Personalized medicine and clinical laboratories: challenges and opportunities

Personalized medicine is an emerging field with the goal of applying the concept of individual variability to determine the predisposition to disease, timely and accurate diagnoses and tailored therapeutic strategies. Laboratory medicine plays a key role in translating the concepts of personalized medicine into clinical practice. Following the sequencing of human genome, many new "omics" disciplines have emerged. These new disciplines are the key to the development of personalized medicine as they contribute to the understanding of disease at a molecular level and to the identification of new biomarkers as quantified parameters predictive to the development of a disease, its prognosis or clinical response, and as target for new treatments. A multiple approach integrating various technologies needs to be pursued and the implementation of new statistical methods and novel algorithms is required. Laboratory professionals have to assure not only the development of robust and accurate assays, but to promote harmonized procedures for sample collection, handling and storage. Finally, a closer interaction with clinicians should be provided as there is an increasing recognition of the need of clinical advice for an appropriate test request and result interpretation and utilization.