FDA Takes One Regulatory Shackle Off 23andMe Gene Testing

Agency still treats consumers like idiots



Two years ago the FDA Shut Down 23andMe: Outrageously Banning Consumer Access to Personal Genome Information. Why? Because the agency's bureaucrats think that consumers are too stupid to understand and handle their own genomic information. The FDA ordered 23andMe to stop offering its popular Personal Genome Service that, among other things, alerted users to possible health risks related to their genotype screening results.

The New York Times today is reporting that the agency has relented somewhat and is now graciously allowing the company to offer genetic testing information to customers that relates to the risk of passing certain inherited diseases to their children.  The Times reports:

The new health-related information 23andMe will provide is called carrier status. That relates to whether people have genetic mutations that could lead to a disease in their offspring, presuming the other parent has a mutation in the same gene and the child inherits both mutated genes. There will be information on 36 diseases, including cystic fibrosis, sickle cell anemia and Tay-Sachs.

Whether that information, which is of most interest to people planning to have babies, will be compelling is unclear, and there are separate carrier tests available through doctors from other laboratories.

Ms. Wojcicki said 23andMe still hoped to gain F.D.A. approval to provide information on health risks, but she would not estimate how long it might take to win that approval.

Fortunately, those of us who were customers before the FDA crackdown still have access to carrier status results for 53 inherited conditions, that is, 17 more than the FDA is now authorizing. For what it is worth, I am clear for all the variants tested, except for Alpha-1 Antitrypsin Deficiency.

Early customers like me also still get information on 123 different health risks. This is specifically the information that the FDA is eager to deny consumers. The information is carefully presented with all kinds of appropriate caveats. According my results, I have elevated risks for illnesses like atrial fibrillation, age-related macular degeneration, and type-1 diabetes. With regard to all of them, I can say, so far, so good. On the other hand, I am at lower risk for gout, Alzheimer's disease, rheumatoid arthritis, and melanoma. Again, so far, so good.

Hooray for this small concession, but it is still outrageous that the FDA is stifling innovation and consumer freedom.

NEXT: The Strange Police Killing of Corey Jones

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  1. I’m still pissed that I was a dead broke college student at the time when you could still get results from 23AndMe. Fuck the FDA.

    1. I: There is a possible workaround. 23andMe will still supply you with your raw test results which you can then load into Promethease. To see what Promethease results look like click on over to SNPedia to view my frequently updated genetic testing report.

      1. Nice, thank you Bailey. I’ll have to try that.

      2. i wonder if i could get raw results from ancestry, they’re still $99

        1. looks like yes! or family tree dna as well. totally doing it!

      3. This is actually an awesome way to use this data. I’d want to look into the privacy around Promethease, but I like the idea of a continually updating database dredged from medical literature, and tighter controls around what the user wants to view or not view.

        Also, I’m in the same boat as Illocust, and couldn’t afford 23andMe when it was actually useful.

        Thanks, Bailey!

    2. Now you can pay 23andme twice as much! I can’t see where the FDA added any value here.

      1. “I can’t see where the FDA added any value here.”

        They’ve added plenty of value to the entrenched DNA testing industry. Instead of paying 23andMe $100 for 1million SNPs, you can pay the incumbents $100 per SNP.

  2. People are too stupid to make choices over their own bodies and in particular will behave like stampeding cattle when given information about their own health. Nonetheless, they are smart enough to elect governments to make such choices for all of us.

    This is what nanny-statists actually believe. I guess the voting booth is like the Great Teacher in ST:TOS.

    1. You forgot the part about how they are perfectly capable of voting properly until big money interests start running expensive TV commercials, which turn the electorate back into drooling morons.

  3. So, they don’t trust me with my health info, but they trust me knowing I’m 1/33rd Jewish on my dad’s side? I’ll show them.

    1. I found out I was way more British and Irish than I realized (50.5%). No wonder I had such bad teeth as a child. :[

  4. Because the agency’s bureaucrats think that consumers are too stupid to understand and handle their own genomic information.

    In their defense, people seem to like to be infantilized these days. Some people even seem to think they’re empowered by victimhood.

    1. The Brown Badge of Victimhood

      Wear it proudly

    2. I was triggered by how white my genetics were when all I wanted was to be a special snowflake.

      Actually it said


        It said I was less than 0.1% sub-saharan African so I’m going to get a spray tan, some hair curlers and run for the head of my local NAACP.

