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The FDA ordered 23andMe to stop offering users unapproved health tests. Now it’s back.

 23andMe co-founder Anne Wojcicki.
23andMe co-founder Anne Wojcicki.
Kimberly White/Getty Images

The genetic testing company 23andMe announced today that it's relaunching its direct-to-consumer health testing kits after shutting them down two years ago when the Food and Drug Administration charged the company with failing to provide evidence that their tests were "analytically or clinically validated."

Like other California-based startups (such as Theranos), 23andMe had charged ahead with promises to disrupt health care. The 23andMe co-founder, Anne Wojcicki, said the company was poised to become the "world's trusted source of personal genetic information" and "empowering" users with information about their genetic makeup.

But that revolutionary language didn't pass muster with health regulators. Many of the genetic analyses 23andMe was giving to consumers hadn't yet been validated or FDA-approved, so the the company's health service had to slow down and reboot for a couple of years until coming back online today.

23andMe had to scale back after the FDA stepped in

Before the FDA ordered 23andMe to stop, the company had offered its million-plus users risk assessments on 254 diseases and conditions based on an analysis of their DNA through a saliva sample.

For a mere $99, 23andMe was telling people about things like their chances of getting serious diseases, such as Alzheimer's or breast cancer, and even offering genetics-based guidance on "steps toward mitigating serious diseases" like diabetes and heart disease.

The trouble is the science hadn't yet caught up to the company's interpretations of these tests. A person's risk of developing a particular disease can be determined by environmental and lifestyle factors as much as it can by genetics. Science is only just in its infancy when it comes to understanding how all these factors come together and influence human health.

So the FDA had serious concerns about the accuracy of the genetic interpretations 23andMe was giving consumers. In 2013, it sent a sternly worded letter to the company, ordering it to stop marketing health interpretations for its genetic testing service. (23andMe continued offering its ancestry services, which were not a source of regulatory controversy.)

That letter was quickly followed by a class-action suit from people who alleged that 23andMe misled them by continuing to promote health promises without regulatory approval or good science behind them. The complaint notice also cited FDA concerns about potentially inaccurate and incomplete health risk assessments, which could lead people to make harmful choices.

23andMe is offering fewer health tests than before

After that, 23andMe went back into negotiations with the FDA, seeking approval for its health data. With this reboot today, they're offering only tests and reports that passed regulators — and the menu is quite a scale back from the early days, though it comes at about double the price ($199).

Instead of disease risk data, 23andMe will now offer "carrier status" reports for 36 diseases, which determine whether a user has a genetic variant for conditions including cystic fibrosis, sickle cell anemia, and hereditary hearing loss. Carriers don't usually have the condition but can pass along those diseases to their children, so it's mainly a service targeted at would-be parents.

This news comes after the FDA’s February approval of a 23andMe carrier test for the rare disease Bloom syndrome, which provided the template for the 35 other carrier tests the regulator okayed.

The company will also offer "wellness reports" that give users insights into whether they have a genetic makeup that could lead to less serious traits like lactose intolerance or alcohol flush.

According to a 23andMe spokesperson, the company is working on getting FDA clearance for other reports but he wouldn't comment on the specifics while discussions are ongoing. This means 23andMe could eventually start offering interpretations on a person's genetic responses to certain medicines, for example, or their risk of developing serious diseases like Alzheimer’s.

For now, 23andMe users can now expect reports that are much more modest than the early ones, albeit more in keeping with science and medical regulations.

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