagnostics and pharmacogenetics
- Molecular toxicology
- Gene expression studies for toxicology
- Toxicogenomics
- Toxicoproteomics
- Mitochondrial assays
- MetaChip/Datachip
- Molecular diagnostics and pharmacogenomics
- Molecular diagnostics and therapeutic drug monitoring
- Applications molecular diagnostics in gene therapy
- Use of PCR to study biodistribution of gene therapy vectors
- PCR for verification of the transcription of DNA
- In situ PCR for direct quantification of gene transfer into cells
- Detection of retroviruses by reverse transcriptase (RT)-PCR
- Assessment of safety issues of gene transfer
- Quantitative PCR for monitoring the effectiveness of gene therapy
- Use of FISH for analysis of adeno-associated viral vector integration
- Monitoring of gene expression by green fluorescent protein
- Quality control of protein therapeutics and vaccines
- Detection of microbial contamination in biopharmaceutical manufacturing
- Role of PCR in detecting contamination
- Systems for rapid detection of contaminants
- Contamination of biopharmaceuticals with prions
- DNA tagging for control and tracing of drug distribution channels
- Molecular diagnostics for organ transplantation
- HLA typing
- Sequencing for HLA typing
- Commercial products for transplant molecular diagnostics
- Post-cardiac transplant patient monitoring for rejection
- Application of molecular diagnostics in blood transfusion
- Molecular diagnostics for testing transfusion compatibility
- Transmission of infections in blood transfusion
- Molecular tests for screening of blood supply for viruses
- Commercial molecular diagnostic technologies for blood screening
- Bridge amplification technology
- COBAS AmpliScreen HCV and HIV Assays
- INACTINE
- NucliSens Extractor system
- Pall's enhanced Bacteria Detection System
- PCR combined with algorithm method
- Prions detection in human blood
- PRISMR automated system
- Procleix HIV-1/HCV Assay
- West Nile virus detection in human blood
- Advantages and limitations of molecular diagnostics for blood screening
- Molecular epidemiology
- Molecular epidemiology of genetic diseases
- Role of CNVs in study of genetic epidemiology
- Monogenic versus polygenic disorders
- Critical issues facing genetic epidemiology
- Molecular epidemiology of infectious diseases
- Methods and purposes
- Emerging infections
- Human vs. non-human infections
- Genetics and susceptibility to infectious disease
- Molecular epidemiology of cancer
- Molecular epidemiology of p53 gene mutations
- Molecular epidemiology of link between virus and cancer
- Molecular epidemiology and cancer prevention
- SNPs and molecular epidemiology
- Molecular diagnostics for identification of food-borne pathogens
- Introduction
- Molecular diagnostic methods used in food-borne infections
- Limitations of use of molecular probes in food analysis
- Detection of Listeria-contaminated foods
- Optical biosensor for detection of Listeria
- Real-time PCR for detection of Listeria
- Detection of Salmonella
- MicroSEQR Salmonella Detection Kit
- E. Coli detection
- MicroSEQR E. Coli Detection Kit
- DuPont Bax system
- Detection of rare strains of E. Coli
- Companies with technologies for food pathogen detection
- Transmissible spongiform encephalopathies (TSEs)
- Basis of molecular diagnosis of prion diseases
- Molecular diagnosis of TSEs
- Companies involved in developing molecular diagnostics for TSEs
- Detection of genetically modified organisms in food
- Molecular diagnostics for detection of doping in sports
- Screening of synthetic glucocorticosteroids in human urine
- Detection of gene doping
- Role of molecular diagnostics in future healthcare
- Translation of genomic research into genetic testing for healthcare
- Molecular diagnostics and disease management
- Role of genetic biomarkers in disease management
- Role of molecular diagnostics in personalized medicine
- Integrated healthcare
- Screening
- Early diagnosis
- Prevention
- Therapy based on molecular diagnosis
