Changes on the horizon for consumer genomics in the EU

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