Founder of 23andMe speaks on FDA concerns

SAN FRANCISCO -- Startup 23andMe founder Anne Wojcicki, who is separated in marriage from Google co-founder Sergey Brin, broke silence on Tuesday in saying she failed to respond to concerns from the Food and Drug Administration about the company's DNA-testing product.

The FDA sent a letter to 23andMe last month demanding the company stop selling its $99 genetics testing kit. On Monday, 23andMe discontinued marketing the kit that analyzed saliva with the promise of providing genetic markers for disease.

"We failed to communicate proactively," Wojcicki said Tuesday evening at a Fortune event held here for the most powerful women.

The FDA sent a warning letter to 23andMe saying the company is marketing its product without approval from the government agency and that its product claims raise concerns. The FDA said the company has failed to address issues the agency raised and hasn't responded to its request to provide adequate information to support its marketing claims.

Startup's 23andMe's website says its product reports on more than 240 health conditions and traits.

The FDA said that some of the uses of the personal genome service were particularly of concern, such as assessment of breast cancer-related genetic risks.

If the finding for risks related to "breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist," the FDA said in its warning letter addressed to Wojcicki and 23andMe.

Actress Angelina Jolie in May publicly disclosed in a bid to raise awareness that she had undergone a double mastectomy after learning of her genetic risks for breast cancer from her doctors.

That led some of 23andMe's customers "to ask about what 23andMe reports concerning breast cancer," the company said in a blog post at the time, warning "23andMe's test is not dia! gnostic."

Troubles in Wojcicki's and Brin's marriage became the Silicon Valley drama du jour in August, when reports surfaced that the two had been living apart and the Google co-founder had become romantically involved with a company employee.

Wojcicki's 23andMe has raised $161 million in funding from investors including the search giant, Sergey Brin, Genentech, Mohr Davidow Ventures, New Enterprise Associates, Russian billionaire Yuri Milner, Google Ventures and others.