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FDA warns companies selling at-home genetic tests
By Carrie Gann The FDA is warning companies that sell laboratory-to-consumer genetic testing that their products cannot be marketed without FDA approval. The agency said that it is concerned about the accuracy of the tests and that consumers may use the results to make important medical decisions. On Friday, the FDA sent letters to five companies - 23andMe, Navigenics, DeCODE Genetics, Illumina and Knome – notifying them that they must submit their products for review or discuss with officials why their products do not require FDA approval. In its letter to 23andMe, the agency said it wants to prevent consumers from being “misled by incorrect test results or unsupported clinical interpretations.” However, the FDA did not say that such genetic testing services should be taken off the market. The five companies had mixed responses to the FDA’s warning. 23andMe said Friday that the company disagreed with the FDA’s decision, while representatives for Knome said that the company welcomed the FDA’s review. The FDA’s warnings come almost one month after Walgreen drugstores halted plans to sell DNA testing kits after the kits’ manufacturers, Pathway Genomics, received a similar letter from the FDA. More recently, officials were concerned when 23andMe reported a laboratory mistake had caused up to 96 of its customers to receive genetic test results about someone else. More information on the benefits and drawbacks of direct-to-consumer genetic tests can be found here. Editor's Note: Medical news is a popular but sensitive subject rooted in science. We receive many comments on this blog each day; not all are posted. Our hope is that much will be learned from the sharing of useful information and personal experiences based on the medical and health topics of the blog. We encourage you to focus your comments on those medical and health topics and we appreciate your input. Thank you for your participation. |
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Wait until the first murders or cases of abuse occur because of genetic testing for paternity.
They may not be happy about this but as a student of genetics I'm well aware that that genetic test results are far from user friendly. I would have been far from impressed if the FDA had failed to do this.
By the same reasoning you should not be able to take a picture of someone's face because the picture could be used to improperly diagnose a skin condition.
And of course this wouldn't have *anything* to do with the fact that the at-home test cost about 5% of what having it done at a clinic does...would it?
I mean, come on...That would imply that the FDA is in the pocket of the big medical companies and is actually controlled by lobbyists.
That would mean that they are corrupt to the core... possibly with a "revolving door" of doctors and administrators going back and forth from one medical giant to a government job and back again...
That could *never* happen, right?
[-Dripping Sarcasm-]
How many snake oil products are on the market now that say on the box, "Not FDA approved" thousands, does the FDA send them letters and stop them..nope...
Is it primarily paternity, or predisposition to disease, or just to leave a cool CD for the grandkids?
" June 14th, 2010 17:35 ET
By the same reasoning you should not be able to take a picture of someone's face because the picture could be used to improperly diagnose a skin condition."
No. Your example would be valid only if a company was offering a service where they would tell you whether or not you might have susceptibility to various skin conditions if you mailed them a photo. Saying that taking a photo of a face should not be allowed would be like saying that someone is not allowed to apply a cotton swab to the inside of their cheek (a typical method for collecting a DNA sample). There is a difference between the act of collecting information, and the act of providing medical advice based on that information.
My greatest fear is that of Insurance companies negotiating secret agreements with the testing Labs to monitor the test results to the detriment of the the person contracting the genetic tests !
Yukio Yano
Just wait til the insurance companies start requiring these tests for policies..they have several being finalized, then when a test comes up positive for something carried in your family you won't have a chance in hell of keeping your insurance. Don't think it won't happen...insurance companies here have stopped the sale of new policies for kids to protest any reform or regulation.
It's not a food, it's not a drug, it's outside the FDA's purview.
I have genetic testing pending with 23andMe ... will keep you posted on the outcome!
So let me get this this straight – the FDA allows homeopathy and it's blatantly false and misleading claims, but has a problem with a test rooted in science? Who is running the FDA and exactly what is their agenda? If the FDA really wants to protect people – I suggest they review their stance on homeopathy and stop looking for trouble where none exists.
This product is neither a Food or a Drug, so why would the FDA be concerned about it? These things sound about as accurate as a horoscope, and plenty of people make major decisions based on what they read in their horoscopes, yet nobody tries to regulate that.
