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| 23andMe CEO Anne Wojcicki |
In a sure sign of recovery from a famous setback dealt by the FDA, Anne Wojcicki promised she will not sell her once again trendy diagnostics company 23andMe.
"The idea that the consumer is empowered and that genetic testing is going to be a foundation for healthcare in the future is just core to my being. And I'm wedded to this company for the rest of my life. So I'm not interested in selling," she said in an interview on Bloomberg TV.
23andMe lost its luster in November 2013 when the FDA finally prevailed over the company, forcing it to yank its popular Personal Genome Service diagnostic, which claimed the ability to provide health reports on 254 diseases and conditions based on a sample of saliva. The FDA's letter to the company is one of the agency's most harshly worded warnings.
"I wasn't interested in closing up shop and saying 'this is too hard.' It was just a question of saying 'you know what, we entirely need to refocus.' We need to hire the right people. We had a major miscommunication. We need to make sure that we're actually executing the right way," she said.
The refocus comprised two prongs. First, the company is taking a more incremental approach to consumer diagnostics, which are regulated by the FDA. In February, the company earned FDA clearance for its direct-to-consumer (DTC) genetic carrier test for Bloom syndrome. Perhaps more significantly, 23andMe is putting greater emphasis on collecting and using Big Data to benefit the R&D efforts of Big Pharma partners.
In January, the company unveiled a $60 million deal with Genentech and new database-driven collaboration with Pfizer ($PFE) to build a 5,000-person lupus community. By genotyping these people and integrating medical records, Pfizer hopes to better understand the genetic causes of lupus. Pfizer also gained access to 23andMe's analysis of more than 800,000 genotyped individuals.
"I want to translate all this information into really meaningful therapeutics, so that we can come then back and say the same way hepatitis C has been cured, I want to come and say 'we developed the cure for lupus.' When I think about my success moment, it will be when we have that kind of cure that came because like millions of people came together and they shared their data, and because of that, we were able to create something," she said.
An analysis of the Personal Genome Service found that more than 40% of customers went to the physician seeking assistance based on the results, Wojcicki said.
"I think part of the problem in the healthcare system in general, and this is one of the things that got me excited about starting 23andMe, is that we don't know how to monetize prevention. And so, as a result, the industry doesn't put a lot of research into that," she said.
Wojcicki declined to criticize Theranos or its embattled CEO, Elizabeth Holmes, who is fighting a Wall Street Journal report questioning the accuracy of its tests, which the company claimed to conduct based on a single drop of blood collected via finger prick.
"The onus is on us to be really transparent," she said.
But Wojcicki said that in the system Holmes is operating within, "she's not required to have the transparency that people are asking for. And I think that's part of this disconnect that's happening now. The FDA has put out guidance now where they're trying to actually regulate that whole industry. And fundamentally that will actually change everything. Everyone will have to be more transparent about what they're doing in and how they're doing it."
She then endorsed the FDA's ambitious plan to regulate all diagnostics (not just those manufactured by makers of testing equipment), which has met resistance from the clinical testing laboratories who are currently free from the agency's tentacles: "If that is the type of call that the FDA is making, then it will actually be good to actually have that same transparency across all diagnostics."
It would have been hard to imagine Wojcicki siding with the FDA two years ago. Her resurgence on the back of a re-energized 23andMe should offer Holmes hope that she too can overcome doubts and improve healthcare using diagnostics.
- here's the video from Bloomberg