23andMe

Before Busybodies Opposed Home Genome Testing, They Fought Against Home Pregnancy Tests

History shows we have everything to gain from knowing more about our bodies.

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Credit: Kris Tripplaar/Sipa USA/Newscom

The home genome testing company 23andMe has been fighting for the right to inform consumers about their DNA for five years now, ever since speculative fears led the Obama administration to clamp down on the industry. Last month, the company scored a win for the field and for its customers when it won federal approval of the first home BRCA test.

The Food and Drug Administration announced in March that 23andMe would be allowed to market a "Personal Genome Service Genetic Health Risk Report" for three variants of a gene linked to breast cancer in Ashkenazi Jews. While the variants for which the test was approved are not the most common BRCA mutations in the general population—and are, in fact, just three of more than a thousand—the agency's signoff is nevertheless an important step for the democratization of science and the empowerment of the individual.

And it has a rather significant historical precedent. In an article published Monday in STAT News, 23andMe CEO and co-founder Anne Wojcicki notes the story of Margaret Crane, a product designer at Organon Pharmaceuticals who argued in the late 1960s the company's pregnancy test could be simplified and sold directly to consumers. Crane's bosses resisted, not wanting to upset their physician clients, who then had a monopoly on testing women's urine for pregnancy hormones. After the company eventually adopted Crane's position, vendors of the test faced pushback from the United States Public Health Service and the Texas Medical Association.

It's been 50 years since Crane built her prototype, and home pregnancy tests have not caused a rash of suicides or psychotic breaks (as her bosses at Organon initially predicted); nor do women find them inscrutable or impossible to use. There are no contemporary arguments for revoking the right to test at home, and I can't imagine any obstetrician would argue that women are worse off for the invention. Decades from now, if patriarchal forces continue to retreat and retrench in the face of sound science, we will be able to say the same thing about the products offered by 23andMe.

"We know from our research and the work of others that you don't have to be an expert to handle genetic health risk information," Wojcicki writes. "We also discovered through our research that a number of our customers who learned that they carry potentially harmful BRCA-related genetic variants never knew they were at risk for breast or ovarian cancer and would never have been tested for them through the traditional system. For some of these people, the information they got from a direct-to-consumer genetic test truly saved their lives.

I find arguments about the wrong and right sides of history to be pretty cloying, but in this case, I think home testing advocates will eventually win out.

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57 responses to “Before Busybodies Opposed Home Genome Testing, They Fought Against Home Pregnancy Tests

  1. 23andMe would be allowed to market a “Personal Genome Service Genetic Health Risk Report” for three variants of a gene linked to breast cancer in Ashkenazi Jews

    You know who else did genetic tes…….ah, forget it.

    1. Jon Snow?

  2. Listen: I’m totally fine with a company like 23andme getting your DNA and telling you about it… just as long as they keep permanent records and respond in a timely manner to any subpoenas and affidavits of writ and release.

  3. I find it interesting that the government says it has a right to your DNA record even while it says that you don’t. Beyond Orwellian.

  4. Democrats don’t want to find out they have black heritage.

    1. Any guesses on what percentage donkey is lovecon89?

      1. Hey. Donkeys are cute in that kinda ugly cute way.

        I’m guessing approximately 0% donkey, 42% white, 20% Navajo, 18% dog, 5% Magilla Gorilla, 5% Grape Ape, 5% King Gorilla, 2% centipede, 1% hot dog parts, 1% tooth fillings joint replacements and lead particles, and 1% other.

        Among lefties.

        1. Is that 2% HUMAN centipede?

          1. The biggest centipede you’ve ever seen dingleberry.

            1. More like a dingleberrypede

            2. I finally got one of the ancient pop culture references!

      2. 0% donkey.

        I am 100% homo sapien though.

        1. I am 100% homo … though.

          I knew it! FAG!

          1. Are you suer he’s a freaky alien genotype? A bit of a boomerang bigot if he is.

  5. A genetic testing report is neither a food or a drug so exactly what business is of the Food and Drug administration to begin with?

    1. Mind your place, peasant!

    2. Me shooting you in the face isn’t a disease, yet the CDC seems to want to study it like one.

    3. The definition of “medical device” is sufficiently flexible, and if any problems arise, they’ll just trot out its big brothers, the Commerce Clause and the Necessary and Proper Clause.

      1. And as a last resort, the fuck you, that’s why clause.

    4. They have statutory authority over medical devices, whose definition includes diagnostic devices.

  6. Not that there’s anything wrong with a home genome testing kit that should make it ‘illegal’, but it’s certainly going to be harder to read than a binary yes/no to the question ‘am I pregnant’ so ultimately does it really matter if you can use this test at home when you’d need a Ph.D to read the results?


    It’s been 50 years since Crane built her prototype, and home pregnancy tests have not caused a rash of suicides or psychotic breaks…

    Although we have seen abortion become legal since then…not that I’m trying to imply that’s a direct result but it is a thing that’s happened.

    1. Also, in terms of ‘speculative fears’, would you say it’s more likely for someone to kill themselves upon finding out that they have a genetic defect that will cause their death by 40 years old vs. someone that found out they’re pregnant and just fell down a flight of stairs?

      Notably, that’s what I’m trying to get at in the difference between pregnancy and genetic disease. One of those two things is ‘curable’.


    2. The Food and Drug Administration announced in March that 23andMe would be allowed to market a “Personal Genome Service Genetic Health Risk Report” for three variants of a gene linked to breast cancer in Ashkenazi Jews. While the variants for which the test was approved are not the most common BRCA mutations in the general population?and are, in fact, just three of more than a thousand?the agency’s signoff is nevertheless an important step for the democratization of science and the empowerment of the individual.

