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Biomarkers - technologies,markets and companies

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 2013 to 2023 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 301 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 466 collaborations between companies and additional academic collaborations are mentioned in the individual profiles of companies. The report is supplemented by 1,120 references, 70 tables and 16 figures.

Table of Contents

Part - I: Technologies & Markets

0. Executive Summary

1. Introduction

  • Definitions
  • Historical aspects of biomarkers
  • Classification of biomarkers
    • Biological marker as response to therapeutic intervention
    • Pharmacokinetic/pharmacodynamics biomarkers
    • Predictive biomarkers
    • Valid biomarkers
  • Types of biomarkers
    • Genes as biomarkers
    • Epigenetic 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
      • 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® ZChek™ for analysis of biomarkers of hESCs
      • SSEA-4 as biomarker of MSCs
    • Gaseous mediators as biomarkers of disease
    • Autoantibodies as biomarkers of autoimmune diseases
    • 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
  • Epigenomic technologies
    • Discovery of methylation biomarkers
  • Proteomic technologies
    • 2D GE
    • Biomarker Amplification Filter
    • CellCarta® proteomics platform
    • Isotope-coded affinity tags
    • Liquid chromatography-MS/MS
    • Lucid Proteomics System
    • Magnetics beads for protein biomarker discovery
    • MASStermind™
    • 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
    • Gene expression microarray data as a source of protein biomarkers
    • Quantification of protein biomarkers
      • Multiple reaction monitoring assays
      • Real-time PCR for quantification of protein biomarkers
      • CyTOF for quantification of biomarkers
    • Search for biomarkers in body fluids
    • Challenges and strategies for discovey of protein biomarkers in plasma
      • 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
      • 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-based kits 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 prospects 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
    • NanoInk's Nanoarray Assay System
    • 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
    • Nucleoprotein nanodevices for detection of 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
    • Biochips and microarrays
      • Applications of biochips/microarrays
      • Role of biochip/microarrays in discovery of biomarkers
  • 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

