Home DNA testing company 23andMe announced in a blog post Monday that it is attempting to secure the approval of the U.S. Food and Drug Administration to sell its genomic testing kits, which allow consumers to mail a few drops of human saliva back to the company and receive in return information on their genetic background and potential hereditary conditions, including their predispositions to some 151 genetic diseases.
As the company wrote in a blog post:
As with anything new and potentially disruptive, there have also been concerns. The FDA responded to some of these concerns by indicating that direct-to-consumer genetic testing services require regulatory review to remain on the market. We remain strong in our belief that consumers have a fundamental right to their personal genetic data. We believe personal genetic data will power a revolution in healthcare. But we also recognize that appropriate oversight of this industry can be a stepping stone on the path to realizing that revolution.
Though 23andMe, founded in 2006, has long asserted that its tests are safe and compliant with FDA regulations, and sold them as such, other researchers say the results are misleading at best and useless and could misinform consumers at worst. Securing FDA approval would help bolster the soundness of the company’s claims. 23andMe CEO and co-founder Anne Wojcicki is also married to Google co-founder Sergey Brin, and Google has invested heavily into the company.
