[Predictive biomarkers in medical treatment]
Niels Westergaard1, Charlotte Vermehren2,3, Jan Trøst Jørgensen4
1Center for Sygepleje, Professionshøjskolen Absalon.
Ugeskrift for Laeger
|September 6, 2022
Summary
Pharmacogenomics (PGx) and companion diagnostics (CDx) can personalize medical treatment, improving effectiveness and reducing side effects. This review examines their clinical application in Denmark and identifies barriers to wider adoption.
Area of Science:
- Clinical Pharmacology
- Genetics and Personalized Medicine
Background:
- Predictive biomarkers are crucial for tailoring medical treatments to individual patients, aiming for enhanced efficacy and minimized adverse effects.
- Pharmacogenomics (PGx) and companion diagnostics (CDx) represent key advancements in this field, offering a pathway to precision medicine.
Purpose of the Study:
- To review the potential application of pharmacogenomics (PGx) and companion diagnostics (CDx) in Danish clinical practice.
- To assess current knowledge, regulatory frameworks (FDA, EMA, SPC), and resources (PharmGKB, promedicin.dk) relevant to PGx and CDx implementation.
- To identify and discuss barriers hindering the widespread adoption of these technologies in healthcare.
Main Methods:
- Literature review of current scientific knowledge on PGx and CDx.
- Analysis of regulatory guidelines from major health authorities (FDA, EMA).
- Examination of clinical decision support resources like PharmGKB and promedicin.dk.
Main Results:
- PGx and CDx hold significant promise for stratifying patients for more effective treatments with fewer side effects.
- Existing knowledge and regulatory frameworks provide a foundation for clinical application.
- Several barriers impede the broader integration of PGx and CDx into routine healthcare.
Conclusions:
- Implementing pharmacogenomics and companion diagnostics in Danish clinical practice is feasible and beneficial.
- Addressing identified barriers is essential for realizing the full potential of personalized medicine.
- Further efforts are needed to facilitate the widespread use of PGx and CDx for improved patient outcomes.
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