Biomarkers - Technologies,markets and companies

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Biomarkers - Technologies,markets and companies Published on September 2011

Report Summary This report follows the broad definition of a biomarker as a characteristic that can be objectively measured and evaluated as an indicator of normal biological or pathogenic processes as well as pharmacological responses to a therapeutic intervention. Tests based on biomarkers have been around for more than half a century, but interest in their application for diagnostics and drug discovery as well as development has increased remarkably since the beginning of the 21st century. This report describes different types of biomarkers and their discovery using various '-omics' technologies such as proteomics and metabolomics. Molecular diagnostics technologies are used for the discovery of biomarkers and new tests are also based on biomarker. Currently the most important applications of biomarkers are in drug discovery and development. The role of biomarkers in various therapeutic areas particularly cancer, cardiovascular diseases and disorders of the central nervous system, is described. Biomarkers are useful not only for diagnosis of some of these diseases but also for understanding the pathomechanism as well as a basis for development of therapeutics. Biomarkers will facilitate the combination of therapeutics with diagnostics and will thus play an important role in the development of personalized medicine. Biomarkers play a role in use of pharmacogenetics, pharmacogenomics and pharmacoproteomics for development of personalized medicine. Many of the regulatory issues concerning biomarkers are related to genomics, proteomics, molecular diagnostics and pharmacogenomics/pharmacogenetics. Validation of biomarkers and their role in clinical trials is discussed. Biomarker markets are estimated from 2010 to 2020 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 276 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 513 collaborations between companies and additional academic collaborations are mentioned in the individual profiles of companies. The report is supplemented by 1,000 references, 65 tables and 13 figures

Table of Content TABLE OF CONTENTS 0. Executive Summary 21 1. Introduction 23 Definitions 23 Historical aspects of biomarkers 23

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>> Get this Report Now by email! 2D GE 46 Biomarker Amplification Filter 47 CellCarta速 proteomics platform 47 Isotope-coded affinity tags 48 Liquid chromatography-MS/MS 48 Lucid Proteomics System 48 Magnetics beads for protein biomarker discovery 49 MASStermind' 49 Mass spectrometry 49 2D PAGE and mass spectrometry 50 Imaging mass spectrometry 50 MALDI mass spectrometry for biomarker discovery 51 Quantitative tandem MS 52 Single-molecule mass spectrometry using a nanopore 52 Requirements for MS-based proteomic biomarker development 53 Protein tomography 53 Protein biochips/microarrays and biomarkers 53 Antibody-based biomarker discovery 54 Detection of biomarkers using peptide array technology 54 Discovery of biomarkers by MAb microarray profiling 54 Protein nanobiochip 55 Gene expression microarray data as a source of protein biomarkers 55 Quantification of protein biomarkers 55 Mass spectrometry for quantification of protein biomarkers 55 Real-time PCR for quantification of protein biomarkers 56 CyTOF for quantification of biomarkers 56 Search for biomarkers in body fluids 56 Challenges and strategies for discovey of protein biomarkers in plasma 57 3-D structure of CD38 as a biomarker 58 BD' Free Flow Electrophoresis System 58 Isotope tags for relative and absolute quantification 58 Plasma protein microparticles as biomarkers 59 Proteome partitioning 59 Stable isotope tagging methods 60 Technology to measure both the identity and size of the biomarker 60 Targeted proteomic approaches 61 Biomarkers in the urinary proteome 61 Peptides in body fluids and tissues as biomarkers of disease 61 Analysis of peptides in bodily fluids 62 Serum peptidome patterns 62 SISCAPA method for quantitating proteins and peptides in plasma 63 Comparison of proteomic profiling technologies for discovery of biomarkers 63 Verification for interlaboratory reproducibility of protein biomarkers 63 Significance of similar protein biomarkers in different tissues 64 Glycomic technologies 65 Metabolomic technologies 65 Genome-wide association studies for identification of metabolic biomarkers 66 Lipid profiling 66

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>> Get this Report Now by email! Mass spectrometry-based kits for discovery of metabolic biomarkers in plasma 66 Role of metabolomics in biomarker identification and pattern recognition 67 Urinary profiling by capillary electrophoresis 67 Validation of biomarkers in large-scale human metabolomics studies 67 Lipidomics 67 Disease biomarkers in breath 68 Portable breath test for volatile organic compounds 68 Detection of breath biomarkers by sensation technology 69 Detection of breath biomarkers optical frequency comb spectroscopy 69 Detection of breath biomarkers by infrared absorption spectroscopy 69 Fluorescent indicators for biomarkers 70 Molecular imaging technologies 70 Computer tomography 70 Magnetic resonance imaging 71 Positron emission tomography 71 Advantages of imaging biomarkers 72 Monitoring in vivo gene expression by molecular imaging 72 Molecular imaging in vivo as a biomarker 72 Challenges and future prospects of molecular imaging 73 Basic research in molecular imaging 73 Imaging intracellular NADH as a biomarker of disease 73 Devices for molecular imaging 74 Imaging biomarkers in clinical trials 74 Molecular imaging in clinical practice 74 Nuclear magnetic resonance 74 Chemical derivatization to enhance biomarker detection by NMR 75 Fluxomics by using NMR 75 Nanobiotechnology 75 Nanomaterials for biolabeling 76 Quantum dot molecular labels 77 Bioconjugated QDs for multiplexed profiling of biomarkers 77 Magnetic nanotags for multipley detection of biomarkers 78 Nanoproteomics and biomarkers 78 High-field asymmetric waveform ion mobility mass spectrometry 78 Nanoparticles for molecular imaging 78 Nanoparticles for discovering biomarkers 79 Nanosensors for measuring biomarkers in blood 79 Nanobiochip sensor technique for analysis of oral cancer biomarkers 80 Nucleoprotein nanodevices for detection of cancer biomarkers 80 Future prospects of application of nanobiotechnology for biomarkers 80 Bioinformatics 81 Biomarker Workflow Guide 81 Analysis of microarray data for selecting useful biomarkers 81 Role of bioinformatics in discovery of protein biomarkers 82 Role of bioinformatics in detection of cancer biomarkers 82 Biomarker databases 83 Gene networks as biomarkers 83 Role of bioinformatics in integrating various data and biomarker discovery 83

