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Biomarkers - Technologies, Markets & Companies

  • ID: 4748179
  • Report
  • December 2019
  • 1025 Pages
  • Jain PharmaBiotech
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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 the 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 the use of pharmacogenetics, pharmacogenomics and pharmacoproteomics for the 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 2018 to 2028 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 302 of these are profiled in part 2 of the report with classification into various categories. These also include major pharmaceutical companies. There is a tabulation of 471 collaborations between companies and additional academic collaborations are mentioned in the individual profiles of companies. The report is supplemented by 1000 references, 82 tables and 24 figures.

The report contains information on the following:

  • Technologies for Discovery of Biomarkers
  • Biomarkers and Molecular Diagnostics
  • Biomarkers for Drug Discovery and Development
  • Role of Biomarkers in Healthcare
  • Biomarkers in Metabolic Disorders
  • Biomarkers in Immune Disorders
  • Biomarkers of Musculoskeletal Disorders
  • Biomarkers of Infectious Diseases
  • Biomarkers of Genetic Disorders
  • Biomarkers of Aging
  • Nutritional Biomarkers
  • Biomarkers in Cancer
  • Biomarkers of Disorders of the Nervous System
  • Biomarkers of Cardiovascular Disorders
  • Biomarkers of Pulmonary Diseases
  • Biomarkers in Gynecology and Obstetrics
  • Biomarkers and Personalized Medicine
  • Regulatory issues
  • Markets for Biomarkers
  • Companies
Note: Product cover images may vary from those shown
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Part 1: Technologies & Applications

0. Executive Summary  

1. Introduction  
Definitions  
Historical aspects of biomarkers
Classification of biomarkers
Biomarker as a response to therapeutic intervention  
Pharmacokinetic/pharmacodynamics biomarkers  
Predictive biomarkers  
Biomarkers of drug safety
Valid biomarkers
Types of biomarkers  
Genes as biomarkers
Silent gene mutations
Epigenetic biomarkers  
Exosomes as biomarkers  
Proteins as biomarkers  
Proteomics  
DNA biomarkers  
Mitochondrial DNA  
Mitochondrial mutations
RNA biomarkers
Transcriptomics  
MicroRNAs  
Metabolomics  
Glycomics  
Single nucleotide polymorphisms  
Haplotyping
Cell biomarkers of disease  
Stem cell biomarkers
Association of stem cell biomarkers with disease
Cancer stem cell biomarkers
Plectin as biomarker of cancer stem cells  
Endoglin as a functional biomarker of stem cells  
p75NTR as a biomarker to isolate adipose tissue-derived stem cells  
Protein expression profile as biomarker of stem cells  
STEMPRO EZChek for analysis of biomarkers of hESCs  
SSEA-4 as biomarker of MSCs  
Gaseous mediators as biomarkers of disease
Autoantibodies as biomarkers of autoimmune diseases
Digital biomarkers
Variations of biomarkers with circadian rhythms
Comparison of various types of biomarkers  
Biomarkers and systems biology  
Systems biology approach to biomarker identification
Relation of biomarkers to other technologies and healthcare  
Biomarkers and translational medicine
Role of biomarkers in monitoring of diseases
Limitations of use of biomarkers in healthcare  

2. Technologies for Discovery of Biomarkers  
Introduction  
The ideal biomarker  
Genomic technologies
Gene expression  
Whole genome expression array  
Gene expression profiling on whole blood samples  
Profiling gene expression patterns of white blood cells
Tissue microarrays for study of biomarkers  
Technologies for detection of miRNAs as biomarkers  
Microarrays for analysis of miRNA gene expression  
Microarrays vs quantitative PCR for measuring miRNAs
Point-of-care detection of circulating miRNAs as biomarkers
Epigenomic technologies  
Discovery of methylation biomarkers
Detection of epigenetic biomarkers  
Proteomic technologies  
2D GE  
ProteoCarta® integrated proteomics discovery platform  
Isotope-coded affinity tags
Liquid chromatography-MS/MS
Lucid Proteomics System  
Magnetics beads for protein biomarker discovery  
MASStermind™
Combined analysis of protein and nucleic-acid biomarkers  
Mass spectrometry
2D PAGE and mass spectrometry  
Imaging mass spectrometry  
MALDI mass spectrometry for biomarker discovery  
Quantitative tandem MS  
Single-molecule mass spectrometry using a nanopore  
Requirements for MS-based proteomic biomarker development  
Nucleic Acid Programmable Protein Array
Protein tomography
Protein biochips/microarrays and biomarkers  
Antibody array/affinity proteomics-based biomarker discovery
Detection of biomarkers using peptide array technology  
ProtoArray®
Protein nanobiochip
Proximity Extension Assay  
Gene expression microarray data as a source of protein biomarkers
Quantification of protein biomarkers
CyTOF for quantification of biomarkers  
Digital protein biomarker measurement
Multiple reaction monitoring assays
Real-time PCR for quantification of protein biomarkers  
Search for biomarkers in body fluids  
Challenges and strategies for discovey of protein biomarkers in plasma
Technologies for removal of highly abundant proteins in blood
3D structure of CD38 as a biomarker
BD™ Free Flow Electrophoresis System  
Isotope tags for relative and absolute quantification
Plasma protein microparticles as biomarkers  
Proteome partitioning
Stable isotope tagging methods  
Technology to measure both the identity and size of the biomarker
Selected reaction monitoring MS
Targeted MS for verification of biomarkers  
Biomarkers in the urinary proteome  
Peptides as biomarkers of disease
Analysis of peptides in bodily fluids  
Antibody biomarker discovery via evolution of peptides  
Selected reaction monitoring for validating peptide biomarkers
Serum peptidome patterns
SISCAPA method for quantitating proteins and peptides in plasma  
Comparison of proteomic profiling technologies for discovery of biomarkers  
Verification for interlaboratory reproducibility of protein biomarkers  
Significance of similar protein biomarkers in different tissues  
Glycomic technologies  
Cellular glycomics for discovery of cellular biomarkers  
Metabolomic technologies  
Genome-wide association studies for identification of metabolic biomarkers  
Genetic influences on human blood metabolites  
Lipid profiling  
Mass spectrometry for discovery of metabolic biomarkers in plasma
Role of metabolomics in biomarker identification and pattern recognition
Urinary profiling by capillary electrophoresis
Validation of biomarkers in large-scale human metabolomics studies
Lipidomics  
Disease biomarkers in breath  
Portable breath test for volatile organic compounds  
Detection of breath biomarkers by sensation technology
Detection of breath biomarkers by nanosensors
Detection of breath biomarkers optical frequency comb spectroscopy  
Detection of breath biomarkers by infrared absorption spectroscopy  
Detection of biomarkers by electronic nose  
Fluorescent indicators for biomarkers  
Molecular imaging technologies
Computer tomography
Magnetic resonance imaging  
Positron emission tomography
Advantages of imaging biomarkers
Monitoring in vivo gene expression by molecular imaging  
Molecular imaging in vivo as a biomarker
Challenges and future of molecular imaging  
Basic research in molecular imaging
Imaging intracellular NADH as a biomarker of disease  
Devices for molecular imaging  
Imaging biomarkers in clinical trials  
Molecular imaging in clinical practice  
Nuclear magnetic resonance
Chemical derivatization to enhance biomarker detection by NMR  
Fluxomics by using NMR  
Nanobiotechnology  
Dip Pen Nanolithography
Nanomaterials for biolabeling  
Quantum dot molecular labels  
Bioconjugated QDs for multiplexed profiling of biomarkers  
Magnetic nanotags for multipley detection of biomarkers  
Nanoparticles for molecular imaging
Nanoparticles for discovering biomarkers  
Nanoproteomics and biomarkers
High-field asymmetric waveform ion mobility mass spectrometry
Nanosensors for measuring biomarkers in blood  
Nanobiochip sensor technique for analysis of oral cancer biomarkers
Future prospects of application of nanobiotechnology for biomarkers
Bioinformatics  
Biomarker Workflow Guide
Analysis of microarray data for selecting useful biomarkers
Role of bioinformatics in discovery of protein biomarkers  
Role of bioinformatics in detection of cancer biomarkers  
Biomarker databases
Gene networks as biomarkers
Role of bioinformatics in integrating various data and biomarker discovery  
Evaluation of biomarker studies  

