FDA, 23andMe settlement setback for personal analytics
Posted: Fri Dec 06, 2013 2:16 pm
FDA, 23andMe settlement setback for personal analytics
http://www.zdnet.com/fda-23andme-settle ... 000024032/
Summary: Genetic testing service 23andMe said it will comply with an FDA order and that means you'll get a DNA data dump without any interpretation. What's the point?
23andMe said it will only provide ancestry analysis for its genetic testing service and raw data without interpretation following a scuffle with U.S. Food and Drug Administration.
In other words, the most important part of 23andMe's business and a cog in the quantified self movement---you and your health as a ecosystem to be measured and analyzed---took a hit.
The FDA's beef was that 23andMe, which offered genetic tests and then analyzed the data for individuals, shouldn't be able to advertise and offer analysis without its approval. In a blog post, 23andMe CEO Anne Wojcicki said the company had been talking to the FDA since 2008 and submitted an application for clearance in July 2012.
So now 23andMe will comply with the FDA and end consumer access to its health related genetic tests pending a review. What's left is ancestry-related analysis and raw genetic data without the interpretation.
Add it up and 23andMe now has to offer a big data firehouse without the analytics. Thanks for nothing.
Customers who received or purchased kits for health-related results before Nov. 22 will still have access to the data and analysis.
It has been an open question whether consumers would rush out to get their genes analyzed to flag potential problems, but enough folks used 23andMe to indicate that there's a business there. The FDA is late to the game and hampering what could be called a window into personal analytics.
http://www.zdnet.com/fda-23andme-settle ... 000024032/
Summary: Genetic testing service 23andMe said it will comply with an FDA order and that means you'll get a DNA data dump without any interpretation. What's the point?
23andMe said it will only provide ancestry analysis for its genetic testing service and raw data without interpretation following a scuffle with U.S. Food and Drug Administration.
In other words, the most important part of 23andMe's business and a cog in the quantified self movement---you and your health as a ecosystem to be measured and analyzed---took a hit.
The FDA's beef was that 23andMe, which offered genetic tests and then analyzed the data for individuals, shouldn't be able to advertise and offer analysis without its approval. In a blog post, 23andMe CEO Anne Wojcicki said the company had been talking to the FDA since 2008 and submitted an application for clearance in July 2012.
So now 23andMe will comply with the FDA and end consumer access to its health related genetic tests pending a review. What's left is ancestry-related analysis and raw genetic data without the interpretation.
Add it up and 23andMe now has to offer a big data firehouse without the analytics. Thanks for nothing.
Customers who received or purchased kits for health-related results before Nov. 22 will still have access to the data and analysis.
It has been an open question whether consumers would rush out to get their genes analyzed to flag potential problems, but enough folks used 23andMe to indicate that there's a business there. The FDA is late to the game and hampering what could be called a window into personal analytics.