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Reportlinker Adds Molecular Diagnostics - Technologies, Markets and Companies

NEW YORK, Dec. 21, 2010 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

Molecular Diagnostics - Technologies, Markets and Companies

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 291 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 90 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.

SummaryThis 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 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 291 of these are profiled in the report along with tabulation of 650 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 2009 according to technologies, applications and geographical regions. Forecasts are made up to 2018. 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

0. Executive Summary 23

1. Introduction 25

Definitions and scope of the subject 25

Historical evolution of molecular diagnostics 25

Molecular biology relevant to molecular diagnostics 26

DNA 26

DNA polymerases 26

Restriction endonucleases 27

DNA methylation 27

RNA 28

RNA polymerases 28

Non-coding RNAs 28

DNA transcription 29

Chromosomes 29

Telomeres 30

Mitochondrial DNA 30

Genes 31

The genetic code 31

Gene expression 31

The human genome 32

Variations in the human genome 32

Variations in DNA sequences 32

Single nucleotide polymorphisms 33

Copy number variations in the human genome 33

Genotype and haplotypes 34

Insertions and deletions in the human genome 35

Complex chromosomal rearrangements 36

Large scale variation in human genome 36

Structural variations in the human genome 36

Replication of the DNA helix 37

Transposons 37

Proteins 37

Proteomics 38

Monoclonal antibodies 38

Aptamers 38

Basics of molecular diagnostics 39

Tracking DNA: the Southern blot 39

Pulsed-field gel electrophoresis 39

DNA Probes 40

The polymerase chain reaction 40

Basic Principles of PCR 40

Target selection 41

Detection of amplified DNA 41

Impact of human genome project on molecular diagnostics 41

Mapping and sequencing of structural variation from human genomes 42

1000 Genomes Project 42

Human Variome Project 43

Role of bioinformatics in molecular diagnostics 44

Systems biology approach to molecular diagnostics 44

Biomarkers 45

Applications of molecular diagnostics 45

2. Molecular Diagnostic Technologies 47

Introduction 47

DNA sample collection and extraction 47

Blood samples 47

Buccal swabs and saliva 47

Urine samples for transrenal DNA 48

Manual vs automated DNA extraction 48

Sample preparation 49

Pressure Cycling Technology 49

Membrane immobilization of nucleic acids 49

Automation of sample preparation in molecular diagnostics 50

ABI PRISM 6700 Automated Nucleic Acid Workstation 50

BioRobot technology 50

COBAS AmpliPrep System 50

GENESIS FE500 Workcell 50

GeneMole 51

PCR BioCube 51

QIAsymphony 51

Tigris instrument system 51

Techniques for sample preparation that are suitable for automation 52

Xtra Amp Genomic DNA Extraction 52

Extraction of DNA from paraffin sections 52

Dynabead technology 52

Pressure Cycling Technology 52

SamPrep 53

Use of magnetic particles for automation in genome analysis 53

Companies involved in nucleic acid isolation 54

Novel PCR methods 55

Addressing limitations of PCR 55


Combined PCR-ELISA 55

Digital PCR 56

Emulsion PCR 56

ExCyto PCR 57

Long and accurate PCR 57

Real-time PCR systems 57

Dyes used in real-time PCR 58

Commercially available real-time PCR systems 59

LightCycler PCR system 59

LightUp probes based on real-time PCR 60

READ™ real-time PCR method 60

ViiA™ 7 real-time PCR system 60

Applications of real-time PCR 60

Limitations of real-time PCR 61

Improving the reliability of low level DNA analysis by real-time PCR 61

Guidelines for real-time quantitative PCR 62

Future applications of real-time Q-PCR 62

Reverse transcriptase (RT)-PCR 62

Standardized reverse transcriptase PCR 63

Single cell PCR 64



AmpliGrid-System 65

Post-PCR genotyping methods 65

High-resolution melt analysis 66

Monitoring of gene amplification in molecular diagnostics 66

Non-PCR nucleic acid amplification methods 66

Linked Linear Amplification 66

Multiplex Ligation-Dependent Probe Amplification 67

Transcription mediated amplification 67

Rapid analysis of gene expression 67

WAVE nucleic acid fragment analysis system 68

DNA probes with conjugated minor groove binder 68

Rolling circle amplification technology 69

Gene-based diagnostics through RCAT 70

RCAT-immunodiagnostics 70

RCAT-pharmacogenomics 71

Circle-to-circle amplification 71

Ramification amplification method 71

Single Primer Isothermal Amplification 72

Isothermal reaction for amplification of oligonucleotides 72

ICAN (Isothermal and Chimeric primer-initiated Amplification of Nucleic Acids) 72

