DNA Testing Company 23andMe To Comply With FDA; Faces Lawsuits For Misleading Customers

By Rhonda J. Miller on December 8, 2013 9:44 PM EST

DNA Testing
At-home DNA testing has attracted consumers, but some companies have come under scrutiny and criticism as to the scientific accuracy of the results. (Photo: Prevention / Rhonda J. Miller)

DNA testing company 23andMe has agreed to stop offering interpretation of personal genetic data, and to stop marketing its Personal Genome Service, to comply with a directive from the U.S. Food and Drug Administration (FDA). The FDA was concerned about the public health consequences of inaccurate results that might lead consumers to seek ineffective or unnecessary medical treatment. The FDA ordered 23andMe to stop marketing its test in late November.

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The Mountain View, Calif.-based DNA testing company, however, said it will continue to provide raw genetic data and ancestry information to customers. The agreement to work with the FDA may be seen as too little, too late by some, including San Diego resident Lisa Casey, who filed a lawsuit in U.S. district court of California on Nov. 27, alleging that the test results from 23andMe are meaningless and that the DNA testing company uses false and misleading advertising to promote its services to U.S. consumers.

The lawsuit seeks at least $5 million under various California state laws and estimates "tens or hundreds of thousands" of U.S. customers are entitled to damages from the company, according to the San Francisco ChronicleAccording to the lawsuit, Casey bought 23andMe's $99 genetic test in September and received her results in a Nov. 19 email, which she anticipated, based on 23andMe's marketing, would provide information about possible health risks and ancestry, The Scientist magazine reported.

The lawsuit claims that, "In fact, the Personal Genome Service does none of those things and the results it provides are not supported by any scientific evidence," The Scientist reported. The suit also says that Casey suffered injury, in addition to losing money, as a result of 23andMe's "false and misleading representations."

23andMe sells a saliva-based kit that claims to tell customers if they are at risk for more than 250 diseases or health conditions. Customers receive a small tube in the mail which they return with a saliva sample for DNA analysis, according to the Associated PressIn a Dec. 3 letter published in the Wall Street Journal, FDA Commissioner Margaret Hamburg said, "The agency supports the development of innovative tests that provide health-care professionals and consumers with useful information to aid medical decision-making. Over the past decade, the FDA has cleared and approved several innovative genetic tests that have allowed health-care professionals to personalize patient care."

But in the case of 23andMe, the FDA commissioner said regulatory review is necessary. "The agency's desire to review these particular tests is solely to ensure that they are safe, do what they claim to do and that the results are communicated in a way that a consumer can understand," Hamburg wrote.

23andMe announced its revised polices on its website: "At this time, we have suspended our health-related genetic tests to comply with the U.S. Food and Drug Administration's directive to discontinue new consumer access during our regulatory review process. We are continuing to provide you with both ancestry-related genetic tests and raw genetic data, without 23andMe's interpretation. We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives."

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