23andMe will stop providing health results to new customers in order to appease the Food and Drug Administration during this ongoing regulatory review process.
Late last month, the FDA demanded 23andMe in a warning letter to stop marketing its DNA testing device. There were, and are, two big issues: 23andMe is selling a medical device that is intended to diagnose diseases without approval from the FDA; and it has failed to prove that it has clinically validated its personal genome service.
And just a few days ago, one 23andMe customer filed a $US5 million class action lawsuit against the company.
But 23andMe says that it will still continue to provide customers with ancestry information and raw genetic data without interpretation, the company says.
23andMe Inc., the leading personal genetics company, today announced that it will comply immediately with the U.S. Food and Drug Administration’s directive to discontinue consumer access to its health-related genetic tests during the ongoing regulatory review process. The company will continue to provide consumers both ancestry-related information and raw genetic data without interpretation. In addition, the company will continue to conduct research using its database of genetic and phenotypic data, and also will continue its educational efforts.
“We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives,” said Anne Wojcicki, co-founder and CEO of 23andMe. “Our goal is to work cooperatively with the FDA to provide that opportunity in a way that clearly demonstrates the benefit to people and the validity of the science that underlies the test.”
Update for Customers:
Current 23andMe customers who received health-related results prior to November 22, 2013 will continue to have access to that information.
Customers who purchased kits before November 22, 2013 will still receive health-related results.
Customers who purchase or have purchased 23andMe’s Personal Genome Service (PGS) on or after November 22, 2013, the date of the Warning Letter from the FDA, will receive ancestry information, as well as their raw genetic data without interpretation. These new customers may receive additional health-related results in the future, dependent upon FDA marketing authorization. Customers who purchased kits on or after November 22, 2013 will be eligible for a refund. 23andMe will be sending an email with refund instructions to all eligible customers.
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