3. Biomarkers and Molecular Diagnostics  
Introduction  
Molecular diagnostic technologies  
Polymerase chain reaction
Amplification  
Target selection
Detection of amplified DNA
Limitations of PCR
Real-time PCR systems
Limitations of real-time PCR  
Future applications of real-time qPCR  
Real-time qPCR for quantification of circulating mtDNA
Combined PCR-ELISA  
Non-PCR methods
Linked Linear Amplification
Transcription mediated amplification  
Rapid analysis of gene expression
WAVE nucleic acid fragment analysis system
DNA probes with conjugated minor groove binder  
Rolling circle amplification technology
Gene-based diagnostics through RCAT
RCAT-immunodiagnostics
RCAT-biochips  
RCAT-pharmacogenomics  
Circle-to-circle amplification  
Biomarkers and high throughput molecular screening
Detection and expression profiling of miRNA
Real-time PCR for expression profiling of miRNAs
Use of LNA to explore miRNA
Microarrays for analysis of miRNA gene expression  
Devices for biomarkers  
Biochips and microarrays  
Applications of biochips/microarrays
Role of biochip/microarrays in discovery of biomarkers  
Biosensors for biomarkers
Biosensor for analysis of sweat biomarkers  

4. Biomarkers for Drug Discovery & Development  
Introduction  
Biomarker technologies for drug discovery
Proteomics-based biomarkers for drug discovery  
Chemoproteomics  
Activity-based chemical proteomics  
Transcriptomics for drug discovery
Metabolomics for drug discovery
Biomarkers and drug safety
Biomarkers of adverse drug reactions
Applications of biomarkers in drug safety studies  
Genomic technologies for toxicology biomarkers  
Proteomic technologies for toxicology biomarkers  
Metabonomic technologies for toxicology biomarkers
Integration of genomic and metabonomic data to develop toxicity biomarkers
Toxicology studies based on biomarkers  
Biomarker of genotoxicity  
Biomarkers of hepatotoxicity  
Biomarkers of nephrotoxicity  
Cardiotoxicity  
Neurotoxicity
Applications of biomarkers for drug development  
Application of metabonomics/metabolomics for drug development  
Application of biomarkers by the pharmaceutical companies
Biomarkers in clinical trials
NIH recommendations on the use of biomarkers in clinical trials  
Advantages of biomarkers for drug development  
Limitations and problems with use of biomarkers in clinical trials  
Development of static and dynamic biomarkers  
Molecular imaging as a biomarker in drug development
Molecular imaging in preclinical studies
Molecular imaging in clinical trials  
Prospects of molecular imaging in drug discovery and development  
Pharmacogenomic biomarker information in drug labels
Role of biomarkers in vaccine development and testing for efficacy  
Role of biomarkers in relation to stage of drug discovery and development  
Role of pharmacokinetic/pharmacodynamic biomarkers in drug development  
Role of biomarkers for drug development in cardiovascular disorders  
Role of biomarkers for drug development in neurological disorders
Significance of biomarkers in drug development  
Organizations & resources for biomarker-based drug development  
Biomarker Alliance  
Biomarkers Consortium  
Molecular Libraries and Imaging Roadmap of NIH  
Rare Diseases Clinical Research Consortia
Future of biomarker-based drug development

5. Role of Biomarkers in Healthcare  
Introduction  
Biomarkers of inflammation
ESR and CRP as biomarkers of inflammation  
Metabolic biomarkers of inflammation
YKL-40 as a biomarker inflammation and predictor of mortality  
Biomarkers of allergic disorders  
Biomarkers of oxidative stress  
1,4-dihydroxynonane-mercapturic acid
Oxidized phospholipids  
Oxidative DNA damage
Proteins as biomarkers of oxidative stress in diseases  
Testing for oxidative stress  
Biomarkers of hypoxia
Pathophysiology of hypoxia  
Hypoxia inducible factor as biomarker of hypoxia and response to oxygenation  
Identification of hypoxia biomarkers from exhaled breath  
Metabolic biomarkers of hypoxia  
Biomarkers of liver disease
Breath biomarkers of liver disease  
Biomarkers of liver injury
Fibrosis and cirrhosis of liver  
FibroMax
Hepatic encephalopathy
miRNA biomarkers of liver disease  
Viral hepatitis B and C  
Biomarkers of hepatitis C
Biomarkers of hepatitis B
Biomarkers of pancreatitis
Biomarkers of renal disease
Biomarkers of lupus nephritis  
Biomarkers of diabetic nephropathy  
Cystatin C as biomarker of glomerular filtration rate (GFR)  
Estimated GFR and albuminuria as biomarkers of chronic kidney disease  
Proteomic biomarkers of acute kidney injury  
Symmetric dimethylarginine as biomarker of chronic kidney disease in dogs  
Troponin-T as a biomarker for predicting end-stage renal disease  
Biomarkers in pediatrics  
Estimation of DNA methylation age in pediatrics by PedBE clock  
Pediatric critical care  
Biomarkers of acute kidney injury in children  
Biomarkers of miscellaneous disorders
Biomarkers of acid-base disorders in acute care setting  
Biomarkers of carbon monoxide poisoning  
Biomarkers of alcoholism and nicotine addiction  
Biomarkers of Castleman disease
Biomarkers of erectile dysfunction
Biomarkers of fever
Biomarkers of heat stroke
Biomarkers of hyponatremia  
Biomarkers of inflammatory bowel disease
Biomarkers of radiation injury  
Biomarkers for prediction of all-cause mortality  
Biomarkers common to multiple diseases
Nasal nitric oxide as a biomarker of response to rhinosinusitis therapy  
Biomarkers of gene-environmental interactions in human disease
Application of biomarkers in animal health

6. Biomarkers in Metabolic Disorders  
Introduction  
Biomarkers of acute intermittent porphyria
Liver X receptors  
Biomarkers of diabetes mellitus  
β-cell function as biomarker of diabetes
Biomarkers of hyperglycemia  
Biomarkers of diabetes-associated oxidative stress  
Biomarkers of inflammation associated with diabetes  
Biomarkers of renal complications in diabetes mellitus type 2
Biomarkers of diabesity  
Biomarkers of prediabetes  
Biomarkers of insulin resistance
Elevated plasma furin level  
Glycosylated hemoglobin in diabetes mellitus  
Glycated albumin as a biomarker of diabetes mellitus
Low C-peptide as a biomarker of complications of diabetes type 1  
Personalized management of diabetes mellitus based on biomarkers
Biomarkers of metabolic syndrome
Adiponectin
Advanced glycation end products  
Cystatin C
Human plasma lipidome
Neurotensin as biomarker of obesity  

7. Biomarkers in Immune Disorders  
Introduction  
Biomarkers relevant to organ transplantation  
Biomarkers of graft versus host disease
Biomarkers of renal allograft failure  
Biomarkers of renal transplant tolerance
Biomarkers of lung transplant rejection  
Biomarkers of GVHD following transplantation of hematopoietic cells
Plasma biomarkers of response to therapy of GVHD  
Systemic lupus erythematosus  
Current management and need for biomarkers of SLE  
Role of collaborative efforts and databases of SLE biomarkers  
Biomarkers of SLE
Adiponectin as biomarker of SLE
C4d-bearing reticulocytes  
CB-CAPS
Circulating pentraxin-3 levels  
Epigenetic biomarkers of SLE  
Genetic loci of SLE  
HMGB1  
Biomarkers of systemic sclerosis
Biomarkers of Sjögren syndrome

8. Biomarkers of Musculoskeletal Disorders  
Introduction  
Muscle disorders
Biomarkers of muscle fatigue during exercise  
Biomarkers of mitochondrial content in skeletal muscle  
Idiopathic inflammatory myopathies
Rheumatoid arthritis
Assays for biomarkers of RA
Biomarkers for personalizing therapy of rheumatoid arthritis  
Circulating cytokines in RA
Epigenetic biomarkers of rheumatoid arthritis
miRNA biomarkers in RA
Serum CRP in RA  
Biomarkers of spondylarthritis  
Biomarkers of axial spondyloarthritis  
Biomarkers of psoriatic arthritis  
Osteoarthritis  
Molecular pathophysiology of OA  
Biomarkers of osteoarthritis  
Assays for biomarkers of OA
Biomarkers of OA
Concluding remarks and future prospects of biomarkers of OA
Biomarkers of osteoporosis  
Assays for detection of biomarkers of osteoporosis
Bone imaging with quantitative CT and MRI  
Circulating miRNAs as biomarkers of osteoporosis
Dual x-ray absorptiometry  
Utility of biomarkers of osteoporosis
Biomarkers of osteonecrosis
Osteonecrosis in Gaucher’s disease  

