Pharmacogenomics: An In-House Advantage?

Introduction With the expectation that future drug approval may hinge on pharmacogenomic testing of patients, what are the advantages of the in-house testing of patient samples compared to supplying diagnostic kits? The genetic testing industry provides an interesting reference from which to examine this question. The genetic testing industry falls chiefly under the less stringent, regulatory oversight of the Centers for Medicare and Medicaid Services (CMS) and not the Food and Drug Administration (FDA). Genetic testing is also a service and not a product, with different, perhaps lesser, legal liabilities. Additionally, in-house testing may provide unique business advantages. This article examines the genetic testing industry and how the benefits of in-house testing may apply to the nascent pharmacogenomics industry.