The Introduction of targeted therapeutics into clinical practice has created major opportunities for further development of the molecular diagnostics industry. Emerging genomic and proteomic technologies and information are now resulting in the molecular subclassification of disease as the basis for diagnosis, prognosis and therapeutic selection. The ultimate goals of personalized medicine are to take advantage of a molecular understanding of disease, both to optimize drug development and direct preventive resources and therapeutic agents at the right population of people while they are still well. Single nucleotide polymorphisms identification and genotyping have uncovered predisposition markers from cancer and heart disease as well in the prediction of both drug efficacy and toxicity. Pharmacogenomic and pharmacodynamic assays are being developed to enhance the speed and decrease the cost of drug development, as well as reduce side effects and increase response rates in a variety of diseases. The traditional trial and error practice of medicine is progressively eroding in favor of more precise marker-assisted diagnosis and safer and more effective molecularly guided treatment of disease. For the diagnostics industry this represents an unprecedented opportunity for integration, increased value and commercial opportunities for molecularly-derived tests.