        1. .1% does that violate the one drop rule. How big of a percent is one drop?

          1. Be it enacted by the general assembly of Virginia, That the State registrar of vital statistics may, as soon as practicable after the taking effect of this act, prepare a form whereon the racial composition of any individual, as Caucasian, Negro, Mongolian, American Indian, Asiatic Indian, Malay, or any mixture thereof, or any other non-Caucasic strains, and if there be any mixture, then, the racial composition of the parents and other ancestors, in so far as ascertainable, so as to show in what generation such mixture occurred, may be certified by such individual, which form shall be known as a registration certificate.

            1. It’s interesting that the Racial Integrity Act of 1924 had a Pocahontas exception since so many prominent Virginia families claimed to be descended from her.

              Funny how that never goes out of fashion.

          2. The human body has about 4700 mL of blood. A drop is 0.05mL. So any percentage over 0.001% makes you black.

            1. Well it does say

              1. *sigh*

                less than 0.1% african with no lower bound.

                I am, however, 1% Ashkenazi, whatever that is.

                1. You’re Jew-ish

                  1. Nice. I like what you did there.

                2. Time for your bris, boychik!

        2. Why don’t you just check the Native American box on your form and run for Senate?

        3. But how much Neanderthal are you?

          23andMe asys I’m 3% Neanderthal (I’m more Neanderthal than Fauxcahontas is Native American). I self identify as Neanderthal, and am horribly oppressed by the *genocide* you homo sapiens inflicted on my race.

          Reparations for Neanderthals Now!

  5. Has anyone done the 23andme testing anonymously?

    1. Doesn’t that make it harder for the feds to seize 23andme’s customer profiles and build a DNA database?

      1. I believe 23andme is subsidizing the cost of the testing with the promise of being able to sell advertising using that info in the future. I’m not inclined to put my kids in that database for the rest of their lives.

        That, and yeah, I don’t trust Big Daddy.

      2. Why build your own DNA database when you can just strong arm 23andme into giving you the data you want?


        “Your relative’s DNA could turn you into a suspect,” warns Wired, writing about a case from earlier this year, in which New Orleans filmmaker Michael Usry became a suspect in an unsolved murder case after cops did a familial genetic search using semen collected in 1996. The cops searched an Ancestry.com database and got a familial match to a saliva sample Usry’s father had given years earlier. Usry was ultimately determined to be innocent and the Electronic Frontier Foundation called it a “wild goose chase” that demonstrated “the very real threats to privacy and civil liberties posed by law enforcement access to private genetic databases.”

  6. Hooray for this small concession, but it is still outrageous that the FDA is stifling innovation and consumer freedom.

    Denying you things helps remind you government is ‘there’. Why do you think the feds went to such extraordinary lengths to make sure “you couldn’t” during a government shutdown– actually invoking thousands of hours of overtime for employees to rope off random areas and even close things they didn’t even run.

    Why do you think governments encourage pubsec unions to strike? It helps remind the proles who the real masters are.

  7. For once being Canadian pays off. 23andMe is uncensored over here.

    1. Yes, but since there’s only about 15 of you living way up there, the gene pool is more of a gene puddle. Accordingly, they just send the same results to every envelope with a Canadian return address.

  8. The FDA is like Dr. Zaius, and all of you are trying to go into the Forbidden Zone to find your answer. “Don’t look for it, Taylor. You may not like what you’ll find.”

  9. you can’t just have someone shouting DNA results in a crowded theatre

    1. You don’t necessarily need 23andMe when children are hungry in this country.

      1. You don’t need one genome per person when kids are going hungry.

    2. I do tend to shout “FIRE, FIRE, FIRE!” when I am leaving my DNA samples in a theater. It is just common courtesy. Like yelling “fore” on the golf course.

  10. “Agency still treats consumers like idiots the tax cattle that we are.”

    1. “but it is still outrageous par for the course that the FDA is stifling innovation and consumer freedom.”

  11. According my results, … I am at lower risk for gout, Alzheimer’s disease, ….

    Emphasis added. Ron, are you *sure*? 😉

    1. lysdexia wasn’t on the list of things risk not.

  12. I’m so pissed I didn’t jump on that early on, it was pretty cheap even and i’d love to have the extra information

  13. I bought brand new BMW by working ONline work. Six month ago i hear from my friend that she is working some online job and making more then 98$/hr i can’t beleive. But when i start this job i have to beleived her

    ??????? —— http://www.HomeJobs90.Com

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