FDA orders 23andMe, backed by Google, to halt sales of DNA test service

US regulators have ordered 23andMe Inc., the DNA analysis company co-founded by Anne Wojcicki and backed by Google, to halt sales of its "spit kits" and home DNA testing kits because they're being sold without “marketing clearance or approval.” [Bloomberg]

Here is the stern letter Wojicki received from the FDA. [WSJ]


The FDA said some of the intended uses of the company's Saliva Collection Kit and Personal Genome Service (PGS) are particularly concerning, including risk assessments for certain cancers. The agency said that if the company's risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo preventative surgery, intensive screening or other potentially risky procedures. A false negative, on the other hand, could result in a failure to recognize actual risk.
Disclosure: I am a cancer patient. I have used a complimentary trial version of their service, and found it interesting. I did not rely on the results alone for medical advice. The genetic tests for cancer I took were ordered by doctors at my hospital, and performed by Myriad Genetics, which at the time held a monopoly on the most common tests. I have always considered 23andme to be a provocative kind of experiment, and a source for questions for my doctors, or followup testing with my doctors-- but 23andme is not the same as medical screening overseen by a doctor. I would not base decisions for surgery or chemo on the results of the 23andme spit kit alone, and I can't imagine any sensible patient or doctor doing so. The service explicitly tells users not to make medical decisions based on test results, if I recall correctly.

And Matthew Herper in Forbes:

Either 23andMe is deliberately trying to force a battle with the FDA, which I think would potentially win points for the movement the company represents but kill the company itself, or it is simply guilty of the single dumbest regulatory strategy I have seen in 13 years of covering the Food and Drug Administration.
And in the WaPo, Timothy B. Lee, who believes the feds should leave 23andMe alone:
Having more information about your health status is never dangerous by itself. It only becomes dangerous if patients use it to make dangerous medical decisions.

Notable Replies

  1. marc45 says:

    The insurance industry is probably worried that people will ask their doctors to do(expensive) medical tests if they find out their genome has issues.

  2. 23andMe was set up because Sergey's mother had Parkinson's. It's always been about getting as many people as possible to test so they can do genetic research on that particular disease. Now that Anne and Sergey are kaput, it'll be interesting to see if she just lets the company die a slow death or changes the strategy moving forward.

  3. As a genomics researcher I'm dismayed by this decision. I think it is another case where the medical profession and science are in conflict. What 23andMe provided was not a medical diagnostic, but a dataset in which variations in your genome which are associated with various phenotypes were noted. Some of them were, yes, correlated with disease, but not all of them. And even in the case where they are, what makes physicians think they have any more insight in such scientific findings than everybody else? It's not like they have a background in genomics.

    I absolutely agree that quack medicines need to be stopped by the FDA but this isn't the same thing at all -- nobody is claiming that the SNP analysis provided by 23andMe is faulty, only that it is dangerous for the public to see it. And that's just bogus.

  4. Don't think the FDA had much choice here - I think they've been more patient with them than they are with many device manufacturers. (A test is a "device" to FDA, who don't speak English.) This paragraph:

    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.[...]FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns,[...] an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.

    That's the most seriously-worded warning letter I've ever seen. FDA may be dickbags, I agree, but their job is to stop people marketing "devices" without validating their accuracy and precision first.

    Disclaimer: I worked for many years in clinical laboratories, which are allowed by law to market tests without submission to the FDA[1]. (We come under CMS and follow their rules for validation.) We have watched as FDA has attempted to shoot down a number of fly-by-night "labs" trying to market genetics tests, and companies such as 23andMe which may have a better foundation for its tests, but who really knows until the clinical and analytical performance of the test has been validated and reviewed?

    [1]Edit: Before FDA weighs in, I better say that they don't agree that laboratories are allowed by law to market tests - they call us not having to submit to them their "enforcement discretion" which they say they can remove at any time. Many lawyers are getting rich off this argument as I write.

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