23andMe, the DNA testing service backed by Google (NASDAQ:GOOG) and run by the estranged wife of company founder Sergey Brin, will discontinue its genetic health screening service to comply with an FDA warning.
The company will continue to offer DNA testing, providing ancestry-related analysis as well as “raw genetic data,” which consumers can then have screened for health risks by third-party websites. 23andMe will offer customers who purchased the service after Nov. 22 a refund. Those who paid before Nov. 22 will continue to have access to health-related results.
The FDA threatened 23andMe with seizure, injunction as well as civil financial penalties, claiming the company took too long to respond to a warning last month. Two weeks ago, 23andMe responded to the FDA by saying it would continue selling the genetic health screening kits, but no longer advertise them.
“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,” CEO and co-founder Anne Wojcicki said in a statement.
The FDA will require 23andMe to receive clearance as a medical device before it can again offer health screening services to customers. The FDA says that consumers might take action on genetic information provided by 23andMe, or become falsely complacent if the test fails to notify a person from risks.
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The FDA does not yet offer medical device classification for a service like 23andMe, so there may be a long timeline before the company is able to offer full service again. 23andMe now offers similar screening to AncestryDNA, a genetic paternity test offered by Ancestry.com.
Here is the full text of the company’s press release:
23ANDME, INC. PROVIDES UPDATE ON FDA REGULATORY REVIEW
Company discontinues new consumer access to health-related data pending completion of FDA review
Continues direct-to-consumer ancestry-related information and raw genetic data
MOUNTAIN VIEW, CALIF. (December 5, 2013) 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.