Personal genetics: here is why 23andMe, discontinues new consumer access to health-related data.



This is henceforth official, 23andMe Inc., the leading personal genetics company, 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.
However, Connectikpeople recalls that the company will continue to:
·        Provide its consumers both ancestry-related information and raw genetic data without interpretation,
·        will continue to conduct research using its database of genetic and phenotypic
data,
·        and also will continue its educational efforts.
Connectikpeople has also captured the following update for its 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.
 “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.” said Anne Wojcicki, co-founder and CEO of 23andMe.

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