An Update Regarding The FDA’s Letter to 23andMe

23andMe was started in 2007 with the belief that consumers have the right to get access to their genetic information and that information can help them live healthier lives.23andMe_Logo_blog

It is absolutely critical that our consumers get high quality genetic data that they can trust.   We have worked extensively with our lab partner to make sure that the results we return are accurate.  We stand behind the data that we return to customers — but we recognize that the FDA needs to be convinced of the quality of our data as well.

In 2008 we began our dialogue with the FDA. The relationship with the FDA remains critically important to 23andMe.

In July 2012 23andMe submitted its first application for FDA clearance and followed on with another submission at the end of August. We received feedback on those submissions and acknowledge that we are behind schedule with our responses.

This is new territory for both 23andMe and the FDA. This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public’s safety.

I am committed to making sure that 23andMe is a trusted consumer product. I believe that genetic information can lead to healthier lives — a goal that all of us share.

We will provide updates as they become available.






  • Paul Gill

    Get into Ydna Full Genome Sequencing.

    Don’t let FDA get away with this nonesense.

  • xceedsaid

    I wholeheartedly agree with all the comments in support of 23andme, it is a great service to the entire world that need to be expanded and supported not curtailed.
    I for one from North Africa, I found out so much info from the test 23andme provided, very useful not just to me but for an entire community.
    Please don’t sit on the fence – write to your representative or whoever can leverage some power over the FDA to support 23andMe.
    23andME, we are all behind you – you are doing great job, stand your ground.

  • Carole Burrowbridge

    My biggest concern is that currently using 23and me I control my genetic information. If it becomes controlled by the doctors and insurance, be it private or government, they will control my genetic information. When I pay out of pocket for 23andme as a direct to consumer service, I can choose when and how to share it. If it is treated as a medical service controlled by doctors and insurance, it becomes like every other medical record. As someone who has repeatedly had to print out the law and state statute and assert my Patient Rights to Medical Records in order to get copies of my medical records, I can see how doctors would make it very difficult for me to access my genetic information and they and the insurance or government would own it and control it, not me.

  • MP Follett

    23 & me test results indicated I have the “Diet Response’ rs101282 marker. I immediately started the Mediterranean Diet and have lost 50 lbs easily! I had been gaining weight around my waist despite diet efforts, headed toward diabetes and high cholesterol medication: not good for someone approaching 60 yrs old. I feel 10 yrs younger now! Amazing results acting on scientific data. THANKS! KM

  • Doug

    I believe the 23andMe test is an excellent screening test. Having worked in the medical field for many years I know that screening tests are designed to identify possible conditions to be further evaluated. Doctors usually look at multiple factors and often repeat tests before deciding on a plan of action. I have confidence that 23andMe can meet the expectations of the vast majority of reasonable people.

  • Chris Rogers

    FDA…let’s see Food and Drug Administration. How is this company even required to file reports or receive approval from the FDA? In our world of GMO (genetically modified foods) and amalgam fillings in our teeth leaching mercury daily into our systems, they want to waste my tax dollars shutting down this greatly beneficial service provided to anyone with health concerns? I am not even sure what country I live in anymore!

  • rollincrichmond

    I heartily agree with Ms. Chapman. Doesn’t the FDA have better things to do with their time and our money?

  • David Sarney

    I read the article in the WSJ recently and thought they presented the
    problem pretty well. I have enjoyed and used my 23andme account for
    both family ancestry and health. I received the account and kit from my
    daughter Beth as a Christmas gift almost 2 years ago. I had done some
    family research on my own but hesitated to spend too much time and money
    going through the ancestry businesses on the Internet. 23and me allows
    me to do some research efficiently and points to other places that may
    be helpful either free or at a cost. I especially have found the
    ability to check for possible relatives helpful and even got what looks
    like a hit on a 5th to 7th cousin recently that has allowed me to grow
    and fix a few errors in my family tree. Moreover, I found a new friend
    that I can chat with over the Internet. Medically,,I took advantage of
    going over my DNA results in all areas but Alzheimer’s and Parkinson’s
    (I’m 69 and at this point would rather not worry, just my personal
    opinion–there are good points both ways but I know myself well enough
    to choose not to get it–I’m not a terrible worrier but those might
    bother me too much). I’m sure that’s the kind of rational, personal
    decision almost all of us using 23andme would make. Of course, being on
    the cutting edge always presents new problems that must be worked
    through and there’ll always be some mistakes made, but again most of us
    here can “live” with that. I’m hoping that the FDA and 23andme can work
    closely together to come to a balanced decision on the best way to move
    forward. All in all, in most cases the rewards for all our futures are
    worth some risk and mistakes and help make our lives and the future
    generation’s lives better ones. Happy Thanksgiving to everyone.

