Tuesday, November 3, 2015

23andme Gains FDA Approval

Remember 23andme, the genetic testing company that got chastised by the FDA for providing what the FDA called a "medical device" without the proper documentation? (See this blog, Dec. 5, 2013.) Well, they're back in action again, this time with FDA approval.

Back in 2013, 23andme was offering to analyze samples of saliva and provide "health reports on 254 diseases and conditions" for just $99. The sticking point for the FDA was that the company was providing estimates of a person's risk for developing various genetic diseases and conditions, such as Alzheimer's disease; information that the FDA said was tantamount to offering a medical device without proof of the accuracy of the risk estimates the device provided. The company was ordered to stop providing risk estimates until proof of their accuracy was provided.

Against what seemed like formidable odds, the company stayed in business, providing information on ancestry instead. And they went to work to satisfy certain requirements of the FDA. Now they're back, this time providing information that IS acceptable to the FDA. For just $199 (notice that the price has doubled!) the company now provides basic information about a person's genetic "carrier" status for just 36 conditions, including cystic fibrosis and sickle cell anemia. While that may not seem like much, such information could be useful to prospective parents who want to know their chances of passing these genetic mutations on to their children before they make the decision to have children.

The company says that they still hope to provide accurate, defensible personal risk information for certain diseases (such as the risk of developing Alzheimer's disease later in life) in the future. And who knows, maybe they will. I didn't think the company would ever survive the debacle of 2013, but they did.

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