Cancer Biomarkers: New Tools for Transforming Cancer Management

Published by: Decision Resources

Published: Apr. 20, 2007 - 34 Pages

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

Abstract

• 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?

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