    • Carl

      THERE ARE NO GOOD POINTS FOR NOT GETTING YOUR ALZHEIMER’S STATUS!
      Alzheimer’s is believed to be preventable and treatable if you catch it early. Don’t foolishly reject health information. The prevention may be as simple as exercising, drinking coffee, taking vitamins, and losing weight. So there’s no reason not to check if you need to take steps to prevent it.
      I’m heterozygous for APOE4, and I’m glad to know that in advance so I can look after my health and talk to my doctor.

  • Kevin Norton

    Welcome to regulation nation! It is all about the government sticking their nose in everything. Geez

  • vowels

    What’s remarkable to me is that neither the email sent to 23andme customers nor the two 23andme blog entries referred to in the email actually state what the FDA warning is. As such, these blog entries and the email come across as exercises in damage control. It would have been so much simpler to provide a link to the FDA letter or an article in an outside news source, and to provide a straightforward summary of the letter and an explanation how the problems with the FDA might affect current and future customers. Instead we have what appears as double talk from 23andme.

    • Laura Henze Russell

      Just Google and you’ll pull it right up. The FDA has a poor track record on a number of products and actions, by the way, enabling dental amalgam, and shutting down some promising companies and therapies that then offshore to Europe and beyond.

  • Yogi108

    I believe folks who navigate to this site will have a strong bias (as do I) to support 23andme, which is borne out by the comments. Salient points:
    1) 23andme needs to let folks know if their kits will be processed in a timely manner, or if that has been suspended;
    2) 23andme should have been more on the ball with responding to FDA letters;
    3) Textbook case of government intrusion into our lives, ostensibly to ‘protect us’;
    4) FDA is only authorized to act in US; 23andme could conceivably relocate to offshore location and provide same services with no FDA intrusion;
    5) (redundancy alert) Biggest lie of the past century: “I am from the government, and I am here to help.”

    • Laura Henze Russell

      I expect 23andMe doesn’t yet know how it will play out re #1, and will let us know when they do.

    • Yogi108

      On the plus side, there is no such thing as bad publicity. This was widely covered by the press, so I imagine that once the green light is lit once again, 23&me will have a plethora of new orders….

  • encierro

    Please sign the petition below directed to the FDA and let them know of your concerns. Support is critically needed in this matter.

    https://www.change.org/petitions/fda-administrator-margaret-hamburg-don-t-ban-home-genomics-kits

  • Phil Jones

    My cousin died earlier this year because she had a bacterial infection that the doctors couldn’t treat because they couldn’t identify it.

    It’s trivially easy to identify bacterial infections. We do it all the time at my work. You use DNA-based methods such as PCR or a DNA microarray. Or you can just sequence all the DNA. It’s fast, cheap, and accurate.

    Almost no one does that in American hospitals, and tens of thousands of people die every year in America, because the FDA will not approve general DNA diagnostics, because their approval system assumes that every test must be validated for every specific pathogen it can detect. So instead we use expensive immunological tests that take days, cost hundreds of dollars each, each test for only one pathogen, and are completely unreliable. They are strictly inferior on every measure, but we’re stuck with them by the FDA. No one will ever put general pathogen PCR testing through FDA approval because it would cost, literally, trillions of dollars, and yet the resulting test cannot be patented.

    A fellow came to my workplace a while ago and gave a presentation on a new microfluidics-based PCR system that can do nearly-instantaneous pathogen identification in the field. They’re making them for crops, for farm animals, and for use in Africa, but have no plans to ever make it available to humans in America, because of the FDA.