- Monitoring of therapy
- Advantages and limitations of integrated healthcare
- Commercially available systems for integrated healthcare
- Combination of diagnostics and therapeutics
- Companion diagnostics
- Companies involved in companion diagnostics
- Point-of-care diagnosis
- Technologies for point-of-care diagnosis
- Biochips for POC diagnosis
- Advantages versus disadvantages of POC diagnosis
- Future prospects of POC testing
- Companies developing POC diagnosis
- The impact of molecular diagnostics on clinical laboratory practice
9. Molecular Diagnostics in Forensic Medicine and Biological Warfare
- Application of molecular diagnostics in forensic medicine
- Technologies
- Extraction of DNA from forensic samples
- Mitochondrial DNA (mtDNA) analysis
- Polymorphic Alu insertions
- Single Nucleotide Polymorphisms (SNP) analysis
- Short tandem repeat (STR)
- Fluorescent detection systems
- ABO genotyping
- DNA analysis for identification of ancient or historical specimens
- Applications
- Applications in criminology
- Identification of remains of military personnel
- Identification of remains of victims of mass disasters
- Parentage testing
- Gender determination
- Companies developing molecular diagnostics for forensic science
- Molecular detection of biological warfare agents
- Introduction to biological warfare agents
- Role of PCR in the diagnosis of biological warfare agents
- Multiplex PCR microarray assay to detect bioterror pathogens in blood
- Laboratory diagnosis of Anthrax
- Challenges in diagnosis of biological warfare agents
- US government efforts for detection of biological warfare agents
- The US Army Medical Research Institute of Infectious Diseases
- Homeland Security Advance Research Projects Agency
- Handheld Isothermal Silver Standard Sensor
- Commercial development of diagnostic devices for biological agents
- Companies developing diagnostic devices for biological agents
- Biodefence microarray
- Identification of genetic markers of individual pathogens
- Microbial Identification System based on OptiChip"!
- Hand-Held Advanced Nucleic Acid Analyzer
- Nanogen's portable detection device
- Nanode Array Sensor Microchips
- MicroChemLab
- BioThreat Alert Test Strip
- Benchtop living cell biosensor
- BioForce NanoArray sensor technology
- QTL handheld biosensor
- Analyte 2000 biosensor
- Airborne bacterial spore detection technology
- Destruction and detection of anthrax by lysin
- Biosensor based on mass spectrometry of microorganisms's RNA
- Bead ARray Counter
- ProteinChip-based detection of bioterroism agents
- TIGER biosensor
- The PathAlert™ Detection System
- VereThreat"!
- Concluding remarks about biodefense applications of diagnostics
10. References
Tables
- Table 1 1: Landmarks in development of molecular technology and its
application to diagnosis
- Table 1 2: Applications of molecular diagnostics
- Table 2 1: Companies with products for nucleic acid isolation
- Table 2 2: Some commercially available real-time PCR systems
- Table 2 3: Applications of real-time PCR
- Table 2 4: A selection of companies with commercially available FISH
diagnostics
- Table 2 5: Selected companies with RNA diagnostic tests
- Table 2 6: Companies involved in whole genome amplification
- Table 2 7: Companies involved in sequencing
- Table 2 8: Companies involved in application of sequencing in molecular
diagnostics
- Table 2 9: Comparison of methods of identification of unknown DNA sequences
- Table 2 10: Classification of methods of gene expression analysis
- Table 2 11: A selection of companies with gene expression technologies
- Table 2 12: Companies involved in developing PNA diagnostics
- Table 2 13: Companies with bead-based diagnostic assay platforms
- Table 2 14: Companies developing nucleic acid lateral flow molecular
diagnostics
- Table 3 1: Applications of biochip technology in relation to molecular
diagnostics
- Table 3 2: Companies developing whole genome chips/microarrays
- Table 3 3: Companies involved in biochips for molecular diagnostics
