Abstract
Overview
A great deal of descriptive material concerning multiplex assay technologies
has been written and discussed during the past decade. Multiplex Assays:
Evolving Technologies, Applications and Future Directions focuses mainly on
significant recent developments in the multiplex assay field.
Pharmaceutical companies are also 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. We deal with 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.
Following a brief introduction, Chapter 2 provides background, definitions,
describes the evolution of multiplex assays, and the development of
translational medicine as both a concept and a manifest reality.
Chapter 3 provides an in depth examination of technological aspects of
multiplex assays with emphasis on transcriptomics, proteomics, and
metabonomics. The emphasis here is on recent developments and newer players in
the multiplex assay field. Also included is a discussion of the potential role
of next-generation sequencing in replacing DNA microarray technology for
transcriptomics.
Chapter 4 examines applications of multiplex assays in translational medicine,
and does so from the perspective of pharma R&D, companion diagnostic products,
and the new diagnostics as a contributor to translational medicine.
Chapter 5 places the emphasis on market perspectives in the field. We examine
the competitive environment in “omics” technology via results of
an online survey of people active in the field, and also examine recent deal
activity and what it reveals about the market for multiplex assays and their
technologies.
Chapter 6 of the report makes some general observations relevant to a number
of issues raised in earlier chapters, leaning heavily on extracts from
interviews conducted for this report with people highly knowledgeable in this
field. Extracts from these interviews are also to be found in earlier chapters
where relevant to highlight various issues. Complete transcripts of these
interviews are contained in Chapter 7.
About the author:
Ken Rubenstein, PhD, a biochemist and molecular biologist, received his
PhD at the University of Wisconsin and postdoctoral training at the University
of Pennsylvania School of Medicine. He was a key innovator and research
manager for Syva Company, the diagnostics branch of Syntex Corporation. During
his 13 years with Syva, Dr. Rubenstein became vice president, scientific
affairs, a function that included strategic planning. Since 1983, he has
served as a technology and marketing consultant to biomedical companies and an
industry analyst, with more than 40 published studies to his credit.
Table of Contents
CHAPTER - 1
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
