This seems absolutely reasonable. The letter indicates that the FDA has notified 23andMe that their products are not satisfactorily cleared, they're reached out to them several times, and they've offered assistance through a group they specifically set up to help companies in this situation.<p>Meanwhile, 23andMe went ahead and began marketing and selling their product, despite the FDA's concerns.<p>Relevant quotes:<p>> Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.<p>> 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<p>> 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; ...<p>> ...we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification.<p>> 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...<p>> 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.
Am I the only one this seems completely reasonable to? There are probably people who take action over the results they get from the service and if the results are incorrect the actions could have negative impact on their health. Therefore the service should have to prove the results are accurate before advertising it as a first step in prevention.
Summary:
5 years ago, 23andMe started marketing a test for among other things a BCRA indicator<p>July and Sept 2012 - 23andMe submits a form to the FDA saying "our test isn't really useful for diagnosis and thus shouldn't fall under these rules"<p>Nov 2012 - FDA says we don't agree with you you need to either prove your effectiveness or change your marketing<p>Jan 2013 - 23andMe says "it will take us a couple months to do the tests, we'll get back to you"<p>Nov 2013 - FDA says, "its been 11 months and you never got back to us. Stop selling and let us know within 15 days what you're going to do explicitly because you ignored us for close to a year"
I'd like to point out that -- as much as I'm sure most people love 23andMe -- it's not really a scrappy start-up. It's a nearly 8 year old company which has received something like a hundred million in funding.<p>So this isn't really a case of the gov't stomping on the little guy before he has a chance to grow; 23andMe has had its chance to grow into a fairly big deal, and now it's time to start playing by the rules.
This reminds me of a blog post in German [1] by a person who due to a software bug had been falsely diagnosed by 23andMe with limb-girdle muscular dystrophy. (Fortunately, he was able to identify that it was a misdiagnosis.) It appears that in this case potential misdiagnoses aren't just a theoretical problem.<p>[1] <a href="http://www.ctrl-verlust.net/23andme-wie-ich-fur-todkrank-erklart-wurde-und-mich-wieder-gesund-debuggte/" rel="nofollow">http://www.ctrl-verlust.net/23andme-wie-ich-fur-todkrank-erk...</a>
As usual, the government is trying to meddle with companies. Read the letter, but make no mistake - the "kind" tone, especially when reminding how they did they best to get in touch, have meetings, help insuring compliance etc. is just a decoy. The truth is with "must immediately discontinue marketing the PGS".<p>The gov wants to decide what's best for the people. Should the people decide differently, using their wallets for example, this anomaly will be quashed.<p>This trend is especially strong in the medical field - gov approval required everywhere, then people wonder why medical things are so damn expansive.<p>I use 23andme and I'm happy with the information provided. I know it's not reliable - it's not a lab test anyone will use to base important decisions on, since it is not a full sequence of genes.<p>Yet, by being commercially available and easy to use, it is paving the way for commercial offers of full genome sequencing, which I damn well intend to use when they reach the $500 threshold.<p>However, gov actions like this one may very well make that impossible, making sure the only full genome sequencing offers there will be will be "FDA cleared" at a huge markup.<p>Suggestions to "medical" like companies - get out the gov eye. Move your business to Asia, the caribbean or wherever the gov will not get in your way like this. I want to keep using (and recommending) your products!
> For instance, if the BRCA-related 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.<p>I cannot imagine someone getting surgery or chemo solely based on a 23andme heads up warning and without consultation with a specialist physician.<p>As someone working in medical devices, this dramatic language is extremely frustrating.
Anyone who thinks the FDA is overreaching here has little awareness of how stupid the majority of the world's population is. The people that this protects don't know how to even read this statement from the FDA.<p>Perhaps the startup echo chamber has more respect for unchecked opportunism; if that's the case, someone should make a startup called 23andMeFree (monetized by ads, duh) that has you spit in a tube, send it to some PO Box, then randomly generate positive and negatives across the board. If you wanted the scam to last longer, you could even generate random values based on statistics of certain characteristics. A true libertarian must support such a business.
I understand the FDA getting pissy if I'm consuming/injecting a substance that may or may not harm me, but why this? I spit in a tube and get some results which may or may not be accurate. Go away, FDA.
When the FDA sends you a letter like this, you either pay a fine and change tactics or you embark on one of the most frustrating approval processes known to the world (all for people's protection.) Good luck with that.
It is only reasonable in the context of the standard operating procedures of the FDA. As this is essentially prior restraint upon speech and/or trade, it is unreasonable, but no more unreasonable than anything else the FDA does.<p>Ideally, the FDA would have independently-generated evidence indicating that the product in question is unreasonably dangerous or ineffective for some intended purpose before issuing a cease and desist order. Instead, they simply assume guilt and place the burden of proof upon the vendor.<p>Given that the FDA has vastly more resources than 23andMe, and companies like it, this makes the FDA seem like bullies against microbusinesses, and like the captured servants of agricultural and pharmaceutical megabusinesses.
