In 2008, 23andMe’s suite of direct-to-consumer genetic testing services was named “Invention of the Year” by Time magazine.
Just five short years later, however, the FDA demanded that 23andMe stop selling its health-related tests pending scientific analysis, casting a huge shadow of doubt on the future of personal genetic testing. Will the challenges facing 23andMe also affect public trust in personalized medicine?
Doubts go back a long way. In 2008, the American Society for Clinical Oncology commissioned a report that concluded the partial type of analysis involved wasn’t clinically proven to be effective in cancer care. In 2010, the US Government Accountability Office concluded that “direct-to-consumer genetic tests [involve] misleading test results… further complicated by deceptive marketing”.
This is the root of the FDA’s concerns. In its letter to 23andMe, it raised the risk that customers could get false information that leads to drastic and misguided medical steps. 23andMe founder Anne Wojcicki now says: “We want to work with [the FDA], and we will work with them.” But is it too little, too late?
While the most consciously populist genetic testing service wrestles with its critics in the months ahead, there is a growing danger that wider public acceptance of personalised medicine in the clinical setting may also suffer in the fallout from 23andMe’s woes.
Read the full, original article: Testing times for the consumer genetics revolution
- Is the Food and Drug Administration killing personalized medicine? Reason
- Researchers extend human epigenomic map, possibilities of personalized medicine, Genetic Literacy Project
- Personalized medicine gives rise to new ethical questions, Cancer Network