Multiplex Assays in Translational Medicine

Technologies, Applications, and Future Directions

Publication Date	February 2008
Publisher	Insight Pharma Reports
Product Type	Report
Pages	150
ISBN Number	not applicable
Product Code	IPR00021

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Summary

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.

Multiplex Assays in Translational Medicine: Technologies, Applications, and Future Directions provides a full discussion of the current state and future directions for assay technologies used in translational medicine. In translational medicine, information flows in multiple directions-as the common phrase "bench to bedside and back" describes. Information taken from the clinical level can be used to refine techniques used at the "bench", and the whole process begins again. Data collected from assays will assist researchers all through drug discovery, the phases of clinical development, and in obtaining drug approval by the Food and Drug Administration. This information can also be used to help with the selection and development of next-generation compounds.

Today, pharmaceutical companies are faced with many hurdles to get a discovered compound through drug development and finally to market. This report provides a thorough discussion of the roles multiplex assay technologies play in pursuing that goal.

Content

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, Verrires 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
Figures
- Figure 1.1. Cycle of Translational Medicine in Clinical Research and Development
- Figure 1.2. Biomarker Discovery Can Lead to A Marketed Diagnostic Product
- Figure 3.1. Use of High-Throughput Technology and Low- to Mid-Density Assays
- Figure 3.2. Roche Diagnostics' Amplichip Cyp450 Array, Based on Affymetrix Genechip Technology
- Figure 3.3. Roche Diagnostics' Amplichip Leukemia Test
- Figure 3.4. Agendia's Mammaprint Test Technology
- Figure 3.5. Asper Biotech's Genotyping Process
- Figure 3.6. Osmetech's Esensor Cystic Fibrosis Carrier Screening Cartridge
- Figure 3.7. Taqman Probe Chemistry
- Figure 3.8. Epigenomics' Quantitative Methylight
- Figure 3.9. Genomic Health's Oncotype Dx's Validated Use in Breast Cancer Patients
- Figure 3.10. Oncomethylome Sciences' Product Pipeline
- Figure 3.11. Oncomethylome Sciences' Patented Methylation-Specific Pcr (Msp) Process
- Figure 3.12. Gene Express' Start-Pcr Process
- Figure 3.13. Zeptosens' Ultra-Sensitive Planar Wave Guide Technology, Based on Evanescent Excitation
- Figure 3.14. High Throughput Genomics' Assay Schema
- Figure 3.15. Luminex's Xmap Technology
- Figure 3.16. Schematic of The Overall Structure of Molecular Probes' Qdot Nanocrystal Conjugate
- Figure 3.17. Bio-Rad's Bioplex 2200 Ana Screen
- Figure 3.18. Monogram Biosciences' Etag Technology
- Figure 5.1. from Diagnosis to Treatment (Dx2tx)
Appendix Figures
- Figure 1a. Organizations Represented by Respondents
- Figure 2a. Functional Areas
- Figure 3a. Approach to Drug Discovery Projects
- Figure 4a. Primary Goal of Translational Medicine
- Figure 5a. Profiling Techniques
- Figure 6a. Mrna Profiling Techniques
- Figure 7a. Needed Improvements to Mrna Analysis
- Figure 8a. Snp Microarray Vendors
- Figure 9a. Needed Improvements to Snp Microarrays
- Figure 10a. Needed Improvements to Amplification Technologies
- Figure 11a. Immunoassay-Based Technologies
- Figure 12a. Protein Analysis
- Tables
- Table 2.1. Timeline of Early Technologies Used in The Pharmaceutical and Diagnostics Industries
- Table 2.2. Timeline of Significant Events Relating to Mass Spectrometry
- Table 2.3. Timeline of Microarray Milestones
- Table 3.1. Selected Commercial, Positional Array-Based Multiplex Technologies
- Table 3.2. Selected Companies Involved in Pcr-Based Technologies
- Table 3.3. Benefits of Start-Pcr Method for Multigene Expression Measurement as Compared to Traditional Microarrays and Pcr Technologies
- Table 3.4. Selected Companies with Bead-Based Technologies