23andMeのCEOが顧客に書簡を送る: “FDAは弊社の重要なパートナー”

FDAが23andMeの家庭用DNA検査キットの販売を禁ずる決定を発表したとき、同社は短い声明を出したが、その後同社のCEO Anne Wojcickiは顧客たちに書簡を送り、この禁令や、医療機器や医療技術を監督する政府機関と同社の関係について説明した。





Dear 23andMe Customers, I wanted to reach out to you about the FDA letter that was sent to 23andMe last Friday.

It is absolutely critical that our consumers get high quality genetic data that they can trust. We have worked extensively with our lab partner to make sure that the results we return are accurate. We stand behind the data that we return to customers – but we recognize that the FDA needs to be convinced of the quality of our data as well.

23andMe has been working with the FDA to navigate the correct regulatory path for direct-to-consumer genetic tests. This is new territory, not just for 23andMe, but for the FDA as well. The FDA is an important partner for 23andMe and we will be working hard to move forward with them.

I apologize for the limited response to the questions many of you have raised regarding the letter and its implications for the service. We don’t have the answers to all of those questions yet, but as we learn more we will update you.

I am committed to providing each of you with a trusted consumer product rooted in high quality data that adheres to the best scientific standards. All of us at 23andMe believe that genetic information can lead to healthier lives.

Thank you for your loyalty to 23andMe. Please refer to our 23andMe blog for updates on this process.

Anne Wojcicki

Co-founder and CEO, 23andMe

写真出典: Flickrユーザkingair42

(翻訳:iwatani(a.k.a. hiwa))