23andMe Stops Marketing Of Genetic Test Kits, But What About Everyone Who Already Has One?

The company has not yet said what is to be done with unused or in-process kits.

The company has not yet said what is to be done with unused or in-process kits.

Shortly before Thanksgiving, the Food and Drug Administration ordered that Google-backed 23andMe stop marketing its at-home genetic testing kits because the company had failed to get regulatory clearance for many of the product’s advertised uses. On Monday, the company announced it was abiding by that decision but hopes to work something out with the FDA, but has yet to tell any of its current customers what is going on with their kits.

FastCompany’s Austin Carr details his own experience trying to get an answer to that question, having purchased one of the $99 kits for his mother to try out.

Carr’s mom had not yet sent in her swab kit, and now he was just trying to find out if she should hold onto it, ask for a refund, or just toss it in the trash as a lesson learned. And what about the customers who had sent their kits back to the company but had not received results?

The FDA order stops the company from marketing and selling the kits as a method for diagnosing diseases and conditions, as that makes the kit a regulated medical device under the Federal Food, Drug and Cosmetic Act. But does the order stop the company from testing those kits it has already received? Maybe there are some tests the company could do that would not violate the FDCA? It’s all very unclear, and the company’s response thus far has not made it any more transparent.

In response to Carr’s questions on this topic, a 23andMe rep would only say, “Our response to the FDA is in progress. I can’t comment any further than what we’ve already stated on our blog and in our communications directly to customers,” and later added, “We are still working on getting answers to your questions, as well as questions from many other customers about the implications of the FDA letter.”

We’ve also reached out to 23andMe to see if it has any updated information for consumers. If so, we’ll post it here.

Meanwhile, the company now faces a possible class-action lawsuit in California from a customer who claims that the advertising for the product was misleading, the results “meaningless” and that 23andMe is more interested in compiling a huge bank of DNA information that it can then market to researchers.

“It seems to me to be a very thinly disguised way of getting people to pay them to build a DNA database,” says the plaintiff’s lawyer.

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