Mountain View "personal genetics" startup 23andMe on Wednesday released another conciliatory statement in its unusual war of words with the federal Food and Drug Administration, which has demanded the company stop marketing its signature DNA tests.
"We stand behind the data that we return to customers -- but we recognize that the FDA needs to be convinced of the quality of our data as well," co-founder and Chief Executive Anne Wojcicki wrote in a blog post.
The company sells a $99 test that, using genetic material from a customer's saliva, can identify DNA variants. Users then can compare their genotypes to others in the company's database of nearly 1 million samples to learn, for instance, how many traits they share with people prone to breast cancer.
The company, which has come under fire before from federal officials and others concerned about the direct marketing of gene tests, has argued that it's simply in the business of crunching data, not diagnosing disease.
But the FDA, in a harshly worded letter released Monday, said the product falls under federal rules for medical devices. And, the agency wrote, 23andMe has failed to assuage regulators' concerns despite more than a dozen meetings and "hundreds of email exchanges" over the past year and a half.
Expressing fears that consumers might opt for unnecessary medical treatments -- or forgo needed ones -- based on information from a 23andMe test, the FDA ordered the company to drop plans for a TV marketing campaign and provide information it's requested within 15 days.
23andMe customer Jim Shuma, via email, called the FDA's letter "regrettable and shortsighted," saying that information from one of the company's tests led him and his doctors to discover a greatly elevated risk of heart disease.
The startup would seem to be financially well-positioned for a legal fight with the feds. 23andMe has raised more than $125 million from backers including Google (GOOG) co-founder Sergey Brin -- Wojcicki's estranged husband, whose fortune is estimated by Forbes to approach $23 billion
But perhaps acknowledging the very long odds of winning a fight, the company on Monday released a statement acknowledging it had "not met the FDA's expectations regarding timeline and communication. ... Our relationship with the FDA is extremely important to us."
Wednesday's blog post by Wojcicki does not delve into much greater detail, and a company spokeswoman said there would be no further comment for the time being.
Contact Peter Delevett at 408-271-3638. Follow him at Twitter.com/mercwiretap.
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Original headline: 23andMe's Anne Wojcicki issues another response to FDA demand
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