23andMe remains optimistic despite FDA issues: 'We are not going anywhere' (exclusive)

Above: 23andMe tests are sent directly to consumers

Should the FDA even regulate 23andMe?

23andMe may not have expected to be a target, as it’s still up for debate whether the company should be regulated — and how. 23andMe is a pioneer in this regard — it’s the last of its kind. Large vendors acquired rivals like Navigenics and deCODEme (and in the deCODEme’s case, shut it down).

This issue is another contested one — academics and policy-makers have not reached an agreement. I recommend this discussion on KQED Forum, where I duked out many of these issues with Greely and Nita Farahany, professor of genome sciences and policy and law professor at Duke University.

It’s worth noting that the FDA has not regulated  “laboratory developed tests” (LDTs), performed from scratch by clinical laboratories. 23andMe has a clinical laboratory and works with the National Genetics Institute (NGI), a wholly owned subsidiary of LabCorp. However, 23andMe works a bit differently that most genetic testing providers, as your saliva is not collected by a doctor with their own equipment in an office, but by a tube 23andMe sends out.

This saliva collection tube is the root of the problem, as the FDA claims it should be regulated as a class III medical device. 23andMe stresses that all the equipment it uses, and its various partners, are all approved.

This begs some interesting and complex questions about what constitutes a medical device, and whether we should regulate companies that provide health information directly to consumers.

Greely hopes that the FDA will finally release a final guidance, which should provide some much-needed clarity on how it plans to regulate 23andMe and other genetic testing companies. In the future, companies will begin to offer whole exome and whole genome sequencing — 23andMe’s genotyping method is just the beginning.

“Genetics is such a new field, but we stayed committed, knowing that it would be a bumpy ride,” said Afarian. “We’re setting precedents, and terms that will have ramifications for the entire industry.”

‘I am unaware of a single adverse event’

Afarian realizes that 23andMe is controversial, but she stresses that consumers have not been harmed over the years. The company declined to comment on the class action it is facing, which was filed in the U.S. district court of California last week. The lawsuit, filed by San Diego resident Lisa Casey, alleges that the test results are “meaningless,” and that the company uses misleading advertising to promote its services to consumers.

Afarian seemed surprised by lawsuits like these. She claims that in the company’s history, she hasn’t seen any evidence of patients receiving 23andMe results and taking extreme measures, like a double mastectomy. However, some doctors disagree (read our report here) and 23andMe cites an anonymous customer in its own blog who opted for a double mastectomy, after receiving the results of the test (although this particular patient *Jill appears to have also consulted a genetic counselor, and opted for another test from a genetic testing company).

23andMe is on a crusade to bring health information to consumers, which can be used to make more informed decisions. Wojcicki is particularly passionate about this mission, and sources familiar with the matter tell me that she considered taking on the FDA.

The most repeated point in our hour-long conversation: 23andMe is not going to simply crawl into a hole. The company remains fiercely committed, and between its funding and genealogy business, it can keep operating for some years. “We have a strong leadership team, we have amazing investors, and we’re more dedicated than ever,” Afarian said.