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
    • AvalonRx® drug discovery platform
    • 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
      • Biomarkers of hepatotoxicity
      • Biomarkers of nephrotoxicity
      • Cardiotoxicity
      • Neurotoxicity
  • Applications of biomarkers for drug development
    • Application of metabonomics/metabolomics for drug development
    • Role of pharmacokinetic/pharmacodynamic biomarkers in drug development
    • 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
    • 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
    • Application of biomarkers by the pharmaceutical companies
    • Use of biomarkers in relation to stage of drug discovery and development
    • Drug development in cardiovascular disorders
    • Drug development in neurological disorders
    • Future prospects of biomarker-based drug development
      • The Biomarker Alliance
      • Biomarkers Consortium
      • Molecular Libraries and Imaging Roadmap of NIH
      • Pharmacogenomic biomarker information in drug labels
      • Rare Diseases Clinical Research Consortia
      • Systems Approach to Biomarker Research in Cardiovascular Disease
      • Concluding remarks on the future trends in biomarker 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
    • Oxidative DNA damage
    • Proteins as biomarkers of oxidative stress in diseases
    • Testing for oxidative stress
  • Biomarkers in metabolic disorders
    • 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
      • Glycosylated hemoglobin in diabetes mellitus
      • Glycated albumin as a biomarker of diabetes mellitus
      • Lack of C-peptide as biomarker of complications of diabetes type 1
      • Personalized management of diabetes mellitus based on biomarkers
    • Biomarkers of metabolic syndrome
      • Adiponectin
      • Cystatin C
      • Human plasma lipidome
  • Biomarkers in immune disorders
    • Biomarkers relevant to organ transplantation
      • Biomarkers of graft versus host disease
      • Plasma biomarkers of response to therapy of GVHD
      • Biomarkers of renal allograft failure
      • Biomarkers of renal transplant tolerance
      • Biomarkers of lung transplant rejection
    • Systemic lupus erythematosus
      • Current management and need for biomarkers
      • Role of collaborative efforts and databases of SLE biomarkers
      • C4d-bearing reticulocytes
      • Adiponectin
      • CB-CAPS
      • HMGB1
      • Genetic loci of SLE
      • Epigenetic biomarkers of SLE
    • Biomarkers of systemic sclerosis
  • Biomarkers of musculoskeletal disorders
    • Muscle disorders
      • Biomarkers of muscle fatigue during exercise
      • Biomarkers of mitochondrial content in skeletal muscle
    • 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
    • Osteoarthritis
      • Molecular pathophysiology of OA
      • Assays for biomarkers of OA
      • Biomarkers of OA
      • Concluding remarks and future prospects of biomarkers of OA
    • Biomarkers of osteoporosis
      • Dual x-ray absorptiometry
      • Bone imaging with quantitative CT and MRI
      • Assays for detection of biomarkers of osteoporosis
    • Biomarkers of osteonecrosis
      • Osteonecrosis in Gaucher's disease
  • Biomarkers of infectious diseases
    • Application of proteomics for discovering biomarkers of infections
    • 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
    • Chemokines as biomarkers of infection
