Biomarkers - Technologies, Markets & Companies

Table of Contents

Biomarkers  
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  
• SELDI-TOF MS 
• Serum proteome analysis for early detection of cancer 
• Synthetic biomarker-based POC diagnostic for cancer  
• Triple-quadrupole MS for detection of mutant proteins
• Targeted MS for validation of cancer biomarkers in plasma  
• Tissue proteomics for discovery of cancer biomarkers  
• VeraTag system for cancer biomarkers  
• Metabolomic biomarkers of cancer
• Magnetic resonance for detecting metabolomics biomarkers of cancer
• Choline phospholipid biomarkers of cancer
• Hypoxia-inducible factor-1
• Detection of drug resistance in cancer by metabolic profiling 
• Plasma free amino acids profiling in cancer 
• Urinary metabolomic biomarkers of cancer
• Epitomics for the early detection of cancer  
• Epigenetic biomarkers of cancer 
• Detection of biomarkers of DNA methylation  
• Epigenomics Marker Machine for DNA methylation biomarkers  
• Histone deacetylase 
• MDScan microarray technology  
• Mucins as epigenetic biomarkers in epithelial cancers  
• PCR with bisulfite for detecting DNA methylation biomarkers in cancer  
• Detection of methylated DNA in serum and urine 
• Integrated platform for genetic and epigenetic analysis
• Nanobiotechnology for early detection of cancer to improve treatment
• Aptasensor for electrochemical detection of exosomes
• Nanovesicles for detection of cancer biomarkers
• Nanowire biosensors for detection of cancer biomarkers  
• NP-peptide complexes for detection of cancer biomarkers in urine
• Ultrasound radiation to enhance release of a tumor biomarker  
• In vivo imaging of cancer biomarkers
• Computer tomography
• Optical systems for in vivo molecular imaging of cancer
• Positron emission tomography  
• Imaging of tumor oxygenation and microvascular permeability by MRI  
• Xenon-enhanced MRI  
• Kallikrein gene family and cancer biomarkers  
• Detection of CTCs as biomarkers of cancer  
• Applications of cancer biomarkers
• Use of biomarkers for cancer classification  
• Cancer classification using microarrays  
• Proteomic classification of cancer  
• Use of biomarkers for early detection of cancer
• Applications of biomarkers for cancer diagnosis
• Methylated DNA sequences as cancer biomarkers
• MicroRNA expression profiling for diagnosis of human cancers  
• MUC4 as a diagnostic biomarker in cancer  
• Applications of biomarkers for cancer diagnosis and therapy
• Asparagine synthetase as biomarker for therapy with L-asparaginase 
• Peptide-based agents for targeting cancer biomarkers
• PI3K mutations as a biomarker for use as a companion diagnostic 
• Biomarkers for assessing efficacy of cancer therapy
• ERCC1-XPF expression as a biomarker of response to chemotherapy
• P53 expression level as biomarker of efficacy of cancer gene therapy 
• Biomarkers of angiogenesis for developing antiangiogenic therapy
• Biomarkers of response to antiangiogenic agents 
• Circulating endothelial cells as targets for antiangiogenic drugs 
• Imaging biomarkers for evaluation of antiangiogenic agents
• Tumor endothelial biomarkers  
• VEGF signaling inhibitors as biomarkers
• VEGF-PET imaging for analysis of angiogenic changes within a tumor 
• Biomarkers of prognosis in cancer treatment
• Biomarkers for monitoring cancer therapy
• Biomarkers of drug resistance in cancer  
• A systems approach to biomarkers of innate drug resistance 
• Epithelial membrane protein-1 as a biomarker of gefitinib resistance
• Metabolomic biomarkers of cancer 
• Methylation biomarkers of drug resistance in cancer 
• STAT3 and resistance to cisplatin  
• Biomarkers of radiation therapy for cancer  
• Biomarkers of minimal residual disease in cancer
• Role of biomarkers in drug development in oncology 
• Biomarker-based approval of an anticancer drug regardless of site 
• Biomarkers in plucked hair for assessing cancer therapy
• Biomarkers for drug discovery in cancer
• ARTS as a biomarker as well as a basis of anticancer drugs  
• Met receptors as targets for anticancer drugs
• Overexpression of ERBB2 as biomarker for anticancer drug discovery 
• Molecular imaging of tumor as a guide to drug development
• Use of PET and SPECT to assess response to anticancer drugs  
• Use of MRI to assess response to anticancer drugs  
• Role of biomarkers in phase I clinical trials of anticancer drugs  
• Safety biomarkers in oncology studies 
• Biomarkers according to organ/type of cancer  
• Bladder cancer biomarkers 
• Detection of FGFR3 mutations in urine for diagnosis of bladder cancer
• NMP22 BladderChek 
• Urinary telomerase as biomarker for detection of bladder cancer  
