Tag Archives: FDA


I am sure that you have heard in the news about 23andMe and the letter from the FDA.  If you have not heard about it, you have missed out on some great science news.  Basically, 23andMe is a company in Mountain View, CA that for $99 will analyze a sample of your genetic code for various ancestry and disease markers and give and interpretation of the results.  The interpretation tells you what genes for certain diseases you may carry, how rare that mutation is, and how important/reliable this result is.  Since the letter from the FDA, 23andMe is no longer offering an interpretation of the results of your tests for disease risk factors.  

Welcome to 23andMe.

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

We are continuing to provide you with both ancestry-related genetic tests and raw genetic data, without 23andMe’s interpretation.

If you are an existing customer please click the button below and then go to the health page for additional information, including information about refunds.

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.

Upon entering the site, please confirm you understand the new changes in our services.

-From the 23andMe website entrance portal

You can still get the ancestry information and your raw genetic data, but that is it for the moment.  Anyone with a basic background in bioinformatics can do a lot with even that much data on their own.  There are many open source sequence alignment options that you can use to compare your results and perform your own analysis with.

This whole sittuation makes me wonder if people were getting their reports back and taking drastic measures due to the results they were given.  Were people seeing that they have a 0.4% increased risk due to a BRCA1 mutation and running out and getting double mastectomies? Are people completely ignoring the current debate of genes vs. environment?  Are we so uneducated that we jump at the first hint of possible bad news and make drastic life changing decisions?  I would hope not.

I think that we all have a right to know our own genetic code, whether it comes with a nice printed interpretation or not.  The interpretation is convienient, but must be taken in perspective.  A genome sequence does not take into account the methylation of the DNA and how that affects gene expression.  Just beacuse you have a specific gene, does not mean that it is affecting you.  I think that people (and the FDA) need to calm down about this whole issue and let one get their genes sequenced and interpreted if they want to.  I also think that anyone purchasing such a service has the responsibility to read the manual, as it were, and learn a bit about the data they are recieving before they jump to any conclusions.