23andMe issues response following FDA warning and sales halt

Nov 27, 2013
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Earlier this week, the genetic testing company 23andMe was forced to stop selling its testing kit following an FDA decision that the kit is a medical device and requires regulatory approval. The decision was largely based on concern over inaccurate results, and led to a warning letter being published by the FDA. In response to the issue, 23andMe has published its own statement on the matter.

According to the statement, 23andMe has "worked extensively" with its lab partner to ensure that its customers get accurate results, something the company's chief executive says is "absolutely critical". The company says that it provides such accurate results, but that now it needs to convince the FDA of this reality in light of the recent decision on its part.

While updates are being posted on the Google-backed company's blog, many questions regarding the service's future and the FDA letter have gone unanswered, something 23andMe's statement says is due to not having answers for them at this time. The company promises to keep customers and interested parties updated as it progresses through this issue, however.

Said 23andMe's co-founder and CEO Anne Wojcicki: "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."

SOURCE: Boing Boing


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