Although their heart is in the right place when they say they "want to prevent consumers from being “misled by incorrect test results or unsupported clinical interpretations.” But I am pretty sure that truth in advertizing and other consumer protection laws are a job for the FTC.
The simply do not want you to make your own mind up. If people actually knew more about genetics, they would not probably get married to certain tested people. Would you, if you knew???
As a consumer of 23andme's product I am deeply ashamed of the FDA and their inability to let these tests alone. Our DNA is not to be regulated through layers of medical "professionals" who themselves have never studied genetics, and stand only to add to the cost of what belongs to us- our genetic and medical information. There is nothing that 23 does that is not user friendly and understandable. The government cannot even take care of itself: the fraud in the FDA is well known, and they need to stand back from this one because they are unconstitutional in what they are doing.
Paternity DNA tests have been around for a very long time. This is not an issue. The DNA tests are helping adoptees learn their ancestry and the same for sperm donor kids. Adoption and sperm and egg donation is identity theft on a grand scale. Genetic testing companies are restorative justice. The FDA is paternalistic and needs to step back from over-regulating the basis of life – our own DNA. What they want to do is have it collected and put in a data base, don't let them do it.
As previously mentioned, genetic testing is nowhere near ready to be sold @ local drugstores. Does the FDA have any real authority in this country? Who regulates this stuff? Sounds like the FTC until it becomes a problem they turn over to the FDA.
Yet another way we can use to prevent people from getting jobs. Only the worthy should have jobs....all others should be beaten...like that homeless guy over there!
Is anyone else disturbed by the FDA's position that the companies have to show why their products don't require FDA approval rather than the FDA having to show the legal basis for regulating such products?
The tests are not being marketed as a food OR a drug. The Police State marches on.
Awesome. Another example of the FDA protecting big business.
I work for one of the mentioned companies and I can tell you that thousands, if not millions, will benefit from the latest and greatest in genomics research & technology. Being one of the fastest growing industries, genomic testing can save millions by knowing of any predisposition to diseases. Heck, even drug manufactures are starting to use sequencing or GWAS research or core labs for their own product testing. It may even help them prevent recalls on "FDA approved" drugs one day.
I think any new reliable product that allows us to "fine tune" our bodies and adjust our nutrition or medical care based on the results of this testing is a good thing. I only hope to live long enough to see medical stations in our homes that can be used to take and analyse blood and urine samples. These sample might be used for early detection of disease or to simply adjust our eating, exercise routines to help promote a healthier life. Putting our faith in any government agency to do the right thing for the masses is ridiculous. The FDA is just like every other bloated, massively unreliable government entity. They are completely ineffective and slow to move. When decisions have been made in the past by the FDA they are rarely in the best interest of the majority of the people in this country.
Too bad – the FDA is known for dragging it's feet on important medical issues. Probably very well explains why we don'y have cancer cures or Parkinson's cures. Those people just sit on their fat ass and do nothing but draw a paycheck.
Man buys kit and tests child. The results say child isn't his, and more has a genetic disorder. Man goes crazy, kills child and then his wife. Later on, a letter arrives in the mail stating that they received the wrong results.... Child's grandparents sue the company for wrongfull death claim. Millions of dollars of our tax money and insurance premiums is spent defending the company...
Can't wait.
An interesting follow-up would be if the author (Carrie Gann) were to purchase all of these and compare for accuracy.
It does make sense that paternity is the main reason one would use these, unless there is a huge guidebook that identifies genetic abnormalities included with your test. Oh joy, the look-up table on that must be so easy to follow....
>>Is it primarily paternity, or predisposition to disease, or just to leave a cool CD for the grandkids?
- I don't know, but I want one.
This is dumb. Why can't we just have them and be allowed to make our own decisions? Don't think I can handle the truth? I hate it when the government babysits me.
It's not food; it's not a drug. What is the FDA's authority for issuing warnings to these companies? The FDA, like many, MANY government agencies, needs to focus its attention on those areas it IS responsible for, and stay out of areas for which they have no responsibility. This is a great example of a government agency imposing its belief system on others, without having clear authority to do so. This is a very slippery slope, and one this administration slides down all too often.
Let's see...is it food? Nope. Is it a drug? Nope Is it another of the never-ending overreaches of Federal authority?
