Reportlinker Adds Biomarkers - Technologies, Markets and Companies

Dec 21, 2010, 11:53 ET from Reportlinker

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

Biomarkers - Technologies, markets and companies

http://www.reportlinker.com/p0203536/Biomarkers---Technologiesmarkets-and-companies.html

Summary

This report follows the broad definition of a biomarker as a characteristic that can be objectively measured and evaluated as an indicator of normal biological or pathogenic processes as well as pharmacological responses to a therapeutic intervention. Tests based on biomarkers have been around for more than half a century, but interest in their application for diagnostics and drug discovery as well as development has increased remarkably since the beginning of the 21st century. This report describes different types of biomarkers and their discovery using various "-omics" technologies such as proteomics and metabolomics. Molecular diagnostics technologies are used for the discovery of biomarkers and new tests are also based on biomarker.

Currently the most important applications of biomarkers are in drug discovery and development. The role of biomarkers in various therapeutic areas particularly cancer, cardiovascular diseases and disorders of the central nervous system, is described. Biomarkers are useful not only for diagnosis of some of these diseases but also for understanding the pathomechanism as well as a basis for development of therapeutics.

Biomarkers will facilitate the combination of therapeutics with diagnostics and will thus play an important role in the development of personalized medicine. Biomarkers play a role in use of pharmacogenetics, pharmacogenomics and pharmacoproteomics for development of personalized medicine.

Many of the regulatory issues concerning biomarkers are related to genomics, proteomics, molecular diagnostics and pharmacogenomics/pharmacogenetics. Validation of biomarkers and their role in clinical trials is discussed.

Biomarker markets are estimated from 2009 to 2019 according to share of markets for various technologies and applications: proteomics, metabolomics, molecular diagnostics, drug discovery, clinical trials, and bioinformatics. Market values are further split according to therapeutic applications and major geographical areas. Unfulfilled needs in biomarkers are identified as well as the drivers for biomarker markets. Challenges facing the biomarker industry and strategies for developing biomarker markets are discussed.

A large number of companies with varying technical backgrounds are involved in biomarkers and 257 of these are profiled in part 2 of the report with classification into various categories. These also include major pharmaceutical companies. There is tabulation of 460 collaborations between companies and additional academic collaborations are mentioned in the individual profiles of companies. The report is supplemented by 800 references, 61 tables and 12 figures

