Author: Ken Rubenstein, PhD
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