Reportlinker Adds Biomarkers - Technologies, Markets and Companies
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
Radioiodinated c
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