FDA Tells 23andMe to Halt Sales of Gene-Testing Service

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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.