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Body blow: How 23andMe brought down the FDA's wrath

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From the very beginning, 23andMe was the stuff TED talks are made of, promising to harness the staggering quantity of information in the human genome with big data and user-friendly web savvy. Now, it’s all but shut down. This morning, the FDA ruled 23andMe’s saliva test kit, the company’s only product, to be in violation of federal marketing guidelines. Until the company passes the FDA’s marketing approval process, all of its ambitious plans are on hold.

Can the dream of the personal genome survive?

It’s very bad news for 23andMe. And for anyone who bought into the dream of personally managed genetic data, the FDA’s move is bewildering. For all the site's problems, including occasionally threadbare scientific data, giving users access to their genome was a potentially industry-changing idea. Now, the abrupt halt has left more questions than answers. After six years on the market, why is 23andMe's sole product being barred from sale now? And without the company that pioneered it, can the dream of the personal genome survive?

23andMe, for its part, seems to be remaining optimistic. In an official response to the FDA's letter, the company came off as penitent. "We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission," the statement reads. "Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns." In short, they're working on it.

23andme is way behind in doing the necessary studies to back up their claims

The FDA’s marketing requirements put 23andMe in a particularly tricky spot. The requirements are designed to make sure that anyone marketing a medical product isn’t lying about what their product can do. If I want to start advertising Cholesterol-Lowering Pills, I have to prove to the FDA that the pills really do lower patients’ cholesterol — usually with a battery of scientific studies that takes years and costs millions. 23andMe’s claims are even trickier to prove. The website bills the service as a "first step in prevention," to help users in "mitigating serious diseases." They may not seem like it, but those are medical claims — and 23andMe is way behind in doing the necessary studies to back up their claims.

"The FDA and 23andme have done a sort of strange frenemy dance."

To make matters worse, the FDA seems furious. The agency’s public letter to 23andMe takes an unusually frustrated tone, detailing the hundreds of emails and 14 face-to-face meetings that led up to the block. As of January, the company still had not completed the studies it would need to make a marketing submission, despite operating for more than five years. It’s unclear whether it was startup arrogance, bad test results, or simple naiveté that led 23andMe to ignore the warnings, but the company’s marketing push only increased. A recent surge of television ads seems to have been the final straw.

Finally, the agency seems to have run out of patience

For many observers, the FDA’s rebuke has been a long time coming. As geneticist Misha Angrist puts it, "The FDA and the company have done a sort of strange frenemy dance since the beginning." The mere fact that 23andMe was able to operate for six years without marketing approval speaks to how much leeway the FDA was willing to extend at first, especially while many doctor's groups were skeptical of personal genetics from the beginning. As early as 2008, the New York State Department of Health had banned 23andMe from operating within the state, requiring laborious workarounds for New York-based users. But federal agencies were more patient. The FDA dispatched its Office of In Vitro Diagnostics and Radiological Health to work with 23andMe on approvals, but according to the letter, the company kept stalling. "I think the FDA was antagonized by what it perceived to be 23andMe's inattention to its demands and the company's simultaneous ramp-up of its marketing campaign," Angrist says. Finally, the agency seems to have run out of patience.

"There's always the potential for results to be misused or misinterpreted."

Some medical groups have already eagerly seized on the letter as a chance to point out the failings of any genetic testing outside the medical sphere. Speaking to The Verge this morning, the president of the National Society of Genetic Counselors, Rebecca Nagy, said the ruling highlights the questions consumers should be asking about personal genomics services. "Is a genetics professional involved in ordering or interpreting the test? If not, there's always the potential for results to be misused or misinterpreted," says Nagy. That's a larger issue than just 23andMe's failure to work with the FDA — but after this morning's order, everything seems to be on the table.

"It's simply gotten too cheap and too easy to do."

And in a sense, they're right. Many of the FDA's complaints are aimed at the core idea of personal genomics: that a delicate and expensive medical test could become as simple as an iPhone app. 23andMe didn't invent the saliva test, after all. All it did was bring such testing outside the doctor's office and make it available without the headaches of the health-insurance system. It was a consumer-grade version of a professional service: cheaper, easier, and not quite as good. And because the testing could be done in bulk, the service added a lot of genes that would never be tested in a medical lab, from the gene responsible for "asparagus pee" to the markers used to track a person’s Neanderthal ancestors. But that same fast-and-loose approach can cause problems if a faulty test turns up in an area with real medical complications, as vividly recounted here. And when the bad news does arrive, whether it’s an increased risk of Parkinson’s or a higher chance of heart disease, 23andMe didn’t have any counselors on hand to guide users to the medical options available or provide the proper context for understanding the results. Even if the service solves its marketing problems, those issues are likely to remain.

Still, you shouldn't count out personal genetics just yet. "I think the cow is a fair ways out of the barn," Angrist says. "Ultimately, I don't think the FDA can keep people from learning about the content of their own cells. It's simply gotten too cheap and too easy to do." But in the future, companies might need to be more modest in their goals. They might steer clear of high-stakes tests like BRCA, which is so strongly linked to breast cancer that it often spurs preventative surgery, and is currently included in the 23andMe pack. Instead, companies could focus on genomics as a hobby or a deep dive for geneology buffs. It would mean less world-changing ambition, and less startup bravado, but that might not be a bad thing. Mostly, it would mean less of a challenge to the medical industry.

The Verge
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