9. Biomarkers of Infectious Diseases
Introduction  
Technologies for discovery of biomarkers of infection  
Chemokines as biomarkers of infection  
Endotoxin as biomarker of infection
Proteomics for discovering biomarkers of infections
Soluble urokinase plasminogen activator receptor  
Sepsis  
Biomarkers of sepsis  
Circulating CPS-1 as biomarkers of organ damage in sepsis  
CoQ10 level reduction in septic shock
Multibiomarker-based outcome risk stratification of septic shock
Nitric oxide as a biomarker of sepsis  
SuPAR as a biomarker of sepsis  
Systemic inflammatory response syndrome
Tuberculosis  
Conventional diagnosis of tuberculosis
Molecular diagnostics for tuberculosis
Biomarkers for tuberculosis
Biomarkers of pulmonary tuberculosis in the breath  
Transcriptional signatures in active vs asymptomatic tuberculosis  
Biomarkers of viral infections  
Viral hepatitis  
Biomarkers of SARS  
Biomarkers of HIV
Biomarkers in parasitic infections
Role of biomarkers in malaria  
Identification of biomarkers in Schistosomiasis infections
Diagnostic & therapeutic applications of biomarkers of infections
Biomarkers to discriminate bacterial from nonbacterial respiratory infections
Procalcitonin as a guide to antibiotic therapy in infections  

10. Biomarkers of Genetic Disorders
Introduction  
Biomarkers of Down’s syndrome  
Biomarkers of muscular dystrophy  
Biomarkers of phenylketonuria
Genetic biomarkers of psoriasis
Biomarkers of lysosomal storage disorders  
Biomarkers of Niemann-Pick disease  
Bile acids as biomarkers for the early diagnosis of NPD
Cholesterol oxidation products as biomarkers of NPD
Biomarkers of mucopolysaccharidoses  
Proteomic technologies for biomarkers of MPS
Glycan-based biomarkers for MPS
Biomarkers of LSD  
Prenatal diagnosis of LSD
Biomarkers of Fabry’s disease  

11. Biomarkers of Aging  
Introduction  
Biomarkers of biological age
Gene variants as determinants of biological age
Gene expression profiles for calculating transcriptomic age  
Telomere attrition as aging biomarker  
Biomarkers of healthy aging
Biomarkers of longevity
Effect of calorie restriction on biomarkers of longevity  
Healthy aging index  
Low serum thyroid hormone level as biomarker of longevity
Biomarkers as predictors of mortality with aging  
Genetic biomarkers of aging
Genetic signatures of longevity
Biomarkers of accelerated biological aging in smokers
Metabolomic biomarkers of aging
Mitochondrial mutations as biomarkers of aging  
Oxidative biomarkers of aging
Molecular diagnostics and biomarkers of age-related diseases
Protein biomarkers of aging  
Carbamylated proteins as biomarkers of aging  
Proteomic biomarkers of muscle aging
Role of humanin in age-related diseases  
Role of bioinformatics in search for biomarkers of aging
Aging biomarkers in a genetically homogeneous population  
Biomarkers of aging of various organs  
Biomarkers of aging brain  

12. Nutritional Biomarkers  
Introduction  
Biomarkers of Nutrition for Development project  
Biomarkers in nutritional epidemiology  
Biomarkers of nutritional status  
Ferritin as biomarker of nutritional status
Folate biomarkers related to nutritional health status  
Iodine as biomarker of nutritional status
Zinc as a biomarker of nutritional status  
Biomarkers of branched chain amino acid status
Biomarkers of caloric restriction
Biomarkers of malnutrition
Maternal nutrition during early pregnancy causes epigenetic changes
Proteomic biomarkers and nutrition  
Vitamin deficiency as biomarker of disease  
Vitamin A biomarkers  
Vitamin B12 deficiency  
Vitamin D deficiency as a biomarker of disease
Role of biomarkers in the development of personalized nutrition  