    I’ve had several medical conditions that are considered untreatable in America humans, but for which my doctor told me about a treatment available in Europe, or for dogs or horses, but not for humans in America because of the FDA. I have several times had to buy black-market drugs from Mexico and administer them to myself because the effective, proven treatments had never been approved by the FDA.

    The FDA kills many more people than it saves. It’s good to have a government agency that evaluates drugs and devices, but there is no need for them to have the authority to ban either. Any American should have the freedom to use any medical drug or device they choose, after being informed of the risks.

  • GG SanDiego

    Editorial appearing in the San Diego Union Tribune, Nov. 28, 2013

    FDA halts wealth of info on ‘me’

    Intrigued by the thought of getting some cutting-edge genetic information about me for only $99, I signed up for a 23andMe genetic test kit (“FDA orders company to stop sale of DNA test kits,” Nov. 26).

    Within a few weeks my kit arrived, and I mailed it back. My genetic information arrived electronically. Using my unique name and password, I read a wealth of fascinating data about me. It wasn’t about lab rats, or a controlled study of select subjects. It was about me, down to the natural color of my hair and eyes.

    Genetics is a fascinating new frontier, and I was excited to be receiving genetic information about me. Could I have handled bad news? Sure. It would give me time to plan accordingly. Would I have gone to my doctor for a second opinion if the results were troublesome? Of course.

    The information I received about me was far superior to anything I could find on the Internet. Self-diagnosing via the Internet is rampant, and I haven’t heard a peep from the FDA on that front. FDA, lighten up. Don’t kill this innovative company. People are adults. If they can’t handle knowing specific and accurate information about their genetic makeup they won’t get their genes tested.

    subscriber
    San Diego

  • Odog55

    What I don’t understand is why Ms. Wojcicki has chosen to “dodge and weave” with the FDA and the public? This is a business and like most business, it falls under government regulation. If they can address the FDA’s request for information, then do so. If they feel they don’t need to then say so. It seems they simply chose not to respond to the FDA at all. If they think the laws the FDA are enforcing governing this testing are antiquated, then get congress to change them. It seems this will likely be litigated, if so say so and mover forward. The evasive “answer” in this blog is non-responsive.

  • tonobungay

    There has got to be some proper bureaucratese disclaimer that makes the difference between a medical claim and what this is: a really cheap you-get-what-you-pay-for test for a variety of genes coupled with some over-simplified explanation of what the medical literature says about that gene. It’s more accurate than that other diagnostic tool where my doctor asks me about my ethnicity and which relatives got which disease. Apart for some suggestions about my diet, which he might have made anyway, my doctor took no action based on my report other than ordering one for himself.

    However, any public health policy based on the superiority of ignorance over imprecise information is seriously flawed.

  • Tim Mahoney

    I would think the FDA would better serve its mandate by applying its limited resources to investigating and regulating foreign fish farms that routinely maintain aquaculture with massive dosages of veterinary antibiotics and export the product to every major grocery store chain in the US without so much as a warning label as opposed to regulating scientists trying to bring additionL knowledge about the human genome from voluntary participation of citizens.

  • Glenn Barres, Jr.

    I am not worried and I am still pleased with teh service and results I got from 23andme. Just do what you need to do

  • Autumn Foghamar

    Frankly, I think the FDA is acting in a hysterical manner and I trust that you will move forward to resolve this with them. My brother and his wife have sent off for kits, I had my daughter tested, and a number of my friends are waiting for their kits. I approve of the fact you give people the best possible information based on the existing technology.

  • Autumn Foghamar

    I will add that there have been so many hits that had I known this information 10 years ago I could have been spared many problems or have been able to address them differently. I’ve had so many “hits” on problems that developed long before I took this test. The information is remarkable and I appreciate the continuing rollout of data.

    Honestly, I have to agree that the FDA has lost their everlovin’ minds. This is my DNA and I have the right to know what potential problems I have – and what has missed me. It doesn’t change my relationship with my doctor at all.

