展開医療における多重分析：技術、応用および将来の方向性

Abstract

Author: Olivia Scaros, PharmD

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.

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