Technologies for signal amplification 73

3 DNA dendrimer signal amplification 73

Hybridization signal amplification method 74

Signal mediated amplification of RNA technology 75

Invader assays 75

Hybrid Capture technology 77

Branched DNA test 77

Tyramide signal amplification 78

Non-enzymatic signal amplification technologies 78

Direct molecular analysis without amplification 79

Trilogy™ Platform 79

Direct detection of dsDNA 80

Multiplex assays 80

Fluorescent in situ hybridization 80

FISH technique 81

Applications of FISH 82

Modifications of FISH 82

Direct visual in situ hybridization 83

Direct labeled Satellite FISH probes 83

Comparative genomic hybridization 83

Primed in situ labeling 83

Interphase FISH 84

FISH with telomere-specific probes 84

Multicolor FISH 85

Automation of FISH 85

Companies involved in FISH diagnostics 85

RNA diagnostics 86

Branched-chain DNA assay for measurement of RNA 87

Cycling probe technology 87

Invader RNA assays 87

Linear RNA amplification 88

Non-isotopic RNase cleavage assay 88

Nucleic acid sequence-based amplification 88

Q Beta replicase system 90

RNAScope 90

Solid Phase Transcription Chain Reaction 91

Transcriptome analysis 91

Visualization of mRNA expression in vivo 91

MicroRNA diagnostics 92

Real-time PCR for expression profiling of miRNAs 92

Microarray vs quantitative PCR for measuring miRNAs 92

Use of LNA to explore miRNA 93

Nuclease Protection Assay to measure miRNA expression 93

Microarrays for analysis of miRNA gene expression 93

Modification of in situ hybridization for detection of miRNAs 94

Whole genome amplification 94

Companies that provide technologies for whole genome amplification 95

QIAGEN's Repli-G system 95

GenomePlexO Whole Genome Amplification 96

DNA sequencing 96

Companies involved in sequencing 97

Applications of next generation sequencing in molecular diagnostics 99

Genome-wide approach for chromatin mapping 100

Mitochondrial sequencing 100

Identification of unknown DNA sequences 100

Optical mapping 101

Gene expression analysis 101

Gene expression profiling on whole blood samples 102

Gene expression patterns of white blood cells 102

Gene expression profiling based on alternative RNA splicing 103

MAUI (MicroArray User Interface) hybridization 103

Monitoring in vivo gene expression by molecular imaging 103

Serial analysis of gene expression (SAGE) 104

Single-cell gene expression analysis 104

T cell receptor expression analysis 105

Tangerine™ expression profiling 105

Whole genome expression array 105

Ziplex™ system 106

Companies involved in gene expression analysis 106

Peptide nucleic acid technology 107

Use of PNA with fluorescence in situ hybridization 108

PNA and PCR 108

Use of PNA with biosensors 109

PNA-based PD-loop technology 109

PNA-DNA hybrid quadruplexes 110

Companies involved in PNA diagnostics 110

Locked nucleic acids 110

Zip Nucleic Acids 111

Electrochemical detection of DNA 112

Mediated nucleic acid oxidation 112

Detection of hybridized nucleic acid with cyclic voltametry 113

Electrochemical detection based on Toshiba's CMOS technology 113

Concluding remarks on electrochemical DNA detection 113

Bead-based assay platforms 113

Scorpions™ technology 114

The Scorpions reaction 114

Applications of Scorpions 115

3. Biochips, Biosensors, and Molecular Labels 117

Introduction to biochip technology 117

Applications of biochips in diagnostics 117

GeneChip 118

GeneChip Human Genome Arrays 119

AmpliChip CYP450 119

Electronic detection of nucleic acids on microarrays 119

Microchip capillary electrophoresis 120

Strand displacement amplification on a biochip 120

Rolling circle amplification on microarrays 120

LiquiChip-RCAT 120

Fast PCR biochip 121

Multiplex microarray-enhanced PCR for DNA analysis 121

Multiplexed Molecular Profiling 121

Universal DNA microarray combining PCR and ligase detection reaction 122

Genomewide association scans 122

Whole genome chips/microarrays 123

Transposon insertion site profiling chip 123

