23andMe resumes sales: Ancestry only!

Apr 30 2014 Published by under Ethics, Medicine and Law, Public Health

Well this is interesting. After being spanked by the FDA for selling their services without proper review and approval of their medical test (as the FDA interpreted it), the 23andme company is back.

I received an email spam suggesting I purchase one of their kits as a Mother's Day present.

Intrigued, I see this in an alert banner across the linked page.

23andMe provides ancestry-related genetic reports and uninterpreted raw genetic data. We no longer offer our health-related genetic reports. If you are a current customer please go to the health page for more information.

When you go to purchase a new kit you are obliged to check a box indicating you've read an additional warning.

I understand I am purchasing ancestry reports and uninterpreted raw genetic data from 23andMe for $99. I understand I will not receive any reports about my health in the immediate future, and there is no timeline as to which health reports might be available or when they might be available.

Ok. Got it.

So what about existing customers who purchased their kit in the old, pre-ban era? Guess I'd better visit that "health page".

Current 23andMe customers who received health-related results prior to November 22, 2013 will continue to have access to that information. However, no new health-related updates will be provided to your account.

Customers who purchased kits before November 22, 2013 will still receive
health-related results.

Customers who purchase or have purchased 23andMe’s Personal Genome Service (PGS) on or after November 22, 2013, (date of compliance letter issued by the FDA) will receive their ancestry information and uninterpreted raw genetic data. At this time, we do not know the timeline as to which health reports might be available in the future or when they might be available.

Customers who purchased kits on or after November 22, 2013 through December 5, 2013 are eligible for a refund. 23andMe has notified all eligible customers by email with refund instructions. If you are eligible and have not received an email, please click here.

Ok, so they are not turning off the results already provided to the older customers. If you fell into the cease-and-desist gap, you don't get your info (boo FDA) but you can get a refund.

In the mean time, 23andme is an ancestry / genealogy company.

I suppose that is it until they pass regulatory approval for their health and trait information?

20 responses so far

  • CeCe Moore says:

    Hi,
    23andMe never ceased sales of their test. Yes, they stopped offering health reports, but they have continued providing ancestry-related results all along. As great as it would be for us genealogists if 23andMe decided to exclusively focus on ancestry (imagine what they could do!), they remain committed to their goal to make a difference in health care and are, therefore, not going to become a genealogy DNA company. They can't return medical genetic risk reports to customers currently, but that doesn't mean that they can't still research medical genetics with the large amount of data they have amassed.

  • lylebot says:

    Yeah, they never stopped, and that additional warning has been there since at least Xmas time. My wife got me and her dad kits for Xmas. We knew the health stuff was done, but it's still interesting. I found out I have a little bit of Ashkenazi DNA, and I'm in the top 1% for Neanderthal DNA!

  • DrugMonkey says:

    Huh. I had no idea they were still marketing all along. And I know I've logged in since the news and never saw this kind of disclaimer.

  • clueless noob says:

    All you have to do is dump their raw data into Promethease, and you'll get all the health reports you could ever want. Easy, peasy.

  • @clueless
    Yep. Promethease was better than 23&me's analysis in the first place, but we'll see how long that lasts. After all, the whole point of all this flap was MDs with their nose out of joint because people were actually getting information without their influence, even it was genomics which 99.99% of MDs know fuck-all about.

  • mh says:

    The interpretome also gives you clinical info

    http://www.interpretome.com/

  • becca says:

    So, hypothetically, if one wanted to help some unemployed genetics/genomics PhDs and get them trained as some kind of certified genetic counselor who could take this raw data and counsel patients, would that fly? Or is there some kind of MD monopoly on this deal? I seem to remember an alt career panel with a genetic counselor on it, with a PhD rather than an MD, but I wouldn't swear to it.

  • mh says:

    How could they stop you? There are homeopaths, reiki jedis, astrologists. As long as they sign something that says it's not "real" medical advice you can tell people whatever the fuck you want.

  • Stochastic Sam says:

    If you want to claim to offer medical advice, you may want to look into the certification process for becoming an accredited genetic counselor. You'd start by getting an Official Genetic Counselor Masters degree. So yes, there is a kind of monopoly on this kind of work.

    http://nsgc.org/p/cm/ld/fid=44

    If that doesn't sound appealing, you could just start a business and see how long it takes the FDA to notice.

  • clueless noob says:

    Just call it a "Life Coach" -- they seem to be able to do anything that doesn't involve cutting or pills.

  • anonymous says:

    And yet, still banned in Maryland (which outlawed providing health info directly to customer long before fda took that position.

  • dsks says:

    Pfft. Ancestry. I looked into my family name once after being told by the old man countless times that we were related to Dutch Royalty. What a load of horseshit. The earliest person carrying our surname was listed in the Weymouth parish records with the term "Vagrant" in the column entitled "Profeffion". On top of that the olde English translation of the name is "Semi-intelligent", which I guess during the Dark Ages was probably a kind of compliment relatively speaking, but still, not much to boast about.

  • For whatever reason, I haven't the faintest interest in my "ancestry". I get that the shittio is wildly popular, but I really couldn't care less.

  • DrugMonkey says:

    Maybe your ancestors suck?

  • SidVic says:

    dsks- yeah I had similar experience when I looked up surname and found it meant "worker".
    I was hoping for royalty or at least a middle management meaning name.

    Incidentally- I have always been a little jealous of scientists with cool-sounding smart names like "brilliant" or "sharp"

    CPP- heh sleeping dogs best left alone sometimes

  • @anon
    Yes, when Craig Venter's institute was just in Maryland (we're on both coasts now) he joked that maybe he was committing a crime for analyzing his own genome. But he was a Navy corpsman in Vietnam, so maybe he qualifies as a medical professional.

  • Jonathan says:

    Was the law against DTC testing even passed while Venter was still working in MD? Not sure that it was. Still, he never lets facts interfere with a good story.

    DM: AIUI 23andMe have to go through the PMA route (rather than the easier 510k) now with their Personal Genome Service. They're looking for a new regulatory person to get that underway, I believe.

  • Craig still works part-time in Maryland -- he spends his time between the two campuses of JCVI in Rockville and La Jolla (as well as at the half-dozen startups he's involved in to some degree). But I recall the quip was made when I was still in Rockville (and I've been in La Jolla since 2009), so I think when the ban was first proposed.

  • Ancestor says:

    A friend was told by her father that their last name is the name of a street in the town their ancestors were from, and that they only named streets after royalty back then therefore they must be related to royalty. I explained that if your ancestors came to live in the U.S. where titles of nobility are not given they were most likely NOT royalty. Who would leave that gig? (Unless you were in France or Russia at the wrong time.) The fact is, if you reside in the U.S. the odds are very high that your ancestors were peasants in their former country.

  • drugmonkey says:

    Interesting JB...guess I just assumed Venter directed things from his hidden island lair....

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