    • Endotoxin as biomarker of infection
    • Procalcitonin as a guide to antibiotic therapy in infections
    • Soluble urokinase plasminogen activator receptor
    • Systemic inflammatory response syndrome
    • Tuberculosis
      • Conventional diagnosis of tuberculosis
      • Molecular diagnostics for tuberculosis
      • Biomarkers for tuberculosis
      • Biomarkers of pulmonary tuberculosis in the breath
    • 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
  • Biomarkers of liver disease
    • Breath biomarkers of liver disease
    • Biomarkers of viral hepatitis B and C
    • Biomarkers of liver injury
    • Biomarkers of liver cirrhosis
    • Biomarkers of hepatic encephalopathy
    • FibroMax
  • 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
  • Biomarkers of pulmonary diseases
    • Association of biomarkers of inflammation with lung function in the elderly
    • Biomarkers of oxidative stress in lung diseases
    • 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 lung failure in COPD
      • BNP as a biomarker of chronic pulmonary disease
      • Chromagranin A (CgA) as biomarker of airway obstruction in smokers
      • Gene expression profile in peripheral blood of patients with 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
      • 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
    • Biomarkers for cystic fibrosis
  • 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
  • Biomarkers in gynecology and obstetrics
    • Biomarkers of menopause
    • Biomarkers of premenstrual dysphoric disorder
    • Biomarkers of endometriosis
    • Biomarkers for 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
      • sFlt1 and soluble endoglin as biomarkers of preeclampsia
      • RNA biomarkers
      • Genes associated with preeclampsia
    • Biomarkers of premature birth
    • Biomarkers of oxidative stress in complicated pregnancies
    • Fetal biomarkers in maternal blood
    • Metabolic biomarkers of prenatal disorders in maternal urine and blood
  • Biomarkers for genetic disorders
    • Biomarkers for Down's syndrome
    • Biomarkers for muscular dystrophy
    • Biomarkers of phenylketonuria
    • Genetic biomarkers for psoriasis
    • Biomarkers of lysosomal storage disorders
  • Biomarkers of aging
    • Effect of calorie restriction on biomarkers of longevity
    • Genes as biomarkers of aging
      • Mitochondrial mutations as biomarkers of aging
      • Telomere attrition as aging biomarker
      • Gene variants as determinants of biological age
      • Genetic signatures of longevity
    • Low serum thyroid hormone level as biomarker of longevity
    • Role of bioinformatics in search for biomarkers of aging
    • Study of biomarkers of aging in a genetically homogeneous population
  • Biomarkers in pediatrics
    • Pediatric critical care
    • Biomarkers of acute kidney injury in children
  • Biomarkers of miscellaneous disorders
    • Biomarkers of carbon monoxide poisoning
    • Biomarkers of inflammatory bowel disease
    • Biomarkers of erectile dysfunction
    • Biomarkers of fever
    • Biomarkers of heat stroke
    • 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 and nutrition
    • Biomarkers in nutritional epidemiology
    • Biomarkers 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 D as a biomarker of disease
      • Vitamin B12 deficiency
  • Biomarkers of gene-environmental interactions in human disease

