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Risk Stratification in the Diagnosis of Cardiovascular Disease

Decision Resources, Inc, Sep 2005, Pages: 18


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The burden of cardiovascular disease continues to increase, particularly in the developed world, because of the aging demographic and the increasingly sedentary lifestyle people are adopting. The American Heart Association (AHA) estimates that the cost of cardiovascular diseases and stroke in the United States alone will be $393.5 billion in 2005. In an attempt by payers to contain costs, risk management strategies have become a central consideration during the diagnosis of key cardiovascular diseases to ensure that resources are targeted appropriately and that potentially costly sequelae are avoided.

In this report, we focus on three disease areas (coronary heart disease [CHD], acute coronary syndrome [ACS], and chronic heart failure [CHF]) in which diagnostics that provide better patient risk stratification are having-and will continue to have-a significant impact. We discuss the role of currently available invasive (bioassays) and noninvasive (imaging systems) diagnostic tools with regard to risk stratification in each of these disease areas, and we provide insight as to how emerging technologies will influence future patient management.

Business Implications
- Available assays for established biomarkers such as cardiac troponins and BNP are now an integral part of risk assessment for cardiovascular disease. Nonetheless, experts in the field point to a lack of standardization of such assays that may ultimately lead to problems interpreting the results. Ways to address this issue include a thorough analysis of the scientific literature for these biomarkers; opportunity also exists for diagnostics companies to develop improved assay systems.
- The ability to measure multiple biomarkers using a point-of-care (POC) assay system provides physicians with a more complete and timely assessment of a patient's cardiovascular risk. Despite the commercial availability of such multi-marker assay systems, the National Academy for Clinical Biochemistry (NACB) guidelines do not yet recommend this approach. Although the majority of experts strongly believe that a multi-marker approach is the future of diagnosis, some physicians urge caution, highlighting the need for a detailed cost-benefit analysis.
- The market for in vitro diagnostics (IVD) for the risk management of CHD remains largely untapped; significant opportunity exists for companies with exciting new product concepts. Atherosclerotic plaque stability and vulnerability are the buzzwords within the cardiac IVD arena. Companies including Prognostix, Abbott Diagnostics, Dade Behring, Biosite, and Ark Therapeutics are positioning themselves to capitalize by developing bioassays for markers associated with plaque vulnerability. Physicians urge some caution, stressing that there is still a need to establish which markers are of prime importance with regard to risk in CHD patients. They state that strong evidence is needed to justify the use of many, often expensive, diagnostic tools.
- The use of noninvasive imaging techniques for risk management in cardiovascular disease has been increasing over the last decade. It is now possible to acquire quality magnetic resonance (MR) images of the heart; various functional, high-resolution, high-speed MRI techniques are increasingly encroaching on market segments traditionally dominated by ultrasound.
- Molecular imaging is an exciting emerging field that aims to integrate patient-specific and disease-specific molecular information with current imaging modalities. The use of molecular imaging techniques could provide key functional information for physicians regarding the biological processes involved in disease processes such as atherosclerosis, potentially improving risk assessment. The major manufacturers of imaging equipment (GE Medical Systems, Philips Medical Systems, and Siemens) are forming strategic partnerships with companies that are developing molecular imaging agents for therapeutic areas, including cardiovascular.



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