- Table 3 4: Companies developing microfluidic technologies
- Table 3 5: Biosensor technologies with potential applications in molecular
diagnostics
- Table 3 6: Important applications of biosensors
- Table 3 7: Companies involved in application of biosensors in molecular
diagnostics
- Table 3 8: Selected labels for nucleic acid detection
- Table 3 9: Selected companies with fluorescence and chemiluminescence
products
- Table 3 10: Companies involved in molecular beacon manufacture and research
- Table 3 11: Selected companies involved in molecular imaging
- Table 3 12: Nanotechnologies with potential applications in molecular
diagnostics
- Table 3 13: Companies developing nanomolecular diagnostics
- Table 4 1: Applications of protein biochips/microarrays
- Table 4 2: Companies involved in developing diagnostic applications of
protein biochips
- Table 4 3: Disease-specific proteins in the cerebrospinal fluid of patients
- Table 5 1: Mutation detection technologies
- Table 5 2: Technologies for SNP analysis
- Table 5 3: A sampling of companies involved in technologies for SNP
genotyping
- Table 5 4: Application of preimplantation genetic diagnosis in monogenic
disorders
- Table 5 5: Companies involved in prenatal/preimplantation diagnostics
- Table 5 6: CFTR genotyping in cystic fibrosis - companies and technologies
- Table 5 7: X-linked immunodeficiency disorders
- Table 5 8: Genes that cause cardiovascular diseases
- Table 5 9: A selection of companies developing molecular diagnostics for
cardiovascular diseases
- Table 5 10: Available molecular diagnostics for neurogenetic diseases
- Table 5 11: Companies offering genetic screening tests directly to
consumers
- Table 6 1: Molecular techniques for the diagnosis of infections
- Table 6 2: Bacteria and fungi that can be detected by molecular diagnostic
tests
- Table 6 3: Viruses that can be detected by recombinant DNA methods
- Table 6 4: Companies with molecular diagnostics for avian influenza virus
H5N1
- Table 6 5: Companies with molecular diagnostics for influenza virus H1N1
- Table 6 6: Companies developing POC tests for the diagnosis of infections
- Table 6 7: Selected companies involved in molecular diagnosis of infections
- Table 7 1: Estimated new cases of cancer in the US of most involved organs
- 2010
- Table 7 2: Tumor suppressor genes, their chromosomal location, function,
and associated tumors
- Table 7 3: Viruses linked to human cancer
- Table 7 4: A classification of molecular diagnostic methods in cancer
- Table 7 5: Desirable characteristics of biomarkers for cancer
- Table 7 6: Approved monoclonal antibodies for cancer diagnosis
- Table 7 7: Methods for comparison of gene-expression profilling in tumor
specimens
- Table 7 8: Impact of in vivo molecular imaging of cancer on oncology
practice
- Table 7 9: Molecular diagnostic tests for breast cancer
- Table 7 10: Companies developing cancer molecular diagnostics
- Table 8 1: Applications of molecular diagnostics in the biopharmaceutical
industry
- Table 8 2: Molecular diagnostic technologies for drug discovery
- Table 8 3: Molecular diagnostic technologies used for pharmacogenetic
studies
- Table 8 4: Companies with novel molecular toxicology technologies
- Table 8 5: Applications of molecular diagnostics in gene therapy
- Table 8 6: Companies involved in transplant molecular diagnostics
- Table 8 7: Companies involved in molecular diagnostics of blood
transfusions
- Table 8 8: Pathogenic bacteria in food and targets for molecular
diagnostic probes
- Table 8 9: Companies involved in molecular diagnostics for food-borne
infections
- Table 8 10: Testing for harmful prions in brain tissue from dead cattle
- Table 8 11: Companies involved in developing molecular diagnostics for TSEs
- Table 8 12: Companies involved in companion diagnostics
- Table 8 13: Applications of point-of-care diagnosis
- Table 8 14: Companies developing point-of-care diagnostic tests
- Table 9 1: Forensic and legal applications of molecular diagnostics.
