The FDA has ordered 23andMe to stop marketing its Personal Genome Service

23andMe DNA test kitsMost genealogists have heard of 23andMe. They offer services that can be interesting to people who are trying to learn more about their family tree. 23AndMe offers a service that can connect you to other users who share similar DNA.

The thing that 23andMe is the most noted for, however, is their DNA testing kits. A person buys a kit, sends out a sample of their DNA, and waits for results. People have used these kits to learn if their genetics indicated that they were at risk for certain diseases or conditions. The results could also tell a person more about his or her heritage.

The Food and Drug Administration (FDA) has ordered 23andMe to stop selling their home-testing kits. One problem that the FDA has identified is that the 23andME Saliva Collection Kit and Personal Genome Service (PGS) has been marketed without having the proper clearance or approval of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

The FDA has been interacting with 23andMe in regards to their home-testing kits for a while. At this time, the FDA feels that they don’t have any assurance that 23andMe has “analytically or clinically validated the PGS for its intended uses”. As such, 23andMe must discontinue marketing (or selling) its Personal Genome Service until such time as it receives FDA marketing authorization.

What is the FDA concerned about? The agency is worried about the potential health consequences for customers who received inaccurate results from their DNA testing kit. The kits do not require the opinion of a doctor. This could lead to people making inaccurate health choices, based upon the results they received.

For example, a person who got results from 23andMe that incorrectly indicated that he was at low risk of cancer might choose to skip some types of testing or preventative care that he actually did need. Conversely, a woman whose DNA test kit said she was at high risk for breast cancer might seek out surgery or chemotherapy that was not truly necessary.

This brings up a question that has been floating around for a while now. Should companies that sell home DNA testing kits be allowed to do so? Should these types of home testing kits be restricted to people whose doctor’s prescribe them (so the doctor can provide appropriate follow up care)?

What about genealogists who are using the DNA kits to fill in their family tree (and not for medical purposes)? How will restrictions on the sale of the kits affect their research? There are no easy answers to these questions.

Meanwhile, 23andMe has posted a statement on the 23andMe blog regarding the letter they received from the FDA. Their short statement reads:

We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”

Image by Sergio Calleja on Flickr.

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