Standardizing the microarrays 124

Companies involved in developing biochip technology for diagnostics 124

Future of biochip technology for molecular diagnostics 125

Microfluidic chips 126

Fish-on-chip 126

Lab-on-a-chip 126

LabCD 127

Micronics' microfluidic technology 127

Microfluidic chips/arrays using PCR 127

Microfluidic automated DNA analysis using PCR 127

Digital PCR Array 127

Digital PCR on a SlipChip 128

Microfluidic chips integrated with RCAT 128

Microfluidic chips integrated with PET 128

Companies developing microfluidic technologies 129

Biosensor technologies 129

Classification of biosensor technologies 130

DNA-based biosensors 131

DNA hybridization biosensor chips 131

PCR-free DNA biosensor 131

DNA based biosensor to detects metallic ions 132

Genetically engineered B lymphocytes 132

Biosensors immunoassays 132

PNA (peptide nucleic acid)-based biosensors 133

Protein-based biosensors 133

Antibody biosensors 133

Cell-based biosensors (cytosensors) 133

Multicell biosensors 134

Microbial biosensors 134

Optical biosensors 135

Surface plasmon resonance technology 135

Label-free optical biosensor 136

Microsensors using with nano/microelectronic communications technology 136

Electrochemical sensors 136

Enzyme electrodes for biosensing 136

Conductometric sensors 137

Electrochemical genosensors 137

Electrochemical nanobiosensor 137

Bioelectronic sensors 138

Phototransistor biochip biosensor 138

Ribozyme-based sensors 138

RiboReporters 139

Concluding remarks and future prospects of biosensor technology 139

Companies developing biosensors for molecular diagnostics 140

Molecular labels and detection 141

Detection technologies for molecular labels 142

Fluorescence and chemiluminescence 142

Fluorescence technologies for label detection 143

Companies with fluorescence and chemiluminescence products 143

Molecular beacons 144

The Green fluorescent protein 145

Multiophoton detection radioimmunoassay 146

Multi-pixel photon counter 146

Enzyme labels and detection by fluorescence 146

Phase-sensitive flow cytometry 147

Microtransponder-based DNA diagnostics 147

Laboratory Multiple Analyte Profile 148

Multiple labels 148

Protein-DNA chimeras for detection of small numbers of molecules 149

Single molecule detection 149

Atomic force microscopy 150

Capillary electrophoresis 150

Confocal laser scanning 150

Spectrally resolved fluorescence lifetime imaging microscopy 150

Molecular imaging 151

Basic research in molecular imaging 151

Devices for molecular imaging 152

Molecular imaging in clinical practice 152

Challenges and future prospects of molecular imaging 152

Companies involved in molecular imaging 152

Nanobiotechnology for molecular diagnostics 153

Magnetic nanoparticles 154

Gold nanoparticles 154

Quantum dot technology 155

Nanotechnology on a chip 156

Nanogen's NanoChip 157

Fullerene photodetectors for chemiluminescence detection on microfluidic chip 157

Diagnostics based on nanopore technology 157

Nanosensors 157

Detection of cocaine molecules by nanoparticle-labeled aptasensors 158

Nanosensors for glucose monitoring 158

PEBBLE nanosensors 158

Quartz nanobalance biosensor 159

Cantilever arrays 159

Resonance Light Scattering technology 159

DNA nanomachines for molecular diagnostics 160

Nanobarcodes technology for molecular diagnostics 160

Qdot nanobarcode for multiplexed gene expression profiling 161

Role of nanobiotechnology in improving molecular diagnostics 161

Companies involved in nanomolecular diagnostics 162

Concluding remarks about nanodiagnostics 164

Future prospects of nanodiagnostics 165

4. Proteomic Technologies for Molecular Diagnostics 167

Introduction 167

Proteomic technologies 167

Biomarkers of disease 167

Proteomic tools for biomarkers 167

Search for biomarkers in body fluids 168

Captamers with proximity extension assay for proteins 168

Cyclical amplification of proteins 168

Detection of misfolded proteins by ELISA with exponential signal amplification 169