6. Biomarkers of Cancer

  • Introduction
    • The ideal biomarker for cancer
    • Biomarkers and hallmarks of cancer
    • Single vs multiple biomarkers of cancer
  • Types of cancer biomarkers
    • Biomarkers of epigenetic gene silencing in cancer
    • Carcinoembryonic antigen
    • Circulating tumor cells as cancer biomarkers
    • Circulating nucleic acids as potential biomarkers of cancer
    • DNA repair biomarkers
    • HER3 as biomarker of cancer
    • Immunologic biomarkers of cancer
    • Metastatic cancer biomarkers
    • miRNAs as biomarkers in cancer
      • Circulating miRNAs for cancer detection
      • Diagnostic value of miRNA in cancer
    • Tumor microvesicles or exosomes
  • 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
      • Early detection of tumor suppressor gene mutations
      • 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
      • Sequencing-based approaches for detection of cancer biomarkers
      • Telomerase as a biomarker of cancer
    • Tissue microarrays for study of cancer biomarkers
    • Molecular fingerprinting of cancer
    • Biomarkers of inflammation in cancer
    • 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
      • eTag assay system for cancer biomarkers
      • Glycoprotein biomarkers of cancer
      • HER-2/neu oncoprotein as biomarkers for cancer
      • Humoral proteomics
      • Laser capture microdissection
      • Membrane-type serine protease-1
      • Phage display technology
      • 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
    • 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
      • Combined use of tissue-specific genetic and epigenetic biomarkers
      • Detection of biomarkers of DNA methylation
      • Epigenomics Marker Machine for DNA methylation biomarkers
      • Histone deacetylase
      • MDScanmicroarray technology
      • Mucins as epigenetic biomarkers in epithelial cancers
      • PCR with bisulfite for detecting DNA methylation biomarkers in cancer
      • Rubicon MethylPlex technology
      • Agena's integrated platform for genetic and epigenetic analysis
    • Nanobiotechnology for early detection of cancer to improve treatment
    • NP-peptide complexes for detection of cancer biomarkers in urine
    • Selective expression of biomarkers by cancer compared with normal tissues
    • 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
      • ARTS as a biomarker as well as a basis of anticancer drugs
      • 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 markers
      • 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
      • Methylation biomarkers of drug resistance in cancer
      • STAT3 and resistance to cisplatin
    • Biomarkers of radiation therapy for cancer
  • Role of biomarkers in drug development in oncology
    • Molecular imaging of tumor as a guide to drug development
      • Use of PET to assess response to anticancer drugs
      • Use of MRI to assess response to anticancer drugs
    • Biomarkers in plucked hair for assessing cancer therapy
    • Molecular targets of anticancer drugs as biomarkers
    • Safety biomarkers in oncology studies
    • Role of biomarkers in phase I clinical trials of anticancer drugs
  • 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 positive expression as a prognostic biomarker for GBM
      • 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 protein profiling
      • 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 GBM
      • Neuroimaging biomarkers combined with DNA microarray analysis
      • 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
      • xAutoantibody biomarkers of breast cancer
      • Biomarkers of breast cancer in breath
      • Biomarkers for breast cancer in nipple aspiration fluid
      • Circulating tumor DNA as biomarker of breast cancer
      • Flow cytometry for quantification of biomarker expression patterns
      • Plasma proteomics for biomarkers of breast cancer
      • Quantitative realtime PCR assays for biomarker validation
      • Cdk6 as a biomarker of breast cancer
      • Centromere protein-F
      • Carbonic anhydrase IX
      • COX-2 as a biomarker of breast cancer
      • G88 as a biomarker of progression of ER+ breast cancer
      • Glycomic biomarkers of breast cancer
      • HER-2/neu oncoprotein
      • 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
      • Progranulin as a biomarker of breast cancer
      • Proliferating cell nuclear antigen
      • Protein kinase C as a predictive biomarker of metastatic breast cancer
      • 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
      • Suppressor of deltex protein
      • Tumor microenvironment as biomarker of metastasis in breast cancer
      • Type III TGF-β receptor as regulator of cancer progression
      • Diagnostic tests based on breast cancer genes
      • Prognostic role of breast cancer genes
      • Protein biomarkers for breast cancer prevention
      • Biomarkers to evaluate efficacy of chemoprevention
      • Biomarkers of response to chemotherapy of breast cancer
      • 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
      • Metabonomic profiles discriminate HCC from liver cirrhosis
    • 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
      • Gene expression profiling for 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
    • Oral cancer biomarkers
    • Ovarian cancer biomarkers
      • 3D microfluidic platform to assess multiple ovarian cancer biomarkers
      • 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
      • Serum albumin-associated peptides and proteins
      • 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
      • 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
    • Parathyroid cancer biomarkers
    • 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
      • Huntingtin Interacting Protein 1 overexpression in prostate cancer
      • Id proteins expression in prostate cancer
      • Identification of prostate cancer mRNA biomarkers
      • Integrative genomic and proteomic profiling of prostate cancer
      • Kallikreins as biomarkers of prostate cancer
      • LCM for diagnosis of prostate cancer
      • Loss of p27 as predictor of recurrence 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
      • Tests for prostate cancer based on genetic dislocations
      • Concluding remarks on biomarkers of prostate cancer
    • Renal cancer biomarkers
      • Gene expression profile of RCC for biomarkers
      • 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
      • Multiple endocrine neoplasia type 2B as risk factor for thyroid cancer
      • miRNA biomarkers of thyroid cancer
      • Biochemical biomarkers of thyroid cancer
  • Role of the NCI in molecular diagnosis of cancer
    • The Cancer Genome Anatomy Project
    • Molecular profiling of cancer
    • Cancer Genome Atlas
    • Cancer Genetic Markers of Susceptibility Project
    • Oncology Biomarker Qualification Initiative
    • Role of NCI in cancer biomarker development and validation
  • Projects for cancer biomarker research in Europe
    • COBRED project
    • COLTHERES consortium
    • PREDICT Consortium
  • Future prospects for cancer biomarkers
    • Cancer biomarker research at academic institutions
    • Future prospects and challenges in the discovery of cancer biomarkers

