FDA

FDA Loosens Its Shackles on 23andMe Personal Genomics Company

Still forbidden to tell customers nearly 90 percent of what the company used to be able to share

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23andMe
23andMe

Back in 2013 the regulators at the Food and Drug Administration basically shut down the burgeoning field of direct-to-consumer personal genomics when it ordered the genotype screening company 23andMe to stop testing new consumers for genetic health risks. Why? Because the regulators had ginned up some speculative scenarios in which, for example, a woman who tested positive for a deleterious BRCA breast cancer variant would run to her kitchen, grab a butcher knife, and lop off her breasts (I exaggerate slightly.) As a long time and happy 23andMe customer, I was particularly irked by the FDA's nonsensical decision to keep people in the dark about their genetic makeup.

Before the FDA brought its hammer down, 23andMe was developing a wonderful explanatory interface to help customers understand their genetic information. The company provided some insights on more than 200 health risks, drug responses, and inherited traits—and was adding more all of the time.

After 2013, the company was allowed to tell folks what their genes suggested about their ancestry and traits like dry earwax or the likelihood that their second toes are longer than their big toes. (As if anyone needs genetic tests to discern that information.) In their "wellness" reports, the company could inform customers about how their genes affect the speed with which they metabolize caffeine or their tolerance for milk.

Today, the company is announcing that the FDA is loosening its noose a bit and permitting it to tell customers some genetic risk information for ten different conditions, including late-onset Alzheimer's disease, Parkinson's disease, celiac disease and hereditary thrombophilia (harmful blood clots). As an early customer, the company had already provided me with some genetic insights with regard to all of these health risks, plus about 140 others.

Here's hoping that the Trump administration will roll back these unnecessary regulations and free up personal genome companies like 23andMe to provide Americans with access to their genetic information.

To find out what's genetically wrong with me, click over to SNPedia where I have posted the results of my 23andMe genotype screening tests for all to see.

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  1. I was particularly irked by the FDA’s nonsensical decision to keep people in the dark about their genetic makeup.

    I was tested before the FDA’s rules came into effect, and my results were not surprising:

    45% studmuffin, 45% beefcake, 10% Hefner.

    1. I always suspected that you had three parents.

  2. Standard gov empire building. Take an industry, threaten to strangle it to death, wait a few months, then give back 10% of what you’ve taken and expect gratitude.

    1. 15% if you grease the right politicos

  3. What value does one get from knowing where their great grandparents are from? I mean that most everyone knows their European heritage via your surname and your grandparents.

    I know i’m a dick but why spend money to find out that your wop relative banged a limy two centuries ago?

    Also, if you are descended from slaves, as the commercial alludes to, how the hell do they know your heritage? From what I understand, there was not a lot of recordkeeping when they were trading humans like farm animals.

    1. t: 23andMe and companies like Ancestry.com can use genetic testing to trace from what region a person’s African ancestors may have come – given, as you note, the paucity of slave traders’ records this provides folks with some information that they may otherwise not have had.

  4. Gene testing rations have been increased by 50%, wooo!

  5. Download your raw data from 23andMr, and go over to Promethease to get a huge report mapping SNPedia medical information to your genomic results.

    They’re updating SNPedia all the time, so you can keep updating your medical results periodically.
    Producing a report costs $5. You get a zip file to download with a appified web page to view your results.

    Promethease

    1. I forgot to mention: fuck the FDA with a rusty pipe.

    2. b: Which is exactly what I did and then posted at SNPedia. The folks at Promethease are doing a nice job, but the 23andMe interface was a lot more consumer-friendly.

      1. Depends what you’re using it for. I use Promethease’s results more.

        23andMe gives you a few reports. But if you’re trying to search on your own issue, using the search box on Promethease is much handier. It searches across information, including description and gene.

        1. Promethease has a nice video on using their service and navigating their report.

          You can even extract their data to an excel spreadsheet.

          This is what I’ve wanted!

        2. You can use the Table button to create a table of the currently filtered data, then in that table to get an excel spreadsheet of it all.

          This is so awesome!

        3. Squirrels!

    3. b: Which is what I did and the posted the results at SNPedia where Promethease constantly updates with relevant studies. As nice a job as the folks at Promethease are doing, the 23andMe interface was more consumer-friendly.

      1. Damned squirrels – you’re supposed screw around with commenters, not me.

        1. One of us! One of us!

    4. Found out something interesting about Promethease coverage. Seems that Ancestry has significantly more coverage than 23andme, though I don’t have a measure of the clinical significance of the different coverage.

      Ancestry is also often cheaper, with sales to

      1. Damn it. Got hosed by a wiki control character.

        … with sales to less than $70 fairly often.

        SNPedia FAQ

        How many SNPs are in SNPedia?
        There are currently 94593 SNPs in SNPedia.

        47612 are tested by Ancestry.com’s current v2 platform
        25695 are tested by 23andMe’s current v4 platform
        26247 are tested by 23andMe’s older v3 platform
        16178 were tested by the older v2
        14372 were tested by the original v1

  6. I too had my 23andMe test done before the FDA screwed it up. 23andMe should have told the FDA to go fuck themselves. My network tells me that they were about to do just that and Obama got involved and called Ann W. to urge her to come to an arrangement with the FDA.
    Evidently the British are smart enough to read the full genetic testing but we Americans aren’t. In Britain you can still order the full 23andMe health traits that we used to have.
    The British MHRA came to the conclusion (with the FDA’s advice!!!) that 23andMe health traits were OK to market in the UK. Here’s the quote from the British government:
    “The MHRA discussed the 23andMe Personal Genome Service with the US Food and Drug Administration (FDA) and shared information under the confidentiality commitment that is in place between the two agencies.”
    See http://www.parliament.uk/busin…..02/HL3348/ for the full posting.
    I’ve submitted a FOIA request to see what the FDA told them, and I urge the rest of you to do the same.

  7. After Ron wrote of the attack on 23andme, I went ahead and had them do my genes. About the only thing interesting I learned is that I have the gene to make my armpits funky. As do something like 95% of Europeans and Africans. But the really interesting thing is that Koreans are the opposite: something like 95% of them do not have the gene for stinky pits and therefore they never need to use deodorant. Other Asians are similar but with smaller percentages I think.

    Was it worth 100 bucks? Yeah.

    (In all truth there were a few other interesting things.)

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