Diagnostics based on designed repeat proteins 169

Differential Peptide Display 169

Light-switching excimer probes 170


Molecular beacon aptamer 171

Molecular beacon assay 171

Proteomic patterns 172

Real-time PCR for protein quantification 172

Protein biochip technologies 173

ProteinChip 174

LabChip for protein analysis 174

TRINECTIN proteome chip 175

Protein chips for antigen-antibody interactions molecular diagnostics 175

Microfluidic devices for proteomics-based diagnostics 175

Nanotechnology-based protein biochips/microarrays 176

Nanoparticle protein chip 176

Protein nanobiochip 176

Protein biochips based on fluorescence planar wave guide technology 176

New developments in protein chips/microarrays 177

Antibody microarrays 177

Aptamer-based protein biochip 178

Multiplexed Protein Profiling on Microarrays 178

Proteomic pattern analysis 178

Single molecule array 179

Viral protein chip 179

Commercial development of protein chips for molecular diagnostics 179

Proteome Identification Kit 181

Laser capture microdissection (LCM) 181

LCM technology 181

Applications of LCM in molecular diagnostics 182

Proteomic diagnosis of CNS disorders 182

Cerebrospinal fluids tests based on proteomics 182

Urine tests for CNS disorders based on proteins in urine 183

Diagnosis of CNS disorders by examination of proteins in the blood 183

Diagnosis of CNS disorders by examination of proteins in tears 184

Role of proteomics in the diagnosis of Alzheimer's disease 184

Role of proteomics in the diagnosis of Creutzfeldt-Jakob disease 185

Future prospects of use of proteomics for diagnosis of CNS disorders 185

Concluding remarks on the use of proteomics in diagnostics 185

5. Molecular Diagnosis of Genetic Disorders 187

Introduction 187

Cytogenetics 188

FISH with probes to the telomeres 188

Single copy FISH probes 188

Comparative genomic hybridization 189

Use of biochips in genetic disorders 189

Representational oligonucleotide microarray analysis 190

SignatureChip®-based diagnostics for cytogenetic abnormalities 190

Diagnosis of genomic rearrangements by multiplex PCR 190

Quantitative fluorescent PCR 190

Mutation detection technologies 191

PCR-based methods for mutation detection 192

Cleavase Fragment Length Polymorphism 192

Direct dideoxy DNA sequencing 192

Digital Genetic Analysis (DGA) 192

Fluorescence-based directed termination PCR 193

Heteroduplex analysis 193

Restriction fragment length polymorphism 194

Single-stranded conformation polymorphism (SSCP) analysis 194

TaqMan real-time PCR 195

Non-PCR methods for mutation detection 195

Arrayed primer extension 195

BEAMing (beads, emulsion, amplification, and magnetics) 195

ELISA-protein truncation test 196

Enzymatic mutation detection 196

Specific anchor nucleotide incorporation 196

Conversion analysis for mutation detection 197

Biochip technologies for mutation detection 197

Combination of FISH and gene chips 197

Haplotype Specific Extraction 198

Technologies for SNP analysis 198

DNA sequencing 199

Electrochemical DNA probes 200

Use of NanoChip for detection of SNPs 200

Single base extension-tag array 200

Laboratory Multiple Analyte Profile 200

SNP genotyping with gold nanoparticle probes 201

PCR-CTPP (confronting two-pair primers) 201

Peptide nucleic acid probes for SNP detection 201

SNP genotyping on a genome-wide amplified DOP-PCR template 202

Pyrosequencing 202

Reversed enzyme activity DNA interrogation test 203

Smart amplification process version 2 203

Zinc finger proteins 204

UCAN method (Takara Biomedical) 204

Biochip and microarray-based detection of SNPs 204

SNP genotyping by MassARRAY 204

Electronic dot blot assay 204

Biochip combining BeadArray and ZipCode technologies 205

SNP-IT primer-extension technology 205

OmniScan SNP genotyping 206

Affymetrix SNP genotyping array 206

Concluding remarks on SNP genotyping 206

Limitations of SNP in genetic testing 206

Haplotyping versus SNP genotyping 207

Companies involved in developing technologies/products for SNP analysis 207

Role of copy number variations in genetic diagnostic testing 208

