Policy ForumSCIENCE AND REGULATION

Changes on the horizon for consumer genomics in the EU

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Science  17 Oct 2014:
Vol. 346, Issue 6207, pp. 296-298
DOI: 10.1126/science.1256396

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Summary

Although the direct-to-consumer (DTC) genetic testing market has been developing for over a decade, effective oversight has been challenging, with regulations remaining complex and often unclear. Recent developments indicate that important changes in the regulatory landscape may be imminent. In November 2013, the U.S. Food and Drug Administration (FDA) halted the DTC genetic testing company 23andMe from marketing its “Personal Genome Service” without marketing clearance or approval, which highlighted concerns over potential adverse health consequences of the genome-wide testing offered (1). The company has no timeline for when it will offer health-related genetic testing again in the United States (2). Meanwhile, in the European Union (EU), a proposed regulation could limit availability of such test results directly to consumers. We describe this ongoing revision of the EU in vitro diagnostic (IVD) medical device directive and how this may drastically affect market authorization of genetic tests.