  • Liz Schroeder

    23andMe has affected me and my family in more ways than I think the FDA realizes. I am a graduate student in genetics at Yale, and probably like most grad students I’ve struggled with how to relate what I do every day to my family. 23andMe has given me the invaluable opportunity to share modern genetic research with my family on a level that is immediately relevant to them. The information we gather from ANY genetic test (FDA approved, patented, or not) is only as valuable as a patients’ ability to understand that data and its relevance to his or her disease risks. I think that by making genetic information accessible and understandable, 23andMe provides an invaluable service that moves the population closer to being able to interpret and apply genetic information. The moments that I spend discussing 23andMe results and quizzes with my family gives me hope that one day the entire U.S. population will learn and benefit from the type of information that you provide. I stand by your mission as a customer and student.

    Sincerely,

    Liz S.

  • Brin

    I think is outrageous that FDA would consider a saliva kit as a Class III device or De Novo. Why FDA would not have the same requirements for Quest Diagnostics. Double standards? Funding agencies as well as regulatory agencies have been failing us by blocking innovation and only authorizing studies that fit their paradigm of interest.

  • http://www.saltusa.com/ Annie Ashe Fields

    So… The BIG question in MY mind is:

    Will testing still continue?

    I’m awaiting my results and would LOVE to know!

  • Gaby

    I received my confirmed shipment email the DAY before the news broke. It was my Christmas gift! I would really love a response to the debate of ‘processing’ vs. ‘ordering.’
    If kits are still floating around, will the work be carried out? Will I get a refund?

  • Sue Bennett

    The FDA has once again overstepped their bounds and is violating basic constitutional rights, such as freedom of speech and information. Why shouldn’t we have the basic right to obtain information about our genes. This isn’t a medical procedure and it isn’t a drug. We need a major revision to our laws on supplements which are based upon a lie – that natural supplements don’t treat, prevent or cure diseases – there is too much solid research now to the contrary. Obviously broccoli and cruciferous vegetables can reduce risk of cancer but the FDA prevents food companies and supplement manufacturers from saying so. I think they should limit their activities to shutting down products proven unsafe or harmful – but wait. . . .this would put most pharmaceutical companies out of business. . . Statistically the amount of people harmed by prescription drugs and by additives the FDA allows in foods far outstrips any harm (if any) done by supplements and natural foods.

  • Gayle

    I am curious what those two letters from the FDA questioned. It’s surprising that 23andme did not or could not respond in a timely manner. Was this yet another get-rich-quick scheme? My daughter has spent in excess of $2000 purchasing these as gifts for family and friends, We should have realized there was something wrong when the initial price of $299 suddenly did a nosedive down to $99. It’s quite likely 23andme realizes they are in trouble — the reason for hastily sending emails to all.

  • SpamJay

    Considering that many of the people who advise/work for the FDA and/or the
    CDC are also board members for the various companies they are supposed to
    protect consumers from, I no longer believe any word that comes out of either
    agency. In addition, I believe that their main aim is not to protect or even
    inform consumers about harmful additives, chemicals, drugs, etc. but to funnel
    as much money to the medical and chemical establishments as possible.

    Consider this for example: if the FDA truly had the consumers’ back, they
    would mandate labeling of transgenic foods, as well as what types of chemicals
    that food was treated with before it ended up on our tables. None of that is
    happening in the U.S. the way it does in Europe. Not saying Europe is better in
    everything, but U.S. infant mortality is double that of most European nations,
    so you do the math.

    If anyone is dumb enough to use a 23andme report as the only means of
    diagnosis, then that is their problem. But for the FDA to want to stick their
    nose into a privately run company’s business is inadequate in this case. They
    need to go regulate the “weight loss” and supplement sector first
    because it is ripping people of and causing much more harm than genetic testing ever will. Both my wife and I had our 23andme testing done and the results were spot on and allowed us to finally conceive after we found out what the problem was (MTHFR, Factor V, etc.). So FDA-approved testing or not, I could care less. We received much more information for a measly $99/person than we ever did with testing done through the medical establishment (who was milking our insurance to the tune of thousands for a couple of FDA-approved tests, some of which even turned out to be giving false results).

