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Searching for 'omic' biomarkers
David Lin1, Zsuzsanna Hollander, Anna Meredith
1NCE CECR Centre of Excellence for Prevention of Organ Failure.
Insights
The study discusses the need for new cardiovascular disease biomarkers. Advances in
Area of Science:
- Biomarker Discovery
- Cardiovascular Diseases
- Personalized Medicine
Background:
- Cardiovascular diseases (CVDs) present significant societal and economic challenges.
- Current clinical indicators for CVD risk (e.g., blood pressure, cholesterol, obesity) have limitations.
- There is a critical need for sensitive, specific, and minimally invasive biomarkers for personalized patient care.
Purpose of the Study:
- To provide perspective on current strategies in cardiovascular biomarker development.
- To discuss the potential limitations in the biomarker discovery and validation pathway.
- To highlight the role of recent technological and regulatory advancements in accelerating biomarker implementation.
Main Methods:
- Review of current biomarker development strategies.
- Analysis of regulatory frameworks (FDA, Health Canada) for 'omic' biomarkers.
- Examination of ongoing Canadian biomarker studies.
Main Results:
- The transition of cardiac biomarker discovery to clinical practice has historically been slow and unregulated.
- Technological advancements and regulatory guidance are improving biomarker discovery and validation.
- Canadian studies demonstrate potential for omics biomarkers in risk assessment, diagnosis, prognosis, and therapy response.
Conclusions:
- Personalized healthcare for cardiovascular diseases requires novel, sensitive, and specific biomarkers.
- Streamlined discovery and validation pathways, supported by regulatory bodies, are crucial for clinical uptake.
- Ongoing research, particularly in Canada, showcases the potential of 'omic' biomarkers to revolutionize cardiovascular care.
Abstract:
Cardiovascular diseases impose enormous social and economic burdens on both individual citizens and on society as a whole. Clinical indicators such as high blood pressure, blood cholesterol and obesity have had some utility in identifying those who are at increased risk of cardiovascular events. However, there remains an urgent need for sensitive and specific indicators, preferably acquired through minimally invasive means, to help stratify patients for more personalized health care. As such, there has been a steadily growing interest in searching for 'omic' biomarkers of cardiovascular diseases. Historically, the transition of cardiac biomarker discovery to implementation has been a lengthy and somewhat unregulated process. Recent technological advancements, as well as concurrent efforts by regulatory agencies such as the Food and Drug Administration (United States) and Health Canada to establish policies and guidelines in the 'omic' arena, have helped propel the discovery and validation of biomarkers forward. The present paper provides perspective on current strategies in the biomarker development pathway, as well as the potential limitations associated with each step from discovery to clinical uptake. Canadian biomarker studies now underway illustrate the possibilities for assessment of risk, diagnosis, prognosis and response to therapy, and for the drug discovery process.
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