Table of Contents

0. Executive Summary 19

1. Introduction 21

Definitions 21

Historical aspects of biomarkers 21

Classification of biomarkers 22

Biological marker as response to therapeutic intervention 23

Pharmacokinetic/pharmacodynamics biomarkers 23

Predictive biomarkers 23

Valid biomarkers 24

Types of biomarkers 24

Genes as biomarkers 24

Proteins as biomarkers 25

Proteomics 25

DNA biomarkers 26

Mitochondrial DNA 26

Mitochondrial mutations 26

RNA biomarkers 26

Transcriptomics 27

MicroRNAs 28

Metabolomics 28

Glycomics 28

Single nucleotide polymorphisms 29

Haplotyping 29

Cell biomarkers of disease 30

Stem cell biomarkers 30

Association of stem cell biomarkers with disease 30

Cancer stem cell biomarkers 30

Endoglin as a functional biomarker of stem cells 31

p75NTR as a biomarker to isolate adipose tissue-derived stem cells 31

Protein expression profile as biomarker of stem cells 31

STEMPROO EZCheka for analysis of biomarkers of hESCs 32

SSEA-4 as biomarker of MSCs 32

Gaseous mediators as biomarkers of disease 32

Autoantibodies as biomarkers of autoimmune diseases 32

Comparison of various types of biomarkers 33

Biomarkers and systems biology 33

Systems biology approach to biomarker identification 35

Relation of biomarkers to other technologies and healthcare 35

Biomarkers and translational medicine 36

Limitations of use of biomarkers in healthcare 36

2. Technologies for Discovery of Biomarkers 39

Introduction 39

The ideal biomarker 39

Genomic technologies 39

Gene expression 39

Whole genome expression array 40

Gene expression profiling on whole blood samples 41

Profiling gene expression patterns of white blood cells 41

Tissue microarrays for study of biomarkers 41

Epigenomic technologies 42

Discovery of methylation biomarkers 42

Proteomic technologies 43

2D GE 44

Biomarker Amplification Filter 45

CellCarta® proteomics platform 45

Isotope-coded affinity tags 46

Liquid chromatography-MS/MS 46

Lucid Proteomics System 46

Magnetics beads for protein biomarker discovery 47

MASStermind™ 47

Mass spectrometry 47

2D PAGE and mass spectrometry 48

Imaging mass spectrometry 48

MALDI mass spectrometry for biomarker discovery 49

Quantitative tandem MS 50

Single-molecule mass spectrometry using a nanopore 50

Requirements for MS-based proteomic biomarker development 51

Protein tomography 51

Protein biochips/microarrays and biomarkers 51

Antibody-based biomarker discovery 52

Detection of biomarkers using peptide array technology 52

Protein nanobiochip 52

Gene expression microarray data as a source of protein biomarkers 53

Quantification of protein biomarkers 53

Mass spectrometry for quantification of protein biomarkers 53

Real-time PCR for quantification of protein biomarkers 53

CyTOF for quantification of biomarkers 54

Search for biomarkers in body fluids 54

Challenges and strategies for discovery of protein biomarkers in plasma 54

3-D structure of CD38 as a biomarker 55

BD™ Free Flow Electrophoresis System 56

Isotope tags for relative and absolute quantification 56

Plasma protein microparticles as biomarkers 57

Proteome partitioning 57

Stable isotope tagging methods 57

Technology to measure both the identity and size of the biomarker 58

Biomarkers in the urinary proteome 58

Peptides in body fluids and tissues as biomarkers of disease 59

Analysis of peptides in bodily fluids 59

Serum peptidome patterns 60

SISCAPA method for quantitating proteins and peptides in plasma 60

Comparison of proteomic profiling technologies for discovery of biomarkers 61

Verification for interlaboratory reproducibility of protein biomarkers 61

Significance of similar protein biomarkers in different tissues 62

Glycomic technologies 62

Metabolomic technologies 63

Genome-wide association studies for identification of metabolic biomarkers 63

Lipid profiling 63

Mass spectrometry-based kits for discovery of metabolic biomarkers in plasma 64

Role of metabolomics in biomarker identification and pattern recognition 64

Urinary profiling by capillary electrophoresis 64

Validation of biomarkers in large-scale human metabolomics studies 65

Lipidomics 65

Disease biomarkers in breath 66

Portable breath test for volatile organic compounds 66

Detection of breath biomarkers by sensation technology 67

Detection of breath biomarkers optical frequency comb spectroscopy 67

