The U.S. Food and Drug Administration is ordering Mountain View-based 23andme to end sales of a $99 DNA collection kit the company markets as a way to screen for more than 240 diseases.

A Nov. 22 FDA letter says 23andMe has gone ahead with sales of its DNA Saliva Collection Kit and Personal Genome Service even though regulators have raised concerns about the company’s claims about the product’s ability to detect genetic susceptibility to some diseases.

23andme logo The company’s website says, “Our genes make us who we are, so naturally they impact our health. By knowing your DNA, you can take steps toward living a healthier life.” The site says the 23andMe “spit kit” can help people learn whether they carry dangerous genes, such as the BRCA genes linked to a dramatically heightened risk of breast cancer and ovarian cancer. 23andMe also says its DNA analysis can help detect users’ sensitivity to drugs that might be used to fight the cancer.

The FDA noted that 23andMe’s inclusion of BRCA analysis is “particularly concerning” since false positives and false negatives are potentially lethal:

For instance, if the BRCA-related risk assessment for 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. Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment.

23andMe was founded by Anne Wojcicki, the currently separated wife of Google founder Sergey Brin, and is backed by the search and advertising giant. In a statement this morning, the company acknowledged it had failed to answer FDA concerns about the Saliva Collection Kit and Personal Genome Service:

We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.

The FDA’s letter demands that 23andMe halt sales of the product until it gets marketing approval. As of this morning, the Saliva Collection Kit and Personal Genome Service appears to still be available for purchase.

FDA Tells 23andMe to Halt Sales of Gene-Testing Service 25 November,2013Dan Brekke


Dan Brekke

Dan Brekke is a blogger, reporter and editor for KQED News, responsible for online breaking news coverage of topics ranging from California water issues to the Bay Area’s transportation challenges. In a newsroom career that began in Chicago in 1972, Dan has worked as a city and foreign/national editor for The San Francisco Examiner, editor at Wired News, deputy editor at Wired magazine, managing editor at TechTV as well as for several Web startups.

Since joining KQED in 2007, Dan has reported, edited and produced both radio and online features and breaking news pieces. He has shared in two Society of Professional Journalists Norcal Excellence in Journalism awards — for his 2012 reporting on a KQED Science series on water and power in California, and in 2014, for KQED’s comprehensive reporting on the south Napa earthquake.

In addition to his 44 years of on-the-job education, Dan is a lifelong student of history and is still pursuing an undergraduate degree.

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