13. Biomarkers of Cancer
Introduction  
The ideal biomarker for cancer  
Biomarkers and hallmarks of cancer  
Single vs multiple biomarkers of cancer  
Types of cancer biomarkers  
miRNAs as biomarkers in cancer  
Diagnostic value of miRNA in cancer
Biomarkers of epigenetic gene silencing in cancer  
5-hydroxymethylcytosine as a biomarker of cancer  
Carcinoembryonic antigen
Circulating cancer biomarkers
Circulating tumor cells as cancer biomarkers  
Circulating nucleic acids as potential biomarkers of cancer  
Circulating exosomes and microvesicles as biomarkers of cancer  
Circulating miRNAs for cancer detection
DNA repair biomarkers  
ERBB3 as biomarker of cancer  
Immunologic and inflammation biomarkers of cancer  
Metastatic cancer biomarkers  
Molecular diagnostic techniques for cancer  
Technologies for detection of cancer biomarkers
Genomic technologies for cancer biomarkers  
Biomarkers of PTEN tumor suppressor gene status
Cold-PCR  
ddPCR for detection of cancer biomarkers in cell free plasma DNA
Digital karyotyping for cancer biomarkers  
Genome analysis at the molecular level  
KRAS as a biomarker of cancer  
LigAmp for detection of gene mutations in cancer  
Mitochondrial DNA as a cancer biomarker
Next generation squencing for detection of cancer biomarkers
Telomerase as a biomarker of cancer  
Tissue microarrays for study of cancer biomarkers  
Molecular fingerprinting of cancer  
NIPT for detecting biomarkers of gynecological cancers  
Proteomic technologies for detecting biomarkers of cancer
2D PAGE
Antibody-based detection of protein biomarkers  
Aptamer-based molecular probes for cancer biomarker discovery
Biomarkers of protein-drug interactions in cancer  
Cancer immunomics to identify autoantibody signatures  
Desorption electrospray ionization for detection of cancer biomarkers
Detection of circulating nucleosomes in serum of cancer patients  
Detection of tumor biomarkers with ProteinChip technology  
Glycoprotein biomarkers of cancer  
HER-2/neu oncoprotein as biomarkers for cancer  
Humoral proteomics  
Laser capture microdissection
Membrane-type serine protease-1
Proteomic analysis of cancer cell mitochondria
Proteomic technologies for detection of autoimmune biomarkers  
SELDI-TOF MS
Serum proteome analysis for early detection of cancer  
Synthetic biomarker-based POC diagnostic for cancer
Triple-quadrupole MS for detection of mutant proteins
Targeted MS for validation of cancer biomarkers in plasma  
Tissue proteomics for discovery of cancer biomarkers
VeraTag system for cancer biomarkers  
Metabolomic biomarkers of cancer  
Magnetic resonance for detecting metabolomics biomarkers of cancer  
Choline phospholipid biomarkers of cancer  
Hypoxia-inducible factor-1  
Detection of drug resistance in cancer by metabolic profiling  
Plasma free amino acids profiling in cancer  
Urinary metabolomic biomarkers of cancer
Epitomics for the early detection of cancer  
Epigenetic biomarkers of cancer  
Detection of biomarkers of DNA methylation  
Epigenomics Marker Machine for DNA methylation biomarkers
Histone deacetylase  
MDScan microarray technology  
Mucins as epigenetic biomarkers in epithelial cancers  
PCR with bisulfite for detecting DNA methylation biomarkers in cancer  
Detection of methylated DNA in serum and urine  
Integrated platform for genetic and epigenetic analysis  
Nanobiotechnology for early detection of cancer to improve treatment  
Aptasensor for electrochemical detection of exosomes
Nanovesicles for detection of cancer biomarkers  
Nanowire biosensors for detection of cancer biomarkers  
NP-peptide complexes for detection of cancer biomarkers in urine
Ultrasound radiation to enhance release of a tumor biomarker  
In vivo imaging of cancer biomarkers  
Computer tomography
Optical systems for in vivo molecular imaging of cancer
Positron emission tomography  
Imaging of tumor oxygenation and microvascular permeability by MRI  
Xenon-enhanced MRI  
Kallikrein gene family and cancer biomarkers  
Detection of CTCs as biomarkers of cancer
Applications of cancer biomarkers
Use of biomarkers for cancer classification  
Cancer classification using microarrays  
Proteomic classification of cancer  
Use of biomarkers for early detection of cancer  
Applications of biomarkers for cancer diagnosis  
Methylated DNA sequences as cancer biomarkers  
MicroRNA expression profiling for diagnosis of human cancers  
MUC4 as a diagnostic biomarker in cancer
Applications of biomarkers for cancer diagnosis and therapy  
Asparagine synthetase as biomarker for therapy with L-asparaginase
Peptide-based agents for targeting cancer biomarkers  
PI3K mutations as a biomarker for use as a companion diagnostic  
Biomarkers for assessing efficacy of cancer therapy  
ERCC1-XPF expression as a biomarker of response to chemotherapy
P53 expression level as biomarker of efficacy of cancer gene therapy  
Biomarkers of angiogenesis for developing antiangiogenic therapy
Biomarkers of response to antiangiogenic agents  
Circulating endothelial cells as targets for antiangiogenic drugs  
Imaging biomarkers for evaluation of antiangiogenic agents
Tumor endothelial biomarkers  
VEGF signaling inhibitors as biomarkers
VEGF-PET imaging for analysis of angiogenic changes within a tumor  
Biomarkers of prognosis in cancer treatment
Biomarkers for monitoring cancer therapy
Biomarkers of drug resistance in cancer
A systems approach to biomarkers of innate drug resistance
Epithelial membrane protein-1 as a biomarker of gefitinib resistance
Metabolomic biomarkers of cancer  
Methylation biomarkers of drug resistance in cancer
STAT3 and resistance to cisplatin
Biomarkers of radiation therapy for cancer
Biomarkers of minimal residual disease in cancer
Role of biomarkers in drug development in oncology  
Biomarker-based approval of an anticancer drug regardless of site  
Biomarkers in plucked hair for assessing cancer therapy
Biomarkers for drug discovery in cancer  
ARTS as a biomarker as well as a basis of anticancer drugs
Met receptors as targets for anticancer drugs  
Overexpression of ERBB2 as biomarker for anticancer drug discovery
Molecular imaging of tumor as a guide to drug development  
Use of PET and SPECT to assess response to anticancer drugs  
Use of MRI to assess response to anticancer drugs
Role of biomarkers in phase I clinical trials of anticancer drugs
Safety biomarkers in oncology studies  
Biomarkers according to organ/type of cancer
Bladder cancer biomarkers
Detection of FGFR3 mutations in urine for diagnosis of bladder cancer  
NMP22 BladderChek  
Urinary telomerase as biomarker for detection of bladder cancer  
Concluding remarks abut biomarkers of urinary cancer  
Brain tumor biomarkers  
14-3-3zeta expression as prognostic biomarker for glioblastoma
ALDH1A3 as a biomarker of glioblastoma
Biomarkers to predict response to EGFR inhibitors  
Biomarkers for predicting recurrence of meningiomas
CD133 as biomarker of resistance to radiotherapy  
Circulating microvesicles as biomarkers  
CSF attractin as a biomarker of malignant astrocytoma  
ELTD1 as a biomarker of gliomas  
Methylation profiling of brain tumors  
Metabolite biomarkers of brain tumors
miRNAs as biomarkers of brain tumors  
MRI biomarker for response of brain tumor to therapy
Multigene predictor of outcome in glioblastoma  
Neuroimaging biomarkers combined with DNA microarray analysis
Proteomic analysis of CSF for identification of biomarkers for gliomas
Receptor protein tyrosine phosphatase  as biomarker of gliomas  
Serum protein fingerprinting  
VEGF-R2 as biomarker of angiogenesis in brain tumors
Future prospects of biomarkers of malignant gliomas  
Bone tumor biomarkers  
Cytogenetics for the study of bone and soft tissue tumors
Biomarkers of Ewing’s tumors
Role of biomarkers in the diagnosis of bone tumors
Breast cancer biomarkers  
Autoantibody biomarkers of breast cancer
Biomarkers of breast cancer in breath  
Biomarkers for breast cancer in nipple aspiration fluid  
Biomarkers to evaluate efficacy of chemoprevention  
Biomarkers of response to chemotherapy of breast cancer  
Biomarker-guided decisions for breast cancer therapy  
Carbonic anhydrase IX
Cdk6 as a biomarker of breast cancer
Centromere protein-F  
Circulating tumor DNA as biomarker of breast cancer  
Circulating exosomes as biomarkers of breast cancer  
COX-2 as a biomarker of breast cancer
Diagnostic tests based on breast cancer genes  
ERBB2 overexpression as biomarker of breast cancer  
G88 as a biomarker of progression of ER+ breast cancer  
Glycomic biomarkers of breast cancer
High mobility group protein A2  
Hypermethylated genes as biomarkers of metastatic breast cancer  
Lipocalin 2 as biomarker of breast cancer progression  
Long intervening non-coding RNAs  
Mammaglobin
miRNA biomarkers of breast cancer
p27 expression as biomarker for survival after chemotherapy
Podocalyxin
Proneurotensin and Proenkephalin  
Proliferating cell nuclear antigen  
Protein kinase C as a predictive biomarker of metastatic breast cancer  
Proteomic biomarkers of breast cancer  
Quantification of biomarker expression patterns by flow cytometry  
Quantitative realtime PCR assays for biomarker validation  
Retinoblastoma tumor suppressor gene as a biomarker  
Riboflavin carrier protein
Risk of invasive cancer after diagnosis of ductal carcinoma in situ  
Serum CA 15-3 as biomarker of prognosis in advanced breast cancer
Stage-specific embryonic antigen-3
Suppressor of deltex protein
Tumor microenvironment as biomarker of metastasis in breast cancer
Type III TGF- receptor as regulator of cancer progression  
Prognostic role of breast cancer genes
Protein biomarkers for breast cancer prevention  
Concluding remarks and future prospects of breast cancer biomarkers  
Cervical cancer biomarkers  
Gastrointestinal cancer biomarkers  
Esophageal cancer biomarkers
Gastric cancer biomarkers
Colorectal cancer biomarkers
Head and neck cancer  
Leukemia biomarkers  
Chromosome translocations in leukemias  
DNA methylation biomarkers in leukemia
Gene mutations as biomarkers in leukemia  
Molecular diagnostic techniques for leukemia
Proteomic technologies for discovering biomarkers of leukemia
Biomarkers of chronic lymphocytic leukemia
Biomarkers of chronic myeloid leukemia  
Biomarkers of drug resistance in leukemia  
Biomarkers of myelodysplasitic syndromes
Lymphoma biomarkers  
Liver cancer biomarkers
Biomarkers indicating lower risk of HCC in coffee drinkers
Metabonomic profiles discriminate HCC from liver cirrhosis  
Urinary biomarkers of HCC
Lung cancer biomarkers
Autoantibodies as biomarkers in lung cancer  
Biomarkers associated with neuroendocrine differentiation in NSCLC  
Biomarkers of chronic inflammation in lung cancer  
Biomarkers for predicting sensitivity to chemotherapy in lung cancer  
Biomarkers for prediction of sensitivity to EGFR inhibitors  
CTCs as biomarkers of lung cancer
Genomic biomarkers of lung cancer
Methylation biomarkers of lung cancer
miRNA biomarkers in lung cancer
Noninvasive detection of lung cancer using exhaled breath.  
Serum protein biomarkers of lung cancer  
tNOX as biomarker of lung cancer  
Tumor-derived DNA and RNA markers in blood  
Volatile organic compounds in the exhaled breath  
Malignant pleural mesothelioma
Melanoma biomarkers  
Nasopharyngeal carcinoma biomarkers
Proteomic biomarkers of nasopharyngeal cancer  
miRNA biomarkers of nasopharyngeal carcinoma  
Neuroendocrine tumors  
Oral cancer biomarkers
Ovarian cancer biomarkers
3D microfluidic platform to assess multiple ovarian cancer biomarkers  
CA125 as biomarker of ovarian cancer
Epitomics approach for ovarian cancer biomarkers in serum
FGF18 as a biomarker in ovarian cancer  
Gene expression studies in ovarian cancer  
HE4 protein in urine as a biomarker for ovarian cancer  
Hematogenous metastasis of ovarian cancer  
HtrA1 as a biomarker of response to chemotherapy in ovarian cancer  
Mutation of genes in ovarian cancer  
Serum biomarkers of ovarian cancer prognosis
TIM-3 as a biomarker of ovarian cancer  
Multiplex assays for biomarkers of ovarian cancer  
Concluding remarks on biomarker-based tests of ovarian cancer
Pancreatic cancer biomarkers  
Discovery and validation of pancreatic cancer biomarkers  
Cancer stem cells as biomarkers of pancreatic cancer  
Circulating exosomes as biomarkers of pancreatic cancer
Histone modifications used as biomarkers in pancreatic cancer  
miRNA biomarkers of pancreatic cancer  
Macrophage inhibitory cytokine-1 as biomarker of pancreatic cancer  
Proteomic biomarkers of pancreatic cancer
Concluding remarks on biomarkers of pancreatic cancer  
Parathyroid cancer biomarkers  
Peripheral nerve tumors  
Biomarkers of neurofibromatosis
Prostate cancer
Adipose tissue-derived biomarkers of obesity-related prostate cancer
B7-H3 as biomarker of prostate cancer  
Cancer genetics-guided biomarker signatures of prostate cancer  
Detection of prostate cancer biomarkers in urine  
Detection of prostatic intraepithelial neoplasia  
Epigenetic biomarkers of prostate cancer  
Exosomes as biomarkers of prostate cancer  
Gene expression analysis of prostate cancer
Genetic biomarkers of prostate cancer  
Identification of prostate cancer mRNA biomarkers  
Kallikreins as biomarkers of prostate cancer  
LCM for diagnosis of prostate cancer  
Microarray for diagnosis of prostate cancer  
miRNA biomarkers of prostate cancer  
Prostate cancer biomarkers in semen  
PSA as biomarker of prostate cancer  
ProPSA as biomarker of prostate cancer
Prostate Health Index
Prostasomes in blood as biomarker of prostate cancer  
PSMA as biomarker of prostate cancer  
Sarcosine as a metabolic biomarker of prostate cancer  
Silenced CDH13 gene as a biomarker of cancer  
Serum-protein fingerprinting  
Concluding remarks on biomarkers of prostate cancer  
Renal cancer biomarkers
Gene expression profile of RCC for biomarkers  
KIM-1 as a plasma biomarker of RCC  
miRNA biomarkers of renal cancer  
Use of proteomics for detection of RCC biomarkers  
Use of RCC biomarkers for prognosis and therapy  
Thyroid cancer biomarkers  
Detection of BRAF mutation
Gene expression biomarkers of thyroid cancer  
miRNA biomarkers of thyroid cancer
Multiple endocrine neoplasia type 2B as risk factor for thyroid cancer  
Role of the NCI in cancer biomarkers
Future prospects for cancer biomarkers  
Cancer biomarker research at academic institutions  
Future challenges in the discovery of cancer biomarkers  