Fluorescent indicators for biomarkers 67

Molecular imaging technologies 68

Computer tomography 68

Magnetic resonance imaging 68

Positron emission tomography 69

Advantages of imaging biomarkers 69

Monitoring in vivo gene expression by molecular imaging 69

Molecular imaging in vivo as a biomarker 70

Challenges and future prospects of molecular imaging 70

Basic research in molecular imaging 71

Imaging intracellular NADH as a biomarker of disease 71

Devices for molecular imaging 71

Imaging biomarkers in clinical trials 71

Molecular imaging in clinical practice 72

Nuclear magnetic resonance 72

Chemical derivatization to enhance biomarker detection by NMR 72

Fluxomics by using NMR 73

Nanobiotechnology 73

Nanomaterials for biolabeling 73

Quantum dot molecular labels 74

Bioconjugated QDs for multiplexed profiling of biomarkers 75

Magnetic nanotags for multipley detection of biomarkers 75

Nanoproteomics and biomarkers 75

High-field asymmetric waveform ion mobility mass spectrometry 76

Nanoparticles for molecular imaging 76

Nanoparticles for discovering biomarkers 76

Nanosensors for measuring biomarkers in blood 77

Nanobiochip sensor technique for analysis of oral cancer biomarkers 77

Nucleoprotein nanodevices for detection of cancer biomarkers 77

Future prospects of application of nanobiotechnology for biomarkers 78

Bioinformatics 78

Biomarker Workflow Guide 78

Analysis of microarray data for selecting useful biomarkers 79

Role of bioinformatics in discovery of protein biomarkers 79

Role of bioinformatics in detection of cancer biomarkers 80

Biomarker databases 80

Gene networks as biomarkers 80

3. Biomarkers and Molecular Diagnostics 83

Introduction 83

Molecular diagnostic technologies 83

Polymerase chain reaction 83

Amplification 83

Target selection 84

Detection of amplified DNA 84

Limitations of PCR 84

Real-time PCR systems 85

Limitations of real-time PCR 85

Future applications of real-time Q-PCR 86

Combined PCR-ELISA 86

Non-PCR methods 86

Linked Linear Amplification 87

Transcription mediated amplification 87

Rapid analysis of gene expression 87

WAVE nucleic acid fragment analysis system 87

DNA probes with conjugated minor groove binder 88

Rolling circle amplification technology 88

Gene-based diagnostics through RCAT 89

RCAT-immunodiagnostics 89

RCAT-biochips 90

RCAT-pharmacogenomics 90

Circle-to-circle amplification 90

Biochips and microarrays 90

Applications of biochips/microarrays 91

Role of biochip/microarrays in discovery of biomarkers 91

Biomarkers and high throughput molecular screening 92

Detection and expression profiling of miRNA 92

Real-time PCR for expression profiling of miRNAs 93

Real-time PCR for expression profiling of miRNAs 93

Use of LNA to explore miRNA 93

Microarrays for analysis of miRNA gene expression 93

4. Biomarkers for Drug Discovery & Development 95

Introduction 95

Biomarker technologies for drug discovery 96

Proteomics-based biomarkers for drug discovery 96

Chemoproteomics 96

Activity-based chemical proteomics 96

Transcriptomics for drug discovery 97

Metabolomics for drug discovery 97

Biomarkers and drug safety 98

Biomarkers of adverse drug reactions 98

Applications of biomarkers in drug safety studies 98

Genomic technologies for toxicology biomarkers 99

Proteomic technologies for toxicology biomarkers 99

Metabonomic technologies for toxicology biomarkers 100

Integration of genomic and metabonomic data to develop toxicity biomarkers 100

Toxicology studies based on biomarkers 100

Biomarkers of hepatotoxicity 101

Biomarkers of nephrotoxicity 102

Cardiotoxicity 103

Neurotoxicity 104

Applications of biomarkers for drug development 105

Application of metabonomics/metabolomics for drug development 105

Role of pharmacokinetic/pharmacodynamic biomarkers in drug development 105

Molecular imaging as a biomarker in drug development 106

Molecular imaging in preclinical studies 106

Molecular imaging in clinical trials 107

Prospects of molecular imaging in drug discovery and development 108

Biomarkers in clinical trials 108

NIH recommendations on the use of biomarkers in clinical trials 109

Advantages of biomarkers for drug development 110

Limitations and problems with use of biomarkers in clinical trials 111

Application of biomarkers by the pharmaceutical companies 111

