23andMe has been selling genetic analyses for nearly six years. A device for collecting saliva is sent to a consumer’s home and returned for evaluation of a litany of information, such as the presence or potential for genetic disease, paternity, and historical lineage.
The FDA issued guidelines in 2010 for the approval of any accessory used for genetic testing for medical diseases. One of the nations largest health insurers, UnitedHealth Group, Inc., issued a report early in 2012 that challenged the accuracy of mail-order chromosome analysis. 23andMe filed requests with the FDA on behalf of its apparatus shortly after that statement, but were denied approval because the device has not been shown to be reliable. In its response to 23andMe, the FDA cited concerns about the impact upon public health and perception caused by shoddy test results.
23andMe was formed by Anne Wojcicki, wife of Google co-founder Sergey Brin. No official response has yet been released by her or the company.
By Daniel Annear