23andMe Halts Genetic Health Reports

The Google-backed company had been rebuked by the FDA

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In response to a request from the Food and Drug Administration (FDA), 23andMe will no longer provide consumers with health-related information based on their genome.

In a news release posted on its website on Thursday, the company said it’s temporarily suspending these services while it continues discussions with the FDA. The agency questioned whether the Google-backed company’s direct-to-consumer genetic testing service received the proper approval from the FDA for ensuring the safety of the public’s health. The company has said that its reports are educational and informational, not diagnostic, but the FDA raised concerns that consumers could make medical decisions based on their results.

Consumers who purchased test kits prior to the FDA’s warning letter, which was issued on Nov. 22, will still have access to their health-related genetic results on the company’s website, and can still see their genetic lineage or ancestry reports. But for the time being, their health information will no longer be updated with new interpretations based on the latest studies, as the company had been doing.

Those who purchased kits on or after Nov. 22 will be eligible for a refund, or, if they prefer, they can still receive ancestry-related information and their raw genetic data, without analysis of what that data means. If they choose the latter option, customers may eventually receive interpretations of their data, if the FDA decides that such analysis meets its requirements for providing consumers with reliable information that won’t result in undue harm.

5 comments
ryanl28
ryanl28

When first seeing this my wife and I immediately dismissed it and thought it was nothing but a hoax.  After speaking to my wife's brother and sister in law they immediately peaked my interest when they said they were going to do it and then gave details of it from someone they knew who had already done it.  I would just like to see it so that I can see how athletic I am and if my genetics say the same about what I think.  

I am not sure that using it for medical reasons is a great idea, but each person has a right to do what they choose with the information.  If you go to this website: http://www.singularityweblog.com/23andme-dna-test-review-its-right-for-me-but-is-it-right-for-you/  you can see videos about genetics and why it is important to know about it.  I felt that these videos were very informative and could help with whether you decide to do this in the future or not.  

britster
britster

I did it in time and though I originally did it for the health information (and got my boyfriend to do it, too), I was actually more intrigued by what I found in the ancestry results. It has sparked an interest that never previously existed for me, and I was actually contacted by an estimated 2nd-4th cousin who was adopted and looking to figure out who her family is. It's really cool to see the breakdown of my ancestry, and my results have definitely de-bunked some family myths (for instance that there is some cherokee in our family) while also raising new mysteries to be solved (who was my Sub-Saharan African ancestor?).


The value of the health information was only ever as good as the research that was done in the first place, which obviously has some serious limitations for women, minorities, and people of mixed ethnicity (like me). While that will change over time, the information is different for a Caucasian male than it is for a mixed ethnicity female (especially for mixed ethnicity and non-caucasian). For much of the health results I would see a drop down box where you could select the race that the study's data was on, so it would be "assuming Caucasian" or "assuming Asian." Well, I'm some of each, but on certain things, the conclusions were conflicting based on the ethnicity….which makes the analysis pretty much inapplicable to me, but interesting to think about nonetheless. I liked looking at some of the less reliable information (they have a star-rating system that kind of rates how many studies the analysis of the data is based on), knowing very well that the "results" in regards to those portions were not at all reliable, but it made me want to read more about certain studies on people that had certain genetic variations in common with me. 


I also downloaded the raw data, and used the free tools on the site GEDmatch.com to do all kinds of other stuff.


Anyway, all in all, I would still think this was worth the $99 even if I didn't get the "health information," though I can't say that I would have initially purchased it If I knew I would not get those results. I just didn't see the value of the information until after I got my results. 


Anyway, If you do decide to buy, click my link so I get $10 on amazon…http://refer.23andme.com/a/clk/1XcZjn

(I didn't know that they gave referral bonuses before, and I could have done my christmas shopping for free if I actually earned the money for the referrals I generated through word of mouth!)


adoctor'svoice
adoctor'svoice

As a physician and a consumer who has a dominant genetic mutation that influences cancer development; not BRCA 1 or 2;  I am 

concerned that genetic testing could be misinterpreted by the general public. However, that should not hinder the availability of this testing.  After all this is just "testing", any action taken would involve health care professionals.The FDA should be more concerned about devices already approved for use by patients which are not being monitored for safety as they have directed; ie breast implants, both saline and silicone. Surgeons are not mandated to report side effects to the FDA, only deaths. Breast implants don't always rupture, but they do "bleed" silicone through the silicone shell of the implant into the patient. Yes, there is a cancer associated with implants, Anaplastic Large Cell Lymphoma. This is a rare cancer, but I do not know of many women who would "elect" to have cosmetic breast implants if they knew the truth.  Why dear FDA, is it harmful for us to have genetic information about ourselves; but OK to risk women's health and lives by approving breast implants?  Why don't you force the manufacturers of implants to supply all the post approval study information you mandated ? When physicians are not mandated to routinely report side effects only deaths; is that akin to allowing the Fox to guard the Henhouse?

Bofu2U
Bofu2U

Grrrr... I just had my kits delivered. Thanks, FDA. Complete waste of time.