Use of biomarkers in relation to stage of drug discovery and development 112

Drug development in cardiovascular disorders 113

Drug development in neurological disorders 113

Future prospects of biomarker-based drug development 114

The Biomarker Alliance 114

Molecular Libraries and Imaging Roadmap of NIH 114

Biomarkers Consortium 115

Pharmacogenomic biomarker information in drug labels 116

5. Role of Biomarkers in Healthcare 117

Introduction 117

Biomarkers of inflammation 117

ESR and CRP as biomarkers of inflammation 118

Biomarkers of oxidative stress 118

1,4-dihydroxynonane-mercapturic acid 118

Oxidative DNA damage 119

Proteins as biomarkers of oxidative stress in diseases 119

Testing for oxidative stress 119

Biomarkers in metabolic disorders 119

Biomarkers of acute intermittent porphyria 119

Liver X receptors 120

Biomarkers of diabetes mellitus 120

Biomarkers of hyperglycemia 121

Biomarkers of diabetes-associated oxidative stress 121

Biomarkers of inflammation associated with diabetes 122

Biomarkers of renal complications in diabetes mellitus type 2 122

Biomarkers of diabesity 122

Glycosylated hemoglobin in diabetes mellitus 122

Lack of C-peptide as biomarker of complications of diabetes type 1 122

Serum retinol binding protein 4 as biomarker of insulin resistance 123

Biomarkers of metabolic syndrome 123

Adiponectin 123

Biomarkers in immune disorders 124

Biomarkers relevant to organ transplantation 124

Biomarkers of graft versus host disease 124

Biomarkers of renal allograft failure 126

Biomarkers of renal transplant tolerance 127

Biomarkers of lung transplant rejection 127

Systemic lupus erythematosus 128

Current management and need for biomarkers 128

Role of collaborative efforts and databases of SLE biomarkers 128

C4d-bearing reticulocytes 129

Adiponectin 129

CB-CAPS 129

Genetic loci of SLE 129

Epigenetic biomarkers of SLE 129

Biomarkers of musculoskeletal disorders 130

Biomarkers of rheumatoid arthritis 130

Circulating cytokines in RA 130

Serum CRP in RA 130

Assays for biomarkers of RA 131

Biomarkers of spondylarthritis 131

Biomarkers of osteoarthritis 132

Biomarkers of osteoporosis 133

Dual x-ray absorptiometry 133

Bone imaging with quantitative CT and MRI 133

Assays for detection of biomarkers of osteoporosis 134

Biomarkers of infectious diseases 134

Chemokines as biomarkers of infection 135

Circulating CPS-1 as biomarkers of organ damage in sepsis 135

Endotoxin 136

Procalcitonin 136

Application of proteomics for discovering biomarkers of infections 137

Systemic inflammatory response syndrome 137

Nitric oxide as a biomarker of sepsis 138

Tuberculosis 138

Conventional diagnosis of tuberculosis 139

Molecular diagnostics for tuberculosis 139

Biomarkers for tuberculosis 139

Biomarkers of pulmonary tuberculosis in the breath 140

Biomarkers of viral infections 140

Viral hepatitis 140

Biomarkers of SARS 142

Biomarkers of HIV 143

Biomarkers in parasitic infections 143

Role of biomarkers in malaria 143

Identification of biomarkers in Schistosomiasis infections 144

Biomarkers of liver disease 145

Breath biomarkers of liver disease 145

Biomarkers of viral hepatitis B and C 145

Biomarkers of liver injury 146

Biomarkers of liver cirrhosis 146

FibroMax 146

Biomarkers of pancreatitis 147

Biomarkers of renal disease 147

Biomarkers of lupus nephritis 148

Biomarkers of diabetic nephropathy 148

Cystatin C as biomarker of glomerular filtration rate (GFR) 148

Estimated GFR and albuminuria as biomarkers of chronic kidney disease 148

Proteomic biomarkers of acute kidney injury 149

Biomarkers of pulmonary diseases 149

Biomarkers of oxidative stress in lung diseases 150

Biomarkers of survival in acute respiratory distress syndrome 150

Urinary NO as biomarker 150

Plasma biomarkers related to inflammation 150

Pulmonary surfactant proteins as biomarkers for lung diseases 151

Cytokine/chemokine biomarkers of SARS 151

Biomarkers of chronic obstructive pulmonary disease 151

Increased expression of PIGF as a biomarker of COPD 152

Chromagranin A (CgA) as biomarker of airway obstruction in smokers 152

BNP as a biomarker of chronic pulmonary disease 152

Alpha1-antitrypsin gene polymorphisms predisposing to emphysema 153

Biomarkers of asthma 153

Comparison of biomarkers of asthma and COPD 153

Exaled NO as a biomarker of asthma 153

Cytokines as biomarkers of asthma severity 154

