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SUMMARY
Introduction
Demographic and cost data provide clear reasons for pharmaceutical industry
investment in CVD biomarkers and diagnostics. CVDs are highly prevalent and
potentially lethal diseases with high treatment costs; biomarkers offer the
potential to decrease these costs by helping physicians to more effi ciently
manage CVD patients.
Get the Answers You Need to Shape Your Strategy
- Debate surrounds the comparative value of new cardiac biomarkers versus
established markers for risk assessment and prognosis. Have clinical
studies supported the value of new cardiac biomarkers? Which new biomarkers
have been shown to add independent capabilities for risk assessment and
prognosis?
- The 2007 National Academy of Clinical Biochemistry (NACB) guidelines
provide the most up-to-date thinking in biochemical diagnostic procedures for
CVDs. Do these new guidelines support the use and value of cardiac
biomarkers? Have these new guidelines seen aggressive uptake in the medical
community?
- Point-of-care cardiac tests offer their own unique benefi ts to CVD care,
but many debate their correlation with central laboratory tests. What are
the economic benefi ts of these POC tests? Are POC tests proving to be better
than central lab tests?
Scope
- Focus on use of biomarkers in three key CVDs: coronary heart
disease (CHD), acute coronary syndrome (ACS), and chronic heart failure (CHF).
- Review of imaging technologies used for CVD: magnetic resonance
imaging, computed tomography, positron emission tomography, single photon
electron computed tomography, and near infrared fl uorescence.
- Targeting of disease progression and risk stratifi cation: genetic
testing in CHD, biomarkers of plaque instability, serum markers for ACS and
CHF.
- POC testing: economic benefi ts, comparison with central lab tests,
top competitors.
- Strategic business models for CVD diagnostics: mergers and
acquisitions, licensing activities.
- Investment considerations in CVD diagnostics: clinical validation
and acceptance of new cardiac markers, need to control healthcare costs,
debate over added value of new markers, increased investment in research, POC
opportunities, improved modalities.
TABLE OF CONTENTS
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Value of Biomarkers and Diagnostics in Cardiovascular Disease
- New Guidelines for Cardiac Biomarkers
- Targeting Disease Progression
- Genetic Testing in Coronary Heart Disease
- Biomarkers of Plaque Instability
- sCD40 Ligand
- Myeloperoxidase
- Placental Growth Factor
- Pregnancy-Associated Plasma Protein-A
- Targeting Risk Stratifi cation
- Serum Markers for Acute Coronary Syndrome
- Cardiac Troponins
- C-Reactive Protein
- Heart Fatty Acid Binding Protein
- Serum Markers for Chronic Heart Failure
- Brain Natriuretic Peptide
- ST2
- Point-of-Care Testing in Cardiovascular Disease
- POC Tests Offer Economic Benefi ts
- POC Tests Versus Central Laboratory Tests
- Capturing Market Share
- Diagnostic Imaging Technologies for Cardiovascular Diseases
- Need for Noninvasive Diagnostic Imaging Procedures
- Magnetic Resonance Imaging
- Computed Tomography
- Nuclear Medicine
- Positron Emission Tomography
- Single Photon Emission Computed Tomography
- Near Infrared Fluorescence
- Strategic Business Models for Cardiovascular Diagnostics
- Mergers and Acquisitions
- Licensing Activities
- Issues to Consider When Investing in Cardiac Biomarker and Diagnostics R&D
- Clinical Validation and Acceptance of New Cardiac Markers
- Need to Control Spiraling Healthcare Costs
- Debate Over Value of New Cardiac Biomarkers in Risk Assessment
- Greater Investment in Biomarker Research
- Opportunities in Cardiac POC Testing
- Improved Diagnostic Imaging Modalities
Tables
- 1. NACB Classifi cations and Weight of Evidence
- 2. NACB Recommendations for Use of Biochemical Markers for Diagnosis of
Acute Coronary Syndrome
- 3. NACB Recommendations for Use of Markers for Diagnosis and Risk Stratifi
cation of Chronic Heart Failure
- 4. Potential Biochemical Markers for Acute Coronary Syndrome
- 5. Select Commercially Available Point-of-Care Tests for Cardiovascular
Disease
- 6. Select Molecular Imaging Agents for Cardiovascular Disease
- 7. Select Diagnostics Partnerships for Cardiac Biomarker Technology,
2006-2007
Figures
- 1. Development Process of Coronary Heart Disease, Acute Coronary Syndrome,
and Chronic Heart Failure
- 2. Plaque Formation
- 3. Emergency Department Visits and Charges
Sidebar
- Review of CHD, ACS, and CHF
- Sidebar fi gure: Comparison of STEMI and NSTEMI Pathology
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