7. Biomarkers of Disorders of the Nervous System

  • Introduction
  • Discovery of biomarkers for neurological disorders
    • Biomarker identification in the CSF using proteomics
    • Biomarker identification in the CSF using lipidomics
    • Cerebral microdialysis for the study of biomarkers of cerebral metabolism
    • Detection of protein biomarkers of CNS disorders in the blood
    • Brain imaging for detection of biomarkers
  • Biomarkers of the aging brain
    • Cellular biomarker of aging of the brain
    • CSF F2-isoprostanes as biomarker of aging brain
    • IL-6 as a biomarker of cognitive impairment with aging
    • Protein aggregation as a biomarker of aging brain
    • Telomere shortening as a biomarker of aging brain and dementia
  • Data mining for biomarkers of neurological disorders
  • Antibodies as biomarkers in disorders of the nervous system
  • 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
    • 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
  • 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
      • MRI for biomarkers of AD
      • Nanotechnology to measure Aβ derived diffusible ligands
      • PET scanning for biomarkers of AD
      • Radioiodinated clioquinol as a biomarker for Aβ
      • 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
      • Glycerophosphocholine as CSF biomarker in 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
      • Plasma protein biomarkers of AD
      • Protein kinase C in red blood cells
    • Urine tests for 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
      • 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
    • 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
    • Serum vitamin D as a biomarker of PD
    • Future prospects for biomarkers of PD
  • Biomarkers of Huntington's disease
    • 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
    • Biomarkers of neuroinflammation in ALS
    • Detection of ALS biomarkers in blood vs CSF
    • Ideal biomarker of ALS
    • Imaging biomarkers of ALS
    • Metabolomic biomarkers of ALS
    • Proteomic biomarkers of ALS
    • Future prospects of biomarkers of ALS
  • Biomarkers of dementia in HIV-1-infected patients
  • 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
    • 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 a biomarker of cognitive function
    • Brain imaging biomarkers of multiple sclerosis
      • MRI biomarkers of multiple sclerosis
      • Myelin imaging by PET
    • Biomarkers of response to therapy of multiple sclerosis
      • DNA motifs in the blood as biomarkers of response to treatment
    • 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
    • Gene expression profiling of biomarkers in multiple sclerosis
    • Matrix metalloproteinases as biomarkers in multiple sclerosis
    • Serum proteomic pattern analysis 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
      • Brain natriuretic peptide as a biomarker for cardioembolic stroke
      • Brain lactate and N-acetylaspartate as biomarkers of stroke
      • 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
      • 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
    • 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
      • Systemy biology approach for discovery of biomarkers of TBI
    • Biomarkers of TBI
      • C-tau as biomarker of TBI
      • Diffusion tensor imaging in TBI
      • Hyperphosphorylated axonal neurofilament protein
      • IL-6 and nerve growth factor as biomarkers of TBI
      • Myelin basic protein
      • Neurofilament heavy chain
      • Serum S100β as biomarker of TBI
      • SNTF as a biomarker for predicting cognitive decline after mild TBI
      • Ubiquitin C-terminal Hydrolase-L1
    • Biomarkers of inflicted TBI in infants
    • 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
  • Biomarkers of epilepsy
    • Genetic epilepsies
    • Biochemical markers of epilepsy
    • Biomarkers of temporal lobe epilepsy
    • Imaging biomarkers of epilepsy
  • Biomarkers of normal pressure hydrocephalus
  • 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
      • Gastrointestinal microbiota disturbances and ASD
      • Genetic factors in ASD
      • Immune biomarkers of ASD
      • Metabolic disturbances in autism
      • Neurophysiological biomarkers
      • Role of oxidative stress in autism
      • Test for ASD based on a 55-gene expression panel
      • Trophoblastic abnormalities in placenta
      • Umbilical cord biomarkers
    • Biomarkers of bipolar disorder
    • Biomarkers of depression
      • Biochemical biomarkers of depression
      • Cingulate cortex activityand response to antidepressants
      • Gene polymorphisms and response to antidepressants
      • Inflammatory biomarkers of depression and psychosis
      • Panel of blood transcriptomic biomarkers for diagnosis of MDD
      • Plasma metabonomics for diagnosis of MDD
      • Post-partum depression
    • Biomarkers of psychosis
    • Biomarkers of schizophrenia
      • Biomarkers of abnormalities of visual information processing
      • 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 suicide

8. Biomarkers of Cardiovascular Disorders

  • Introduction
    • Epidemiology of cardiovascular disease
  • Biomarkers of cardiovascular diseases
    • Biomarkers of acute myocardial infarction
    • Genetic biomarkers of cardiovascular disorders
  • 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
      • YKL-40 as an inflammatory biomarker in ischemic heart disease
    • Biomarkers of heart failure
      • Angiogenesis biomarkers
      • beta-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
      • miRNA biomarkers of heart failure
      • Natriuretic peptide as biomarker of heart failure
      • Oxidative stress as biomarker of heart failure
      • Future prospects for 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 markers of atherosclerosis
    • Biomarkers of coronary heart disease
      • Antibody to oxidized-LDL
      • Apolipoproteins as risk factors for coronary heart disease
      • CRP as biomarker of risk for coronary heart disease
      • 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
      • VILCAD biomarker score for prediction of long-term mortality in CHD
    • Biomarkers for pulmonary arterial hypertension
    • Biomarkers of abdominal aortic aneurysm
    • 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
    • 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
  • Future prospects for cardiovascular biomarkers
    • Cardiovascular Biomarker Consortium
    • Systems Approach to Biomarker Research in Cardiovascular Disease

