- Nov 26, 2013
FDA orders DNA test service to cease marketing
In a crackdown on genetic testing offered directly to consumers, the Food and Drug Administration is demanding that 23andMe immediately cease marketing its main DNA service until it receives marketing clearance from the agency.
In a warning letter issued Friday and posted on the FDA's website Monday, the FDA said the company had failed to provide adequate evidence that its Personal Genome Service provided accurate results.
"FDA is concerned about the public health consequences of inaccurate results from the PGS device," the agency said in its letter.
23andMe, which is backed by Google and run by Anne Wojcicki, wife of Google co-founder Sergey Brin, is perhaps the best known of the personal genome testing companies. Its service, which has been used by about half a million people, tells consumers whether they might be at a higher or lower risk of developing various diseases, among other things.
Whether such tests require FDA approval and whether doctors must be involved in ordering such tests have been the subject of debate. 23andMe has long held that consumers are entitled to the information on their own DNA, although it has also been talking to the FDA about how its tests could receive regulatory approval.
Wojcicki did not immediately respond to an email seeking comment, and her company, which is based in Mountain View, Calif., had not yet responded on its website Monday.
The FDA warning letter said the agency considered the Personal Genome Service a medical device that required approval.
The letter noted that 23andMe did apply for approval for some uses of the test in 2012. However, it said, the company did not provide the additional information requested by the agency.
The letter accused 23andMe of dragging its feet despite "14 face-to-face or teleconference meetings, hundreds of email exchanges and dozens of written communications" since 2009.
"However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions," the letter said.
23andMe now sells its service, which also offers ancestry information, for $99. It is aiming to grow to 1 million customers by early next year. Part of its business plan is to use the information on its customers to perform biomedical research, such as finding genetic causes of diseases.
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