CNVs in various diseases 209

CNVs in genetic epilepsy syndromes 209

CNVs associated with schizophrenia 209

Methods for determination of CNVs 209

Digital array for CNV detection 210

Wellcome Trust Case Control Consortium CNV typing array 210

CNVer algorithm for CNV detection 210

Study of rare variants in pinpointing disease-causing genes 211

Prenatal DNA diagnosis 211

Amniocentesis 211

Chorionic villus sampling 212

Separating fetal cells in maternal blood for genetic diagnosis 212

Antenatal screening for Down's syndrome 212

Fetal DNA in maternal blood 213

Molecular methods for prenatal diagnosis 213

aCGH for prenatal diagnosis 213

BAC HD Scan test 214

FISH for prenatal diagnosis 214

PCR for prenatal diagnosis 214

Plasma DNA sequencing to detect fetal chromosomal aneuploidies 215

In vivo gene expression analysis of the living human fetus 215

Noninvasive prenatal diagnosis of monogenic diseases 215

Digital relative mutation dosage 216

Massively parallel plasma DNA sequencing 216

Applications of prenatal diagnosis 216

Diagnosis of congenital infections 217

Diagnosis of eclampsia 217

Use of transrenal DNA for prenatal testing 218

Preimplantation genetic diagnosis 218

Technologies for preimplantation genetic diagnosis (PGD) 218

PCR for preimplantation genetic diagnosis 218

FISH for preimplantation genetic diagnosis 219

Microarrays for preimplantation genetic diagnosis 219

Conditions detected by preimplantation genetic diagnosis 220

The future of preimplantation genetic diagnosis 220

Companies involved in prenatal/preimplantation diagnosis 221

Cystic fibrosis 222

Detection of CFTR gene mutations 222

CFTR technologies of various companies 222

Genzyme's CF gene sequencing 223

CF PlusO Tag-It Cystic Fibrosis Kit 224

Asuragen's bead array test 224

The Ambry CF Test 225

Biochip for CF diagnosis 225

Identification of CF variants by PCR/Oligonucleotide Ligation Assay 225

SensiGene (SEQUENOM) CF carrier screening test 225

Serum proteomic signature for CF using antibody microarrays 226

Guidelines for genetic screening for CF 226

Congenital adrenal hyperplasia 226

Primary immunodeficiencies 227

Hematological disorders 228

Hemoglobinopathies 228

Sickle cell anemia 228

Thalassemia 228

Paroxysmal nocturnal hemoglobinuria 229

Hemophilia 229

Hereditary hemochromatosis 229

Polycystic kidney disease 230

Hereditary metabolic disorders 230

Lesch-Nyhan Syndrome 230

Gaucher's Disease 231

Acute Intermittent Porphyria 231

Phenylketonuria 231

Hereditary periodic fever 232

Achondroplasia 232

Molecular diagnosis of cardiovascular disorders 232

Coronary Heart Disease 233

Cardiomyopathy 234

Familial Hypertrophic Cardiomyopathy 234

Idiopathic dilated cardiomyopathy 234

Cardiac Arrhythmias 234

Long Q-T Syndrome 234

Familial atrial fibrillation 235

Idiopathic ventricular fibrillation 235

Congestive heart failure 235

Hypertension 236

Disturbances of blood lipids 236

Familial dyslipoproteinemias 236

Hypercholesterolemia 236

Thrombotic disorders 237

Factor V Leiden mutation 237

Pulmonary embolism 238

Molecular diagnosis of eye diseases 238

Molecular diagnosis of retinitis pigmentosa 238

Genetic screening for glaucoma 239

Role of molecular diagnostics in rheumatoid arthritis 239

Molecular diagnosis of neurogenetic disorders 240

Alzheimer's disease 241

Autism spectrum disorders 241

CNVs associated with autism 242

Charcot-Marie Tooth disease 243

Down syndrome 243

Duchenne and Becker muscular dystrophy 244

eNOS gene polymorphisms as predictor of cerebral aneurysm rupture 244

Fragile X syndrome 245

Huntington disease 245

Hereditary neuropathy with liability to pressure palsies 246

Mitochondrial disorders affecting the nervous system 246

Parkinson's disease 246

Pompe's disease 247

Spinal muscular atrophy 248

Triple repeat disorders 248

Genetic testing for disease predisposition 248

Direct-to-consumer genetic tests 249

6. Molecular Diagnosis of Infections 251

Introduction 251

Molecular techniques for the diagnosis of infections 251

Antibody-enhanced microplate hybridization assays 252