The tone of the letter was surprising to me. I wouldn't expect the FDA to go quite so far in explaining the why behind the desist letter. I suppose that's because it was written just as much for public consumption as it was for 23andMe.
Obviously 23andMe results are not a diagnosis from your physician. You should use 23andMe in conjunction with a real physician. For example, I used 23andMe back in 2010 and it told me I had a high risk for a certain genetic condition which I recalled one of my family members having, so I <i>went to see my physician</i> for a real diagnosis, armed with this newly found information.<p>23andMe helped me catch this early enough <i>with the assistance of my physician</i> that I was able to get treatment long before I would have developed symptoms. If I never used 23andMe I probably would not have had this diagnosed until years later.
I'm most curious to see how 23andMe is going to respond to this, because the more technical-regulatory language in this letter says essentially that in FDA's opinion the device is Class III (the highest risk of all medical device/diagnostics) and would require a PMA, unless 23andMe provides the evidence that allow FDA to de novo classify the device as Class II.<p>A Class III ruling would destroy the personal genomics market, because it would mean extensive clincial testing and documentation about the development of the device. I hope it doesn't stand.
More evidence that we live in a very mixed economy, not under free market capitalism.<p>Government agencies empowered to weild regulatory force against citizens are a threat to everyone, and this is case in point.
Silicon Valley "It is better to ask for forgiveness" culture meets the worst of government "We'll need that in triplicate 5 years in advance of starting to look at the paperwork."<p>This should be interesting, if you have the patience to watch the fallout in slow motion.
CMS/HHS will look like idiots as mRNA sequencing dips below the $100 per test price point and doctors for the first time will have a histogram of genes turned on for use in their diagnosis.<p>Instead of whinging, FDA needs to partner with NIST to come up with quality control protocols so doctors know the error distribution in data that they receive.
I have to agree that this seems completely reasonable... glad to see so few commenters jumping to the expected conclusion that this is some kind of government oppression.
If you believe 23andMe is a sound source for the clinical diagnosis of medical conditions, you're probably not going to read the fine print telling you otherwise.
> Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.<p>No joking around.
Never once did they attack the technology but rather the potential for error or the consequences if the public "can't handle the truth."<p>The closest they come to calling her a "quack" is when they state "...We still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses..."<p>The bigger question is why is the FDA having a seizure over this? Could it be the potential for added treatment and preventative healthcare measures that insurers vis a vis the Affordable Care Act and not looking forward to paying for? (Not a rhetorical question, just asking)
I JUST bought the kit yesterday. The FDA is right though. Imagine making extreme decisions (e.g., double masectomy to avoid breast cancer) based upon the information. This is making me consider cancelling my order.
This is simply the result of the medical lobby. This pressure is being put on them simply because it takes power from the gods of medicine. If I order my own bloodwork, (from the same labs that my medical foundation does), somehow the same bloodwork costs me 20% of what it would otherwise. This is about taking away the ability to monitor your own health, in order to enrich the medical community.<p>This will simply result in this type of testing to move beyond FDA borders. Great job FDA, you're helping kill a successful and profitable US company. Un-F-ing-believable.
Is there anyone else that sees this as a positive thing for the company? They've lived under the cloud of potential FDA regulation for a while, and I'm a bit surprised that it took this long for the FDA to step in.<p>Obviously, it would have been preferable to have the company and FDA work together to announce how FDA regulations apply before an enforcement action. But, now that it has happened, the process has started. If the company can come out of this with some kind of FDA approval, then that cloud will be lifted and they can keep on working. And then the company will know exactly what rules they'll have to play by. So, depending on how things work out, it could end up being a positive for the company.<p>Now that the FDA has played their hand, I'm very curious to know how the company will respond.
Crap... I better buy the test for an older relative (84) like I have been saying I would, pronto.<p>Before the FDA gets its hooks into it and the price goes up...
I'm not sure if 23andme's management team is totally out of touch or if they have genuinely mislead the public about their product's effectiveness. I'd assume the latter. They could have easily done periodic check-ins with the FDA to throw them a bone while gathering longitudinal data to support their claims.
You would think that before putting in so much money, time, and effort into 23andMe they would have had discussions with the FDA and actually responded with more information. I'm amazed that it didn't happen.
Why not just put a disclaimer like one you'd see on a late night psychic ad service?<p>"This service is intended for entertainment purposes only."<p>No disclaimer about medical anything. And people pay more than 99$ for psychic services.
I wonder whether a company could bypass the FDA by simply giving people their genome data, without any interpretation or diagnosis, which could be left up to people's doctors, opensource software, etc.
Is there a list of government agencies IP addresses? I would like to block them from accessing my sites. And write in the ToS that they are not allowed to browse and read more.
When evaluating startup risks/events there needs to be a standard term or acronym for "doesn't matter; spouse is multi-billionaire."
Well I suppose that now that all the food is safe to eat, they've got time on their hands to take down the sinister corporate bad guys behind 23&Me.