14. Biomarkers of Disorders of the Nervous System
Introduction  
Discovery of biomarkers for neurological disorders
Antibodies as biomarkers in disorders of the nervous system  
Biomarker identification in the CSF using proteomics
Biomarker identification in the CSF using lipidomics  
Cerebral microdialysis for the study of biomarkers of cerebral metabolism  
Brain imaging for detection of biomarkers  
Data mining for biomarkers of neurological disorders  
Detection of protein biomarkers of CNS disorders in the blood
Genomic technologies for study of biomarkers of neurological disorders
Telomere length as a biomarker of structural changes in the brain  
Biomarkers of neuroinflammation  
Biomarkers of neural regeneration  
Biomarkers of disruption of blood-brain barrier
Biomarkers of neurotoxicity
Glial fibrillary acidic protein as biomarker of neurotoxicity  
Single-stranded DNA as a biomarker of neuronal apoptosis  
Biomarkers of neurogenetic disorders  
Charcot-Marie Tooth disease  
Duchenne and Becker muscular dystrophy  
Early-onset torsion dystonia
Fragile X syndrome  
Genetic neurotransmitter disorders  
Hereditary neuropathy with liability to pressure palsies
Hereditary metabolic storage disorders with neurologic manifestations  
Gaucher disease  
Pompe’s disease  
Mitochondrial disorders affecting the nervous system  
Spinal muscular atrophy  
Biomarkers of SMA
Biomarkers of neurodegenerative disorders  
MicroRNAs as biomarkers of neurodegenerative disorders  
Biomarkers of dementia
Biomarkers of vascular dementia  
Biomarkers of Alzheimer’s disease  
The ideal biomarker for AD
Methods for determining biomarkers of AD
Gene expression patterns in AD  
Magnetic resonance spectroscopy in AD
Biomarkers of the aging brain  
Biomarkers of memory decline with aging  
CSF F2-isoprostanes as biomarker of aging brain  
IL-6 as a biomarker of cognitive impairment with aging
MRI transverse relaxation rate alteration as biomarker of aging brain
Protein aggregation as a biomarker of aging brain
Telomere shortening as a biomarker of aging brain and dementia  
MRI for biomarkers of AD
Nanotechnology to measure Aβ-derived diffusible ligands  
PET scanning for biomarkers of AD
Simultaneous measurement of several biomarkers for AD  
Targeting of chemokine receptor as biomarker for brain imaging  
Biomarkers of AD in CSF
CSF sulfatide as a biomarker for AD  
CSF Reelin as biomarker of AD  
Monitoring of synthesis and clearance rates of Aβ in the CSF  
Protein biomarkers of AD in CSF  
Tau proteins in CSF  
Tests for the detection of Aβ in CSF
Tests combining CSF tau and Aβ
Blood biomarkers of AD  
A serum protein-based algorithm for the detection of AD  
Amyloid precursor protein  
Detection of aggregated misfolded proteins in the blood  
Lipid biomarkers for preclinical detection of AD
Lymphocyte Proliferation Test
Metabolomic biomarker profiling  
miRNA biomarkers for AD  
Plasma protein biomarkers of AD  
Protein kinase C in red blood cells  
Urinary biomarkers of AD
A biomarker-based skin test for AD
Salivary biomarkers of AD
Applications of biomarkers of AD
Biomarker changes in autosomal dominantly inherited AD
Correlation of imaging biomarkers with CSF biomarkers of AD  
Genetic tests for AD  
Humanin as a biomarker as well as neuroprotective in AD
Plasma biomarkers of drug response in AD
PredictAD project
TOMM40 gene and risk of AD
Use of biomarkers to predict AD in patients with MCI
Concluding remarks about biomarkers for AD and future prospects  
Biomarkers of Parkinson’s disease  
Autoantibodies as biomarkers of PD  
Biomarkers of PD based on gene expression in blood
Cardiac denervation as a biomarker of PD
Caffeine levels in blood
Genetic biomarkers of PD
Imaging biomarkers of PD
Metabolic brain networks as biomarkers
Metabonomic biomarker profile for diagnosis and monitoring of PD  
Protein biomarkers of PD  
α-synuclein as a biomarker of PD  
P11 protein as a biomarker of depression in PD  
Serum vitamin D as a biomarker of PD  
Biomarkers of prodromal PD
Future needs for biomarkers of PD  
Biomarkers of Huntington's disease  
Genetic biomarker of HD progression  
Quantitative MRI measurement of brain atrophy as biomarker of HD
Metabolic networks as biomarkers of preclinical Huntington disease  
Biomarkers of Wilson’s disease  
Biomarkers of amyotrophic lateral sclerosis  
ALS biomarker detection in blood vs CSF  
Biomarkers of neuroinflammation in ALS
Genetic biomarkers of ALS  
Epigenetic biomarkers of ALS  
Imaging biomarkers of ALS  
Metabolomic biomarkers of ALS  
Proteomic biomarkers of ALS
Ideal biomarker of ALS  
Future of biomarkers of ALS
HIV-1-associated neurocognitive disorders  
Biomarkers of dementia in HIV-1-infected patients
Biomarkers of autoimmune encephalitis
Biomarkers of prion diseases
14-3-3 protein and tTau/P-Tau ratio
Bioluminescence imaging as a surrogate biomarker of prion infectivity  
miRNAs as biomarkers of prion-induced neurodegeneration  
MRI biomarker of CJD
Prion protein detection by real-time quaking-induced conversion  
Prions in the urine of patients with variant CJD
Biomarkers of multiple sclerosis
Antibodies in multiple sclerosis  
Antibodies to galactocerebroside
Antibodies to myelin oligodendrocyte glycoprotein  
Brain N-acetylaspartylglutamate as biomarker of cognitive function in MS
Brain imaging biomarkers of multiple sclerosis
MRI biomarkers of multiple sclerosis
Molecular imaging
Biomarkers of response to therapy of multiple sclerosis  
Biomarkers of response to of interferon β-1a
DNA motifs in the blood as biomarkers of response to treatment  
Gene expression  
Lymphocyte subsets as biomarkers of therapeutic response  
Neurofilaments  
Vitamin D as predictor of activity and progression of MS  
CSF biomarkers in multiple sclerosis
CSF Cystatin C as a biomarker of multiple sclerosis  
Detecting autoantibodies in multiple sclerosis  
Switch-associated protein 70 antibodies in multiple sclerosis  
Gelsolin as a biomarker of multiple sclerosis
Matrix metalloproteinases as biomarkers in multiple sclerosis  
Oligoclonal bands as biomarkers of MS  
Serum proteomic pattern analysis in multiple sclerosis  
SIRT 1 as a biomarker in multiple sclerosis  
T cells as biomarkers of multiple sclerosis  
Concluding remarks and future perspective for biomarkers of multiple sclerosis
Biomarkers of cerebrovascular disorders
Biomarkers of stroke  
Etiological biomarkers of ischemic stroke  
Brain natriuretic peptide as a biomarker for cardioembolic stroke
Brain lactate and N-acetylaspartate as biomarkers of stroke
Calcium ion fluctuations as a biomarker of cerebral ischemia
CCL23 for prediction of stroke patient outcome
CRP as biomarker of risk of stroke  
CSF biomarkers in acute stroke  
Gene expression in blood following ischemic stroke  
Glutathione S-Transferase-π
Intercellular adhesion molecule 1 as biomarker of ischemic stroke  
Lp-PLA2 and CRP as biomarkers for stroke  
Matrix metalloproteinase-9
miRNAs as biomarkers of stroke  
Neuroserpin polymorphisms as a biomarker of stroke  
NMDA receptors as biomarkers of excitotoxicity in stroke
Nucleosomes as biomarkers of stroke
PARK7 and nucleoside diphosphate kinase A as biomarkers of stroke
Visinen-like protein 1
Biomarker panels for stroke  
Future prospects for biomarkers of stroke  
Biomarkers of cerebral vasospasm  
Biomarkers of intracerebral hemorrhage  
Biomarkers of hypoxic brain damage
Biomarkers of ischemic brain damage
D-dimer as a biomarker of cerebral venous thrombosis
Biomarkers of traumatic brain injury
Technologies for identification of biomarkers of TBI
Cerebral microdialysis for study of biomarkers of TBI  
Proteomic technologies for biomarkers of TBI  
Systems biology approach for discovery of biomarkers of TBI  
Biomarkers of TBI  
Aβ as a biomarker of TBI  
CCL11 as a biomarker of chronic traumatic encephalopathy  
Diffusion tensor imaging in TBI  
Glial fibrillary acidic protein as biomarker of TBI  
Hyperphosphorylated axonal neurofilament protein  
IL-6 and nerve growth factor as biomarkers of TBI
Myelin basic protein  
Neural exosome cargo  
Neurofilament heavy chain
Serum S100β as biomarker of TBI
SNTF as a biomarker for predicting cognitive decline after mild TBI  
Tau as biomarker of TBI  
Ubiquitin C-terminal Hydrolase-L1
Biomarkers of inflicted TBI in infants  
Biomarkers of concussion
Clinical applications of biomarkers of TBI  
Biomarkers of CNS infections
Biomarkers of bacterial meningitis  
Biomarkers of viral infections of CNS
Biomarkers of CNS HIV infection
CSF kynurenic acid level as a biomarker of tick-borne encephalitis  
Serum uric acid levels as biomarker of acute CNS viral infections
Biomarkers of epilepsy  
Biochemical markers of epilepsy  
Biomarkers of temporal lobe epilepsy  
Biomarkers of drug-resistant epilepsy
Electrophysiological biomarkers of epilepsy  
Imaging biomarkers of epilepsy  
Protein biomarkers of inflammation in epilepsy  
Genetic epilepsies  
RNA biomarkers of epilepsy
miRNA biomarkers of epilepsy  
tRNA fragment level increase in plasma for prediction of seizure risk  
Clinical trials for biomarkers of epilepsy  
Biomarkers of normal pressure hydrocephalus
Biomarkers of pseudotumor cerebri
Biomarkers of retinal disorders  
Biomarkers of age-related macular degeneration  
Biomarkers of sleep disorders  
Biomarker of excessive daytime sleepiness  
Biomarkers of obstructive sleep apnea
Biomarkers of restless legs syndrome
Biomarkers of pain
Biomarkers of disorders with musculoskeletal pain
Biomarkers of neuropathic pain  
Brain insular glutamate as biomarker of fibromyalgia  
Biomarkers of visceral pain  
Biomarkers of migraine
Biomarkers of myalgic encephalomyelitis/chronic fatigue syndrome  
Biomarkers of psychiatric disorders
Anorexia nervosa
Attention-deficit hyperactivity disorder  
Biomarkers of autism  
Epigenetics of ASD
Eye gaze tracking patterns
Gastrointestinal microbiota disturbances and ASD
Genetic factors in ASD
Immune biomarkers of ASD  
Metabolic disturbances in autism
Neuropeptide receptor levels in blood  
Neurophysiological biomarkers  
Role of oxidative stress in autism
Test for ASD based on a 55-gene expression panel  
Umbilical cord biomarkers  
Biomarkers of bipolar disorder  
Biomarkers of depression
Biochemical biomarkers of depression  
Biomarkers and response to antidepressant treatment  
Cingulate cortex activity and response to antidepressants
Genetic biomarkers of response to antidepressants  
Inflammatory biomarkers of depression and psychosis  
P11 as a biomarker of depression  
Panels of blood-based biomarkers for diagnosis of MDD  
Plasma metabonomics for diagnosis of MDD  
Post-partum depression
Biomarkers of posttraumatic stress disorder  
Biomarkers of psychosis  
Biomarkers of schizophrenia
Biomarkers of abnormalities of visual information processing  
Computational biomarkers of PTSD  
Genetic biomarkers of schizophrenia  
Gene expression analysis of blood for biomarkers of schizophrenia
Metabolic biomarkers of schizophrenia
Proteomic studies for biomarkers of schizophrenia  
Biomarkers of stress  
Biomarkers of suicide  