    I’m so sick of this money-grubbing!!!

  • W.c. Varones

    Screw the overreaching FDA. This is a clear First Amendment case. Send those government goons back to the Soviet Union!

  • PC Tactical Wargamer

    ok so my test results came back for my family. It indicates I have the worst Alzheimer genes possible yikes! But good to know…. What further testing should I have at this stage (44 years of age) to confirm my risk assessment? The genes I have indicate a distinct possibly of an early onset of Alzheimer’s.

    • Alpentrudel Alpi

      Any relatives like sisters, parents, grand-parents, aunts or uncles who have or had Alzheimer disease?

  • shawn

    I had a kit for my dad still out ,it is being processed and was expecting it in a week or so but i’m not sure now:/ it also appears that they are still selling kits?! I was planning on getting one more for another family member but think ill wait to try after this thing gets resolved…I know my medical results were pretty spot on with what I already know.. I hope they can still offer this service at such a good price. I dont know of any other dna company that also gives you ydna and mtdna along with ancestry and everthing else ,that is huge.

  • shawn

    I had some trouble getting my comments to show up so if this duplicates appologies….I still have a kit out that Iorder for my dad ,was expecting the results in a week or so but not sure now. it also appears that they are still selling kits?? I was planning on getting one more for another family member but think i’ll wait till this is resolved . I know that the medical on mine was spot on with what i know, i hope that they can still offer this service at such a good price.This is the only dna company i am aware of that give y-dna and mtdna results with the ancestry and everything else,this is huge.

    • Carl

      Don’t wait. Order while you still can. You may not get another chance if the FDA gets their way.

  • http://jpwhitehome.wordpress.com JP White

    I do wonder why the FDA is so concerned about the accuracy of 23andme’s $99 genetic lab work. The FDA have approved countless medical screening tests that they and the medical profession know are of dubious quality, but are very cheap. Cheap screening followed up with more accurate lab work to confirm a positive result is the mainstay of medical practice. No doctor worth his salt would grab a scalpel and start cutting off body parts on the basis of a $99 test he didn’t order, clearly the patients concerns will either be confirmed or otherwise by additional tests and examination.

  • 23blog

    Shawn, Could you direct your questions to our Customer Care team. Go to this link to find the form to email questions to the Customer Care team – https://customercare.23andme.com/anonymous_requests/new?reference=via_search_box.

  • 23blog

    You should talk with your doctor. Remember even having the higher risk mutation does not mean that you are going to get Alzheimer’s.

    • PC Tactical Wargamer

      Thanks…..wondering if I should test again with another company just to ensure the results are accurate. Can anyone suggest further type of genetic tests?
      My Alzheimer genes seem to indicate early onset. From Canada so seeing a doctor with rationed health care – well they have no idea about genetic testing. He mentioned – oh hey too bad maybe take Vit D. Pathetic huh?

  • 23blog

    The email to customers and post were an attempt to address the issues we felt we could address. As our CEO said there are many questions to our customers have that we do not have the answers to. We will answer them when we can.

  • 23blog

    Faith, 23andMe does not diagnose illness. We look at genetic markers that are associated with risks. Using those markers we can give you a genetic risk for certain conditions and traits.

    • Faith

      Yes, thank you, I do understand that. However, no matter how right that may seem to you or I or everyone else, the finite-ness of the law may be trickier than this (why I suggest that you at least consult a lawyer, because I very much want 23andMe to continue). While I am unsure of the un-authorized practice of medicine law…and it seems a bit liberal as nurses are writing prescrips now and physician’s assistants are indeed practicing medicine with what appears to be no-oversight…the laws on the unauthorized practice of law are clearly defined. The case that decided what was the unauthorized practice of law had to do with a paralegal (an attorney’s assistant to compare to physician’s assistant), when a client was filling out divorce papers accidently checked the wrong box, the paralegal pointed out that they may want to re-look at that…and that was deemed the unauthorized practice of law. My guess is that even providing those connections (which you appear to be pulling from all the known studies, and I have no problem with) may very well fall into that gray area. Lawyers can help find you the legal arguements and protections to keep your site up and even possibly get the FDA’s blessing. I have much appreciation and gratitude for your service…it has greatly helped my doctors help me and my health is doing much better today as a result…so thank you, thank you, thank you…and keep up the good work.

