Customers Of Genetic Testing Company 23andMe Are Caught In DNA Limbo

Anne Wojcicki's Google-funded pioneering genetic testing company stops marketing its test. Can current customers expect refunds? And what happens to their results?

Earlier this year, I purchased my mother a DNA kit from 23andMe, the genetic-testing company. I thought she’d be intrigued by the product, which enables average consumers to gain insight into their personal genomes, providing them with fascinating data on inherited conditions, genetic health risks, and ancestry information. My mom was skeptical about its efficacy from the start. She hasn't returned her test kit, and now, like other 23andMe customers caught in limbo with unused kits, she might never be able to.

Anne Wojcicki

On Nov. 25, The U.S. Food and Drug Administration ordered the company to cease marketing its testing kit. In a public letter, the FDA's Alberto Gutierrez posed concerning scenarios involving unneeded medical procedures and false-positive results from 23andMe's Personal Genome Service (PGS). He wrote: "[The] 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." He went on to spell out how the company's direct-to-consumer business model could lead its customers to "self-manage," raising "serious concerns…if test results are not adequately understood by patients or if incorrect test results are reported." For example, the FDA said, if the "risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist."

As outlined in our recent cover story on the Google-backed startup, 23andMe could be a disruptive force in the health care and insurance industries. For only $99, consumers could purchase a 23andMe "spit kit," which includes a plastic tube that allows them to collect a saliva sample and send it back to 23andMe’s lab, where it’s then tested for more than 240 health conditions.

DNA-testing kitImage: Flickr user Pelle Sten

But since the FDA’s order to stop marketing the company’s DNA-testing kit, 23andMe has offered little guidance to the public, other than a blog post written by CEO Anne Wojcicki promising to address the FDA’s concerns. San Diego resident Lisa Casey filed a lawsuit in the U.S. district court of California in late November claiming the company misled customers about the accuracy of tests; and only this week, 23andMe decided to cease all marketing of its gene testing, as demanded by the FDA’s warning.

Meanwhile, confusion only grows for 23andMe customers (including me and my mom), stuck in limbo between their potential genetic future and a $99 refund. What if these customers were to now mail in their saliva samples? Does the FDA’s stop order retroactively include a halt to returning results to customers who have already paid for the kit? And for that matter, what about customers who mailed in their DNA kits before the FDA’s stop order, but have yet to have their results processed? Will those results be used by 23andMe or destroyed?

From a business standpoint, does 23andMe's decision to halt marketing of the kit amount to compliance with the FDA procedure, or are they saving their ammo for a larger fight?

A company spokesperson would only say, "Our response to the FDA is in progress. I can't comment any further than what we've already stated on our blog and in our communications directly to customers."

Fast Company raised many of these concerns with 23andMe’s customer service representatives. They first returned an automated answer, addressing none of these problems. After a more specific follow-up—does this mean that results won't be returned, or worse, that results shouldn't be trusted?—the company responded, days later, replying only, "This is in response to your questions regarding the FDA letter and how it will impact our service. We are still working on getting answers to your questions, as well as questions from many other customers about the implications of the FDA letter…. However, many of your specific questions remain unanswered."

It’s a thorny issue. But should it be so unexpected for a company whose business model is built on the idea of offering a glimpse into the future?

In her first interview since the debacle began, on Tuesday, Anne Wojcicki acknowledged, "We failed to communicate proactively."

[Image: Flickr user Nathan Siemers]

Add New Comment


  • Pierre Bataille

    I bet the FDA has been pressured by insurance and pharmaceutical companies who want to control DNA data. I wouldn't be surprised f the 'FDA approved' DNA companies that pop up in the future are backed by insurance and pharmaceutical companies (openly or not). Luckily the FDA does not control the whole world of DNA science.

  • PIERRE BATAILLE, I suggest you actually read the scientific studies supporting the test by 23andMe before you automatically assume there's some massive conspiracy. The science just isn't there to support this test at an individual level.

  • Bill Freeman

    The FDA will have hell to pay if they attempt to deny people the right to view their own personal genetic data at will. The public will not stand for these types of shenanigans.

  • Mary Hawkins

    Yeah right! The FDA is a joke... They approve everything for Monsanto, but this - now you've gone too far knowledge-seeking-general-public!

    I got the test done just out of plain curiosity and there are disclaimers everywhere
    on the site and emails that state the results ARE NOT a diagnosis. I never mistook the data to be a diagnosis. 23andMe's results did get a lot of info correct about me that I already knew so I deduced that most of the data presented to me is/was accurate. But even then I haven't changed my lifestyle at all. I told my doctor I was getting the test done and he was just as interested in the test and results as I was. We looked over the results, but neither one of us felt it was necessary to pursue anything.