15. Biomarkers of Cardiovascular Disorders  
Epidemiology of cardiovascular disease
Biomarkers of cardiovascular diseases  
Biomarkers of acute myocardial infarction
Genetic biomarkers of cardiovascular disorders
β2-adrenergic receptor gene polymorphisms  
Methods for identification of cardiovascular biomarkers  
Application of proteomics for biomarkers of cardiovascular disease  
Targeted MS-based pipeline approach  
Cardiovascular disease biomarker panel
Detection of biomarkers of myocardial infarction in saliva by a nanobiochip
Metabolomic technologies for biomarkers of myocardial ischemia
Imaging biomarkers of cardiovascular disease  
Annexin A5 as an imaging biomarker of cardiovascular disease
Cardiovascular MRI  
Cardiovascular hybrid imaging
Myocardial perfusion imaging  
Implantable magnetic biosensors for detecting cardiac biomarkers
Applications of biomarkers of cardiovascular disease
Biomarkers for ischemic heart disease and myocardial infarction  
Troponin  
Natriuretic peptide  
Copeptin
Creatine kinase muscle brain
miRNAs as biomarkers of acute coronary syndrome  
Myoglobin  
Fatty acid binding protein
Growth Differentiation Factor-15
High density lipoprotein 2  
Cripto-1 as a biomarker of myocardial infarction  
Cataract as a biomarker of ischemic heart disease  
Plasma CD93 as a biomarker for coronary artery disease  
Plasma fetuin-A levels and the risk of myocardial infarction
PIGF and sFlt-1 as biomarkers of ischemic heart disease
YKL-40 as an inflammatory biomarker in ischemic heart disease
Biomarkers of cardiomyopathy  
miRNA biomarkers of peripartum cardiomyopathy
Takotsubo cardiomyopathy  
Troponin T levels in hypertrophic cardiomyopathy  
Biomarkers of heart failure
Annexin A5 for prognosis of heart failure  
Angiogenesis biomarkers  
β-2a protein as a biomarker of heart failure  
Desmin
Galectin-3 as biomarker of acute heart failure  
G protein-coupled receptor kinase-2 as biomarker of CHF  
KIF6 gene as biomarker of heart failure  
Metabolic biomarkers of heart failure
miRNA biomarkers of heart failure
Natriuretic peptide as biomarker of heart failure  
Osteoprotegerin
Oxidative stress as biomarker of heart failure
Soluble source of tumorigenicity 2  
Future of biomarkers of heart failure  
Biomarkers for atherosclerosis
9p21-3 locus and coronary atherosclerosis  
Adipocyte enhancer-binding protein 1
Gene signatures on leucocytes as biomarkers of atherosclerosis  
Ghrelin as a biomarker of atherosclerosis
Imaging biomarkers of hypercholesterolemia/atherosclerosis  
Inflammatory biomarkers of atherosclerosis  
Lipid-modified proteins as biomarkers of atherosclerosis  
Lp-PLA2 as biomarker of atherosclerotic heart disease
Metabolomic profile in hypercholesterolemia
Nitric oxide impairment and atherosclerosis  
Oxygen free radicals as biomarkers of atherosclerosis  
Proteomic profiles of serum inflammatory biomarkers of atherosclerosis  
Biomarkers of coronary heart disease
Apolipoproteins as risk factors for coronary heart disease  
CRP as biomarker of risk for coronary heart disease  
High level of blood ceramides as a biomarker of CHD  
Impairment of EPCs by oxidative stress as a biomarker of disease  
Role of TNF in acute coronary syndromes
Serum parathyroid hormone as biomarker of CHD
Serum stem cell factor as a biomarker of CHD
VILCAD biomarker score for prediction of long-term mortality in CHD
Biomarkers for pulmonary arterial hypertension
Biomarkers of abdominal aortic aneurysm
Biomarkers of thrombotic disorders  
Biomarkers of arterial thromboembolism
Nanoparticles as synthetic biomarkers of thrombus formation  
Biomarkers of venous thromboembolism
BNP and cTnT as biomarkers of outcome in pulmonary embolism
D-dimer as biomarker of venous thromboembolism
Molecular biomarkers of venous thromboembolism
Genetic biomarkers for cardiovascular disease
Biomarkers of inherited cardiomyopathies  
Gene mutations in pulmonary arterial hypertension
Gene variant as a risk factor for sudden cardiac death
Genetic biomarkers of early onset myocardial infarction
Genetic biomarkers of atherosclerosis
IL-1 gene polymorphism as biomarker of cardiovascular disease
IL-6R signaling pathway and coronary heart disease  
Kallikrein gene mutations in cardiovascular disease
Kallikrein gene and essential hypertension.  
Mutations in the low density lipoprotein receptor gene
Mutations within several genes that code for ion channel  
Polymorphisms of the eNOS gene and angina pectoris  
Lipoprotein (a) genetics  
Polymorphisms in the apolipoprotein C gene
Polymorphisms in the apolipoprotein E gene
Polymorphism in the angiotensinogen gene
Multiple biomarkers for prediction of death from cardiovascular disease
Role of biomarkers in the management of cardiovascular disease
Biomarkers in the diagnosis/prognosis of myocardial infarction
Biomarkers for prevention of cardiovascular disease
C reactive protein as biomarker of response to statin therapy
C125 as biomarker for stratification in heart disease  
HSP72 and eNOS as biomarkers of cardioprotective effect of HBO
Multimarker panel for prognosis in chronic heart failure  
Molecular signature analysis in management of cardiovascular diseases  
Presage ST2 Assay
Role of circulating biomarkers and mediators of cardiovascular dysfunction
Use of protein biomarkers for monitoring acute coronary syndromes  
Use of biomarkers for prognosis of recurrent atrial fibrillation  
Use of multiple biomarkers for monitoring of cardiovascular disease
Use of biomarkers in the management of peripheral arterial disease  
Use of biomarkers in the management of hypertension
Systems approach to cardiovascular biomarker research  

