<p>^^FDA has written and approved a formal guidance for LDTs. But it’s release has been hung up by Washington politics. It’s a real sore point within the industry, because the lack of these rules allows one segment to remain out of control. The delayed guidance is supposed to be published soon, but that’s been the case for over a year now so I’m not holding my breath.</p>
<p>Is the FDA draft available anywhere? I’m confused by the “release has been hung up” part – does that mean that no one can see what the FDA proposal is? or that everyone can see it, but it’s uncertain if and when it will actually be implemented?</p>
<p>^^ No, it’s not available to the public until it’s released. And in fact this the Draft Guidance we are talking about and not the final one that is hung up. Before being made final, drafts must be published and public comments collected for a while. FDA will then modify the doc according to whichever comments it agrees with or at least accepts and then will be made final. But even if available only as draft guidances people will usually follow them, because it gives you something to point to or an argument to make if and when FDA challenges something you did. </p>
<p>Right now I have no idea what the document says, but I suspect it is something bold (i.e. imposing stiff new regulations) otherwise its release would not be politically controversial.</p>
<p>But in any case I doubt the 23&me test could be considered an LDT. Tests made by commercial manufacturers generally qualify as regular medical devices. And indeed the FDA apparently holds this opinion too, because they are sure trying to regulate it as a regular device and not as an LDT. If FDA thought this was a legit LDT this whole battle never would have happened.</p>
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<p>A spokeswoman said the company decided to stop all advertisements on television, radio and online for its $99 personal genome service, which analyzes consumers’ saliva samples for genetic clues to ancestry and risk for various diseases. Some 23andMe ads may continue to air because it takes time to bring them to a complete halt, the spokeswoman said. One television commercial promoting the test as a gift idea ran Saturday on the Travel Channel, for instance.<<<</p>
<p>The next step will be to stop SELLING as ordered. Playing games of semantics will not get the company far with the FDA. The website, as it existed last week, will come down.</p>
<p>Well, sent the spit in today since, well what the heck. Said “no” to their keeping the sample in storage and also to participating in “research”, since I do not know what it is about. I am not a fan of signing a blank informed consent.</p>
<p>Meanwhile…</p>
<p>[Class</a> Action Law Suit Filed Against 23andMe - Forbes](<a href=“http://www.forbes.com/sites/danmunro/2013/12/02/class-action-law-suit-filed-against-23andme/]Class”>Class Action Law Suit Filed Against 23andMe)</p>
<p>calmom, now they do need to lawyer up. :)</p>
<p>Good job, Jym! You successfully operated a Class III medical device. Now, you might find out you are a distant cousin of Cobrat. Of course, the odds of that occurring are stratospheric.</p>
<p>^^ AAAGGHHH!!! :eek: :eek: :eek:</p>
<p>^^^^^lol!!!
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<p>ROFL!!! Jym might be even related to a certain photography enthusiast. ;)</p>
<p>I talked to some folks over the holiday weekend who, after getting their genealogy test results, in all seriousness are planning a Euro trip to visit the lands of their ancestors this summer. The ancestors we are talking about are… the Neanderthals. :eek:</p>
<p>I sent in my sample (hate saying spit) two days before the FDA order came out. I heard about 23andme from my son-in-law. He and his mother (she did it too) found out that they had Sami ancestry (indigenous Finno-Ugric tribal folks who inhabit the Arctic). They were both born in Russia–anyway, they were excited to find out about their ancestry and created tee-shirts for themselves (Proud to be a Sami). I don’t think I’ll find such exotic ancestry. That’s mostly why I’m curious. My folks were immigrants from Croatia and very certain that their families had thousands of years of Croatian ancestry. I’m guessing that might not be the case. I hope the company will still process the samples that folks have sent to them. Wonder if we’ll get our money back if they don’t process?</p>
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<p>I am very, very angry. I was planning on buying these for Christmas. </p>
<p>No, you will NEVER convince me that the FDA should be regulating these. This is our genetic make-up and we have a right to see what it potentially says. It is not used to diagnose or treat and illness. No, you will never convince me otherwise. </p>
<p>I am firmly of the belief that this is a HUGE overreach.</p>
<p>I would wager 3 pigs and a cow that I am in NO way related to EITHER of them!</p>
<p>Also, for anyone still thinking of purchasing, here is 23andMe’s response: </p>
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<p>There are plenty of sites where you can upload the raw data and it will provide analysis.</p>
<p>What does that mean? What are they no longer sending? What analyses can be gotten elsewhere, and is there a cost?</p>
<p>** Ah, its a non issue. It says any kits purchased after Nov 22 will be affected by not receiving health info. My kit was purchased in the summer.</p>
<p>No surprise at all. People with serious money and a modicum of brains knew better than starting a martyrdom with the FDA. 23AM would have been crucified as they do not have a leg to stand on, as anyone with a bit of knowledge of the regulations might have told you.</p>
