Abstract
Introduction
Although novel cancer biomarkers are reported on a weekly basis, only a handful are actually translated into fully validated diagnostic tools. To fully understand the process, we explore the current status of the cancer biomarker fi eld, roadblocks that slow the development process, the cancer biomarker pipeline, as well as the outlook for integrating cancer biomarkers into clinical practice. We also profi le select companies that are actively pursuing cancer biomarker discovery and development.
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- Companies are utilizing cutting-edge technologies to develop, validate, and implement cancer biomarkers for clinical use. What impediments still exist to incorporating promising research into clinical practice? Which biomarkers show the most promise for approval?
- Integrating cancer biomarkers into clinical practice is the goal for development companies as well as clinicians. What are the economic challenges to approval? How can regulatory oversight drive approval and adoption of new technologies?
- No one company or agency has the necessary scope or expertise to drive the discovery, development, and implementation of sensitive and specifi c biomarkers. Which alliances show the greatest synergy in bringing valid biomarkers to market? Which shared technologies are driving the most encouraging development?
Scope
- Trends in Cancer Biomarker Development: Biomarker discovery and validation, as well as the role of the diagnostics.
- Emerging Biomarkers in Select Cancers: Bladder, breast, colorectal, lung, pancreatic, prostate, and renal cell.
- Profi les of Select Cancer Biomarker Companies: Biomarker Technologies, Ciphergen, Claros Diagnostics, Epigenomics, Exagen Diagnostics, Genesis Genomics, Health Discovery Corporation, Ipsogen, Matritech, Miraculins, Orion Genomics, Phenomenone Discoveries, Power3 Medical Products, Upstream Biosciences.
- Challenges: How strategic alliances and interdisciplinary involvement will need to drive development and implementation of emerging biomarker technologies.
Mentioned in This Spectrum Report
- Access Genetics
- Acrongenomics
- Advanced Magnetics
- Affymetrix
- Agendia
- Atairgin Technologies
- Applied Biosystems
- Arcturus Biosciences
- AstraZeneca
- AviaraDx
- Bayer
- Bayer HealthCare
- Baylor College of Medicine
- BioAlliance Pharma
- BioGenex Laboratories
- Biomarker Technologies
- bioMerieux
- Biomira Diagnostics
- Biosite
- Brigham and Women' s
- Hospital
- The Burnham Institute
- Cangen Biotechnologies
- Centocor
- Centre National de la
- Recherche Scientifi que
- Children' s Medical Center
- Ciphergen Biosystems
- Claros Diagnostics
- CMX Research
- Cornell Research Foundation
- Cytoclonal Pharamaceutics
- Cytyc Health
- Dade-Behring
- Dako
- DiaDexus
- DiagnoCure
- EDP Biotech
- Elan
- Emory University
- EntreMed
- Epigenomics
- Erasmus MC, University
- Medical Center Rotterdam
- Exagen Diagnostics
- Genaissance Pharmaceuticals
- Gene Fluidics
- GeneNews
- Genentech
- Genesis Genomics
- Genomic Health
- Genzyme
- Gerald P. Murphy Cancer
- Foundation
- Glycominds
- Health Discovery Corporation
- Henry M Jackson Foundation
- for the Advancement of
- Military Medicine
- Hycor Biomedical
- Immunicon
- InterGenetics
- Intracel
- Ipsogen
- Inverness Medical Innovations
- JTAT
- Johns Hopkins University
- Johnson & Johnson
- Loma Linda University
- Matritech
- Mayo Foundation for Medical
- Education and Research
- Medical College of Georgia
- Research Institute
- Millennium Pharmaceuticals
- Miraculins
- Mount Sinai Hospital
- Myriad Genetics
- Nanogen
- Nanospectra Biosciences
- Nanosphere
- Orion Genomics
- Ortho-Clinical Diagnostics
- Oxford Genome Sciences
- Panacea Pharmaceuticals
- Pfi zer
- Phenomenome Discoveries
- Polymedco
- Power3 Medical Products
- PrecisionMed
- Proteome Systems
- Quantum Dot
- Quest Diagnostics
- Qiagen
- Roche
- Shimadzu
- Sloan-Kettering Institute for
- Cancer Research
- Texas A&M University
- Thomas Jefferson University
- TriPath Imaging
- UB Institute for Lasers,
- Photonics, and Biophotonics
- University of Michigan
- University of Mississippi
- Medical Center
- University of New Mexico' s
- Science and Technology
- Corporation
- University of Pittsburgh
- University of Texas Systems
- Upstream Biosciences
- Urocor
- Ventana Medical System
- Vysis
- Wako Chemicals USA
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Overview
- Traditional Use of Biomarkers in Cancer Management
- Trends in Cancer Biomarker Development
- Biomarker Discovery
- Clinical Validation of Cancer Biomarkers
- Ciphergen
- Miraculins
- Panacea Pharmaceuticals
- Biomarker Technologies
- Engagement of Diagnostics Industry
- Recent Advances in Detection Technologies
- Image-Based Biomarkers
- The "omics" Platforms
- Nanodiagnostics
- Applications of Cancer Biomarkers
- Transformation of Clinical Trial Design
- Genetic Predisposition
- Screening and Early Detection of Cancer
- Diagnosis and Prognosis
- Treatment Selection and Response
- Recurrence
- Emerging Biomarkers in Select Cancers
- Bladder Cancer
- Breast Cancer
- Colorectal Cancer
- Lung Cancer
- Pancreatic Cancer
- Prostate Cancer
- Renal Cell Carcinoma
- Roadblocks to Integrating Cancer Biomarkers into Clinical Practice
- Technical Challenges
- Lack of a Centralized Database
- Economic Challenges
- Regulatory Oversight
- Current Activities of Cancer Biomarker Companies
- Biomarker Technologies
- Ciphergen
- Claros Diagnostics
- Epigenomics
- Exagen Diagnostics
- Genesis Genomics
- Health Discovery Corporation
- Ipsogen
- Matritech
- Miraculins
- Orion Genomics
- Phenomenome Discoveries
- Power3 Medical Products
- Upstream Biosciences
Tables:
- 1. Sensitivities and Specifi cities of Select FDA-Approved Traditional Cancer Biomarkers
- 2. FDA-Approved Cancer Biomarkers with Companion Diagnostic Tests
- 3. Select Cancer Biomarker Patent Filings
- 4. Select Issued Patents for Cancer Biomarkers in the United States (2001-Present)
- 5. Select Nanodiagnostic Products
- 6. Available Tests for Genetic Predisposition to Cancer Development
- 7. Profi les of Companies Engaged in Cancer Biomarker Development
Figures:
- 1. Overall Five-Year Survival, by Stage
- 2. Potential Impact of Cancer Biomarkers in Drug Discovery and Drug Development Processes
- 3. Applications of Biomarkers in Cancer Management
