FORTUNE -- Less than two weeks ago, the Food and Drug Administration sent a rather terse letter to Anne Wojcicki, founder and CEO of Google-backed 23andMe. The jargon-filled message asked Wojcicki to stop marketing her company's $99 DNA testing kits because she had failed to receive "FDA marketing authorization for the device." In her first media interview since the headline-making letter (and 23andMe's equally terse response to the FDA), Wojcicki told Fortune that her company fell behind schedule and failed to communicate proactively with the FDA and the public. At the same time, she also said she is taking steps to work with the government agency to rectify the situation and move forward.
"We want to work with them and we will work with them," Wojcicki told the audience at a Fortune Most Powerful Women event, which took place in San Francisco on Tuesday evening. "I can't say much [more] because we're actively engaged in what is the next step forward."
Fortune senior editor at large Pattie Sellers interviewed Wojcicki, along with her sister, Google (GOOG) executive Susan Wojcicki, who is tasked with the search giant's ad products and commerce business. The sisters are among Silicon Valley's most recognizable female executives (Anne, the younger of the two, is also famous for marrying Google founder Sergey Brin; Susan was the 16th employee at the Mountain View, Calif.-based tech company). Their mother, a high school journalism teacher in nearby Palo Alto, was also in the audience, and the two sisters acknowledged her influence on their career paths--and Anne's determination to get through her company's current challenges.
"It is definitely a big challenge," said the 23andMe founder and former Wall Street exec. "I feel like what helps me deal with this situation is how I saw my mom deal with everyday life. Big challenges are an accumulation of small challenges. My mom was a problem solver."
Her sister Susan has also pitched in to try and give some advice in light of 23andMe's recent troubles. "In some ways both companies [Google and 23andMe] are doing things that have never been done before," said the elder Wojcicki sister. "It's familiar to me because we have similar challenges and we're doing things that are unknown. It is hard when people are questioning why something is being done."
While 23andMe is still a small startup, it's got some deep-pocketed investors--the company has raised a total $126 million from Russian billionaire Yuri Milner and Google. About a year ago, the company lowered the cost of its DNA testing kits--which use a saliva sample to glean information on users' heritage, potential genetic risk to diseases and receptiveness to medications--to $99 in the hopes of bringing in more customers. Anne Wojcicki has said her company's goal is to get to a million total users by end of 2013. Despite the influential backing and ample cash, it's not clear how big of a setback this latest missive from the FDA will be for 23andMe. One of the agency's concerns is that inaccurate results could cause people to undergo unnecessary procedures. But both Wojcicki sisters say that the information given to 23andMe customers can help them make healthier decisions. And, says Anne, she is determined to move forward with her company's mission.
"For me the reaction has been full force--I need to solve the problem," said the younger Wojcicki sister.
Why did an angry letter from the FDA stop one of the hottest genetics companies in America?
By Ryan Bradley, senior editor
FORTUNE -- For $99, 23andMe will sell you a "DNA Spit Kit." It comes in a bright green box with an opening flap that reads "welcome to you." Inside is a barcode, which you register online, and a vial for you to hock some genetic material into. The kit MORENov 26, 2013 10:11 AM ET
Mark Zuckerberg, Sergey Brin, Anne Wojcicki, Yuri Milner, Art Levinson, and others form a new prize for health care breakthroughs.
By Kurt Wagner, reporter
FORTUNE -- Top decision-makers from Apple, Google, and Facebook were in agreement Wednesday afternoon: They want us all the live longer.
Some of Silicon Valley's most influential minds -- including Facebook (FB) founder and CEO Mark Zuckerberg and Google (GOOG) founder Sergey Brin -- announced a new award that MOREFeb 21, 2013 7:46 AM ET
|America's economic mobility myth|
|Snowden docs had NYTimes exec fearing for his life|
|FHA to pull back on big mortgages|
|The economy: The 2014 outlook|
|American Airlines, US Airways to form largest air carrier Monday|