23andMe ordered to stop selling DNA-testing kit

The FDA has ordered 23andMe to immediately stop selling its DNA-testing kit, saying in a letter released today that the product is being marketed without “marketing clearance or approval.”

The $99 Saliva Collection Kit and Personal Genome Service (PGS) — which is meant to let users know whether they’re at risk of disease — was developed by the Silicon Valley company that counts Google Ventures among its backers, and was founded by Anne Wojcicki, wife of Google co-founder Sergey Brin.

The letter from the Food and Drug Administration says 23andMe has not adequately addressed its questions after much back-and-forth between the two parties. The agency said it’s “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. ”

In an emailed statement this morning, 23andMe said: “We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”

The FDA order is just the latest regulatory headache for the Mountain View company. Three years ago, the Government Accountability Office said 23andMe and another Silicon Valley company, Navigenics, peddled information that was “misleading and of little or no practical use,” the Mercury News’ Steve Johnson reported. The tests by the companies were said to be too limited to be of worth.


Photo of 23andMe CEO Anne Wojcicki  by Dai Sugano/Mercury News archives


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  • Steve Hammill

    >>>the product is being marketed without “marketing clearance or approval.”

    Strikes me as substantial over-reach by the FDA. That is, private citizens submit a saliva sample for testing. No danger to the citizen at all. The test results are returned to the citizen who can provide the results to their physician to use them appropriately.

    No risk at all.

    If the test itself is illegitimate – fraudulent, then it is the domain of the DA, State’s Attorney, or the FBI – not the FDA.

  • dave

    FDA should be abolished. Decisions about treatments, drugs, and procedures should be left to the people, not to a government bureaucrat. Read the US Constitution Article I section 8 and the 9th and 10th amendments. It is very clear this is not the job of government.

  • Shara Bingham Mills

    Not fair! What they want is to pull that information into their whole government information pool. Damn fools. I want this information. This is between me and these guys here at 23 and Me. This information is private unless I want to contribute to science, freely. If I could fund each one of these scientists I would. I thought I was when I paid my taxes. We pay the FDA’s work to and I say no! No you may not interrupt my medical concerns and philanthropy with your wicked sense of what is important. There is food out there being processed with toilet germs. Inspections have not been made in food processing plants. You FDA, should get your rear ends out in the field and do your jobs instead of searching for ways to patch into a system that works, just to make you look like you’ve done something.

  • GeneSherpas
  • ProudCapitalistDefender

    “The tests by the companies were said to be too limited to be of worth.”
    To whom?
    Apparently they were ‘of worth’ to folks who willingly paid $99 for the service.
    Apparently they were ‘of worth’ to the company who sold the service at a profit.