|
|
|
시장보고서
Enabling Oncology Diagnostics: Predictive Biomarkers Based on Genes, Proteins, and Pathways
|
Abstract
Introduction
In efforts to fi nd new ways to transform the drug development paradigm and
the clinical management of cancer, scientists are increasingly turning to
discovering cancer biomarkers and developing targeted therapies. The infusion
of novel methods, technologies, and strategies - through exploring genes,
proteins, and pathways - is enriching traditional approaches. Although notable
challenges exist, the possibilities are essentially endless: Where will
targeted therapies and companion diagnostics in oncology take us?
Get the Answers You Need to Shape Your Strategy
- ER/PR, HER2, KRAS mutations, VEGF pathway, and EGFR expression, mutation,
and amplifi cation. An ever-increasing number of identifi ed biomarkers
exist for breast, colorectal, and lung cancers - which ones will lead us to
the better targeted therapies and companion diagnostics?
- The monumental role of Dako' s HercepTest in the dramatic success of
Roche/Genentech/Chugai' s Herceptin is undeniable and infamous in biopharma
circles. How will other companion diagnostics and targeted therapies fare
in comparison? Will Abbott' s recent alliance with Roche, OSI Pharmaceuticals,
and Genentech to develop a diagnostic test for Tarceva in non-small-cell lung
cancer be as successful?
- HER2 protein expression is commonly detected using technologies such as
immunochemistry (IHC), fl uorescence in situ hybridization (FISH), and
chromogenic in situ hybridization (CISH). What is the role of emerging
technologies, such as silver in situ hybridization (SISH), in the discovery
and development of predictive biomarker-based diagnostic tests?
Scope
- Predictive biomarkers for the treatment of breast, colo rectal, and
lung cancers: Explores how genes, proteins, and pathways in oncology are
being studied, incorporated in clinical trials, and used to improve treatment
options for patients suffering from these cancers.
- Industry trends to improve therapeutics: A renewed interest in
predictive biomarkers from both the diagnostics and drug industries is
creating changes and increasing collaboration. Using biomarkers earlier in
drug development, considering changes in business models, and participating in
related consortia are some of the ways companies are advancing the notion of
personalized medicine.
- Expert commentary: Decision Resources analyst Andrew Merron, Ph.D.,
examines the impact of predictive biomarkers on the drug market, with specifi
c emphasis on the role of companion diagnostics as threats or opportunities
for the NSCLC drug market.
- Outlook: Biomarker discovery and diagnostics development are at the
core of novel products in the war on cancer. Examine ways stakeholders can
ensure a streamlined approach to applying cancer biomarker development to
targeted therapies and companion diagnostics.
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Introduction
- Predictive Biomarkers for Targeted Therapies in Breast Cancer
- Key Predictive Biomarkers for Trastuzumab Therapy
- HER2
- PTEN/Akt/PI3K Pathway
- Endocrine Therapy
- Predictive Biomarkers for Anti-EGFR Antibody Therapies in Colorectal Cancer
- EGFR Expression
- EGFR Mutations
- EGFR Amplifi cation
- KRAS Mutations
- PTEN/PI3K/Akt Pathway
- VEGF Pathway
- Predictive Biomarkers for EGFR TKI Therapies in Lung Cancer
- EGFR Mutations
- Secondary EGFR Mutations
- EGFR Amplifi cation
- KRAS Mutations
- Matrix Metalloproteinases-9
- Biomarker-Based Diagnostics in Oncology
- ER/PR Status
- Overexpression of HER2
- KRAS Mutations
- Consortia for Advancing Cancer Biomarker Research
- Oncology Biomarker Qualifi cation Initiative
- The Biomarkers Consortium
- International Cancer Biomarker Consortium
- Key Players in the Cancer Biomarker-Based Diagnostics Market
- Abbott
- Agendia
- bioTheranostics
- Dako
- DxS
- Genomic Health
- Monogram Biosciences
- Rosetta Genomics
- Ventana Medical Systems/Roche
- Recommendations for Streamlining Cancer Biomarker Development
- Providing Tools and Resources for Cancer Biomarker Discovery and
Development
- Providing Guidelines and Incentives for Cancer Biomarker Validation
- Developing a Fair Pricing Structure for Commercialization and Adoption
- Outlook
- Spectrum Expert Commentary:
- Current Trends in Predictive Biomarkers for Targeted Therapies in NSCLC
- A Diagnostic Test for Tarceva - A Long Time Coming
- Impact on Current and Emerging Therapies for NSCLC
- Future Applications of Companion Diagnostics for Predictive Biomarkers
in Oncology
- Current Trends in Predictive Biomarkers for Targeted Therapies in NSCLC,
by Andrew Merron, Ph.D., analyst, Decision Resources
Tables
- 1. Select FDA-Approved Targeted Therapies
- 2. Select Cancer Biomarker-Based Diagnostic Tests for Diagnosis
- 3. Select Cancer Biomarker-Based Diagnostic Tests for Monitoring
Disease Progression
- 4. Select Cancer Biomarker-Based Diagnostic Tests for Selecting
Cancer Therapies
- 5. Select Cancer Biomarker-Based Diagnostic Tests for Prognosis
- 6. Recent Oncology Collaborations Between Pharmaceutical and
Diagnostics Companies
- 7. Members of the Biomarkers Consortium
Figures
- 1. Representative Examples of Cancer Molecular Targets
- 2. Applications of Biomarkers in Cancer Management
|
 |
