23AndMe To Stop Test Sales After FDA Order
December 6th, 2013 // 2:08 pm @ jmpickett
23andMe, a genetic testing company, is complying with an FDA order and is going to stop selling its genetic tests after it received an FDA warning on the matter. The company stated yesterday that it will still sell ancestry related information to those who want it and also raw genetic information without any type of interpretation. Customers who have bought the kits since the order from FDA was issued can get refunds.
23AndMe has sold its health related saliva tests to help customers predict risks of developing several diseases. But in November, the firm was ordered to stop selling the kits. FDA stated that 23andMe did not show that the results of their saliva tests are supported by scientific data.
Another media update noted that 23AndMe is not really stopping the sale of the kits, but it will continue to provide the data from the tests to customers but will not provide any interpretation of results.
FDA wants the company to wait until it is cleared as an approved medical device before it offers full diagnostic services. FDA is worried that people will take medical actions based upon their genetic results. Or, people may get complacent when they should not based upon one of the tests stating, for example, that their risk of a certain form of cancer is low. FDA first sent it a warning letter last month because it lacked medical device approval, and because it had not proven that it had clinical validation of the services it was providing.
It was reported also that 23AndMe also has been hit with a $5 million lawsuit this week. A customer in San Diego filed the suit, claiming that the testing kits are worthless and provide information that is not supported by science.
23AndMe has faced a good deal of legal issues in the past; one concern was that the firm was trying to build a DNA database and create a designer baby market. It holds a patent on allowing egg and sperm recipients to see how their genes will combine with a certain donor’s.