Biomarker for rhinovirus-induced asthma exacerbation 154

Biomarkers for predicting response to corticosteroid therapy 155

IgE as guide to dosing of omalizumab for asthma 155

Endothelin-1 in exhaled breath as biomarker of asthma 155

Biomarkers for cystic fibrosis 156

Biomarkers of pulmonary embolism 156

Biomarkers in gynecology and obstetrics 157

Biomarkers of menopause 157

Biomarkers of premenstrual dysphoric disorder 157

Biomarkers of endometriosis 158

Biomarkers for preeclampsia 158

Protein biomarker of preeclampsia in urine 159

Protein biomarkers of preeclampsia in CSF 159

Protein HtrA1 as biomarker for preeclampsia 159

sFlt1 and soluble endoglin as biomarkers of preeclampsia 160

RNA biomarkers 160

Biomarkers of premature birth 161

Biomarkers of oxidative stress in complicated pregnancies 161

Fetal biomarkers in maternal blood 161

Biomarkers for genetic disorders 162

Biomarkers for Down's syndrome 162

Biomarkers for muscular dystrophy 162

Biomarkers of phenylketonuria 163

Genetic biomarkers for psoriasis 163

Biomarkers of lysosomal storage disorders 164

Biomarkers of aging 165

Effect of calorie restriction on biomarkers of longevity 166

Genes as biomarkers of aging 166

Mitochondrial mutations as biomarkers of aging 166

Telomere attrition as aging biomarker 167

Gene variants as determinants of biological age 167

Genetic signatures of longevity 167

Low serum thyroid hormone level as biomarker of longevity 168

Role of bioinformatics in search for biomarkers of aging 168

Study of biomarkers of aging in a genetically homogeneous population 168

Biomarkers of miscellaneous disorders 169

Biomarkers of chronic fatigue syndrome 169

Biomarkers of inflammatory bowel disease 169

Biomarkers of erectile dysfunction 170

Biomarkers of heat stroke 170

Nasal nitric oxide as a biomarker of response to rhinosinusitis therapy 171

Biomarkers common to multiple diseases 171

Biomarkers and nutrition 171

Biomarkers in nutritional epidemiology 171

Biomarkers of nutritional status 172

Biomarkers of branched chain amino acid status 172

Biomarkers of caloric restriction 173

Biomarkers of malnutrition 173

Proteomic biomarkers and nutrition 173

Biomarkers of gene-environmental interactions in human disease 173

6. Biomarkers of Cancer 175

Introduction 175

The ideal biomarker for cancer 175

Single vs multiple biomarkers of cancer 176

Types of cancer biomarkers 176

HER3 as biomarker of cancer 177

DNA repair biomarkers 177

miRNAs as biomarkers in cancer 177

Circulating miRNAs for cancer detection 179

Diagnostic value of miRNA in cancer 179

Biomarkers of epigenetic gene silencing in cancer 179

Immunologic biomarkers of cancer 180

Molecular diagnostic techniques for cancer 180

Technologies for detection of cancer biomarkers 181

Genomic technologies for cancer biomarkers 181

Cold-PCR 181

Genome analysis at the molecular level 182

Sequencing-based approaches for detection of cancer biomarkers 182

Early detection of tumor suppressor gene mutations 182

Biomarkers of PTEN tumor suppressor gene status 183

HAAH as a biomarker for cancer 183

KRAS as a biomarker of cancer 184

Telomerase as a biomarker of cancer 184

Digital karyotyping for cancer biomarkers 184

LigAmp for detection of gene mutations in cancer 185

Mitochondrial DNA as a cancer biomarker 185

Tissue microarrays for study of cancer biomarkers 185

Molecular fingerprinting of cancer 186

Biomarkers of inflammation in cancer 187

Proteomic technologies for detecting biomarkers of cancer 187

2D PAGE 188

Antibody-based detection of protein biomarkers 188

Aptamer-based molecular probes for cancer biomarker discovery 189

Cancer immunomics to identify autoantibody signatures 189

Desorption electrospray ionization for detection of cancer biomarkers 190

Detection of circulating nucleosomes in serum of cancer patients 190

Detection of tumor markers with ProteinChip technology 190

eTag assay system for cancer biomarkers 191

Glycoprotein biomarkers of cancer 191

HER-2/neu oncoprotein as biomarkers for cancer 192

Humoral proteomics 192

Laser capture microdissection 192

Membrane-type serine protease-1 193

Phage display technology 193

Proteomic analysis of cancer cell mitochondria 193

Proteomic technologies for detection of autoimmune biomarkers 194

SELDI-TOF MS 194

Serum proteome analysis for early detection of cancer 194