Yup!
Until we have real universal healthcare in the US (like almost every other industrialized nations has) which ensures that insurance companies can't drop your coverage or charge you extra for a genetic predisposition I would never get genetic testing done any way other than anonymously. It's ridiculous that the technology exists to help us make better health care decisions but we have to be afraid to use it. What's even worse is if we do use the technology provided by these companies anonymously to keep it from the insurance companies, we can't then share the information with our healthcare providers who can actually interpret the results and use it to our advantage for fear that it will end up in our records and in the hands of the insurance companies.
It's a really sad commentary on our society that our one real chance to fix our healthcare system was gutted by the insurance industry and we sat back in ignorance and let it happen. Unlike our parents, our "greed is good" generation has failed miserably on all fronts to make America better for the generations that follow.
These products don't market themselves for paternity testing – rather they seem to focus on ancestry (using DNA information to tell you where your distant ancestors came from), and disease predisposition (determining if you are a carrier for or harbor the DNA mutations for specific diseases).
The problem is – if you go digging deep enough in anyone's DNA you will find that pretty much everyone is a carrier for SOMETHING...
Considering people will be using the information gleaned from these tests to make very major life decisions (lifestyle choices, whether to have children, etc), I am glad to see they will be regulated.
Calling them snakeoil products isn't accurate – they are selling hard science here, grounded in decades of research – but assuming the average citizen can interpret and understand the implications of the findings on these tests is unfair and possibly dangerous.
I think it is good that the FDA isn't pulling these from the shelves. Too bad their retailers already did. Gun shy.
This is a test, just like a Blood Glucose Meter is a test.
The results need to come with a statement of disclaimer that cautions about accuracy and requests the patient seek professional medical advice from a physician before making any decisions based on the test results.
Other than meeting the safety requirements that a blood glucose meter has to (i.e. the lancet), I see no other need for regulation.
I like to see a wide range of personal lab tests to get on the market. I think it's time.
If the concern is medical shouldn't this be an AMA or health department/CDC issue? Or does the FDA also have jurisdiction over non-drug medical equipment?
There was a story on NPR over the weekend about how one guy bought four different test kits and sent the labs his sample.
He got four completely different responses back.
Well said Kevin......that may be the 'real' story out of this.
If you don't know how genetic testing works you should not be commenting on it. That accounts for the many of the comments above. The FDA is not regulating your DNA, they want to ensure that the results of these tests are accurate and useful.
Our understanding of the genetic contribution of disease is in constant flux. There are only a few diseases with a clear-cut genetic cause. The tests are not diagnostic – there are no conclusions to draw from them apart from 'I have this form of that gene'. These test have no utility at this point except to move money from your wallet into someone else's.
power trip by FDA
Well we dont have to worry about insurance turning you down because they found out that you have something or making the rates so high you cant afford it. Thanks to Obama's health care insurance companies can not deny you because of a preextening conditions or charge you high rates then a healthy person. I think the idea of knowing if you have chance of getting something is good because then you can be on the look for it. Instead of one day waking up with something and have only months to live.
Its not a drug, so the FDA should keep their hands out. They companies will make or break themselves on accuracy. Thats all we need, big brother watching over something thats not in their charter.
Important medical decisions like say...whether or not to get an abortion? Yeah, you don't want THAT decision to be based on a take-home test. You need a doctor's permission to rightfully murder.
There's a whole lot of stupid in these comments. The FDA was formed prior to the development of genetic testing; therefore, genetics is not in its name because, hey it didn't exist. Let's not get hung up on labels.
As for whether or not you can run the test at home, I'm sorry but most people aren't capable of following instructions properly. I have no problem with the FDA requiring approval. Most people don't read the drug warnings on their medications and wind up in the ER. It's not entirely outside the range of possibility that someone would screw up the test and misdiagnose or worse.
