23ANDME, INC. PROVIDES UPDATE ON FDA REGULATORY REVIEW
December 5, 2013
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.
23andMe, Inc., headquartered in Sunnyvale, CA, is a leading consumer genetics and research company. Founded in 2006, the company’s mission is to help people access, understand, and benefit from the human genome. 23andMe has pioneered direct access to genetic information as the only company with multiple FDA clearances for genetic health reports. The company has created the world’s largest crowdsourced platform for genetic research, with 80% of its customers electing to participate. The 23andMe research platform has generated more than 180 publications on the genetic underpinnings of a wide range of diseases. The platform also powers the 23andMe Therapeutics group, currently pursuing drug discovery programs rooted in human genetics across a spectrum of disease areas, including oncology, respiratory, and cardiovascular diseases, in addition to other therapeutic areas. More information is available at www.23andMe.com.