Multiplex Assays: Evolving Technologies, Applications and Future Directions
CHI Insight Pharma Reports
January 1, 2010 190 Pages - SKU: CHI2525165
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| Multiplex Assays: Evolving Technologies, Applications and Future Directions focuses on significant recent developments in the multiplex assay field. Pharmaceutical companies are increasingly committing to associating their drugs with diagnostic assays. The majority of these are single-analyte biomarkers. However, a number of multiplex biomarkers not directly associated with particular drugs are in use as approved or homebrew diagnostics, and these contribute in various ways to the broad field of translational medicine. This report examines the role of multiplex and multi-analyte biomarker assays in translational medicine and their direct contributions to drug discovery and development; their contributions as theranostics, companion diagnostics, etc.; and the reasons why they are not more prevalent despite their apparent high potential. Key challenges and implications presented include: multi-analyte assays versus multiplex assays; the replacement of DNA microarrays with next-generation sequencing; recent developments and newer players in the field; the road toward validation and regulation; and the implications of recent deal activity. Multiplex Assays: Evolving Technologies, Applications and Future Directions examines applications of multiplex assays in translational medicine from the perspective of pharma R&D, companion diagnostic products, and the new diagnostics as a contributor to translational medicine.
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- CHAPTER 1
- INTRODUCTION
- CHAPTER 2
- EVOLUTION OF MULTIPLEX ASSAYS AND TRANSLATIONAL MEDICINE
- 2.1: The Evolution of Now-Classical Diagnostic Biomarkers
- Sensitivity, Specificity, and Predictive Value of Biomarker Assays
- 2.2: Pre-Genomic Biomarkers and Technologies
- Enzyme and Metabolite Assays
- Immunodiagnostics
- Enzyme Immunoassays
- Molecular Diagnostics
- Target Amplification: Polymerase Chain Reaction
- Signal Amplification Methods
- 2.3: Biomarkers in Drug Discovery and Development
- 2.4: Translational Medicine
- CHAPTER 3
- MULTIPLEX TECHNOLOGIES
- 3.1: Nucleic Acid-based Multiplex Assays
- Two-Dimensional Positional Microarrays
- Affymetrix
- Agilent Technologies
- Roche NimbleGen
- Encoded Particle Arrays
- Illumina
- True Materials
- NanoString
- Next-Generation Sequencing as Competition for DNA Microarrays
- Applied Biosystems
- Roche’s NimbleGen
- Agilent Technologies
- Others
- 3.2: Multiplex Assays for Proteins
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- Mass Spectrometry
- Positional Microarrays for Multiplex Protein Analysis
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- Randox Laboratories
- Aushon Biosystems
- Theranostics Health
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Encoded Bead Technology
- Luminex’s xMAP Bead Array
Bio-Rad
Biosite’s Triage Assays
Other
- Theranos
3.3: Multiplex Assays for Small Molecule Metabolites
- Metabolon
BG Medicine
Biosite
CHAPTER 4
APPLICATIONS
4.1: Pharma
- Eli Lilly
- Novartis
- The Theranos Approach
4.2: Predictive Toxicology and Multiplex Biomarkers
4.3: Diagnostics
- Ridge Diagnostics
- Satoris
- Rules-Based Medicine
- Proteome Sciences
- Tethys Bioscience
- Pathwork Diagnostics
- BioTheranostics
- Health Discovery Corporation
- Quest Diagnostics
- Celera Corporation
- Decision Biomarkers
- Banyan Biomarkers
CHAPTER 5
MARKET-RELATED CONSIDERATIONS
5.1: The Competitive Environment
5.2 Deal Patterns
5.3 User Survey Results
CHAPTER 6
GENERAL OBSERVATIONS AND CONCLUSIONS
6.1 Issues Slowing the Deployment of Multiplex Biomarkers
6.2 Pharma’s Shift in R&D Emphasis
6.3 Translation in Theory versus Practice
6.4 Translational Medicine-How Well is it Working?
6.5 Discussion of User Survey Results
CHAPTER 7
INTERVIEW TRANSCRIPTS
David Lester, VP, Human Health Solutions, Theranos
Brian Edmonds, Ph.D., Research Advisor, Global External R&D, Eli Lilly
Stephen Naylor, Ph.D., Founder and Chairman of PPM, Inc.
Stephen A. Williams, M.D., Chief Medical Officer, SomaLogic
Michael Spain, M.D., Chief Medical Officer, Rules-Based Medicine
Peter Tolias, Ph.D., Executive Director, Institute of Genomic Medicine, Research Director, The Autism Center, University of Medicine & Dentistry of New Jersey
REFERENCES
COMPANY INDEX WITH WEB ADDRESSES
APPENDIX
Exhibits
Exhibit 3.1 Readout from an Affymetrix DNA microarray experiment
Exhibit 3.2 Affymetrix photolithographic process for DNA microarray manufacturing
Exhibit 3.3 Roche NimbleGen microarray preparation process
Exhibit 3.4 Image of a scan from the NanoString Digital Analyzer showing immobilized and aligned reporter molecules
Exhibit 4.1: Consortia and Joint Programs for Developing Multiplex Biomarkers for Predictive Toxicology
Exhibit 5.1 Selected Deals Involving Multiplex Biomarkers
Exhibit 5.2 Company Category
Exhibit 5.4 Work Function/Pipeline Stage
Exhibit 5.5 Employment of Multiplex Biomarkers in Preclinical Development
Exhibit 5.6 Employment of Multiplex Biomarkers in Phase 0 Clinical Studies
Exhibit 5.7 Employment of Multiplex Biomarkers in Phase I/IIA Clinical Studies
Exhibit 5.8 Employment of Multiplex Biomarkers in Phase IIB/III Clinical Studies
Exhibit 5.9 Employment of Multiplex Biomarkers in Phase IV Clinical Studies
Exhibit 5.10 Use of the Same Multiplex Biomarkers in both Preclinical and Early Clinical Studies
Exhibit 5.11 Would Like to Use Same Multiplex Biomarkers in both Preclinical and Early Clinical Studies
Exhibit 5.12 Organizational Preference to Use Single-Analyte Biomarkers Whenever Possible
Exhibit 5.13 Reasons to Prefer Single Analyte Biomarkers
Exhibit 5.14 Respondent’s Organization Uses Multiplex Biomarkers Preclinically without Formal Validation
Exhibit 5.15 Respondent’s Organization Uses Multiplex Biomarkers in Phase 0 Studies without Formal Validation
Exhibit 5.16 Respondent’s Organization Uses Multiplex Biomarkers in Phase I/IIA Clinical Studies without Formal Validation
Exhibit 5.17 During the Next Three Years, Organization’s Expectation for Multiplex Biomarkers in Preclinical Development
Exhibit 5.18 During the Next Three Years, Organization’s Expectation for Multiplex Biomarkers in Phases I/IIA Clinical Development
Exhibit 5.19 During the Next Three Years, Organization’s Expectation for Multiplex Biomarkers in Phases IIB/III Clinical Development
Exhibit 5.20 Organization has a Drug in Development that Will Have a Companion Diagnostic
Exhibit 5.21 Diagnostic in Development is Single or Multianalyte
Exhibit 5.22 Organization’s View of Companion Diagnostics
Exhibit 5.23 Organization Has a Formal Translational Medicine Group or Function?
Exhibit 5.24 Contribution of Translational Medicine to Respondent’s Organization
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