    How many of us out there know someone who has been given inaccurate results from a DOCTOR? Why isn't the FDA teaming up with my brother-in-law who had a testicle removed because he was falsely diagnosed with testicular cancer? That was and continues to be proven as false results. Go ahead and step in FDA... we're waiting. Human error can happen anywhere, anytime and with anyone's life. Why is the FDA stringing up 23andMe? Every single person I know that's participated in 23andMe's test have not mistaken the data for anything other than just that, data.

    Also, why now? The company has been in business for some time, but why now? Was it because Angelina Jolie had a mastectomy done based on her test results? Are the masses taking Angelina’s decision about her own life as instructions for theirs? "Got positive results? Remove your breasts!" Hey, if that's how you really want to proceed then by all means, go ahead. Not my body, not my choice. It's just weird to me that the FDA is making a stink about this now. I’m having a hard time believing that any doctor would take this one test as proof positive and say ‘yup, confirmed, let’s get started”.

  • Henrik Kibak

    Have mercy how stupid the FDA is! Yeah, I'm going to go get my breasts removed without a doctors involvement.

    How about a little notice that the results are about 1% inaccurate and for medical purposes you'd need about 20 reads ($2,000+) to be confident.

  • Karen Martin

    The healthcare industry is scared to death to have consumers take control of their healthcare. I know. I've been there. I've been one of them. Try as the FDA might, they will eventually lose the battle. It's a matter of time. Everyone, keep fighting the good fight. Special interests have NO business controlling healthcare information. It's insulting. It's disrespectful. And, ultimately, it will prove to be very bad business. Mark my words.

  • jcray

    If I want to pay a snake oil salesman to give me information, I have the right. I understand I am to take the data with a grain of salt. It's a possible insight into my health and ancestry. Furthermore, I am not in the US and hope not to be affected by an FDA driven ruling. Agree with James, probably a result of interests more than public benefit, or freedom really.

  • Monique Littlejohn

    My doctor ordered a genetic test to look into genetic mutations for the BRACA1 and BRACA2 genes in October. The company was a competing company to 23&me but the difference was that a genetic counselor or the doctor would read the results to me. He thought that my insurance company would pay for the test. I sent in my sample. 2 weeks later, I received a call saying that my insurance denied the claim but that I could still pay for the test on my own for only $5000. Of course I cancelled and immediately ordered the 23&me kit which actually tests for the 2 genetic mutations that my doctor wanted to look for. I am very disappointed that the system was shut down. I was planning on sharing the information with the doctor. If I would have received positive results, then we would have shared them with the insurance company and appealed the decision that they made, and ask for the original test. As it is, with 23andme being shuttered, I am the loser. I do not get the look into my own DNA, the doctor doesn't get the results so that he can evaluate my case, and the insurance company potentially will need to pay for significant tests, treatments, and reconstructive surgery if I end up having breast cancer. My gut tells me that big pharma shut this down since it was cutting into profits....not the FDA.

  • cloudswrest

    According to their blog today they are still testing and providing the full raw data, but they will no longer provide any health reports or interpretations of your data for new customers. You'll just have to compare your data yourself with any of the umpteen various databases. See here:

  • Get a Brain

    Another example of big government stepping in where it has no business. I guess the populace of the US is now not only "ordinary", but also stupid. And, individuals cannot order tests or procedures. Their doctors must do so. And, a doctor is not going to do anything radical based on the 23 and me results! FDA, it's not the ordinary consumer that is stupid, it is you and big government. I found the results fascinating, especially the genealogy part. And, the health results did not tell me anything that I didn't already know based on family history. My doctor was interested in seeing them and made the same conclusion. Back off on 23 and me! They are not a drug and their test results do not direct us to take any kind of action. Give us and our doctors some credit for having a brain, which seems to be direly lacking at the FDA and government in general!

  • June

    According to the Wall St Journal, they only have to stop advertising, especially their tv ads, for the moment. The company should still be up and running.

  • James Goldberg

    I think the FDA was influenced by the Feds and insurance cartel..based on fear that a huge
    $ burden could be placed on the already broken and broke healthcare system. It also is another example of how patient interests come last.

  • justinTimeAgain

    'Stop marketing' - Doesn't sound like "shut down shop" or cease and desist. It also sounds like the FDA (aka the industrial 'health' complex - see what I did there ;) ) is more concerned with keeping people sick and blind to their genetically predisposed conditions. Sure sure sure you might not have it now, but oh no! Watch out! God forbid you take a preliminary course of medical action. Five years early or 6 months too late. I'll take five years early please. Thank you very much.