Blood Biomarkers and Beyond: Biomarker and Diagnostic Opportunities in Cardiovascular Disease

Published by: Decision Resources

Published: May. 28, 2008 - 32 Pages

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

Abstract

• 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?

• 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.

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