ABSTRACT

This chapter examines the role and clinical significance of molecular pathology in personalized medicine. With the recent developments in cancer pathology, a pathologic diagnosis needs to include molecular and genomic information in addition to cancer grading, staging, and histologic findings with prognostic significance. Recently applied targeted cancer therapies demand that pathologists develop and use suitable detection techniques, variously termed "predictive markers," "companion diagnostics," or "advanced personalized diagnostics". Personalized medicine requires multidisciplinary coordination of the surgical, oncology, research, and pathology teams to ensure an accurate and timely diagnosis. Personalized medicine demands personalized pathology with the use of molecular and genomic techniques. Pathologists play a central role in this process by selecting and preparing tissue samples, selecting genetic assays, and by standardizing the reporting of results. The chapter discusses that standardization of molecular pathology requires practical guidance such as preanalytic, analytic, and postanalytic considerations.