Here’s Why the FDA Is More Than a Little Freaked Out by Personal Genetic Testing

On Friday, the FDA sent a warning letter to Anne Wojcicki, the CEO of 23andMe, a personal genome testing service, telling the company to stop selling their product immediately. This was a particularly intense letter. It cited the lack of evidence for several claims the company has made about the medical usefulness of their genetic results and the dangers of those claims, and it’s been described as “unusually stern” and “brutally scathing.”

“You don’t need to be an expert in the regulations covering medical tests to know that the Food and Drug Administration has just about had it with Silicon Valley’s 23andMe,” writes Scott Hensley at NPR.

The issue is not that company does genetic testing, but that it markets the test as medical service that can help people plan healthier lives. But, really, this debate isn’t about 23andMe, but a broader question of how to deliver and interpret personal genetic data. Can people interpret their own results and act in a medically appropriate way?

The FDA points to the BRCA gene as an example:

For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.

The bigger problem, as Christine Gorman points out at Scientific American, the $99 kit from 23andMe can give you data but can’t analyze it for you. Simply getting your genetic sequence without comparing it to others isn’t all that useful. You need analysis to identify medical risks, Gorman writes:

Using home gene kits to imagine where your ancestors might hail from is one thing. That’s basically the 21st century equivalent of looking up your horoscope–entertaining but not really a matter of life and death. Cheap sequence data from 23andMe and other gene testing companies has much greater potential to harm without the proper interpretation of the results, which is still quite difficult and expensive in most cases.

23andMe has never been approved for medical use. The company applied to the FDA for clearance in September of 2012, and not only failed to qualify, but failed to address any of the questions and issues the agency brought up regarding that application, according to the FDA. In fact, the FDA says in its letter, it hasn’t heard a word from 23andMe since May. Most proponents of 23andMe don’t dispute whether the company has played by the rules with the FDA. Instead, they’re arguing that the rules are stupid. At the Conversation, Gholson Lyon writes:

Somehow the US and UK governments find it acceptable to store massive amounts of data about their own citizens and that of the rest of the world. They are happy spending billions on such mass surveillance. But if the same people want to spend their own money to advance genomic medicine and possibly improve their own health in the process, they want to stop them.

At the Washington Post, Timothy B. Lee writes:

More to the point, patients have a right to make dumb decisions if they want to. We don’t ban patients from reading medical textbooks or WebMD, even though doing so undoubtedly leads to some harmful self-diagnoses. In a free society, patients have a right to accurate information about their health, even if medical professionals and regulators fear patients will misuse it. That includes information about our genetic code.

For Lee and Gholson, the question isn’t really about whether or not 23andMe has failed to work with the FDA or not, but rather about our intrinsic right to our own data. And 23andMe’s seemingly complete failure to work with the FDA could set all sorts of genetic testing services back, according to Matthew Herper at Forbes:

The FDA would probably like to be able to regulate genetic tests much the same way as it does drugs, regulating each individual use to make sure there is enough data to support it. But that’s untenable; there are about two dozen drugs approved each year, while there are tens of thousands of genes that mean different things in different combinations, or when there are different changes in them.

For now, if it wants to be on the bleeding edge of personal genetic testing, 23andMe will have to try and patch things up with the FDA. They have 15 days to respond to the FDA’s letter, but it might already be too late.

More from Smithsonian.com:

Genetics Lab or Art Studio?
One Woman Can Have Multiple Genetic Identities—Hers, Her Secret One, And All Her Kids’

Rose Eveleth | | READ MORE

Rose Eveleth was a writer for Smart News and a producer/designer/ science writer/ animator based in Brooklyn. Her work has appeared in the New York Times, Scientific American, Story Collider, TED-Ed and OnEarth.