Anne Wojcicki: FDA shutdown was 'a transformative moment'

anne wojcicki

Running afoul of regulators isn't the worst thing.

Anne Wojcicki, founder of genetic sequencing company 23andMe, says, sometimes, it can be signal of success.

"We had done things in a different enough way that we were stirring up controversy -- and people were taking notice," said Wojcicki at Startup Grind's Global Conference on Wednesday. "It was definitely not the high point of the company -- but it was a transformative moment."

23andMe, founded in 2006, is known for its at-home saliva collection kits. More than 1,000,000 customers have given the firm their spit in exchange for access to information about their genetic history. And more than 80% of customers have participated in genetic research since the firm launched its research program in 2008.

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But in November 2013, the FDA ordered the firm to stop issuing health guidance to consumers the kits. The company couldn't prove that its test results were accurate, the FDA said.

Instead of shutting down, the company stopped providing analysis of the results, giving consumers just raw data and ancestry information. In March 2015, the company made a play to get into drug development, announcing a "therapeutics group" headed by former Genentech executive Richard Scheller.

23andMe is already working to develop new therapies for diseases like Parkinson's, inflammatory bowel disease and lupus by looking at the genetic of people with those diseases.

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Then came more good news: In October 2015, 23andMe received FDA approval to tell customers whether they are carriers of certain disease-causing genes, which could be passed on to their children. Test results are still more limited than they were in the past; the company is working to gain approval to provide customers with information about potential health risks.

"If I didn't love what I did, I would've shut down," said Wojcicki. "The goal of 23andMe was in some ways to wake people up out of a coma and say, 'You're actually in control of your own health.'"

The company is one of Silicon Valley's "unicorns" -- the term for privately-held companies valued at $1 billion or more. It is said to be worth $1.03 billion and has backing from VC firms like Google Ventures.

Wojcicki said the company's success comes with a lot of mistakes, including its dealings with the FDA.

"You have to own it," she said. "You have to be totally comfortable accepting your failures. We fail all the time. I'm constantly reevaluating what we're doing."

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