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026 - Personalized Medicine between research and clinical practice: the role of Laboratory Medicine

Autor(s): P. Cappelletti

Issue: RIMeL - IJLaM, Vol. 5, N. 3-S1, 2009 (MAF Servizi srl ed.)

Page(s): 26-32

Summary
A simple definition of Personalized Medicine is the prescription of specific therapeutics best suited for an individual based on pharmacogenetic and pharmacogenomic information. Nevertheless, defining Personalized Medicine as either “targeted therapies” or “targeted dosing” based on genomics would be an oversimplification of the concept. Personalized Medicine can be viewed more broadly as a comprehensive, prospective approach to preventing, diagnosing, treating, and monitoring disease in ways that achieve optimal individual health care decisions. This health-care paradigm is frequently called Preventive Medicine. However Personalized medicine – medical care tailored to the genomic and molecular profile of the individual- is a paradigm that exists more in conceptual terms than in reality. But the few marketed drug-tests pose several and important issues of governance, patients’ information, and clinicians’ knowledge and competences. The force of technology is providing directional velocity to Personalized Medicine, and recent trends support the notion that the question is not “if ” but “when”. The assumption that “good therapeutics follows good diagnostics” determines a broad field for Laboratory Medicine in the Personalized Medicine, not only following the developments and innovation derived from the “omics”, but also re-evaluating traditional attention to analytic and diagnostic accuracy and biological variation, and integrating research sciences, laboratory testing, and information technology. Moreover, the growing availability of biomarkers determines the need of an effective and rapid translation of these new diagnostics tools into the clinical practice. In the life cycle of biomarkers, several points are of interest for Laboratory Medicine: verification of methods and materials, clinical validation, multidisciplinary evaluation of clinical consequences, implementation of guidelines, application in specific settings and clinical conditions, multimarkers strategy, and evolution of knowledge and clinical use. The Translational Medicine can be a new frontier for clinical laboratories, and requires a continuous and bidirectional exchange of knowledge and information between basic researchers, manufacturers, clinicians, epidemiologists, and laboratory scientists. The new vision roadmap of Translation Research may be coupled to the “innovation theory” multistage process. Therefore, new knowledge and competences, not only restricted to specific analytical field, are required.
Key-words: Personalized Medicine, Translational Medicine, biomarkers, pharmacogenomics.

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