  • 23blog

    Jeri, As our CEO stated we are working with the FDA and we are committed to the process.

    • Jeri Burtchell

      That is an extremely frustrating answer on two counts. 1: it’s a little late to be committed to the process. If that had come from the start you wouldn’t be behind the eight ball like you are. 2: you didn’t answer the question that many of us have posed about whether or not kits purchased will be processed.

      There are many “be patient” comments from other consumers, but did I miss the one from 23andme addressing this legitimate concern?

  • 23blog

    Emjayay, We have a Help page. There are answers to frequently asked questions there. If those do not address you question, you can then contact Customer Care directly. Here is the link: https://customercare.23andme.com/home. As our CEO said in her statement there are still questions for which we do not have the answers. We’ll address those when we do.

  • William Johnston

    i love my DNA, and i enjoyed seeing my 23andme results. i have encouraged my local legislator to pass a law that makes it a CIVIL RIGHT for a person to have DNA and medical information.

  • Amber

    Why is 23andme still selling kits if the FDA has ordered them not to? I’d really like to buy some for Christmas, but I’m afraid to spend the money just to find I can’t get the results back. Clarification please, 23andme!

  • Paula Fedash

    Me also!

  • Gear Mentation

    The FDA seems to be a struggling both to fulfill its mission to keep us safe, and also struggling badly to keep up with changing technology. One can only hope that it gets its act together, because genetics is now an information technology, and our capacities with genetics will therefore grow exponentially, as they have the past decade. If the FDA doesn’t allow safe and effective access to this technology, that will not mean that people go to their doctors. It will mean that we create our own tests, which will have NO quality control. If the FDA wants to keep us safe, it should authorize public access rather than create an opportunity for completely uncontrolled home-brewed genetic testing.

  • Valerie Olague

    So is there anything we as users of 23andme can do with respect to FDA? I work in the embedded business and understand all of the issues associated with FDA approval of medical devices. Stringency is great when it keeps people from being killed. But it is stunning that the FDA is calling 23andme a medical device — they are severely stretching the definition and clearly are mischaracterizing what a ‘medical device’ is for a consumer-used service that provides genetic information. There is no life or death implications for using this service, it is information only and is marketed as such.
    If 23andme is interested in getting any kinds of petitions or user input for whatever reason, I’m here to provide it for sure.

    • Laura Henze Russell

      Call your Congressional delegation and the White House, sign the White House and Change.org petitions, contact your news media to tell your story, etc.

      We need a clear definition of a medical devices as things installed in the body or that pass through the body (like an xray, CT scan or MRI).

      Then two levels of testing: diagnostic, and educational/informative, with the former highly regulated.

      We also need actual real medical devices to have similar requirements for prescription drugs – inserts to patient on materials composition, potential health impacts and mode of action, potential side effects and % reported in tests, where to report adverse events. We also need specific informed consent for all medical devices.

      FDA should be stripped of its ability to regulate medical devices and transferred to the EPA, or a new Toxics Control Agency (Human Healthland Security Agency?) until they ban dental amalgam, as mercury off-gases over time with heat and abrasion, causing needless chronic diseases in genetically susceptible children and adults.

  • Ken Willette

    I agree with zar kers post on Wednesday 11/27/13/@ 11:41 PM. Intelligent people should take this information and put it to use by discuss it with medical doctors, getting retested, and then make an informed decision thereafter. Knowledge is power. To choose ignorance is to choose stupidity.

  • patriot (oops the IRS will cal

    interesting they are told to quit marketing at the same time the FDA approves genetic testing by Illumina from

    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm375742.htm

    FDA Clears Illumina’s ‘Next-Gen Sequencing,’ Cystic Fibrosis Dx

    San Diego-based Illumina will begin filling
    orders for its high-throughput gene sequencing tests and two other
    diagnostics by the end of the year, following FDA 510(k) clearance of
    all four devices.

