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DNA Testing Company “23andMe” Faces Lawsuit and FDA Problems

Imagine having the ability to predict future medical conditions based on a DNA test. Armed with this sort of information, people would know to be particularly aware of heart disease, diabetes and high cholesterol and could take steps to protect themselves against developing such conditions.

Genetic%20Testing%2055993888-001.jpgEssentially, that’s what was promised by 23andMe, a Mountain View, California company that’s been in existence since about 2007. Advertising on television, radio and the Internet promised consumers the ability to gain valuable knowledge about their personal health risks. The company marketed a $99 DNA test kit. Customers merely had to send a saliva sample the company. After analysis, 23andMe would provide a detailed report that people could use to safeguard themselves against certain health risks.

However, a San Diego woman by the name of Lisa Casey recently filed a lawsuit in the U.S. District Court alleging that the company’s results were actually “meaningless.” Moreover, the complaint states that the DNA is being added to a company database and that the data is subsequently being made available to researchers.

As Casey’s attorney puts it, the company’s efforts are “a very thinly disguised way of getting people to pay them to build a DNA database.” The complaint seeks damages on behalf of many thousands of 23andMe customers who were misled by what the filing terms the company’s false advertising.

The lawsuit isn’t the only roadblock that 23andMe is currently facing. Almost simultaneously with the lawsuit filing, the company received a letter from the Food and Drug Administration. In the letter, the company is accused of making medically related claims that have not been vetted by the department. It’s not the first time 23andMe has received warnings from the federal government. In fact, the FDA has been lodging complaints against the company since 2010, alleging that they have not proven that their testing yields accurate results. The administration fears harm as a result of misinformation provided by the company. Concerns that the procedure could be construed as the practice of medicine have caused the FDA to essentially shut down 23andMe pending a satisfactory response to the letter, available HERE.

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