Cancer Biomarkers: New Tools for Transforming Cancer Management

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