Tissue proteomics for discovery of cancer biomarkers 195

Metabolomic biomarkers of cancer 195

Choline phospholipid biomarkers of cancer 195

Hypoxia-inducible factor-1 196

Detection of drug resistance in cancer by metabolic profiling 196

Epitomics for the early detection of cancer 196

Detection of biomarkers of DNA methylation 197

PCR with bisulfite for detecting DNA methylation biomarkers in cancer 198

MDScanO microarray technology 199

Rubicon MethylPlex technology 199

Epigenomics Marker Machine for DNA methylation biomarkers 200

Sequenom's integrated genetic analysis platform 200

Histone deacetylase 200

Mucins as epigenetic biomarkers in epithelial cancers 201

Nanobiotechnology for early detection of cancer to improve treatment 201

Selective expression of biomarkers by cancer compared with normal tissues 201

Ultrasound radiation to enhance release of a tumor biomarker 202

In vivo imaging of cancer biomarkers 202

Computer tomography 202

Optical systems for in vivo molecular imaging of cancer 202

Positron emission tomography 203

Imaging of tumor oxygenation and microvascular permeability by MRI 203

Xenon-enhanced MRI 203

Kallikrein gene family and cancer biomarkers 204

Circulating cancer cells in blood as biomarkers of cancer 204

Applications of cancer biomarkers 205

Use of biomarkers for cancer classification 205

Cancer classification using microarrays 205

Proteomic classification of cancer 206

Use of biomarkers for early detection of cancer 206

Applications of biomarkers for cancer diagnosis 206

Methylated DNA sequences as cancer biomarkers 206

MicroRNA expression profiling for diagnosis of human cancers 207

MUC4 as a diagnostic biomarker in cancer 207

Applications of biomarkers for cancer diagnosis and therapy 208

Asparagine synthetase as biomarker for therapy with L-asparaginase 208

Peptide-based agents for targeting cancer biomarkers 209

Biomarkers for assessing efficacy of cancer therapy 209

ERCC1-XPF expression as a biomarker of response to chemotherapy 209

P53 expression level as biomarker of efficacy of cancer gene therapy 209

Biomarkers of angiogenesis for developing antiangiogenic therapy 209

Biomarkers of response to antiangiogenic agent brivanib alaninate 210

Circulating endothelial cells as targets for antiangiogenic drugs 210

DCE-MRI biomarkers for evaluation of antiangiogenic agents 210

Combination of soluble biomarkers of angiogenesis with imaging 211

Tumor endothelial markers 211

VEGF signaling inhibitors as biomarkers 212

Biomarkers of prognosis in cancer treatment 212

Biomarkers of drug resistance in cancer 212

A systems approach to biomarkers of innate drug resistance 213

Epithelial membrane protein-1 as a biomarker of gefitinib resistance 213

Methylation biomarkers of drug resistance in cancer 213

Biomarkers of radiation exposure and response 214

Role of biomarkers in drug development in oncology 214

Molecular imaging of tumor as a guide to drug development 215

Use of PET to assess response to anticancer drugs 215

Use of MRI to assess response to anticancer drugs 216

Biomarkers in plucked hair for assessing cancer therapy 216

Molecular targets of anticancer drugs as biomarkers 217

Safety biomarkers in oncology studies 217

Role of biomarkers in phase I clinical trials of anticancer drugs 217

Biomarkers according to location/type of cancer 218

Bladder cancer biomarkers 218

Detection of FGFR3 mutations in urine for diagnosis of bladder cancer 218

NMP22 BladderChek 218

Urinary telomerase as biomarker for detection of bladder cancer 218

Concluding remarks abut biomarkers of urinary cancer 219

Brain cancer biomarkers 219

Biomarkers to predict response to EGFR inhibitors 219

CD133 as biomarker of resistance to radiotherapy 220

Circulating microvesicles as biomarkers 220

CSF protein profiling 220

CSF attractin as a biomarker of malignant astrocytoma 221

Methylation profiling of brain tumors 221

Metabolite biomarkers of brain tumors 222

miRNAs as biomarkers of brain tumors 222

MRI biomarker for response of brain tumor to therapy 223

Multigene predictor of outcome in GBM 223

Neuroimaging biomarkers combined with DNA microarray analysis 223

Receptor protein tyrosine phosphatase b as biomarker of gliomas 224

Serum protein fingerprinting 224

VEGF-R2 as biomarker of angiogenesis in brain tumors 224

