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.