Status of our health-related genetic reports.
In February, 2015, 23andMe was granted authorization by the U.S. Food and Drug Administration (FDA) to market the Bloom syndrome carrier status report. This is an important first step in fulfilling our commitment to return genetic health reports to consumers.
This is the first-time the FDA has granted authorization to market a direct-to-consumer genetic test, and it gives us a regulatory framework for future submissions.
While this authorization is for a single carrier status test only; we are committed to returning health information to our US customers who don’t already have this information once more tests have been through this process and we have a more comprehensive product offering.
At this time, we do not know which health reports might be available or when they might be available.
How does this impact you?
- Current 23andMe customers who received health-related results prior to November 22, 2013 will continue to have access to that information. However, no new health-related updates will be provided to your account.
Customers who purchased kits before November 22, 2013 will still receive
- Customers who purchase or have purchased 23andMe’s Personal Genome Service (PGS) on or after November 22, 2013, (date of compliance letter issued by the FDA) will receive their ancestry information and uninterpreted raw genetic data. At this time, we do not know the timeline as to which health reports might be available in the future or when they might be available.
- Customers who purchased kits on or after November 22, 2013 through December 5, 2013 are eligible for a refund. 23andMe has notified all eligible customers by email with refund instructions. If you are eligible and have not received an email, please click here.
- If you purchase today, you are purchasing ancestry-related information and uninterpreted raw genetic data for $99.
- At this time, we do not know the timeline as to which health reports might be available in the future or when they might be available.
We want to make clear that we stand behind the data we generate for customers and are proud of profoundly improving the lives of so many customers. Our lab partner adheres to strict quality standards that are part of the Clinical Laboratory Improvement Amendments of 1988 — known as CLIA. These are the same standards used in the majority of other health and disease-related tests. We decided several years ago to comply with CLIA guidelines to be consistent with other types of laboratory testing and to assure customers about the quality of data.