- Table 9 2: Molecular technologies used for forensic applications
- Table 9 3: Classification of biological and chemical agents used as
weapons of mass destruction
- Table 9 4: Biological warfare agents that can be identified by PCR methods
- Table 9 5: Companies developing detection devices for biological warfare
agents
Figures
- Figure 1 1: Relation of molecular diagnostics to other technologies
- Figure 2 1: Rolling circle amplification technology
- Figure 2 2: A schematic view of the Invader operating system
- Figure 2 3: Principle of fluorescent in situ hybridization
- Figure 2 4: Repli-G system of QIAGEN
- Figure 2 5: DNA sequencing process
- Figure 2 6: Electrochemical detection of DNA
- Figure 2 7: Elements of a Scorpions primer
- Figure 3 1: Affymetrix GeneChip technology
- Figure 3 2: Basic principle of a biosensor
- Figure 3 3: Surface plasmon resonance (SPR) technology
- Figure 6 1: Use of DNA chips in diagnosing microbial infections
- Figure 6 2: High throughput DNA pyrosequencing for pathogen discovery
Part II
11. Ethics, Patents and Regulatory issues
- Introduction
- Ethical concerns about genetic diagnosis
- Ethical guidelines for molecular diagnostics
- Ethical aspects of direct-to-consumer genetic services
- US public attitudes about genetic testing
- Opinion of European geneticists about DTC genetic testing
- Genetic testing for susceptibility to adult-onset cancer
- Ethics of preimplantation genetic diagnosis
- Preimplantation genetic diagnosis to screen for hereditary diseases
- PGD to test for susceptibiliy to cancer
- PGD and stem cells
- Genetic research on stored tissues
- Informed consent in clinical trials of in vitro devices
- Concluding remarks about ethical issues
- Insurance underwriting and gene tests
- Should genetic information be available to health insurers?
- A need for the re-examination of current views
- Genetic Information Nondiscrimination Act of US
- Impact of the US health care reform bill on genetic testing issues
- Patents for molecular diagnostics
- PCR patents
- Patenting DNA sequences
- US policy on gene patenting relevant to molecular diagnostics
- The impact of disease gene patents on molecular diagnostics
- Licensing problems associated with genetic testing
- BRCA1 and BRCA2 gene patents
- Role of the WHO in genetic testing standards
- NIH's Genetic Testing Registry
- Regulatory issues in the US
- Assay Migration Studies for In Vitro Diagnostic Devices
- Assessment of diagnostic accuracy
- Sensitivity and specificity
- Documentation of diagnostic accuracy
- Discovery of incidental findings on genetic screening
- Evaluation of companion diagnostics/therapeutic for cancer
- FDA regulation of multivariate index assays
- FDA guidance for IVDs to detect pathogens
- FDA guidelines for devices to detect and differentiate HPV
- FDA's Microarray Quality Control
- FDA and point-of-care diagnosis
- Genetic testing of rare disorders
- Quality control of molecular diagnostic laboratory procedures
- Quality assurance of rna expression profiling
- Quality control of point-of-care tests
- Regulation of IVD by the FDA
- Regulation of in vitro companion diagnostics by the FDA
- Regulation of in vivo diagnostics by the FDA
- Regulation of laboratory developed tests
- Home-brew tests
- Laboratory-developed tests used by Medicare recipients
- Oversight of LDTs by the FDA
- Regulatory aspects of FISH
- Regulation of genetic testing
- Role of the FDA in genetic testing
- Regulation of direct-to-consumer genetic testing
- Need for regulatory oversight of DTC
- Regulatory issues concerning blood and plasma products
- United States Diagnostics Standards
- Regulation of in vitro diagnostics in the EU
- EU regulations for testing of blood products
- Regulation of genetic testing in EU
- Evaluation of diagnostic laboratory tests in the UK
- Pre-implantation genetic diagnosis in the UK
12. Markets for Molecular Diagnostics
- Introduction
- Methods for study of molecular diagnostic markets
- The overall market for diagnostic technologies
- Molecular diagnostic markets according to technologies
- Marketing strategies according to technologies
- Nucleic acid isolation market
- Market for PCR-based tests
- Markets for PCR instrumentation
- Markets for real-time PCR and qRT-PCR
- PCR market players
- DNA sequencing market
- Cytogenetic market
- Market for FISH technologies
- Biochip/microarray market
- Biosensor market
