Pharmacogenomics and pharmacogenetics will have a major impact on the future of medicine. The FDA is demanding the use of pharmacogenomics in clinical trial design to allow inclusion of patients most likely to benefit and least likely to experience adverse responses to developmental therapeutics. In addition, several pharmacogenomics studies are investigating response to marketed therapeutics. Although pharmacogenomics holds substantial clinical promise, companies pursuing a solely pharmacogenomics-based business still need to prove that they can develop sustainable business models.

Pharmacogenetics is the study of the genetic basis for individuals’ variable drug response, and is being applied with increasing frequency at the clinical level. That work is facilitated by pharmacogenomics, the genome-wide analysis of the genetic determinants of drug efficacy and toxicity. Today’s investments in pharmacogenomics will lead to more cost-effective pharmacogentically driven medical care. The clinical benefits of elucidating the molecular basis of inherited differences in drug metabolism and response, and future automation of molecular diagnostics, will make it increasingly more commonplace to precisely select the optimal drug and dosage for individual patients. Companies that are at the forefront of commercializing these applications include Myriad, Abbott, Quest, Labcorp, deCode, Roche, Affymetrix, Genaissance, Millennium, Amgen, Interleukin Genetics, and GlaxoSmithKline.

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