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Multiplex Assays in Translational Medicine: Technologies, Applications, and Future Directions

Published by: CHI Insight Pharma Reports

Published: Feb. 1, 2008 - 150 Pages


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

Abstract

The development and growth of assay technologies has pushed translational medicine into a category unto itself. In a broad perspective on this field, this new report:
  • Defines translational medicine by giving some historical background as well as providing personal definitions from experts in the field
  • Discusses the evolution of assay technologies
  • Reviews currently available assay technologies that apply directly to translational medicine
  • Describes and evaluates current applications of these technologies
  • Provides case studies of clinicians currently using this technology in their research
  • Discusses future directions of assay technologies for translational medicine
  • Gives input from the FDA on translation medicine and assay technologies
  • Provides interviews from experts in the field of both translational medicine and specific assay technologies
  • Profiles premier companies active in the field
Assay technologies have been evolving since scientists first discovered they could measure glucose, insulin, and several hormones in the blood to help them diagnose disease. Early instruments such as the Ames Reflectance Meter, used for detecting glucose levels, have morphed into such sophisticated systems as flow cytometers. The Human Genome Project provided the basics for researchers to launch into the field of human genomics and they needed the tools to accomplish this. DNA microarrays allowed for massively parallel gene expression analyses. Scientists soon discovered that while the genomewide assays were extremely valuable, there were genes of interest that they had difficulty measuring when they got hundreds of data points from a microarray. Low- to mid-density assays have allowed scientists to pinpoint the genetic code for a variety of uses, from genetic heredity studies to drug metabolism and patient stratification.

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