The smartest thing 23andMe CEO Anne Wojcicki says she did after the FDA told her personal genetics company to cease and desist — avoid reading the press.
Instead, she says she stayed in her pajamas and was on the phone with lawyers, calling everyone for 10 days to figure out what to do and what the next steps for her “doomed” (as the press called it) company were.
“When you have a laser focus and you get distracted by what other people say, you can lose that laser focus,” Wojcicki said onstage at the Fortune Most Powerful Women Next Gen summit.
In November 2013, the FDA barred 23andMe from sending any of that data related to health to customers because of concerns that the company was misrepresenting genetic tests as medical advice. Providing information about things like your risk for developing type 2 diabetes or certain kinds of cancers, for example, was banned.
With half of its product put on hold by the FDA, the company looked as if it was on the verge of falling apart.
To Wojcicki, it was a speed bump, albeit a “big speed bump.”
Her best advice came from the regulatory team at Genentech who told her she had two options: do the quick fix and sell the company, or just do the hard work to gain the long-term change. Wojcicki chose option two and stayed focused on what she needed to get done to do it.
“By working with the FDA and working with the regulating body, you’ll actually drive the change,” Wojcicki said.
At the end of October, the company relaunched with new FDA approvals and her team is working to get new tests approved over time.
In total, 23andMe now provides more than 60 reports based on the samples of saliva you submit, which are then sifted and scanned it for single genetic variations that are linked to specific traits, like hair and eye color and propensity for certain diseases.
One of the additional tests included in the $199 relaunched kit is a “carrier status” test, which can be used to tell users if they have a genetic mutation or if they carry a copy of a recessive (non-expressed) gene that could still be passed down to their children.
The new test’s wellness component is also supposed to fill you in on how your DNA relates to your alcohol, caffeine, and milk consumption, as well as your muscle composition by showing you how your habits relate to other 23andMe customers with a similar genetic makeup.
To Wojcicki, the two-year hiatus was just the first chapter in the company’s history. Her vision of bringing personal genetic testing to everyone has remain unchanged, she said.
“Nothing was insurmountable,” she said. “It was just a question of figuring out the solution.”
from Business Insider http://ift.tt/1lulB2e