Pharmacogenomic diagnostics

VI. New Regulatory Challenges in Assessing the Use of Pharmacogenomic Diagnostics and the Use of Targeted Therapeutics... 

Koch WH. Technology platforms for pharmacogenomic diagnostic assays. Nat Rev Drug Discov 2004 3 749-76L... 

Discovery of new diagnostic and prognostic indicators and biomarkers of therapeutic response, and prediction of patients most likely to benefit from the diug and use in general pharmacogenomic studies (Fig. 2)... 

Pharmacogenomics represents a true paradigm shift for health care. The potential to effectively treat or cure most diseases will come at a price. These therapeutic advances will create economic and ethical dilemmas at all levels of the economy. At the individual level, there will be economic barriers to access, particularly for disadvantaged or disenfranchised populations. The costs of diagnostic tests and treatments may be prohibitive, and mechanisms (e.g., insurance, income subsidies, rationing) to distribute and pay for care must be devised. With limited health care resources, trade-offs between cost, access, and quality are inevitable. 

A new term has recently been introduced to cover the application of pharmacogenomics to the design of drugs for the individual patient, namely theranostics (from therapeutics+diagnostics). This approach involves creating tests that can identify which patients are most suited to a particular therapy and also to provide information on how effective this... 

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