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Genetics for monitoring prescription practices of commonly used drugs in populations.

High-throughput genotyping, the rapid determination of genetic information on an individual basis, is unquestionably one of the most important recent technological developments for medical research and diagnosis and holds the promise of leveraging the human genome sequence for dramatic improvements in healthcare. In research, one gain from high-throughput genotyping is the ongoing dissection of clinical traits that are both prognostic for disease and the targets for therapy, e.g., LDL cholesterol (LDL-C)2 (1). In summary, these studies have found that a large number of common genetic polymorphisms appear to contribute to heritable clinical traits such as LDL-C concentration, with each polymorphism explaining a small fraction of the variance, typically <1%. In addition, the multitude of genetic associations highlights the diversity of biological pathways that contribute to each clinical trait. Among the largest common genetic effects, the E2 and E4 alleles of the APOE (apolipoprotein E) gene are associated with a shift of approximately −0.4 mmol/L and 0.1 mmol/L, respectively, in LDL-C concentration, compared with the E3 allele (2). With minor-allele frequencies of approximately 7%–9% (E2) (3) and 14%–15% (E4) (4) in populations of European ancestry, the APOE variants explain a few percent of the variance on a population basis.

Even effects as large as those observed for the APOE alleles, however, present challenges for translating the newly discovered genetic associations to the clinic. On an individual basis, the incremental prognostic information provided by single common genetic variants is typically small, often smaller than the information gained by examining readily available clinical correlations. This observation has been especially true with respect to predicting future disease, for which easily ascertained clinical characteristics (e.g., age, diet, exercise, body mass index, smoking status, or family medical history) have been more prognostically useful than genotype (5). Some gains have been made by aggregating combinations of …