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FDA Tells Google-Backed 23andMe To Halt DNA Test Service 371

Hugh Pickens DOT Com writes "Bloomberg reports that 23andMe Inc., the Google-backed DNA analysis company, has been told by US regulators to halt sales of its main product, the Saliva Collection Kit and Personal Genome Service, or PGS that tells users whether they carry a disease, are at risk of a disease and would respond to a drug because the kit is being sold without FDA's marketing clearance or approval. 'FDA is concerned about the public health consequences of inaccurate results from the PGS device,' says the agency. 'The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work.' 23andMe was founded six years ago by Anne Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin. The FDA decided in 2010 that services claiming to evaluate a customer's risk of disease must be cleared by regulators if the companies sell directly to consumers. Most FDA-cleared genetic tests are for a single disease while 23andMe's would be the first to test for multiple conditions. 23andMe submitted FDA applications in July and September of 2012 for the least stringent of two types of medical device reviews but the FDA said the company failed to address 'the issues described during previous interactions'."
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FDA Tells Google-Backed 23andMe To Halt DNA Test Service

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  • by PvtVoid ( 1252388 ) on Monday November 25, 2013 @03:35PM (#45517681)
    Suppose I started marketing an HIV test, or a Hepatitis C test, or a tuberculosis test without demonstrating the test was effective? The FDA would be on me like shit on stink, and rightly so. Same here: suppose they incorrectly tell someone they have Huntington's Disease, or carry BRCA?

    Now cue all the Slashbertarians ranting about how restricting unproven medical testing is an assault on freedom...
    • by 0123456 ( 636235 ) on Monday November 25, 2013 @03:39PM (#45517737)

      Suppose I started marketing an HIV test, or a Hepatitis C test, or a tuberculosis test without demonstrating the test was effective?

      Is anyone claiming these tests aren't effective? I don't see it in TFS, only claims that they don't have the right paperwork from the government.

      • by Anonymous Coward on Monday November 25, 2013 @03:45PM (#45517819)

        I believe that's exactly what the problem is. 23&Me is selling the test but never submitted evidence to the FDA that it works. Why should they just assume it's good because they said so?

        I think likely the test is fine, but they haven't shown it to be so, so why should the FDA approve?

        • by timeOday ( 582209 ) on Monday November 25, 2013 @04:10PM (#45518101)
          And if 23&Me does work, then it is in their own best interest for the FDA to enforce these requirements. Otherwise they will be driven out of the market by somebody who makes similar claims at a lower cost, by providing a shoddy and unreliable product. This isn't an area where consumers are able to judge quality for themselves.
      • Is anyone claiming these tests aren't effective?

        Yes. I am claiming these tests aren't effective.

        • by jd ( 1658 )

          Then you're an idiot, because that is the only way to make any claim regarding effectiveness (positive or negative) at the individual gene level when we don't know all the genes, all the interactions of genes or the impact of "Junk DNA" (which we now know isn't junk but metadata).

          23&Me do not diagnose. They identify SNPs that have a given (often very low) correlation with a condition. They state the current best guess at that correlation. That is it. There are no "tests" except for the SNPs themselves.

      • by nbauman ( 624611 )

        "don't have the right paperwork" is a big deal. That's like not having a reliable source in a Wikipedia article.

        You wouldn't want to go to a doctor who didn't have the right paperwork.

    • by TheSync ( 5291 )

      Now cue all the Slashbertarians ranting about how restricting unproven medical testing is an assault on freedom...

      I own my DNA!

    • Re: (Score:3, Interesting)

      by Anonymous Coward

      My brother is working for a company that is in the prototype stage for something similar, but for use in non-developed countries.

      Their test you first create a cartridge that has the dna sample doped with a radioactive substance you want to match against. You insert the patients test sample, it gets treated by different chemicals in the cartridge, and if the dna is a match the radioactive substance is released and a faint glow occurs which the machine reads giving you a nearly instant result to let you know

    • There is a distinct difference between a test for a specific disease and a test that tells you if you have DNA that may make you susceptible to possibly, maybe getting a disease compared to someone else's.

      Also it isn't Food or a Drug or Medicine that involves ingesting/injecting/inhaling and can't cause physical harm if misused. It is a non diagnostic test that as at no point will it say 'you have disease x' or 'you don't have disease y'.

      Its only a super advanced version of taking blood pressure and pulse..

    • Re: (Score:2, Insightful)

      It's pretty simple. This is a screening test. It's supposed to be inaccurate as silly as that sounds. The point of it is, if there are ANY markers for the disease it's supposed to easily test positive. Then the user is supposed to go to a DOCTOR and verify the results. Even the initial tests they do in hospitals can sometimes give false positives as high as 80 to 90% of the time. So even if you do test positive, you still only have a 10% chance of actually having the disease.