Stop complaining about police and nanny states. You all do it to yourselves because you're morons. If people didn't sue because they were stupid, you wouldn't have these problems.
first of all the name FDA has been around forever and it is now involved in and responsible for significantly more than simply food and drugs. they are a branch of the Department of Health and Human Services, and by recalling these tests, they are simply trying to assure that they are safe and accurate and that their results will be used appropriately. the power that comes with the knowledge that some of these at-home genetic tests provide is unfathomable and still greatly misunderstood by both the scientific and non-scientific communities. misuse of the information gained from these tests could have severe consequences. without question genetic testing represents immense potential for the future of science, and will likely become commonplace in the next 50 years in diagnostic and routine medicine. but in the meantime, why not make sure that the tests that will spark this revolution are as scientifically and ethically consumer-ready as we are capable of right now?
These home kit tests should be used the same way the home pregnancy tests are handled. If it indicates pregnancy, go see a doctor. Lawrence Weisdorn
Geez people – stop it with the conspiracy theories. The FDA is not trying to make money – it's the companies selling these – unproven – products to make money – off gullible YOU.
You cannot chastize the FDA for not regulating other products – they try and there's an outcry of personal freedom, and more and more conspiracy. They do, in fact, have the ability to regulate medical products (not just food and drugs as some of you have said) – this is a newer charge. They didn't used to, but now they do. So stop complaining.
These tests have much more enormous implication than a lot of the other crap that's out there on the market. It's kind of important they send out a warning about this stuff. Remember – these companies are making an enormous profit off the gullability of consumers.
As a genetics PhD student, I agree completely with the FDA's concern. First, research laboratory tests are far different from clinical tests. The accuracy may very well be good enough to detect most cases of a disease allele, but whatever threshold of detection can vary between scientist enough to warrant regulation. Second, for severe genetic disorders with late onset, such as Huntington's Disease, a home kit is not advisable. The mental strain for someone who most likely knows it is within his or her family likely also harbors an extreme fear of having the disease, which could amplify the mental distress upon getting a positive result for the disease. It is best that a clinical setting where the individual can be warned of the implications more thoroughly and have counseling options recommended be used rather than a very impersonal mailing to a lab where the company has no obligation to help the individual post results. On a different note, the suggestion that sending a letter to companies offering these to market DNA tests is being paid off by pharmaceutical companies is shortsighted. The companies mentioned are not mom and pop stores and further these tests are very easy for any drug company to produce and offer. Likely, big name pharmaceutical companies have refrained from offering these tests because they want other companies to test the water and develop the regulation that is sure to follow the launch of the first to market DNA markers. To sum it up, this written warning is necessary and here to protect people from what may be an over promised product with large implications for an individual's life.
I think the real fear of the FDA is what people will do with the knowledge of a potential predisposition to a disease or type of behaviour. Having studied psychology, this is a valid concern. Think on it.
If you knew you have a predisposition to developing brain cancer by the time you're 50, what would you do? What wouldn't you do? Would you not have children because you can't bear to leave them in such pain from your death? From them seeing you suffer? Or would you say ... ah to heck with it! I'll do what ever I want ... it doesn't make a difference after all... no matter what I do, I'll get cancer...
So it goes to the old argument... is it nature or nurture?
Or perhaps the better question is, what would you do if you got bad news from the test?
I used to work in medicine, for me, when I got sick or hurt, it wasn't so scary as I knew what was going on, but then again, it was also scarier because I knew what was going on.
So, do you REALLY want to know? If you do, wouldn't you feel some comfort knowing that something/one (agency or whatever) was on your side to ensure you got accurate results, or to turn to in the event of bogus results?
Just slap "for entertainment purposes only" on it and call it a day. As long as they make people aware that these tests aren't highly accurate and that they should consult a professional before taking any action or making any assumptions based on the results I don't see a problem.
You can't prevent stupid people from doing stupid things. People already e-diagnose themselves, surfing the web, thinking they have all sorts of crazy medical conditions because they've got a runny nose, a cough, and their foot itches.
I think that if there was a genetic testing for intelligence, or basic understanding, it should be required to attach the results to the comments sent here.
Just because something is neither "food" nor a "drug" does not mean that the FDA has no authority to regulate. They have the authority, by statute, to regulate "medical devices", which includes diagnostic testing kits.
Federal agencies derive their authority from specific laws, not the keywords that appear in their names.
By FDA standards are we allowed to self diagnose anything?
Should we arrest mothers for practicing medicine without a license?
The patient is always the first opinion, the doctor is the second opinion, and the final decision maker should always be the patient.