Breast cancer biomarkers 224

Biomarkers of breast cancer in breath 226

Biomarkers for breast cancer in nipple aspiration fluid 226

Circulating nucleic acid biomarkers of breast cancer 226

Flow cytometry for quantification of biomarker expression patterns 226

Plasma proteomics for biomarkers of breast cancer 227

Quantitative realtime PCR assays for biomarker validation 227

Cdk6 as a biomarker of breast cancer 228

Centromere protein-F 228

Carbonic anhydrase IX 228

COX-2 as a biomarker of breast cancer 229

Glycomic biomarkers of breast cancer 229

HER-2/neu oncoprotein 229

High mobility group protein A2 231

Hypermethylated genes as biomarkers of metastatic breast cancer 231

Lipocalin 2 as biomarker of breast cancer progression 231

Long intervening non-coding RNAs 232

Mammaglobin 232

miRNA biomarkers of breast cancer 232

p27 expression as biomarker for survival after chemotherapy 233

Podocalyxin 233

Progranulin as a biomarker of breast cancer 234

Proliferating cell nuclear antigen 234

Protein kinase C as a predictive biomarker of metastatic breast cancer 234

Retinoblastoma tumor suppressor gene as a biomarker 234

Riboflavin carrier protein 235

Risk of invasive cancer after diagnosis of ductal carcinoma in situ 235

Serum CA 15-3 as biomarker of prognosis in advanced breast cancer 236

Suppressor of deltex protein 236

Tumor microenvironment as biomarker of metastasis in breast cancer 236

Type III TGF-b receptor as regulator of cancer progression 236

Diagnostic tests based on breast cancer genes 237

Prognostic role of breast cancer genes 238

Protein biomarkers for breast cancer prevention 239

Biomarkers to evaluate efficacy of chemoprevention 239

Biomarkers of response to chemotherapy of breast cancer 239

Cervical cancer biomarkers 240

Gastrointestinal cancer biomarkers 241

Esophageal cancer biomarkers 242

Gastric cancer biomarkers 242

Colorectal cancer biomarkers 243

Head and neck cancer 247

Leukemia biomarkers 248

Chromosome translocations in leukemias 248

DNA methylation biomarkers in leukemia 249

Gene mutations as biomarkers in leukemia 249

Molecular diagnostic techniques for leukemia 250

Proteomic technologies for discovering biomarkers of leukemia 250

Biomarkers of chronic lymphocytic leukemia 251

Biomarkers of chronic myeloid leukemia 251

Biomarkers of drug resistance in leukemia 252

Biomarkers of myelodysplasitic syndromes 252

Lymphoma biomarkers 252

Liver cancer biomarkers 252

Lung cancer biomarkers 253

Autoantibodies as biomarkers in lung cancer 254

Biomarkers associated with neuroendocrine differentiation in NSCLC 255

Biomarkers of chronic inflammation in lung cancer 255

Biomarkers for predicting sensitivity to chemotherapy in lung cancer 255

Biomarkers for prediction of sensitivity to EGFR inhibitors 256

Circulating tumor cells as biomarkers 257

Gene expression profiling for biomarkers of lung cancer 257

Methylation biomarkers of lung cancer 258

miRNA biomarkers in lung cancer 258

Proteomic biomarkers in exaled breath condensate 259

Serum protein biomarkers of lung cancer 259

tNOX as biomarker of lung cancer 259

Tumor-derived DNA and RNA markers in blood 260

Volatile organic compounds in the exhaled breath 260

Malignant pleural mesothelioma 260

Melanoma biomarkers 261

Nasopharyngeal carcinoma biomarkers 262

Proteomic biomarkers of nasopharyngeal cancer 263

miRNA biomarkers of nasopharyngeal carcinoma 264

Oral cancer biomarkers 264

Ovarian cancer biomarkers 265

Epitomics approach for ovarian cancer biomarkers in serum 266

Gene expression studies in ovarian cancer 266

HtrA1 as a biomarker of response to chemotherapy in ovarian cancer 267

Mutation of genes in ovarian cancer 267

Serum biomarkers of ovarian cancer prognosis 267

Serum albumin-associated peptides and proteins 268

Multiplex assays for biomarkers of ovarian cancer 268

Concluding remarks on biomarker-based tests of ovarian cancer 269

Pancreatic cancer biomarkers 269

Discovery and validation of pancreatic cancer biomarkers 270

Cancer stem cells as biomarkers of pancreatic cancer 271

Histone modifications used as biomarkers in pancreatic cancer 271

miRNA biomarkers of pancreatic cancer 271

Proteomic biomarkers of pancreatic cancer 272

Prostate cancer 273

Adipose tissue-derived biomarkers of obesity-related prostate cancer 274

B7-H3 as biomarker of prostate cancer 274