      Government regulation should be

    • by jd ( 1658 )

      They ARE NOT telling you you have X, Y or Z. They are telling you that gene G is ASSOCIATED WITH an N% increased risk.

      For chrissakes (or, as my kindle spellchecker insists, cheesecakes), at least bother to do basic research. Oh, that's right, the serious COMPETENT Slashdotters abandoned the site because of the overwhelming sheer stupidity out here.

      I don't know why I bother. Anyone with an ounce of brain capacity can figure out that raised odds of 0.23% do not equal an absolute certainty of instant death. Bu

  • Someone in another story was just telling us how wonderful the FDA are.

    • by jd ( 1658 )

      The FDA actively work with drug companies known to be carrying out unauthorized tests on unwilling human subjects in Africa. They have accepted results from US prisons, where again no consent was ever given. They encourage the suppression of negative results in journals. Corrupt? They are better than certain historical medical authorities, but not significantly.

      (No, I don't give a damn that 1960s and 1970s America had no restrictions on non-consensual biological and chemical experiments for medical purposes

  • by ponraul ( 1233704 ) on Monday November 25, 2013 @03:43PM (#45517785)
    I can see why cheap and reliable genetic testing you can do without the intervention of medical industry is frightening. For one hundred dollars you can find out if you have markers that put you at elevated odds of hundreds of conditions. If this came from the traditional medical, you would have to go to a doctor who would release the results to your insurance company, it would cost about $1000, and you wouldn't even get to see the results yourself unless the doctor wanted to show you something.

    I've done the 23andMe testing and it has been of value. I'm not in close contact with much of my extended family and have almost no contact with the family on my father's side. It doesn't claim to diagnose or treat diseases or traits. What it does do is tell you if you're at elevated odds for a few select conditions, along with heritable traits. This is can be invaluable if you don't know that much about the medical history of your family.
    • by Jeng ( 926980 ) on Monday November 25, 2013 @03:49PM (#45517869)

      And you are apparently perfectly ok with the possibility that they could be completely wrong.

      Nobody is saying that inexpensive dna testing is bad, just that the process needs to be verified that it works before it should be sold to the individual.

      • > And you are apparently perfectly ok with the possibility that they could be completely wrong.

        Yes. It's not a diagnostic tool. It's a "Hey 5 out of 7 people wearing red shirts die in star trek. You're wearing a red shirt, you've got good odds you might die"

      • Any diagnostic test can be wrong, and the public and medical community is OK with that.

        The problem isn't the test, it's that there's no way to verify that the recipient of the results has any idea what the results mean. If a human being is involved, at least you can pretend that someone attempted to make sure the person in question understood the results.

        Personally, I think 23 and me is fine as it was. OTOH, the FDA has to deal with "the public", who is invariably stupid.

        • by sjames ( 1099 )

          What about those drug tests for worried parents? How do we verify that parents understand that it's just a screening test? How do we verify that they know a positive for 'opium' could mean the kid ate a poppy seed bagel?

          We don't, and the FDA decided that was OK.

    • by Quince alPillan ( 677281 ) on Monday November 25, 2013 @03:56PM (#45517967)

      The FDA has a point, though. If the test isn't accurate and gives false negatives or isn't clear about what the results really mean, it can lure people into overconfidence and that can be dangerous if they really are at risk for one of the diseases.

      Granted, they probably wouldn't have known about these conditions in the first place, but if, as an example, the rest of their family is known for heart disease due to a genetic defect and they get a false negative, they might be overconfident in their chances for heart disease, leading to possible death because they didn't go to a doctor to get checked out.

  • Unlisted subtext (Score:2, Insightful)

    by phayes ( 202222 )

    The FDA states that false positives & false negatives are a major part of the reason that they are outlawing direct sales of these tests to consumers. Because a false positive on the breast cancer gene could lead to "prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions". Yeah, because Physicians using the existing tests never have false positives & even were there to be one, malpractice suits always punish doctors guilty of errors of interpretation...


    • The thing is, doctors using these tests know and understand the possible erroneous results, how to screen for them and how to confirm them. I've rarely had a doctor prescribe treatment for a complex condition based on the results of just one test, there's usually two or three additional tests to confirm the results. Negative results are checked against symptoms, and if the symptoms clearly contradict the test results then additional tests are run to find out why. This isn't what happens with 23AndMe's tests

    • There is most likely a corporate play in action here but I can see if the test in some way makes someone who can't afford medical testing/treatment off themselves because they know how terrible X disease can be then it's probably worth review. Or the inverse, someone not treating a very serious issue because the test came back ok (which is probably more likely).