    The agency called the clearances a major
    advance for personalized medicine. Used together, the Illumina MiSeqDx
    instrument platform and Illumina Universal Kit reagents will allow
    laboratories to sequence and validate any part of a patient’s DNA to
    look for abnormalities. They were cleared through the de novo process
    for novel devices that do not pose a high risk to patients, based on
    safety and efficacy performance “across numerous genomic segments
    spanning 19 human chromosomes,”
    the agency said.

    CDRH Director Jeffrey Shuren called the
    clearance a win for personalized medicine and regulatory science.
    “Knowing the potential of next-generation sequencing to advance
    personalized medicine, FDA researched next-generation sequencers to
    understand how they work and their likely limitations,” he said. “By the
    time Illumina … walked in the door, FDA had the expertise and tools
    needed to timely review the submissions for the next-generation
    sequencers.”

    The company’s two cystic fibrosis detection
    tools also garnered 510(k) clearance. The Illumina MiSeqDx Cystic
    Fibrosis 139-Variant Assay checks a patient’s gene sequence to determine
    what variant of cystic fibrosis he or she may have, while the Illumina
    MiSeqDx Cystic Fibrosis Clinical Sequencing Assay examines a large chunk
    of the patient’s cystic fibrosis gene to understand how it differs from
    a reference gene. To obtain clearance, Illumina submitted data on both
    diagnostics compared
    with human reference genomes.

    • Laura Henze Russell

      What is the cost of that test? I’m sure its great, just beyond the reach of many. It is “relatively” “easy” to get approval for tests for one condition and its markers, but for the whole ball of wax, would be prohibitive, expect we’d all be broke and/or expired before completed.

  • Therese Tomlinson Hostetter

    So can we still purchase the kits or no?

  • 6161940

    I was thirty before I found out that the man my mother was married to was not my father. Even though I know, she refuses to tell me anything about my father. This has gone on for 40 years and even though I have asked her to just tell me his nationality, she still refuses. When I heard about this test, I thought my prayers had been answered. It was received and analysis began on 11/22/13. If the FDA stops this, I don’t know what I will do. 40 years of wondering and now with just a few weeks to go, it could all be stopped. FDA, mind your own business.

  • Kernos

    I would be as interested in your comments concerning the article in Scientific American: http://www.scientificamerican.com/article.cfm?id=23andme-is-terrifying-but-not-for-reasons-fda

    Further, by charging for this test are you not leaving out a big chunk of human data—that from those cursed with poverty?

    • Laura Henze Russell

      Call Congress and ask them to include full gene sequencing in Health Care, and see what reaction you get. Medicare and Medicaid should cover it, it will save them billions. Employers should cover it, it will save them billions on health care insurance, and on time lost to chronic conditions and long-term care for relatives with needless chronic disease. 23andMe has made the test available at incredibly low cost. Read comments on Forbes’ posts on this if you want some interesting comments from diverse stakeholders.

  • Carl

    23andme is more trusted and reliable than the FDA. I’m not even in America, so the FDA should stop interfering with my right to learn about my own body. The FDA has a strong reputation for holding back medical research, drug development, and new treatments.
    This is a completely safe and non-invasive test, it is more accurate than most medical tests, and it doesn’t try to diagnose or treat any disease. There are no possible safety issues or risks. And there are huge benefits for many customers’ health because it encourages them to take better care of themselves. There are also huge potential benefits for the medical research process itself.
    When it comes to things the FDA actually should ban, the FDA allows all kinds of outrageous anti-science health fraud and quackery, such as homeopathy, chiropractic, osteopathy, scientology, falun gong, reiki, etc. And nonsense health claims like “natural”, “gmo free”, etc.

  • gogo

    What is the official response directly from 23andme regarding whether pending test results will be delivered as ordered? I can’t find it anywhere. I’ve seen the PR response, but no definitive response on what status of pending orders is at this time. If I don’t get the full results panel, then I will definitely want a refund and will go with another company.

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