9. Biomarkers & Personalized Medicine

  • Introduction
  • Pharmacogenetics
    • Biomarkers and pharmacogenetics
  • Pharmacogenomics
  • Pharmacoproteomics
    • Single cell proteomics for personalized medicine
  • Role of biomarkers in development of personalized drugs
    • Use of biomarkers for developing MAb therapy in oncology
  • Biobanking, biomarkers and personalized medicine in EU
  • Expression signatures as diagnostic/prognostic tools
  • 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

10. Validation of Biomarkers and Regulatory issues

  • Introduction
  • Biomarker validation
    • FDA criteria for a valid biomarker
    • 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
  • FDA and biomarkers
    • FDA consortium linking genetic biomarkers to serious adverse events
    • Oncology Biomarker Qualification Initiative
    • Critical Path Initiative
      • Predictive Safety Testing Consortium
    • From validated biomarker assay to a clinical laboratory diagnostic
    • Fast Path programs
    • Need for a single federal agency to oversee biomarker field
    • FDA requirements of biomarkers and companion diagnostics

11. Markets for Biomarkers

  • Introduction
  • Biomarker markets according to technologies/applications
    • Markets for protein biomarkers
    • Biomarker market relevant to drug discovery and development
    • 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
  • Unfulfilled needs in biomarkers
  • Drivers for the growth of markets for biomarkers
  • Challenges facing the biomarker industry
    • Pitfalls in the discovery and development of biomarkers
  • Strategies for developing biomarker markets
    • Utilization of biomarker research in academic laboratories
    • Biomarker discovery at pharmaceutical companies
    • Industrial-academic collaborations in biomarkers
    • Application of biomarkers in medical practice
      • Future role of biomarkers in healthcare
    • Applications of biomarkers beyond healthcare
      • Combating bioterrorism
      • Biomarkers for monitoring human exposure to environmental toxins
      • Application of biomarkers in animal health
  • Biomarker patents
    • Factors that enhance the value of biomarker IP
    • US policy on patenting relevant to biomarkers
      • US legal decisions on gene patenting

