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SUMMARY
Introduction
Validating a biomarker is a resource-intensive undertaking. Is it worth it? We
say, Yes. A biomarker that wins "known validated" status is best positioned
for rewards: regulatory approval, optimal reimbursement, incorporation into
personalized medicine approaches alongside companion therapeutics, partnership
and promotion opportunities, and wider awareness and uptake. Companies that
recently began fi elding biomarkerbased tests are reporting success in terms
of a revenue upswing. And they have laid the groundwork for validation of
tomorrow's biomarker-based tools.
Get the Answers You Need to Shape Your Strategy
- In December 2007, Panacea's LC Detect for early lung cancer diagnosis was
named one of Time Magazine's Top 10 Medical Breakthroughs of 2007. What
other biomarker-based tests are changing medical practice, and how?
- Validation is a key step in maximizing the clinical and commercial success
of a biomarker. What is the validation process? What companies have
successfully navigated it? What resources exist to facilitate the process?
- Validated biomarkers are the basis for several marketed companion
diagnostics. Which products have received approval? How are these products
faring? What tests are in development?
- For companies developing biomarker-based tests, a key strategy that taps
the personalized medicine paradigm is to partner with drug developers.
Which biomarker companies lead the pack? Which pharmaceutical companies
have become involved in personalized medicine and drug/diagnostic
codevelopment?
Scope
- About validated biomarkers: defi nitions, classifi cations, the
value and process of validation.
- Types of biomarker-based tests: home-brew, de novo, in vitro
diagnostic multivariate assay, therapeutic area focus (oncology is a leading
area), technology focus (nucleic-acid testing, or NAT, is emerging as the key
approach). Tables detail FDA-approved validated biomarkers and those in trials
to achieve validation.
- Case studies: Genomic Health's Oncotype DX and Agendia's Mammaprint.
- Biomarker development environment: recent approvals, reimbursement
challenges, supporting consortia.
- Where is the pay-off?: company profi les, revenue trends, industry
outlook.
TABLE OF CONTENTS
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Biomarker Opportunity: Driven by Personalized Medicine
- Biomarker Defi nitions: Moving Toward "Known Validity"
- The Importance of Biomarker Validation
- Biomarker Validation Process
- FDA Support for Biomarker Validation
- "Home Brew" Tests
- De Novo Tests
- In Vitro Diagnostic Multivariate Assays
- Case Studies: Two Successful Genetic Profi ling Biomarker Tests
- Genomic Health's Oncotype DX
- Agendia's MammaPrint
- Current Environment for Biomarker-Based Tests Seeking FDA Approval
- Notable Recent FDA-Approved Biomarker Diagnostics
- Agendia's MammaPrint
- Nanosphere's Two Nucleic Acid Biomarker Tests
- Veridex's GeneSearch Breast Lymph Node Assay
- Fujirebio Diagnostics' Mesomark
- Siemens Medical Solutions' Immulite
- Reimbursement Challenges
- Health Insurers' Policy Decisions
- FDA Recommendations
- Consortia to Standardize Biomarker Validation
- Oncology Biomarker Qualifi cation Initiative
- The Cancer Biomarkers Collaborative
- The Severe Adverse Event Consortium
- Key Players in the Current and Emerging Biomarker Market
- Affymetrix
- Dako
- Exagen Diagnostics
- Genzyme Genetics
- Myriad Genetics
- Nanosphere
- Panacea Pharmaceuticals
- Roche Diagnostics
- Third Wave Technologies
- Ventana Medical Systems
- Veridex
- Upside for the Future of Biomarkers
Sidebar:
- Oncotype DX and MammaPrint: How Different Are The Two Gene Expression
Tests?
Tables:
- 1. Biomarker Type and Select FDA-Approved Examples
- 2. Select FDA-Approved Tests for Known Valid Biomarkers
- 3. Select Clinical Trials Testing for Biomarker Validation, as of January
2008
- 4. Comparison of Genomic Health's Oncotype DX and Agendia's MammaPrint
- 5. Select FDA Approvals of Biomarker Diagnostics, 2007
- 6. Cost of Select High-Value Molecular Diagnostic Biomarker Tests
- 7. Organizations That Facilitate Biomarker Research and Validation
Figures:
- 1. FDA Classifi cation of Biomarker Diagnostics for Approval
- 2. Regulations by the FDA and CMS Relating to Diagnostics and Overlapping
Oversight
- 3. Key Molecular Diagnostic Company Revenues
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