<p>Your reaction and firm belief are exactly why there is a regulatory body. And also why the FDA was entirely correct to shot this outfit down. It is because there were people interested in seeing the results that the FDA worked with 23andme as well as the other companies involved in the field. </p>
<p>The good news for you is that, if you are truly interested in seeing the medical results of genetic testing, you WILL be able to obtain them via regulated sources. Regulated providers who will have more interest in providing the results to people who are trained and qualified to EVALUATE them, as opposed to building a database of results for marketing purposes. If your interest was in the ancestry part, that is still available from 23AM or other outfits. </p>
<p>As far as being enraged, you might direct that to the real culprits, and that is none other than the 23AM marketers who were attempting to … dupe you by playing fast and loose with the rules. As far as the FDA, it is obvious that their decision to authorize the devices from Illumina two days before losing their patience with the outfit that blatantly ignored them for years is speaking volumes. Simply stated they do not want a technology and marketing company to market and sell medical diagnoses. It does not get much simpler than that.</p>
<p>The other good news is that the FDA has shown a desire and willingness to develop the appropriate policies and regulations in tandem with the SERIOUS players in the industry. There is a lot to learn from the technology but it has to go well beyond what looks more like a horoscope prediction than real science. It is still a novel field and like it or not, the consumers have to be protected. </p>
<p>And this is coming from someone who has shared his profound distaste for the people who earn a paycheck from our government, and hate overreaching regulations with a passion. </p>
<p>Lastly, I am still flabbergasted that anyone might have thought that 23AM would ignore the cease and desist letters, or believed that this was a matter of hiring unscrupulous litigators to delay it further than the five years it has taken to stop this non-sense.</p>
<p>Romani, it’s not quite the same, but in reading about all of this, I found out that there is an open-source, crowd-sourced software program that will provide information about all the health related data. The software for that costs $5 – it and it integrates very well with the 23andme interface, so it was very easy for me to retrieve the raw data from 23andme and then get very detailed reports on the entire genotype. You can get the program at [url=<a href=“https://promethease.com/ondemand]promethease.com[/url”>Promethease]promethease.com[/url</a>] and I think that it actually provides MORE information overall than 23andme because it gives information about genes that 23andme does not provide because of weaknesses in the supporting studies. But I like seeing everything, I can judge for myself how much weight to give it – and the promethease.com interface does provide the information in very direct way, so it’s pretty easy to see whether there are 1 studies or 10 – and in some ways the information is presented in a way that is more usable. Not as pretty an interface, but it has sorting and search options that 23andme lacks. </p>
<p>I did this because I was afraid I might be cut off from the data I already had, so a utility to help me download and read the raw data was very welcome. </p>
<p>I agree with your point of view: my DNA, my right to have and own my own test results, and my right to pay whoever I want to help me read and interpret the results. I did not see anything as being medically diagnostic, but rather informative in the same way knowing that there is family history of heart ailments and type II diabetes informs the decisions I make about my lifestyle. 23andme isn’t giving me any different information than I might find on WebMD – it is just giving me a different source of information related to heritability than I might get from family history. (I mean, I knew that my maternal uncle, grandfather, and great-grandfather were bald before 23andme told me I carried a gene associated with male pattern baldness; I knew that many of my older relatives suffered from type II diabetes before promethease (but not 23andme) identified the gene pattern possibly associated with that trait. </p>
<p>I didn’t know that I had a gene associated with an elevated risk gallstones – and I don’t currently have a gallbladder related problem- and am unlikely to, as even with the increased risk, the odds still are that I won’t have an issue. But I am sure you would be the first person to appreciate how helpful it will be for me to be aware of that possibility if I do develop any sort of digestive issues or experience abdominal pain.</p>
<p>Yup, cal, which is why I went ahead and just ordered all three kits I was intending on buying. 
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<p>On my mom’s side, her mom died very young of lung cancer and she has no sisters. My only female cousin is younger than me so I have no idea what my genes might say. I’m excited :D</p>
<p>23and me is charging $99 to give people half the information (ancestry but not health) that they were selling for $99 a few weeks ago?</p>
<p>Who’s going to buy that?</p>
<p>Now if they lowered the price to $49.50, it might be worth considering. Half the information, half the price.</p>
<p>No, Marian, they’re still giving you all the same tests and information- they just can’t interpret them for you. Another site will do that for $5 (I kind of wonder if they’ll partner and do it for a lower price). They WILL do it once they get it sorted out with the FDA… which I honestly don’t think will take too long.</p>