Personal genetic profiler ordered to stop selling DNA test kits
Personal genetic profiling company 23andMe has been ordered by the US Food and Drug Administration (FDA) to stop selling its Saliva Collection Kit and Personal Genome Service. The regulator asserts the need for proper regulatory authorisation for medical devices, which 23andMe doesn’t have, and which the FDA says it has explained to the company ‘on numerous occasions’.
The FDA’s warning letter includes a number of concerns that false results from 23andMe’s screens could have serious health implications. 23andMe – which is led by Anne Wojcicki, wife of Google co-founder Sergey Brin – has acknowledged its failings in dealing with the regulator and says that the company is ‘committed to fully engaging with [the FDA] to address their concerns.’