Multiplex Assays in Translational Medicine: Technologies, Applications, and Future Directions
Author: Olivia Scaros, PharmD
TABLE OF CONTENTS
Chapter 1
INTRODUCTION: DEFINITION OF TRANSLATIONAL MEDICINE AND HOW ASSAY TECHNOLOGIES AFFECT ITS COURSE
1.1. Scope of the Report
1.2. Translational Medicine: Beginnings and Biomarkers
Historical Background
Biomarkers
Assay Technologies
Adoption of Translational Medicine
Experts’ Views on Translational Medicine
Chapter 2
THE HISTORY OF ASSAY TECHNOLOGIES
2.1. Early Technologies
2.2. Mass Spectrometry
2.3. DNA Microarrays
Chapter 3
PRODUCTS AND APPLICATIONS OF MULTIPLEX ASSAYS FOR THE ADVANCEMENT OF TRANSLATIONAL MEDICINE
3.1. Microarrays
High-Throughput Microchips
Affymetrix’s GeneChip
Agendia’s MammaPrint
Extension Arrays
Asper Biotech’s APEX Technology
Electronic Platforms
Osmetech’s eSensor Detection Technology
PCR-Based Assays
Applied Biosystems’ TaqMan Probes
Epigenomics’ MethyLight
Genomic Health’s Oncotype DX
OncoMethylome Sciences’ Methylation-Specific PCR (MSP)
Gene Express’ StaRT-PCR
3.2. Protein Microarrays
Antibody Arrays
Biosite’s Protein Arrays
Biosite’s Triage Panel Products
Biacore’s Life Sciences Protein Microarray
BD Biosciences’ Cytometric Bead Array
Zeptosens’ ZeptoMark Capture Microarray and ZeptoMark CeLyA Reverse Microarray
High Throughput Genomics’ ArrayPlate qNPA
Pierce’s Protein Array Kits
PamGene’s PamChip Microarray
Microsphere or Bead-Based Technologies
Luminex’s xMAP Technology
Molecular Probes’ Qdot Nanocrystals
Oxonica’s Nanoplex Technology
Pronostics’ UltraPlex Barcodes Molecules
Illumina’s BeadXpress Reader and VeraCode Technology
BioArray Solutions’ BeadChip
Randox’s Evidence
Xceed Molecular’s Flow-Thru Chip and TipChip Technology
Decision Biomarkers’ Avantra Q400 Biomarker Workstation
Meso Scale Discovery’s Platform
Bio-Rad’s BioPlex
3.3. Imaging Technologies
Stratos Biosystems’ EC-Affinity Biochips
Blueshift Biotechnologies’ IsoCyte
3.4. Miscellaneous Assay Technologies
Monogram Biosciences’ eTag
Chapter 4
TWO CASE STUDIES INVOLVING MULTIPLEX ASSAY TECHNOLOGIES APPLIED TO TRANSLATIONAL MEDICINE
4.1. Blood Testing Technology to Discover Serum Protein Markers for Early Detection of Ovarian Cancer
4.2. StaRT-PCR to Assess Genes Associated with Cisplatin Chemoresistance
Chapter 5
FUTURE DIRECTIONS OF MULTIPLEX ASSAY TECHNOLOGIES APPLIED TO TRANSLATIONAL MEDICINE
5.1. Translating Discoveries Made in Animal Models to Humans
5.2. Discoveries in Pharmacogenomics
5.3. Assay Technologies in Disease Diagnosis
5.4. Translational Research to Help in Disease Prevention
5.5. More “System”-Oriented Assay Technologies
XB TransMed’s XB BioIntegration Suite
5.6. The Growth of Personalized Medicine Companies
Chapter 6
FDA PERSPECTIVE ON MULTIPLEX ASSAY TECHNOLOGIES IN TRANSLATIONAL MEDICINE
6.1. Critical Path Initiative (CPI)
6.2. Oncology Biomarker Qualification Initiative (OBQI)
6.3. Predictive Safety Testing Consortium (PSTC)
Chapter 7
EXPERT INTERVIEWS
Guido Grentzmann, PhD, President, PBS PharmaBioServices, Verrières le Buisson,
France
David Lester, PhD, Senior Vice President of Strategy and Corporate Development, Gene Express, Inc., Toledo, OH
Bruce Littman, MD, President, Translational Medicine Associates; Formerly Global Head of Translational Medicine, Pfizer Global Research and Development, New London, CT
Francesco M. Marincola, MD, Chief, Infectious Disease and Immunogenetics Section, Department of Transfusion Medicine, National Institutes of Health, Bethesda, MD
Gil Mor, MD, PhD, Associate Professor, Department of Obstetrics, Gynecology & Reproductive Sciences, Yale University School of Medicine, New Haven CT; Director of Yale Gynecologic Oncology’s program, Discovery to Cure: Advancing the Prevention, Early Detection and Treatment of Women’s Reproductive Cancers
Deborah J. Neff, President and CEO, Pathwork Diagnostics, Sunnyvale, CA
Scott Patterson, PhD, Executive Director of Medical Sciences, Amgen, Thousand Oaks, CA
Wendy Sanhai, PhD, Senior Scientific Advisor, Office of the Commissioner, Food and Drug Administration
Chapter 8
SELECTED COMPANY PROFILES
Affymetrix
Agendia
Asper Biotech
Biosite
Epigenomics
Gene Express, Inc.
Genomic Health
High Throughput Genomics
Luminex Corporation
Monogram Biosciences
OncoMethylome Sciences
Osmetech
PamGene
Randox Laboratories
Stratos Biosystems
Xceed Molecular
Zeptosens
Appendix
INSIGHT PHARMA REPORTS MULTIPLEX ASSAY SURVEY—DECEMBER 2007
References
Company Index with Web Addresses