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Biomarkers - Technologies, Markets & Companies

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  • 1032 Pages
  • November 2021
  • Region: Global
  • Jain PharmaBiotech
  • ID: 4748179

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 biomarkers.

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 the diagnosis of some of these diseases but also for understanding the pathomechanism as well as a basis for the 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 are discussed.

Biomarker markets are estimated from 2020 to 2030 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 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:

  • Introduction to biomarkers
  • 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

Table of Contents

Part 1: Technologies & Applications  

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  
  • Biomarkers variations with circadian rhythms
  • Biomarkers and systems biology
  • Systems biology approach to biomarker identification
  • Comparison of various types of omic biomarkers
  • Circulating vs tissue biomarkers  
  • 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  
  • Tissue imaging for protein biomarkers
  • 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 & clinical trials
  • 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 alcohol use disorder 
  • 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
  • Long noncoding RNAs as biomarkers for type 2 diabetes
  • 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
  • Prime cells predicting rheumatoid arthritis flares  
  • 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 an 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  
  • Methylation 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

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  
  • 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  
  • miRNA biomarkers of HCC 
  • 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 
  • Biomarkers of pheochomocytoma
  • 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 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 for biomarkers of aging brain  
  • Protein aggregation as a biomarker of aging brain.. 
  • Telomere shortening as a biomarker of aging brain and dementia  
  • 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
  • Imaging biomarkers of AD 
  • 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 disease4
  • 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 hearing disorders 
  • Biomarkers of disorders of hearing perception
  • 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
  • Biomarkers 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 
  • miRNA biomarker of acute myocrditis 
  • 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 
  • KL-6 as biomarker of pulmonary fibrosis 
  • Protein biomarkers identified by the Pulmonary Fibrosis Foundation  
  • 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
  • Biomarkers Consortium & personalized medicine  
  • 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 
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: Various “omics” technologies for discovery of biomarkers  
Table 1-6: Comparison of various types of omic 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: miRNA expression in neurodegenerative diseases
Table 14-3: Classification of biomarkers of Alzheimer disease in blood and CSF
Table 14-4: Characteristics of an ideal biomarker for Alzheimer disease
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 

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: Markets & Companies

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. 
  • Collaborations 

Table 21-1: Biomarker markets according to technologies/applications 2019-2029 
Table 21-2: Biomarker markets according to therapeutic areas 2019-2029
Table 21-3: Geographical distribution of biomarker markets 2019-2029
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.. 

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