How Overcoming the Challenge of Biomarker Validation Can Pay Off for Drug and Diagnostic Developers
Decision Resources, Inc, February 2008, Pages: 35
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 fielding biomarker-based 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: definitions, classifications, 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 profiles, revenue trends, industry outlook.
Key Terms
- Biomarkers
- CLIA
- Clinical Laboratory Improvement Act Amendments
- Clinical trials
- Clinical utility
- Clinical validity
- Co-development of drugs and diagnostics
- Collaboration
- Companion diagnostics
- De novo tests
- Direct-to-consumer advertising
- Drug development
- DTC
- Exporatory biomarkers
- FDA
- Gene profiling
- “Home brew”
- In vitro diagnostic multivariate assays
- Known valid biomarkers
- Microarray
- NAT
- Oncology
- Partnering
- Patient selection
- Personalized medicine
- Pharmacodiagnostics
- PMA
- Probable valid biomarkers
- Reimbursement
- Reverse transcriptase polymerase chain reaction
- Theranostics
- Validation
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 Profiling 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
- Affymetrix
- Agendia
- Biosite
- Cepheid
- Chugai
- Dako
- Eli Lilly
- Exagen Diagnostics
- Fujirebio Diagnostics
- Genentech
- Genomic Health
- Genzyme Genetics
- GlaxoSmithKline
- Immunicon
- Kudos Pharmaceuticals
- LabCorp
- Merck
- Myriad Genetics
- Nanosphere
- Novartis
- Panacea Pharmaceuticals
- Pfizer
- Prometheus Therapeutics & Diagnostics
- OSI Pharmaceuticals
- Roche
- Roche Diagnostics
- Siemens Medical Solutions
- Third Wave Technologies
- Vanda Pharmaceuticals
- Ventana Medical Systems
- Veridex
- VTT
- Vysis
- Wyeth
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