12. References

Tables

  • Table 1-1: Historical landmarks in discovery and development of biomarkers
  • Table 1-2: Classification of biomarkers
  • Table 1-3: Terminology of biomarkers of disease relevant to clinical development
  • 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: Causes of failures in clinical trials and their reduction by use of biomarkers
  • Table 4-3: Biomarker-based drug development at major pharmaceutical companies
  • Table 5-1: Metabolic biomarkers of inflammatory diseases
  • Table 5-2: Biomarkers of diabetes mellitus
  • Table 5-3: miRNAs deregulated in rheumatoid arthritic tissues
  • Table 5-4: BIPED classification of OA biomarkers
  • Table 5-5: Biomarkers of sepsis
  • Table 5-6: Biomarkers of pulmonary diseases
  • Table 5-7: Biomarkers of aging
  • Table 5-8: Examples of biomarkers common to multiple diseases
  • Table 6-1: Desirable characteristics of biomarkers for cancer
  • Table 6-2: Types of cancer biomarkers
  • Table 6-3: A classification of molecular diagnostic methods in cancer
  • Table 6-4: Novel biomarkers of prognosis in cancer treatment
  • Table 6-5: Biomarkers of brain tumors
  • Table 6-6: Biomarkers of breast cancer
  • Table 6-7: miRNA associated with breast cancer
  • Table 6-8: Biomarkers of colorectal cancer
  • Table 6-9: Biomarkers of lung cancer
  • Table 6-10: Classification of biomarkers of melanoma
  • Table 6-11: Biomarkers of nasopharyngeal carcinoma and potential applications
  • Table 6-12: Biomarkers of ovarian cancer
  • Table 6-13: Classification of biomarkers of pancreatic cancer
  • Table 6-14: Biomarkers of prostate cancer
  • Table 7-1: Biomarkers of cerebral metabolism
  • Table 7-2: Classification of biochemical markers of AD in blood and CSF
  • Table 7-3: Characteristics of an ideal biomarker for Alzheimer disease
  • Table 7-4: Biomarkers of Parkinson's disease
  • Table 7-5: Biomarkers of Huntington disease
  • Table 7-6: Classification of biomarkers of sporadic amyotrophic lateral sclerosis
  • Table 7-7: Biomarkers of multiple sclerosis
  • Table 7-8: Gene expression as biomarker of response to interferon-β in multiple sclerosis
  • Table 7-9: Biomarkers of stroke
  • Table 7-10: Biomarkers of traumatic brain injury
  • Table 7-11: Biomarkers of epilepsy
  • Table 7-12: Biomarkers of autism spectrum disorder
  • Table 8-1: Classification of biomarkers for cardiovascular diseases
  • Table 8-2: Genes that cause cardiovascular diseases
  • Table 8-3: Biomarkers of abdominal aortic aneurysm
  • Table 8-4: Biomarkers for cardiovascular disease risk prediction
  • Table 9-1: Pharmacogenetic vs. pharmacogenomic studies
  • Table 9-2: Applications of pharmacoproteomic biomarkers in personalized medicine
  • Table 10-1: Drugs requiring biomarker/companion diagnostic information in the label
  • Table 11-1: Biomarker markets according to technologies/applications 2013-2023
  • Table 11-2: Biomarker markets according to therapeutic areas 2013-2023
  • Table 11-3: Geographical distribution of biomarker markets 2013-2023
  • Table 11-4: Factors driving the growth of biomarker industry
  • 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 5-1: Plasma lipids in metabolic syndrome
  • Figure 6-1: Role of proteomics in the discovery of cancer biomarkers
  • Figure 6-2: Cancer biomarker development and validation
  • Figure 7-1: Discovery and application of biomarkers in neurological diseases
  • Figure 8-1: Biomarkers of acute myocardial infarction related to pathophysiology
  • Figure 9-1: Role of pharmacogenetic biomarkers in personalized medicine
  • Figure 9-2: Impact of biomarkers on personalized medicine
  • Figure 10-1: Stages and timelines of biomarker discovery, development and marketing
  • Figure 10-2: Biomarker qualification pilot process at the FDA
  • Figure 10-3: From a validated biomarker assay to a clinical laboratory diagnostic
  • Figure 11-1: Unfulfilled needs in biomarkers technologies and applications

Part - II: Companies

13. Companies

  • Introduction
  • Top companies in biomarkers
  • Profiles of companies
  • Collaborations

Tables

  • Table 13-1: Companies with focus on biomarkers
  • Table 13-2: Pharmaceutical and biotechnology companies involved in biomarkers
  • Table 13-3: Molecular diagnostic companies
  • Table 13-4: Proteomics metabolomic/metabonomic and systems biology companies
  • Table 13-5: Pharmacogenomic/ personalized medicine companies
  • Table 13-6: Companies with biochips, biosensors and imaging technologies
  • Table 13-7: Nanobiotechnology companies
  • Table 13-8: Companies involved in drug discovery and development
  • Table 13-9: Bioinformatic companies involved in biomarkers
  • Table 13-10: Service, equipment and reagent supply companies
  • Table 13-11: Top biomarker companies
  • Table 13-12: Collaborations between companies
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