• Concluding remarks abut biomarkers of urinary cancer 
• Brain tumor biomarkers 
• 14-3-3zeta expression as prognostic biomarker for glioblastoma
• ALDH1A3 as a biomarker of glioblastoma
• Biomarkers to predict response to EGFR inhibitors  
• Biomarkers for predicting recurrence of meningiomas  
• CD133 as biomarker of resistance to radiotherapy  
• Circulating microvesicles as biomarkers
• CSF attractin as a biomarker of malignant astrocytoma
• ELTD1 as a biomarker of gliomas  
• Methylation profiling of brain tumors
• Metabolite biomarkers of brain tumors
• miRNAs as biomarkers of brain tumors  
• MRI biomarker for response of brain tumor to therapy
• Multigene predictor of outcome in glioblastoma  
• Neuroimaging biomarkers combined with DNA microarray analysis.. 
• Proteomic analysis of CSF for identification of biomarkers for gliomas 
• Receptor protein tyrosine phosphatase  as biomarker of gliomas
• Serum protein fingerprinting 
• VEGF-R2 as biomarker of angiogenesis in brain tumors.. 
• Future prospects of biomarkers of malignant gliomas  
• Bone tumor biomarkers 
• Cytogenetics for the study of bone and soft tissue tumors 
• Biomarkers of Ewing’s tumors. 
• Role of biomarkers in the diagnosis of bone tumors
• Breast cancer biomarkers
• Autoantibody biomarkers of breast cancer  
• Biomarkers of breast cancer in breath
• Biomarkers for breast cancer in nipple aspiration fluid
• Biomarkers to evaluate efficacy of chemoprevention
• Biomarkers of response to chemotherapy of breast cancer
• Biomarker-guided decisions for breast cancer therapy
• Carbonic anhydrase IX
• Cdk6 as a biomarker of breast cancer 
• Centromere protein-F  
• Circulating tumor DNA as biomarker of breast cancer  
• Circulating exosomes as biomarkers of breast cancer  
• COX-2 as a biomarker of breast cancer  
• Diagnostic tests based on breast cancer genes
• ERBB2 overexpression as biomarker of breast cancer  
• G88 as a biomarker of progression of ER+ breast cancer
• Glycomic biomarkers of breast cancer.. 
• High mobility group protein A2
• Hypermethylated genes as biomarkers of metastatic breast cancer
• Lipocalin 2 as biomarker of breast cancer progression
• Long intervening non-coding RNAs 
• Mammaglobin
• miRNA biomarkers of breast cancer
• p27 expression as biomarker for survival after chemotherapy
• Podocalyxin 
• Proneurotensin and Proenkephalin 
• Proliferating cell nuclear antigen
• Protein kinase C as a predictive biomarker of metastatic breast cancer  
• Proteomic biomarkers of breast cancer  
• Quantification of biomarker expression patterns by flow cytometry
• Quantitative realtime PCR assays for biomarker validation
• Retinoblastoma tumor suppressor gene as a biomarker
• Riboflavin carrier protein  
• Risk of invasive cancer after diagnosis of ductal carcinoma in situ
• Serum CA 15-3 as biomarker of prognosis in advanced breast cancer 
• Stage-specific embryonic antigen-3
• Suppressor of deltex protein
• Tumor microenvironment as biomarker of metastasis in breast cancer
• Type III TGF- receptor as regulator of cancer progression  
• Prognostic role of breast cancer genes
• Protein biomarkers for breast cancer prevention
• Concluding remarks and future prospects of breast cancer biomarkers  
• Cervical cancer biomarkers
• Gastrointestinal cancer biomarkers 
• Esophageal cancer biomarkers  
• Gastric cancer biomarkers 
• Colorectal cancer biomarkers 
• Head and neck cancer  
• Leukemia biomarkers
• Chromosome translocations in leukemias
• DNA methylation biomarkers in leukemia
• Gene mutations as biomarkers in leukemia 
• Molecular diagnostic techniques for leukemia 
• Proteomic technologies for discovering biomarkers of leukemia
• Biomarkers of chronic lymphocytic leukemia
• Biomarkers of chronic myeloid leukemia 
• Biomarkers of drug resistance in leukemia
• Biomarkers of myelodysplasitic syndromes
• Lymphoma biomarkers
• Liver cancer biomarkers 
• Biomarkers indicating lower risk of HCC in coffee drinkers 
• Metabonomic profiles discriminate HCC from liver cirrhosis  
• 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 
 
Tables 
Table 1-1: Historical landmarks in discovery and development of biomarkers  
Table 1-2: Classification of biomarkers
Table 1-3: Terminology of clinically relevant biomarkers of disease 
Table 1-4: Autoimmune disorders under study for autoantibodies as predictors
Table 1-5: 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 

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

Biomarkers 
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 

Tables 
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.. 

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

Samples