Detection of prostate cancer biomarkers in urine 275

Detection of prostatic intraepithelial neoplasia 276

Epigenetic biomarkers of prostate cancer 276

Gene expression analysis of prostate cancer 276

Genetic biomarkers of prostate cancer 277

Huntingtin Interacting Protein 1 overexpression in prostate cancer 277

Id proteins expression in prostate cancer 277

Identification of prostate cancer mRNA biomarkers 278

Integrative genomic and proteomic profiling of prostate cancer 278

LCM for diagnosis of prostate cancer 278

Loss of p27 as predictor of recurrence of prostate cancer 279

Microarray for diagnosis of prostate cancer 279

miRNA biomarkers of prostate cancer 279

Prostate cancer biomarkers in semen 280

PSA as biomarker of prostate cancer 280

ProPSA as biomarker of prostate cancer 280

Prostate Health Index 281

PSMA as biomarker of prostate cancer 281

Sarcosine as a metabolic biomarker of prostate cancer 281

Serum HAAH as biomarker of prostate cancer 281

Silenced CDH13 gene as a biomarker of cancer 282

Serum-protein fingerprinting 282

Tests for prostate cancer based on genetic dislocations 282

Concluding remarks on biomarkers of prostate cancer 283

Renal cancer biomarkers 283

Gene expression profile of RCC for biomarkers 283

miRNA biomarkers of renal cancer 283

Use of proteomics for detection of RCC biomarkers 284

Use of RCC biomarkers for prognosis and therapy 284

Thyroid cancer biomarkers 285

Gene expression biomarkers of thyroid cancer 285

Multiple endocrine neoplasia type 2B as risk factor for thyroid cancer 286

miRNA biomarkers of thyroid cancer 286

Biochemical biomarkers of thyroid cancer 286

Role of the NCI in molecular diagnosis of cancer 286

The Cancer Genome Anatomy Project 287

Molecular profiling of cancer 287

Cancer Genome Atlas 287

Cancer Genetic Markers of Susceptibility Project 288

Oncology Biomarker Qualification Initiative 288

Role of NCI in cancer biomarker development and validation 289

COBRED project for cancer biomarker research in Europe 290

Future prospects for cancer biomarkers 291

Cancer biomarker research at academic institutions 291

Future prospects and challenges in the discovery of cancer biomarkers 291

7. Biomarkers of Disorders of the Nervous System 293

Introduction 293

Discovery of biomarkers for neurological disorders 293

Biomarker identification in the CSF using proteomics 294

Biomarker identification in the CSF using lipidomics 294

Cerebral microdialysis for the study of biomarkers of cerebral metabolism 294

Detection of protein biomarkers of CNS disorders in the blood 295

Brain imaging for detection of biomarkers 295

Biomarkers of the aging brain 296

Cellular biomarker of aging of the brain 296

Protein aggregation as a biomarker of aging brain 296

Data mining for biomarkers of neurological disorders 296

Antibodies as biomarkers in disorders of the nervous system 297

Biomarkers of neural regeneration 297

Biomarkers of disruption of blood-brain barrier 297

Biomarkers of neurotoxicity 298

Glial fibrillary acidic protein as biomarker of neurotoxicity 298

Single-stranded DNA as a biomarker of neuronal apoptosis 298

Biomarkers of neurogenetic disorders 299

Charcot-Marie Tooth disease 299

Duchenne and Becker muscular dystrophy 300

Fragile X syndrome 301

Hereditary neuropathy with liability to pressure palsies 301

Hereditary metabolic storage disorders with neurologic manifestations 301

Gaucher disease 302

Pompe's disease 302

Mitochondrial disorders affecting the nervous system 302

Spinal muscular atrophy 303

Biomarkers of neurodegenerative disorders 303

Biomarkers of Alzheimer's disease 303

The ideal biomarker for AD 305

Protein biomarkers of AD in CSF 306

Amyloid precursor protein 307

Tau proteins in CSF 308

Tests for the detection of Ab in CSF 308

Monitoring of synthesis and clearance rates of Ab in the CSF 309

Tests combining CSF tau and Ab 309

CSF sulfatide as a biomarker for AD 310

Glycerophosphocholine as CSF biomarker in AD 310

CSF Reelin as biomarker of AD 310

Urine tests for AD 311

Plasma protein biomarkers of AD 311

A serum protein-based algorithm for the detection of AD 312

Protein kinase C in red blood cells 312

Detection of aggregated misfolded proteins in the blood 312

Lymphocyte Proliferation Test 312

A biomarker-based skin test for AD 313

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