      Just look how many people show up at the doctor because they have convinced themselves their (low blood sugar) symptoms are 100% a brain tumor acco

  • by EmagGeek ( 574360 ) <(gterich) (at) (> on Monday November 25, 2013 @03:54PM (#45517935) Journal

    Turning over your DNA to Google is just plain stupid. Believing you have some semblance of privacy with them is even more stupid.

    Stupid, stupid, stupid.

    • Turning over your DNA to Google is just plain stupid. Believing you have some semblance of privacy with them is even more stupid.

      But now I have a backup in case I die...

  • Medical claims (Score:5, Informative)

    by Animats ( 122034 ) on Monday November 25, 2013 @04:02PM (#45518017) Homepage

    The problem is that 23andMe started making medical claims. As the FDA says, "your company's website at ... markets the PGS for providing "health reports on 254 diseases and conditions," including categories such as "carrier status," "health risks," and "drug response," and specifically as a "first step in prevention" that enables users to "take steps toward mitigating serious diseases" such as diabetes, coronary heart disease, and breast cancer." Those are health claims. Those have to be clinically tested.

    The history of their web site shows the health claims becoming more blatant over time.

    • From 2008: [] "Find out what current research can tell you about your genes."
    • From 2013: [] "Living well starts with knowing your DNA. Our genes make us who we are, so naturally they impact our health. By knowing your DNA, you can take steps toward living a healthier life. Find out if your children are at risk for inherited conditions, so you can plan for the health of your family. Order now."

    Their advertising thus shows a progression from marketing to the technically curious to marketing to parents worried about their kids. That's what properly concerns the FDA.

  • by WaffleMonster ( 969671 ) on Monday November 25, 2013 @04:45PM (#45518473)

    At the rate things are going it is likely to soon become cost effective to sequence everything for what 23andMe is charging now and simply hand customers a DVD with their fully sequenced DNA.

    When that happens the cat is out of the bag all you need is software to do analysis for any and all aliments you want using nothing more than software which can be downloaded and used freely by anyone. Software no government is going to have much luck restricting people from getting their hands on it.

    I am all for FDA regulations but they need to evolve or they will find themselves on the loosing end of a war they cannot win (See also drugs, smokes and alcohol)

    A couple of suggestions:

    1. Carve a space in regulatory regime allowing for speculative technologies provided any test outcomes must be validated by an FDA approved method before actionable decisions are made by a doctor. e.g. what is most likely to happen currently anyway as a result of any 23andMe diagnosis.

    2. Setup a scoring framework and information system allowing people to get statistical information on the accuracy of tests as results are confirmed so they can make up their own minds whether tests are worth their time. Enabling the market to drive accuracy is a win for everyone.

  • The real problem is that you people who buy these tests will incorrectly interpret what they say.

    DNA is really only about 99.5 percent correct using PCR, for one thing.

    Carrying a risk allele that is triggered by environmental conditions or requires other actions to trigger is another.

    But the worst thing is you all incorrectly ascertain risk.

    You overreact, and when you overreact, in medical studies without effective genetic counseling, and even in some of those cases, you almost always do the exact wrong thi

  • by AdamHaun ( 43173 ) on Monday November 25, 2013 @05:16PM (#45518857) Journal

    If even half of the FDA's letter is correct (and I see no reason to doubt it), they've been bending over backwards to work with 23andMe for years. The company made a deliberate decision to both ignore the regulators and (more damningly) fail to study the effectiveness of their own product, and now they're paying for it. Here's the relevant section of the letter []:

    Your company submitted 510(k)s for PGS on July 2, 2012 and September 4, 2012, for several of these indications for use. However, to date, your company has failed to address the issues described during previous interactions with the Agency or provide the additional information identified in our September 13, 2012 letter for (b)(4) and in our November 20, 2012 letter for (b)(4), as required under 21 CFR 807.87(1). Consequently, the 510(k)s are considered withdrawn, see 21 C.F.R. 807.87(1), as we explained in our letters to you on March 12, 2013 and May 21, 2013. To date, 23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it; no other submission for the PGS device that you are marketing has been provided under section 510(k) of the Act, 21 U.S.C. 360(k).

    The Office of In Vitro Diagnostics and Radiological Health (OIR) has a long history of working with companies to help them come into compliance with the FD&C Act. Since July of 2009, we have been diligently working to help you comply with regulatory requirements regarding safety and effectiveness and obtain marketing authorization for your PGS device. FDA has spent significant time evaluating the intended uses of the PGS to determine whether certain uses might be appropriately classified into class II, thus requiring only 510(k) clearance or de novo classification and not PMA approval, and we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification. Further, we provided ample detailed feedback to 23andMe regarding the types of data it needs to submit for the intended uses of the PGS. As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies. As discussed above, FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.

    However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has n

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