The beneficial use of single nucleotide polymorphisms (SNPs) in DNA have been successfully demonstrated for subpopulation screening, disease risk assessment and prediction of therapeutic response in a number of areas. The clinical utility of genetic diagnostic tools has been applied extensively for cancer therapeutics; however, many claims of personalized medicine to revolutionize clinical practice in other disease areas remain unfulfilled. There is a significant need in drug development for reliable markers in complex disease areas to predict patient response, disease severity and progression rates. Utilization of genetic variation markers coupled with other biomarkers represent an exciting opportunity for companies in the development of therapeutics, but the importance of proper study design cannot be underestimated. The key to successfully integrating genetic and other biomarker test panels in drug development and in practice starts with proper clinical design either in retrospective or prospective studies.

• Discuss several types of genetic risk assessment tests in development use of genetic risk assessment from a consumer and medical standpoint
• Discuss differences between dynamic biomarkers and genetic risk testing, since there are key distinctions in these areas of research
• Provide specific examples about clinical indications and successful research relating to genetic tests