      Ah, I see now. The devil is somewhere in the details since it seems this company is marketing individualized DNA testing kits that look for specific issues instead of a broader ‘looks for anything’ type test.

      In essence, they’ll sell you 1000 tests to look for 1000 different potential DNA issues, which I suspect will cost far more than one broad test that takes a Ph.D to read. So these are still binary pregnancy style tests, only they’re looking for potentially thousands of different disorders, each with their own test you’d purchase individually or perhaps in a related pack that look for similar disorders.

      That’s…a great business model. They will profit a lot off of people’s fears, to be sure. Assuming, of course, that this test that is neither a food or a drug doesn’t get snubbed out by…the food and drug administration.

      1. The way they do it now, is you take one test and they give you individual reports on each of the things they test for. At least, that was how it worked when I did it.

        1. My mom went a geneticist to have a more broad test done, and it found some unusual mutations that have a fair likelihood of being present in her relatives, so I could make an informed guess about which to test for. That’d be mad convenient to just do it from home. I need to go see her geneticist anyway because her combo was dangerous.

          1. And I can say nothing about how much 23AndMe does versus other more thorough testing, or if their results are good. I took it as part of a study, and so I did not shop around or do much else with it.

        2. Yep, and honestly this company could provide that very broad spectrum type test by simply running the genetic information through a database and give you a readout of all potential issues rather than charging you even $10 per test, but that’s less cash flow.

          Note that I don’t have any problem with that, but someone else is going to out complete them eventually by doing exactly that if this company doesn’t have that option. It’s pretty clear, at least to me, that revenue drove the decision to make the tests ‘idiot proof’ rather than actual concerns about idiots.

          1. Yep. I have faith in the market to make it more efficient for consumers unless FDA regulation creates a giant barrier to market entry. Which it will. So just like with pharmaceuticals and tobacco and everything else the FDA regulates, only the already-giant corporations will be able to swallow the costs of compliance, creating a de facto monopoly.

          2. They used to do it this way (one saliva sample, ~$400, and all the tests they have on file). They still offer it if you’re canadian (or trick them into thinking you’re canadian). They got shut down by FDA rulemaking. The reason being that when you check for 100s of things at once, you don’t have evidence that all of these tests are sufficiently accurate.

            So breaking them into single-test checks is a way to get back into the US market at all.

            1. I should’ve known that the FDA was involved. The a la carte tests are a great response, though.

    3. “Although we have seen abortion become legal since then…not that I’m trying to imply that’s a direct result but it is a thing that’s happened.”
      We also landed on the moon and created the internet. Related? Maybe.

  7. You know who else was obsessed with genetic testing?

  8. Maybe they could develop a home test so that kids today can figure out if they’re girls or boys.

    1. I wouldn’t mind having a home test kit that tells me my relative hormone levels. I don’t want to go to a doctor and talk about how I feel insufficiently “manly.”

      1. I wonder how they do. When I got my testosterone tested I had to have a blood tested. I wonder if there is an easier way.

        1. I don’t think they exist! I was pining for a hypothetical test. Sorry, not clear.

        2. BUCS: All right doc, give me the numbers.
          DOC: 6..7….8……8 sperm
          BUCS: Whoa, isn’t that quite low?
          DOC: No, not for a stool sample.

          1. Yeah, I really messed up the spit test. I’ll admit it.

        3. ” I wonder if there is an easier way”.
          Sure. They show you a picture of David Hogg. If you feel the desire to punch him in the face you have enough testosterone. If you want to hug him then you’re a beta male cuck.

  9. Also, I don’t have a place to put this. But what is up with Ed leaving? I just saw his dad died this morning as well. And last week he was asking about jobs on Twitter.

    Why the fuck did they get rid of Ed?

    1. He doesn’t have a job lined up? If he got kicked out of Reason for a dumb reason, I have a good reason to be very upset with Reason. Best of luck to you, Kray-Kray. We all miss you.

    2. And sorry about your dad passing away, Ed. 🙁

    3. Don’t know. A few weeks ago he commented and said it was his last article and that he’d be around on Twitter.

      1. Yeah, I know that. Now I’m wondering why. What the hell happened. Heaton too. Heaton was great. Why is he cut off?

    4. Lucy is still selling matches in the street. It’s a tough time to be a mediocre journalist.

  10. Decades from now, if patriarchal forces continue to retreat and retrench in the face of sound science, we will be able to say the same thing about the products offered by 23andMe.

    What a stupid fucking sentence. Are men being allowed to use these products but not women? Then how is it “patriarchal”? Words have meanings, Mike, and since your business involves using them, maybe you should at least pretend to know what the words you use actually mean.

    1. I almost want to think he meant paternalistic forces, because if not then I think it’s a strange implication as well.

      1. Perhaps I was a bit too harsh. I can see how “patriarchal” could slip in when discussing the similarities with pregnancy tests, but it’s still sloppy.

        1. No, I agree with you. I don’t think it was a mistake, and so I’m curious Riggs’ further thoughts. Because “patriarchal” frames it in a very specific way.

        2. I’m thinking he meant paternalistic, too. Daddy gov’t will stop telling us what’s good and bad for us, and that’ll enable such a service to succeed.

    2. Riggs is a ‘tard. Reason gets a tax credit for hiring him

  11. “Imagine trying to explain social media to your grandparents?this was essentially Zuckerberg’s task.”

    Say what you want about our grandparents, Soave, they knew how to change a tire.

  12. “a gene linked to breast cancer in Ashkenazi Jews.”

    You can’t spell Ashkenazi without…..

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