Consuming genomes : scientific and social innovation in direct-to-consumer genetic testing

Since 2006 companies in the US have started to offer direct-to-consumer (DTC) genetic testing for a variety of diseases and traits. Recently, the activities of 23andMe and Navigenics, the two leading providers of DTC genetic services, have come under the scrutiny of various regulators and institutions, including the Food and Drug Administration (FDA) and the House Committee on Energy and Commerce and, in 2008, the California and New York Departments of Health. In this work we first situate this DTC innovation within the historical trajectory of gene testing as it developed in the context of clinical medicine around the three key criteria of analytic validity, clinical validity, and clinical utility. We then analyze the recent encounters between DTC providers and regulators to identify the key scientific and discursive resources that are being employed to position this innovation with respect to analytic validity, clinical validity, and clinical utility. Our empirical analysis of a rich set of primary sources (including websites, policy documents, and interviews) shows that the emergence of DTC gene testing is a conspicuous instance of co-production: a new kind of genetic knowledge and a new kind of biological citizenship is being articulated around the figure of the genetic consumer.