- Nanobiotechnology for molecular diagnostics
- Markets for gene expression technologies
- Reagents and other disposable laboratory materials
- Market for immunochemistry diagnostic
- Markets for tissue diagnostics
- Molecular diagnostic markets according to therapeutic areas
- Genetic disorders
- Prenatal testing
- Cancer
- Potential markets for cancer diagnosis according to type of cancer
- Infectious diseases
- Sexually transmitted diseases
- Hospital-acquired infections
- Testing for HIV drug resistance
- Potential markets for avian influenza diagnostics
- Cardiovascular diseases
- Neurological disorders
- Food testing
- Screening of blood for transfusion
- Tissue typing for transplantation
- Molecular diagnostic markets relevant to pharmaceutical industry
- Molecular diagnosis and personalized medicine markets
- Growth of markets relevant to personalized medicine
- Marketing opportunities according to geographic areas
- Unmet needs in molecular diagnostics
- Major market trends
- Markets according to home-brew and FDA-approved tests
- Decentralization of molecular diagnostics
- Point-of-care testing
- Development of personalized medicine
- Cost of sequencing the human genome
- Cost of genotyping
- Marketing companion diagnostics for personalized medicine
- Development of low-cost tests
- Simplification of test procedures
- Increasing role of proteomics in clinical diagnostics
- Forensic and legal applications
- Marketing strategies
- Role of alliances in commercialization of molecular diagnostics
- Acquisitions vs collaborations
- Analysis of collaborations in molecular diagnostics
- Licensing of the technologies
- Strategies related to laboratory facilities and technologies
- Strategies relevant to the healthcare system
- Cost-Benefit studies
- Genetic susceptibility testing
- Preventive medicine strategies
- Targeting treatable and common diseases
- Information/education
- Physician education
- Patient education
- European diagnostic information platform
- Regulatory strategies
- Merger of in vitro and in vivo diagnostics
- Integration of diagnostics with therapeutics
- Diagnostic applications in clinical trials
- Prospects for development of new technologies
- Drivers for the development of molecular diagnostics
- Factors slowing the development of molecular diagnostics
- Government support of research relevant to molecular diagnostics
- Cost of sequencing the human genome
- European projects for improving molecular diagnostics
- European Consortium for developing new DNA analysis tools
- EU project for improvement of IVD tools procedures
- Genetic knowledge parks in the UK
- Molecular diagnostic opportunities in defense against bioterrorism
- Molecular diagnostics for food safety
- POC diagnostics for the developing countries
13. Companies involved in molecular diagnostics
- Introduction
- Major players in molecular diagnostics
- Profiles of selected companies
- Collaborations
Tables
- Table 12 1: Share of in vitro diagnostics in the global diagnostic market
2011-2021
- Table 12 2: Molecular diagnostics markets according to technologies from
2011-2021
- Table 12 3: PCR market 2011-2021
- Table 12 4: Molecular diagnostics markets according to applications
2011-2021
- Table 12 5: Markets in 2011 for tests to screen healthy persons for
genetic disorders
- Table 12 6: Markets in 2011 for molecular diagnostic tests for cancer
- Table 12 7: Molecular diagnostic markets for selected cancers 2011-2021
- Table 12 8: Markets value in 2011 for molecular diagnostic screening for
infections
- Table 12 9: Future markets for molecular diagnosis of infections 2012-2016
- Table 12 10: Future markets for HAI diagnostics 2012-2016
- Table 12 11: Growth of markets relevant to personalized medicine 2011-2021
- Table 12 12: Molecular diagnostic markets according to geographical areas
2011-2021
- Table 12 13: Molecular diagnostic markets according to home-brew and
approved tests
- Table 12 14: Marketing strategies for molecular diagnostics
- Table 12 15: Acquisitions of molecular diagnostic companies
- Table 12 16: Advantages of the integration of diagnostics with therapeutics
- Table 13 1: Top ten players in molecular diagnostics
- Table 13 2: Collaborations of companies in molecular diagnostics
Figures
- Figure 12 1: Unmet needs in applications of molecular diagnostics
- Figure 12 2: Proportion of various areas in molecular diagnostic
collaborations
