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23andMe

Company seeking to provide genetic information grapples with FDA.

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23andMe promotes its DNA analysis services with television, radio, and web advertisements. But the FDA recently told the company to stop selling its main product because 23andMe was doing so “without marketing clearance or approval.”

The FDA told the California company in a November 22 warning letter that most of the advertised services were medical device uses, which require premarket FDA approval. 23andMe advertised that it could tell users about their risks for various diseases, such as heart disease, breast cancer, and ovarian cancer. The site also promises to tell consumers about heightened risks from medications and whether they might carry the gene for certain diseases.

But the FDA warns consumers that false-positives on DNA analysis could drive consumers to seek treatment or procedures they may not need. (23andMe now faces class-action lawsuits.)

The company, in which Google has invested millions, said in a statement: “Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”

Consumers should be cautious with services that offer to analyze your DNA. Consulting a medical professional may be a better idea than trusting a website (says a website).

For more on 23andMe click here.

UPDATE: In March 2014, the FDA said the company adequately addressed the violations it detailed in its warning letter and in February 2015 it authorized the company’s marketing of its carrier test for Bloom Syndrome. In October 2015, the company announced it would provide health information regarding carrier status — whether a person has a genetic mutation that could lead to disease in their offspring. It is still seeking FDA approval to provide health risk assessments.

This story was updated several times, most recently on 10/22/15. 


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