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


Description: 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 efficiently manage CVD patients.

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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 benefits to CVD care, but many debate their correlation with central laboratory tests. What are the economic benefits 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 fluorescence.

- Targeting of disease progression and risk stratification: genetic testing in CHD, biomarkers of plaque instability, serum markers for ACS and CHF.

- POC testing: economic benefits, 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.


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 Stratification
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 Benefits
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
CVD Biomarkers

Tables

1. NACB Classifications 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 Stratification 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 figure: Comparison of STEMI and NSTEMI Pathology


Companies Mentioned - Abbott Diagnostics - ACS Biomarker - Amersham Biosciences - Ark Therapeutics - AstraZeneca - Baxter - Bayer Diagnostics - Beckman Coulter - Behring Diagnostics - BG Medicine - BioMerieux - Bio-Rad - Bio-Rad Pasteur - Biosite - Cholestech - Competitive Technologies - Critical Diagnostics - Dade Behring - Dainippon Sumitomo - deCode Genetics - Diagnostic Products - DuPont - GE Healthcare - Geymonat SpA - Illumina - Innovectis - Inverness Medical Innovations - Johnson & Johnson - Lab21 - LabCorp - Matritech - Meso Scale Discovery - Nanogen - Ortho Clinical Diagnostics - Philips - Princeton Biomedica - Prognostix - Response Biomedical - Roche Diagnostics - Scios - Shionogi - Siemens Medical Solutions - Singulex - Spectral Diagnostics - Third Wave Technologies - ThromboGenics - Toshiba


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