16. Biomarkers of Pulmonary Diseases
Introduction  
Association of biomarkers of inflammation with lung function in the elderly  
Biomarkers of oxidative stress in lung diseases
Biomarkers of community-acquired pneumonia
Biomarkers of acute lung injury and respiratory distress syndrome  
Cytokine/chemokine biomarkers of SARS
Plasma biomarkers related to inflammation  
Urinary NO as biomarker
Biomarkers of interstitial lung disease  
Pulmonary surfactant proteins as biomarkers for lung diseases
Serum KL-6 as biomarker of interstitial lung disease  
Biomarkers of chronic obstructive pulmonary disease  
Alpha1-antitrypsin gene polymorphisms predisposing to emphysema  
Biomarkers of extracellular matrix turnover in COPD  
Biomarkers of lung failure in COPD
BNP as a biomarker of chronic pulmonary disease
Chromagranin A (CgA) as biomarker of airway obstruction in smokers
C-reactive protein as a biomarker of COPD
Gene expression profile in peripheral blood of patients with COPD
Hyperuricemia as a biomarker of early mortality in COPD
Increased expression of PIGF as a biomarker of COPD  
Biomarkers of asthma  
Biomarker for rhinovirus-induced asthma exacerbation
Biomarkers for predicting response to corticosteroid therapy  
Comparison of biomarkers of asthma and COPD  
Cytokines as biomarkers of asthma severity and response to therapy
Exaled NO as a biomarker of asthma  
Endothelin-1 in exhaled breath as biomarker of asthma
IgE as guide to dosing of omalizumab for asthma  
Periostin as a biomarker for treatment of asthma with lebrikizumab  
Personalized therapy of asthma guided by biomarkers
Biomarkers of cystic fibrosis  

17. Biomarkers in Gynecology and Obstetrics
Introduction  
Biomarkers of menopause  
Biomarkers of premenstrual dysphoric disorder  
Biomarkers of endometriosis  
Biomarkers for preeclampsia  
Genes associated with preeclampsia
Pathogenesis of preeclampsia
Metabolomic biomarkers in urine in preeclampsia
Protein biomarker of preeclampsia in urine
Protein biomarkers of preeclampsia in CSF
Protein HtrA1 as a biomarker for preeclampsia  
Placental growth factor as a biomarker for preeclampsia
Transforming growth factor β superfamily  
sFlt1 and soluble endoglin as biomarkers of preeclampsia  
RNA biomarkers
Biomarkers of premature birth  
Proteomic biomarkers of premature birth  
Biomarkers of oxidative stress in complicated pregnancies
Fetal biomarkers in maternal blood  
Metabolic biomarkers of prenatal disorders in the mother

18. Biomarkers & Personalized Medicine  
Introduction  
Pharmacogenetics  
Biomarkers and pharmacogenetics
Pharmacogenomics
Pharmacoproteomics  
Single cell proteomics for personalized medicine  
Role of biomarkers in development of personalized drugs
Metabolomic biomarker-based drug discovery  
Use of biomarkers for developing MAb therapy in oncology  
Biomarker tests for molecularly targeted therapies
Biobanking, biomarkers and personalized medicine in EU  
Bioinformatics to sort biomarker data for personalized medicine  
Biomarkers for monitoring response to therapy  
Drug rescue by biomarker-based personalized medicine  
Future role of biomarkers in personalized medicine  

19. Biomarkers and Regulatory issues
Introduction  
Biomarker validation  
FDA criteria for a valid biomarker
FDA letter of support for biomarkers  
Role of NIST in validation of cancer biomarkers  
Quality specifications for BNP and NT-proBNP as cardiac biomarker assays  
National Biomarker Development Alliance  
FDA perspective of biomarkers in clinical trials  
FDA and predictive medicine
Biomarkers and FDA’s Voluntary Genomic Data Submission  
Role of imaging biomarkers in approval of drugs
Regulatory oversight of biomarker tests for targeted therapies  
FDA and biomarkers  
FDA consortium linking genetic biomarkers to serious adverse events  
Oncology Biomarker Qualification Initiative  
Critical Path Initiative  
Predictive Safety Testing Consortium
The 21st Century Cures Act and biomarkers
From validated biomarker assay to a clinical laboratory diagnostic  
Fast Path programs  
Regulatory challenges in the biomarker field  
FDA requirements of biomarkers and companion diagnostics  