Bacteriophage-based methods for detection of bacteria 252

Biosensors for detection of microorganisms 253

Ibis T5000™ Biosensor System 253

DNA enzyme immunoassay 253

DNA biochip/microarray in diagnosis of infections 253

DNA-based typing methods 254

Restriction fragment length polymorphism analysis 254

Ribotyping 255

Random amplified polymorphic DNA 255

Combinatorial DNA melting assay 255

Electrochemical detection of pathogens 255

FISH for detection of infections 256

High resolution melt analysis for diagnosis of infections 256

Ligase chain reaction 256

Mass spectrometry for microbial identification 256

Metagenomic pyrosequencing 257

Multiplex PCR for detection of infections 258

Dual priming oligonucleotide for multiplex PCR 259

LightCycler® SeptiFast Test 259

Multiplex amplified nominal tandem repeat analysis 260

VYOO® Sepsis Test 260

NASBA for detection of microorganisms 260

Nucleic acid probes 260

Neutrophil CD11b expression as a diagnostic marker 260

Optical Mapping 261

PNA-FISH for diagnosis of infections 261

Quantitative reverse-transcription PCR for bacterial diagnostics 262

Rupture event scanning 262

Real-time single-molecule imaging of virus particles 262

Single-strand conformational polymorphism 262

SmartGene platform for identifying pathogens based on genetic sequences 262

Tessera array technology 263

Applications, advantages and limitations of molecular diagnostics 263

Molecular diagnostics versus other microbial detection technologies 263

Advantages of nucleic acid-based diagnostics in infections 264

Drawbacks of nucleic acid-based diagnostics in infections 264

Nanotechnology for detection of infectious agents 265

Bacterial and fungal infections 265

Mycobacterium tuberculosis 267

Conventional diagnosis of tuberculosis 267

Microscopic Observation Drug Susceptible Assay for tuberculosis 267

Molecular diagnostics for tuberculosis 268

Combined tuberculin testing and ELISpotPLUS assay 269

Biomarkers for tuberculosis 270

Diagnosis of drug-resistant M. tuberculosis infection 270

Xpert MTB/RIF automated molecular test for MTB 271

Diagnosis of other mycobacteria 271

Chlamydial infections 272

Neisseria gonorrhoeae 273

Bacteria associated with bacterial vaginosis 274

Streptococcal infections 274

Group B Streptococci 274

Streptococcus pyogenes and Streptococcus dysgalactiae 274

Pseudomonas aeruginosa 275

Helicobacter pylori 275

Lyme disease 275

Mycoplasmas 276

Fungal infections 277

Aspergillus 277

Candida species 277

Viral infections 278


Diagnosis of HIV 279

Neonatal screening of infants of HIV-positive mothers 280

Screening of cadaveric tissue donors 280

Detection of HIV provirus 280

Resolution of indeterminate Western blot 280

Global Surveillance of HIV-1 genetic variations 281

Genotyping for drug-resistance in HIV 281

Phenotyping as predictor of drug susceptibility/resistance in HIV 282

Tests used for quantification of HIV 283

Conclusions about HIV genotyping 283

Hepatitis viruses 284

Hepatitis A virus 284

Hepatitis B virus 285

Hepatitis C virus 285

Detection and quantification of HCV RNA 286

Quantification of HCV RNA levels as a guide to antiviral therapy 287

Electrochemical DNA chip for diagnosis of HCV 287

HCV Genotyping as a guide to therapy 287

Enteroviruses 288

Adenoviruses 289

Rhinoviruses 289

Herpes viruses 289

Herpes simplex virus 289

Genital and neonatal herpes simplex 290

Human cytomegalovirus infections 290

Epstein-Barr virus 290

Human papilloma virus 291

Molecular diagnostics for HPV 291

Detection of encephalitis viruses 292

West Nile and St. Louis encephalitis 292

Venezuelan equine encephalitis virus 293

Protozoal infections 293

Amebiasis 293

Cryptosporidium parvum 293

Malaria 293

Neurocysticercosis 294

Pneumocystis carinii 294

Toxoplasmosis 295

Infections of various systems 295

CNS infections 295

Molecular diagnosis in bacterial meningitis 295

Molecular diagnosis in herpes simplex encephalitis 295

Diagnosis of transmissible spongiform encephalopathies 296

Molecular diagnosis of respiratory viruses 297

SARS-associated coronavirus 297