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>> Get this Report Now by email! Evaluation of biomarker studies 84 3. Biomarkers and Molecular Diagnostics 85 Introduction 85 Molecular diagnostic technologies 85 Polymerase chain reaction 85 Amplification 85 Target selection 86 Detection of amplified DNA 86 Limitations of PCR 86 Real-time PCR systems 87 Limitations of real-time PCR 87 Future applications of real-time Q-PCR 88 Combined PCR-ELISA 88 Non-PCR methods 88 Linked Linear Amplification 89 Transcription mediated amplification 89 Rapid analysis of gene expression 89 WAVE nucleic acid fragment analysis system 89 DNA probes with conjugated minor groove binder 90 Rolling circle amplification technology 90 Gene-based diagnostics through RCAT 91 RCAT-immunodiagnostics 91 RCAT-biochips 92 RCAT-pharmacogenomics 92 Circle-to-circle amplification 92 Biochips and microarrays 92 Applications of biochips/microarrays 93 Role of biochip/microarrays in discovery of biomarkers 93 Biomarkers and high throughput molecular screening 94 Detection and expression profiling of miRNA 94 Real-time PCR for expression profiling of miRNAs 95 Real-time PCR for expression profiling of miRNAs 95 Use of LNA to explore miRNA 95 Microarrays for analysis of miRNA gene expression 95 4. Biomarkers for Drug Discovery & Development 97 Introduction 97 Biomarker technologies for drug discovery 98 Proteomics-based biomarkers for drug discovery 98 Chemoproteomics 98 Activity-based chemical proteomics 98 Transcriptomics for drug discovery 99 AvalonRx速 drug discovery platform 99 Metabolomics for drug discovery 99 Biomarkers and drug safety 100 Biomarkers of adverse drug reactions 100 Applications of biomarkers in drug safety studies 101 Genomic technologies for toxicology biomarkers 101 Proteomic technologies for toxicology biomarkers 102

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>> Get this Report Now by email! Biomarkers of radiation therapy for cancer 223 Role of biomarkers in drug development in oncology 223 Molecular imaging of tumor as a guide to drug development 224 Use of PET to assess response to anticancer drugs 225 Use of MRI to assess response to anticancer drugs 225 Biomarkers in plucked hair for assessing cancer therapy 225 Molecular targets of anticancer drugs as biomarkers 226 Safety biomarkers in oncology studies 226 Role of biomarkers in phase I clinical trials of anticancer drugs 226 Biomarkers according to location/type of cancer 227 Bladder cancer biomarkers 227 Detection of FGFR3 mutations in urine for diagnosis of bladder cancer 227 NMP22 BladderChek 227 Urinary telomerase as biomarker for detection of bladder cancer 228 Concluding remarks abut biomarkers of urinary cancer 228 Brain tumor biomarkers 228 14-3-3zeta positive expression as a prognostic biomarker for GBM 229 Biomarkers to predict response to EGFR inhibitors 229 CD133 as biomarker of resistance to radiotherapy 229 Circulating microvesicles as biomarkers 230 CSF protein profiling 230 CSF attractin as a biomarker of malignant astrocytoma 230 Methylation profiling of brain tumors 230 Metabolite biomarkers of brain tumors 231 miRNAs as biomarkers of brain tumors 232 MRI biomarker for response of brain tumor to therapy 232 Multigene predictor of outcome in GBM 232 Neuroimaging biomarkers combined with DNA microarray analysis 233 Receptor protein tyrosine phosphatase ' as biomarker of gliomas 233 Serum protein fingerprinting 233 VEGF-R2 as biomarker of angiogenesis in brain tumors 234 Bone tumor biomarkers 234 Cytogenetics for the study of bone and soft tissue tumors 234 Biomarkers of Ewing's tumors 234 Role of biomarkers in the diagnosis of bone tumors 235 Breast cancer biomarkers 235 Biomarkers of breast cancer in breath 236 Biomarkers for breast cancer in nipple aspiration fluid 236 Circulating nucleic acid biomarkers of breast cancer 236 Flow cytometry for quantification of biomarker expression patterns 237 Plasma proteomics for biomarkers of breast cancer 237 Quantitative realtime PCR assays for biomarker validation 237 Cdk6 as a biomarker of breast cancer 238 Centromere protein-F 238 Carbonic anhydrase IX 239 COX-2 as a biomarker of breast cancer 239 Glycomic biomarkers of breast cancer 239 HER-2/neu oncoprotein 240

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