Support/Before You Buy/Product Overview

FDA Update: December 5th

23andMe
posted this on December 05, 2013 06:16 PM

Here is the latest update regarding the FDA letter and how it will impact our service.

At this time, we have suspended our health-related genetic tests to comply immediately with the U.S. Food and Drug Administration’s directive to discontinue new consumer access during our regulatory review process.

Is 23andMe still selling its Personal Genome Service?

Yes. 23andMe’s Personal Genome Service including ancestry information and access to raw genetic data without interpretation is still available.

Which reports are impacted?

  • All health-related results including health risks, drug response, inherited conditions and traits.

  • 23andMe will continue our education efforts and research using our database of genetic and phenotypic data.

  • Customers will continue to have access to their raw data.

Which customers are impacted?

  • All customers who purchased prior to November 22, 2013 will have access to their health-related genetic results.

  • Customers who purchased on November 22, 2013 or later will not have access to health-related results.

  • Customers who purchased between November 22, 2013 and December 5, 2013 are eligible for a full refund. Eligible customers received an email with personalized instructions on how to elect a full refund.

I currently have access to my health data – will that information be removed from my account?

No. Existing customers will continue to have access to their health-related results.

My sample is currently at the lab for processing, will I get health data?

  • Access to health data is based on your purchase date. If you purchased 23andMe prior to November 22, 2013, you will receive health data.

  • If you purchased a 23andMe kit on or after November 22, 2013, we will not be able to provide health-related results.

I purchased a kit as a gift before November 22nd, but have not given it to the recipient. Will they still receive health results when they send it in?

Yes. Access to health-related results is based on the purchase date of the kit. Any kit purchased before November 22, 2013 and returned to our lab will receive health-related results.

I purchased a kit as a gift after November 22nd, but have not given it to the recipient. Will they still receive health results? Can I get a refund?

Access to health-related results is based on the purchase date of the kit. For any kit purchased after November 22, 2013, we will not be able to provide health-related results. If you are eligible, you will receive an email with personalized instructions for claiming the refund.

Will the company continue to provide new health reports to international customers?

No. At this time 23andMe is not going to provide new health-related results to any customers who purchased on or after November 22, 2013.

Which health reports will be available in the future? Do you have any sense of when health-related results may become available again?

We can’t speculate on the timing or outcome of the regulatory review process, but are committed to working with the FDA.

Will refunds be offered?

  • Yes, customers who purchased between November 22, 2013 and December 5, 2013 received an email with instructions on how to elect a full refund.

  • Due to the volume of impacted customers, it may take a few weeks for refunds to be processed. We appreciate your patience.

  • Eligible customers who do not receive an email with refund instructions are encouraged to double-check their spam email folders. Alternatively, they can contact Customer Care: https://23andme.zendesk.com/entries/23796730-Requesting-a-refund

If I purchase a kit with just ancestry-related results and raw data, is the price still $99?

Yes. The price remains unchanged at $99.

How accurate is 23andMe’s data?

  • We adhere to the highest scientific standards and the same laboratory processing standards currently applied to physician-ordered tests.  

  • Our lab follows strict quality standards that are part of the Clinical Laboratory Improvement Amendments of 1988 — known as CLIA. These are the same standards used in specific health and disease-related testing. 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 our data.

  • White papers that outline our scientific and statistical standards and the criteria for the genetic associations included in our reports are available on our website at: https://www.23andme.com/for/scientists/#whitepapers

 
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