10 years of personalizing medicine: how the incorporation of genomic information is changing practice and policy.

Abstract

On this tenth anniversary of the founding of the journal Personalized Medicine, it is apropos to celebrate not only the founding of what has, over the past 10 years, grown into the premier journal for the field of personalized genomic medicine, but also the growth of the field itself. The field of personalized medicine has indeed grown by leaps and bounds over the last decade: from its tentative beginnings as a nom-de-plume for ‘pharmacogenomics’ to include a broader spectrum of genomic advances and technologies, including genome wide association studies (GWAS), exome sequencing, and next-generation sequencing (NGS) [1]. The personalized genomic medicine approach has now been applied to a number of disease areas including oncology, psychiatry and cardiovascular conditions [1–4]. Some of the most exciting personalized genomic medicine advances have occurred in oncology, including a number of diagnostic tests as a clinical prognostic factors (such as gene expression profiling assays for breast and colorectal cancer and the long-QT syndrome panel) and targeted therapeutics (e.g., trastuzumab and irinotecan). Generally personalized genomic technologies have been applied towards three main purposes: to discern the contribution of polymorphisms to particular adverse drug events (ADEs) or subor-supra-therapeutic drug responses; to identify potential biomarkers for specific diseases; and to assess clinical response with the use of targeted therapeutics. These applications have led to novel therapeutics, increased surveillance, monitoring and risk reduction measures in a number of diseases and conditions, including cancer, cardiovascular and cardiometabolic conditions (e.g., diabetes), and neurodegenerative disorders [1–4]. Since 2004, when the journal Personalized Medicine was launched, there have been major advances in the development and availability of commercially available genomic products, from the 21-gene recurrence score prognostic assay, Oncotype DX for early-stage breast cancer, first marketed in 2004, and Gleevec used in the treatment of chronic myeloid leukemia patients who test positive for the Philadelphia chromosome to the use of VKORC1 and CYP2C9 testing to guide warfarin dosing. Indeed, there was more than a 10-fold increase in the number of commercially available products between 2004 and 2014, across different therapeutic areas. The US FDA now includes genomic information and associated recommendations for well over 100 approved drugs [5].