Influenza viruses 299

Avian influenza 300

H1N1 influenza 304

Gastrointestinal infections 306

Periodontal infections 307

Diagnosis of urinary infections by a biosensor 308

Role of molecular diagnostics in septicemia 308

Limitations and needs of diagnostics for infections 309

Differentiation between live and antibiotic-killed bacteria 310

Cell-based methods for identifying pathogenic microorganisms 310

Cell-based virus assays 310

Cell-based detection of host response to infection 310

Role of molecular diagnostics in hospital acquired infections 311

Detection of hospital-acquired bacterial infections 311

Detection of methicillin-resistant S. aureus 311

Detection of vancomycin-resistant enterococci 312

Detection of hospital-acquired C. difficile 312

Bacterial genome sequencing in antimicrobial resistance 313

Detection of hospital-acquired viral infections 313

Molecular diagnosis of BK virus 313

Diagnosis of hospital-acquired rotavirus gastroenteritis 314

Molecular diagnostics and the microbiome 314

Human Microbiome Project 314

Application of metagenomics to study of the microbiome 315

MicroBiome Analysis Center 315

Concluding remarks and future prospects of diagnosis of infections 316

Rapid point-of-care diagnosis of infection 316

Diagnosis of viruses using protein fingerprinting 318

QIAplex PCR multiplex technology 319

Companies involved in molecular diagnosis of infectious diseases 319

7. Molecular Diagnosis of Cancer 323

Introduction 323

Cancer genomics 323

Cancer genes 324

Oncogenes 324

Tumor Suppressor Genes 324

p53 325

p16 326

CNVs in cancer 326

Allele-specific copy number analysis of tumors 327

Viruses and cancer 327

Detecting viral agents in cancer 328

Conventional cancer diagnosis 329

Molecular techniques for cancer diagnosis 329

Genome analysis at the molecular level 331

Mutation detection at molecular level 331

Expression profiling of tumor cells sorted by flow cytometry 332

MicroRNA expression profiling for cancer diagnostics 332

Biomarkers in cancer 332

Circulating nucleosomes in serum of cancer patients 333

Detection of DNA methylation 333

eTag assay system for cancer biomarkers 335

HAAH as a biomarker for cancer 336

LigAmp for detection of gene mutations in cancer 336

Mitochondrial DNA as a cancer biomarker 336

Oncoproteins as biomarkers for cancer 337

Sequencing-based approaches for detection of cancer biomarkers 337

Molecular fingerprinting of cancer 338

Fluorescent in situ hybridization 338

Genetic analysis of cancer 339

Comparative genomic hybridization in cancer diagnostics 339

Loss of heterozygosity 339

Digital karyotyping 340

Gene expression profiles predict chromosomal instability in tumors 340

PCR Techniques 340

Realtime quantitative PCR for diagnosis of cancer 341

Cold-PCR 341

Antibody-based diagnosis of cancer 341

Monoclonal antibodies for diagnosis of cancer 341

Recombinant antibodies as a novel approach to cancer diagnosis 342

Combined immunological and nucleic acid tests 342

Combination of MAbs and RT-PCR 342

Immunobead RT-PCR 342

Assays for determining susceptibility to cancer 343

Gene expression profiling in cancer 343

Microarrays for gene expression profiling in cancer 344

Serial analysis of gene expression (SAGE) 344

DNA tags for finding genes expressed in cancer 344

Suppression subtractive hybridization 345

Measurement of telomerase activity 345

Detection of circulating tumor cells in blood 346

Biochips/microfluidics for detection of CTCs 346

CellTracks® AutoPrep® System 347

CTCscope system for detection of CTCs 347

Fiber-optic array scanning technology 347

MagSweeper 348

Future prospects of detection of cancer cells in blood 348

Epithelial aggregate separation and isolation 348

Proteomic technologies for the molecular diagnosis of cancer 348

Proteomic technologies for tumor biomarkers 349

Affibodies as contrast agents for imaging in cancer 349

Aptamer-based technology for protein signatures of cancer cells 349

Aptamers for combined diagnosis and therapeutics of cancer 350

Automated image analysis of nuclear protein distribution 350

