23andMe Suspends Genome Service Under FDA Orders—But You Can Still Annoy the Regulators



In late November, the Food and Drug Administration sent the genotype testing company 23andMe a warning letter outrageously ordering it to stop marketing its Personal Genome Service. As a justification for its high-handed demand, the FDA missive suggested some highly implausible ways in which 23andMe customers might harm themselves through misunderstanding the data supplied by the company.

The FDA letter gave the company 15 days in which to respond, advising that if the agency didn't like what it heard it might initiate regulatory actions that could "include, but are not limited to, seizure, injunction, and civil money penalties." To avoid further regulator ire, 23andMe has announced that it is suspending its Personal Genome Service to new customers:

At this time, we have suspended our health-related genetic tests to comply with the U.S. Food and Drug Administration's directive to discontinue new consumer access during our regulatory review process.

We are continuing to provide you with both ancestry-related genetic tests and raw genetic data, without 23andMe's interpretation.

If you are an existing customer please click the button below and then go to the health page for additional information. If you are a customer who purchased before November 22, 2013, you will still have access to your health-related results.

We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives.

The fact that the company will still supply new customers with their raw genetic data provides a bit of a loophole for those of you who would like to annoy FDA bureaucrats.

That data can be uploaded into the online genotype interpretation service Promethease. It's a bit clunkier than 23andMe's well-designed interface, but it does provide a good deal of interesting information. It takes 10 minutes and costs $5.

To get some idea if Promethease is for you, you might want to take a look at my Promethease generated open-access genetic profile at SNPedia. Of course, your report will be private, although genetic privacy is way overrated.