What Does the FDA Want From 23andMe?

Here’s a particularly sharp, context-rich post on that question from  from Margaret Curnutte, currently of Baylor University. It seems one of the more deeply informed takes on this fracas. A couple of the key points:

On what 23andMe was offering:

From its inception, [23andMe] has treaded a fine line between claiming to provide something that is ‘health related,’ yet not medical. The reasons for doing this should be fairly obvious. If your business model relies on directly accessing the genomes of consumers, who wants the medical establishment to get in your way of convincing people to put their genome in your proprietary database?

On what the FDA seems to want:

Does the agency’s most recently expressed concern over the analytic and clinical validity of PGS mark a departure from previous concerns? Not really. As FDA has made clear in the past through their correspondence with DTC firms, the worry with a medical device is that it be accurate and reliable. That is FDA’s rationale for post-premarket review. But back in 2010 Guitierrez, the head of FDA’s Office of In Vitro Diagnostics, did not want the agency to be viewed as paternalistic and said, “We really don’t have any issues with denying people information. We just want to make sure that the information they are given is correct.”1 So, now we are back to worrying about analytic validity (the reliability of the actual genetic test, meaning laboratory performance) and clinical validity (whether the genetic variant actually corresponds to the condition or trait). In the most recent correspondence FDA clarified that 23andMe has not provided sufficient evidence to establish the reliability of their service even after the agency’s repeated requests to do so. Although FDA has intervened on medical grounds by classifying PGS as a medical device, their regulatory stance has and continues to translate into concerns about accurate information, not its medical significance.

via AmericanScience: A Team Blog: What’s better than a holiday card? “Possibly the worst FDA letter of all time.”.

1 Comment

  1. Like most private, entrepreneurial firms 23andMe seems to invest far greater interest in marketing and promotion than in the nitty-gritty paperwork required to show the accuracy/reliability of their product. They may have even cooked their own goose a bit several years back with the incredible 96-well-plate error they failed to catch (the actual error occurred at a contract lab, but a routine QA check at 23andMe should’ve easily caught it before sending results out); and now they’re almost forcing FDA’s hand.

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