Trends in the Commercialization of Biomarkers: Tests and Companies

Published by: Decision Resources

Published: Oct. 1, 2007 - 28 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

The Increasing Importance of Biomarkers

A Wide Variety of Biomarker Technologies and Test Formats

Oncology Biomarkers: Companion Diagnostics for Targeted Cancer Therapies

Overview

Commercial Success: Biomarker Tests for HER2/NEU/ERB2 Used with Herceptin in

Breast Cancer

New Biomarker Tests: Possible Solutions for Prognosis and Therapy Selection in

Breast Cancer

Biomarker Tests for Chronic Myelogenous Leukemia Incorporated Throughout Gleevec

Development

Biomarkers Used for Drug Dosing

Overview

Camptosar

Coumadin

Profiles of Select Companies

Dako (Glostrup, Denmark)

Roche Diagnostics (Basel, Switzerland)

Genomic Health (Redwood City, California)

Agendia (Amsterdam, the Netherlands)

Third Wave Technologies (Madison, WI)

Genzyme Genetics (Framingham, MA)

Veridex (Raritan, NJ)

Lessons Learned

Opportunities

Challenges

Outlook

Biomarkers and Target Diseases

Advantages of a Platform Technology

Reimbursement Issues

Validation and Clinical Trials

Coordination of Product Development and Business Strategies

Tables

1. Major Technologies Currently Used for Biomarker Assays

2. Select Biomarkers Included in Drug Labeling

3. Select Commercialized Biomarkers, Analyte-Specifi c Reagents, and Products in
Advanced Stages of Development

Figures

1. Applications of Biomarkers in Cancer Management

2. EGFR Family

3. Approximate Percentages of Drug Labels in the United States That Include
Pharmacogenomic Information or Information Regarding Recommended or
Required Tests

Sidebars

FDA Biomarker Defi nitions

Targeting EGFR—In Search of Biomarkers

FDA Guidance on In Vitro Diagnostic Multivariate Index Assays

Abstract

As health care moves toward personalized medicine, biomarkers have gained an increasingly important role in the delivery of efficient, quality care. The FDA has established specific definitions for biomarkers, and diagnostics, biotechnology, and pharmaceutical companies have woken up to biomarkers’ potential following the publicity surrounding biomarkers associated with Genentech’s Herceptin. A large number of companies now have commercialized biomarker tests employing a variety of technologies, and activity is particularly prevalent in the oncology and drug dosing arenas. Although larger companies such as Roche have dominated molecular diagnostics, smaller companies willing to invest in niche product areas have seized the opportunity to develop equally valuable products.

Get the Answers You Need to Shape Your Strategy

• Oncology and infectious diseases have proven to be the most popular targets of new biomarker development; however, oncology is favored because it has one specific advantage. What is that advantage?
• Although companies have already successfully commercialized oncology markers in breast cancer, new opportunities lie in other oncology areas. Which company is developing biomarker tests to detect signs of prostate and colon cancer, and which company is developing tests to detect the most common causes of cervical cancer?
• Focusing on generating scientific publications and clinical trial data throughout the development of a new biomarker test can allow for early commercialization of the test. Which company successfully employed this strategy to develop and commercialize its biomarker test—now reimbursable under the insurance plans of 125 million people?
• Increased regulatory oversight may make marketing some types of diagnostic tests more difficult. Which biomarker tests has the FDA specifically suggested it will seek to regulate?
• The approval of Genentech’s Herceptin, requiring the co-development of a test for HER2/NEU to qualify patients for treatment, has inspired other companies to try similar co-development strategies. Which companies have attempted to duplicate Herceptin’s success? Have these companies’ attempts been successful?
• Companies having platform technologies that can provide simpler biomarker assays capable of being automated have an advantage over those companies that cannot provide such assays. Which companies have this capability?
• Roche is currently the dominant player in the field of molecular diagnostics. What types of diagnostic systems have helped Roche to become the dominant player in this field? What strategies has Roche pursued to improve on its diagnostics position?

Scope

• Current biomarker technologies: in vitro diagnostic tests (IVDs), immunohistochemistry (IHC) tests, fluorescent in situ hybridization (FISH) tests, microarrays, and circulating tumor cells (CTCs)
• Biomarker diagnostics for targeted cancer therapies: Herceptin and its companion biomarkers; Genomic Health’s Oncotype DX biomarker test and Agendia’s MammaPrint test for breast cancer; Veridex’s CellSearch system to aid monitoring of metastatic breast cancer; biomarker tests to diagnose and monitor chronic myelogenous leukemia and determine initiation of Gleevec
• Companion biomarker diagnostics for drug dosing: biomarkers for Pfi zer’s Camptosar and Bristol- Myers Squibb’s Coumadin
• Commercialized biomarker products: successful products from Dako, Roche Diagnostics, Genomic Health, Agendia, Third Wave Technologies, Genzyme Genetics, and Veridex
• Opportunities: continued commercialization of oncology biomarkers; attractions of NAT technology; increasing importance of drug labeling; small companies’ successes; significant room for improvement
• Challenges: the reluctance of drug companies to restrict the use of their drugs through biomarker tests; uncertain regulatory environment; low reimbursement rates for diagnostic products; the difficulties of developing companion diagnostics for EGFR-targeted drugs
• Outlook: licensing opportunities for smaller players; the advantages of platform biomarker technologies; reimbursement issues; the launch of validation and clinical trials; increasing chances of early adoption by coordinating product development with business strategy

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