20. References

Tables
Table 1-1: Historical landmarks in discovery and development of biomarkers  
Table 1-2: Classification of biomarkers  
Table 1-3: Terminology of clinically relevant biomarkers of disease
Table 1-4: Autoimmune disorders under study for autoantibodies as predictors  
Table 1-5: Comparison of various types of biomarkers  
Table 1-6: Various “omics” technologies for discovery of biomarkers
Table 1-7: Role of biomarkers in translational medicine
Table 2-1: Classification of methods of gene expression analysis  
Table 2-2: Comparison of proteomic profiling technologies for discovery of biomarkers  
Table 2-3: Companies involved in developing molecular imaging  
Table 3-1: Applications of biochip/microarray technology in relation to biomarkers  
Table 4-1: Companies using metabolomics for drug discovery  
Table 4-2: Biomarker-based drug development at major pharmaceutical companies  
Table 4-3: Causes of failures in clinical trials and their reduction by use of biomarkers  
Table 5-1: Metabolic biomarkers of inflammatory diseases
Table 5-2: Oxidized phospholipids as biomarkers of various diseases  
Table 5-3: Examples of biomarkers common to multiple diseases  
Table 5-4: Examples of use of biomarkers in animal health  
Table 6-1: Biomarkers of diabetes mellitus  
Table 7-1: Biomarkers of Sjögren syndrome  
Table 8-1: miRNAs deregulated in rheumatoid arthritic tissues  
Table 8-2: Classification of inflammatory biomarkers in osteoarthritis
Table 9-1: Biomarkers of sepsis
Table 11-1: Biomarkers of aging
Table 12-1: Nutritional biomarkers
Table 13-1: Desirable characteristics of biomarkers for cancer  
Table 13-2: Types of cancer biomarkers  
Table 13-3: A classification of molecular diagnostic methods in cancer  
Table 13-4: Cancer biomarkers used for diagnosis and therapy  
Table 13-5: Novel biomarkers of prognosis in cancer treatment
Table 13-6: Biomarkers of brain tumors  
Table 13-7: Biomarkers of breast cancer  
Table 13-8: miRNA associated with breast cancer  
Table 13-9: Biomarkers of colorectal cancer
Table 13-10: Biomarkers of lung cancer  
Table 13-11: Classification of biomarkers of melanoma  
Table 13-12: Biomarkers of nasopharyngeal carcinoma and potential applications  
Table 13-13: Biomarkers of ovarian cancer  
Table 13-14: Classification of biomarkers of pancreatic cancer  
Table 13-15: Biomarkers of prostate cancer  
Table 14-1: Biomarkers of cerebral metabolism
Table 14-2: Classification of biomarkers of Alzheimer disease in blood and CSF
Table 14-3: Characteristics of an ideal biomarker for Alzheimer disease  
Table 14-4: miRNA expression in neurodegenerative diseases  
Table 14-5: Biomarkers of Parkinson disease  
Table 14-6: Biomarkers of Huntington disease  
Table 14-7: Classification of biomarkers of amyotrophic lateral sclerosis
Table 14-8: Biomarkers of multiple sclerosis  
Table 14-9: Gene expression as biomarker of response to interferon-β in multiple sclerosis  
Table 14-10: Biomarkers of stroke
Table 14-11: Etiological blood biomarkers of ischemic strokes due to large artery atherosclerosis
Table 14-12: Biomarkers of traumatic brain injury  
Table 14-13: Biomarkers of epilepsy  
Table 14-14: Biomarkers of autism spectrum disorder
Table 14-15: Biomarkers of response to antidepressant treatment
Table 14-16: Biomarkers of posttraumatic stress disorder
Table 15-1: Classification of biomarkers for cardiovascular diseases
Table 15-2: Genes that cause cardiovascular diseases
Table 15-3: Biomarkers of abdominal aortic aneurysm  
Table 15-4: Biomarkers for cardiovascular disease risk prediction  
Table 16-1: Biomarkers of pulmonary diseases
Table 16-2: Biomarkers of asthma  
Table 18-1: Pharmacogenetic vs. pharmacogenomic studies  
Table 18-2: Applications of pharmacoproteomic biomarkers in personalized medicine
Table 19-1: Issued letters of support for biomarkers by the FDA
Table 19-2: Drugs requiring biomarker/companion diagnostic information in the label

Figures
Figure 1-1: Relation of biomarkers to other technologies and healthcare  
Figure 1-2: Role of biomarkers in monitoring of diseases  
Figure 2-1: The central role of spectrometry in proteomics  
Figure 2-2: Selected reaction monitoring workflow for verification of biomarkers  
Figure 4-1: Role of biomarkers in drug discovery and development process  
Figure 4-2: Onion-peel model of biomarker development
Figure 5-1: Diseases associated with myositis autoantibodies
Figure 6-1: Advanced glycation end products as biomarkers of metabolic syndrome  
Figure 6-2: Plasma lipids in metabolic syndrome
Figure 8-1: β-CrossLaps bone resorption biomarker assay  
Figure 13-1: Role of proteomics in the discovery of cancer biomarkers  
Figure 13-2: Nanovesicles for detection of cancer biomarkers  
Figure 13-3: Nanowire biosensor for cancer diagnosis  
Figure 13-4: Cancer biomarker development and validation  
Figure 14-1: Discovery and application of biomarkers in neurological diseases  
Figure 14-2: MRI in Creutzfeld-Jakob disease
Figure 14-3: A scheme of pathogenesis of MDD with relevant biomarkers  
Figure 15-1: Biomarkers of acute myocardial infarction related to pathophysiology
Figure 18-1: Role of pharmacogenetic biomarkers in personalized medicine
Figure 18-2: Workflow for developing metabolomics-based biomarkers for personalized treatment  
Figure 18-3: Impact of biomarkers on personalized medicine  
Figure 19-1: Stages and timelines of biomarker discovery, development and marketing  
Figure 19-2: Biomarker qualification pilot process at the FDA
Figure 19-3: From a validated biomarker assay to a clinical laboratory diagnostic

Part II

21. Markets for Biomarkers  
Introduction  
Biomarker markets according to technologies/applications  
Markets for protein biomarkers  
Biomarker market relevant to drug discovery and development  
Proteomic biomarker-based drug discovery  
Biomarker market relevant to epigenetics  
Biomarket market relevant to bioinformatics  
Biomarker markets according to therapeutic areas  
Markets for cancer biomarkers
Geographical distribution of biomarker markets
Drivers for the growth of markets for biomarkers  
Biomarker patents  
Factors that enhance the value of biomarker IP  
US policy on patenting relevant to biomarkers
US legal decisions on gene patenting
Strategies for developing biomarker markets
Utilization of biomarker research in academic laboratories
Biomarker discovery at pharmaceutical companies
Industrial-academic collaborations in biomarkers  
Unfulfilled needs in biomarkers  
Challenges facing the biomarker industry
Application of biomarkers in healthcare
Applications of biomarkers beyond healthcare  
Combating bioterrorism  
Biomarkers for monitoring human exposure to environmental toxins  

22. Companies  
Introduction  
Top companies in biomarkers  
Profiles of companies
Zeptosens AG
Collaborations

Tables
Table 21-1: Biomarker markets according to technologies/applications 2018-2028  
Table 21-2: Biomarker markets according to therapeutic areas 2018-2028  
Table 21-3: Geographical distribution of biomarker markets 2018-2028  
Table 21-4: Factors driving the growth of biomarker industry
Table 22-1: Companies with focus on biomarkers  
Table 22-2: Pharmaceutical and biotechnology companies involved in biomarkers  
Table 22-3: Molecular diagnostic companies
Table 22-4: Proteomics, metabolomics, glycomics, and systems biology companies  
Table 22-5: Pharmacogenomic/pharmacogenetic & personalized medicine companies  
Table 22-6: Companies with biochips, biosensors and imaging technologies
Table 22-7: Nanobiotechnology companies  
Table 22-8: Companies involved in drug discovery and development
Table 22-9: Bioinformatic companies involved in biomarkers
Table 22-10: Service, equipment and reagent supply companies  
Table 22-11: Top biomarker companies
Table 22-12: Collaborations between companies

Figures
Figure 21-1: Unfulfilled needs in biomarkers technologies and applications 

Note: Product cover images may vary from those shown
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