Laser capture microdissection in oncology 351

Layered expression scanning 351

Membrane-type serine protease-1 352

Survivin and molecular diagnosis of cancer 352

Biochip/microarrays for cancer diagnosis 352

Role of DNA microarrays in gene expression profiling 353

Biochip detection of FHIT gene 353

Nanobiotechnology for early detection of cancer 354

Detection of nanoparticle self assembly in tumors by MRI 354

Differentiation between normal and cancer cells by nanosensors 354

Magnetic nanoparticle probes 354

Quantum dots for early detection of cancer 355

Molecular imaging of cancer 356

In vivo tumor illumination by adenoviral-GFP 356

PET for in vivo molecular diagnosis of cancer 356

Xenon-enhanced MRI 356

Optical systems for in vivo molecular imaging of cancer 357

Detection of micrometastases 357

Molecular diagnosis of cancers of various organs 357

Brain tumors 358

Molecular diagnostic methods for brain tumors 358

Glioblastoma multiforme 358

Circulating microvesicles as biomarkers of glioblastoma 359

Combination of neuroimaging and DNA microarray analysis in GBM 359

Medulloblastoma 360

Multigene predictor of outcome in GBM 360

Oligodendroglioma 360

Advantages and limitations of molecular diagnosis of brain tumors 360

Breast cancer 361

Breast cancer genes 361

Circulating nucleic acid biomarkers of breast cancer 362

Molecular diagnostic tests for breast cancer 363

Mouse ESC-based assays to evaluate mutations in BRCA2 365

Genomic profiles of breast cancer 366

Role of molecular diagnostics in management of breast cancer 366

Tests for prognosis of breast cancer 370

Prediction of recurrence in breast cancer for personalizing therapy 372

Cervical cancer 373

Colorectal ca

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10. Reportlinker Adds High-Tech Patient Monitoring Systems Markets (Remote and Wireless Systems, Data Processing, EMR Data Transfer) Report
11. Reportlinker Adds In Vitro Diagnostics in a Recession: IVD Market Forecasts, Analysis and Success Strategies Report
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(Date:11/24/2015)... FRANCISCO , Nov. 24, 2015  Twist ... announced that Emily Leproust, Ph.D., Twist Bioscience chief ... Jaffray Healthcare Conference on December 1, 2015 at ... Hotel in New York City. --> ... . Twist Bioscience is on Twitter. ...
(Date:11/24/2015)... ... November 24, 2015 , ... InSphero AG, the leading supplier ... models, has promoted Melanie Aregger to serve as Chief Operating Officer. , ... the management team and was promoted to Head of InSphero Diagnostics in ...
(Date:11/24/2015)... 2015 /CNW Telbec/ - ProMetic Life Sciences Inc. (TSX: PLI) ... Pierre Laurin , President and Chief Executive Officer of ... Piper Jaffray 27 th Annual Healthcare Conference to be ... 2015. st , at 8.50am (ET) and ... the day. The presentation will be available live via a ...
(Date:11/24/2015)... 2015 HemoShear Therapeutics, LLC, a privately ... metabolic disorders, announced today the appointment of ... Directors (BOD). Mr. Watkins is the former president ... (HGS), and also served as the chairman of ... , Chairman and CEO of HemoShear Therapeutics. "The ...
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(Date:11/12/2015)... --  Growing need for low-cost, easy to use, ... the way for use of biochemical sensors for ... clinical, agricultural, environmental, food and defense applications. Presently, ... applications, however, their adoption is increasing in agricultural, ... on improving product quality and growing need to ...
(Date:11/9/2015)... , Nov. 09, 2015 ... the addition of the "Global Law ... their offering. --> ) ... "Global Law Enforcement Biometrics Market 2015-2019" ... Research and Markets ( ) has ...
(Date:10/29/2015)... , Oct. 29, 2015   MedNet Solutions , ... entire spectrum of clinical research, is pleased to announce ... Tech Association (MHTA) as one of only three finalists ... "Software – Small and Growing" category. The Tekne Awards honor ... have shown superior technology innovation and leadership. ...
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