Sunday, July 13, 2014





23andMe to follow FDA order to halt test sales


December 06. 2013 8:36AM
Associated Press

Story Tools
PrintPrint | E-MailEMail | SaveSave | Hear Generate QR Code QR
Send to Kindle


(AP) Genetic testing company 23andMe Inc. will comply with a Food and Drug Administration directive to stop selling health-related genetic tests during a regulatory review.


The Mountain View, Calif., company said late Thursday that it will continue to provide ancestry-related information to customers and raw genetic data without interpretation. Customers who bought kits since the FDA order came out last month will be eligible for refunds.


FDA representatives did not immediately return a phone call from The Associated Press seeking comment on the company's announcement.


23andMe's saliva-based test kit, launched more than 5 years ago, claims to tell customers if they are at risk for more than 250 diseases and health conditions. The FDA says only medical tests that have been cleared by the government are permitted to make such claims.


Last month, the agency had ordered 23andMe to stop marketing its test, warning that erroneous results could cause customers to seek unnecessary or ineffective medical care. The FDA warning letter stated that even after numerous meetings and email exchanges with the company, the agency still had no assurance that the firm has analytically or clinically validated its technology.


23andMe sells its tests online. Customers receive a small tube in the mail, which they return to the company with a saliva sample for DNA analysis.


The company was co-founded by Anne Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin. Both Google and Brin have invested millions in the privately held company over the years.


Associated Press


Comments
comments powered by Disqus Commenting Guidelines
Poll
Mortgage Minute


Search for New & Used Cars

Make 
Model
 
Used New All
 

Search Times Leader Classifieds to find just the home you want!

Search Times Leader Classifieds to find just what you need!

Search Pet Classifieds
Dogs Cats Other Animals



Social Media/RSS
Times Leader on Twitter
Times Leader on Youtube
Times Leader on Google+
The Times Leader on Tumblr
The Times Leader on Pinterest
Times Leader RSS Feeds