Multiplex Assays: Evolving Technologies, Applications and Future Directions

Report Description:

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.

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
      Mass Spectrometry
      Positional Microarrays for Multiplex Protein Analysis
            Randox Laboratories
            Aushon Biosystems
            Theranostics Health
      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