Medical history has not wandered far from its original aspirations of being personalized. Diagnostic capability has evolved from the metaphysical to the anatomical to the cellular and ultimately to the molecular level. Now that diseases can be subclassified into categories that indicate the course of disease and in some cases its likely response to treatment, there is a responsibility to act on that information. As more predictive biomarkers become clinically validated and as more targeted therapies become available, single marker companion diagnostics for specific drugs will be replaced by multiplex and multiparameter diagnostics that may be applicable across disease entities preserving sample, time, money and enabling rapid molecular taxonomy. We call this an ensemble relationship model between diagnostics and medicines.
Keywords: biomarker; companion diagnostics (CDx); genome sequence; in vitro diagnostics (IVD); molecular diagnostics; personalized medicine; pharmacogenomics; point-of-care.