June 14th, 2010
02:08 PM ET

FDA warns companies selling at-home genetic tests

By Carrie Gann
CNN Medical News Intern

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.

soundoff (92 Responses)
  1. Robert Dennis

    Ok, send me your tests and $45. I will test them for you and let you know what the tests mean. I think the FDA should get off of our backs and let me provide the test results without oversight. BTW if you send me $95, I will give you whatever results you want. I can use the extra $50 to clean my lab.

    June 15, 2010 at 12:47 | Report abuse | Reply
  2. Soccer Mom

    @Jerry June 15th, 2010 00:22 ET
    "It's not a food, it's not a drug, it's outside the FDA's purview."

    That is not a true statement. According to the Code of Federal Regulation (800 series) these kits are medical devices and subject to FDA review/regulation.

    June 15, 2010 at 12:50 | Report abuse | Reply
  3. sumday

    FDA- Food and Drug Administation- well this is an at home test kit not food or drugs (people don't ingest this) so why is the FDA involved as it appears outside their authority? FDA doesn't regulate ciggerates which are a drug but wants to regulate an at home genetic test? First go get ciggerates off the street then come talk to me about being able to get genetic results without having to pay a doc $150 for 5 min of his time so he can use the same tests.

    June 15, 2010 at 12:58 | Report abuse | Reply
  4. Luellen

    I took the test from 23andMe and it was no big deal, the results were not earth shattering as feared. And there are common mistakes. For one it said I was likely to have blue eyes, but I have green eyes. Things like that. It said I had no Asian or African genes in my bloodline. Well I figured that since my family is Irish and German on both sides. I think good can come from these tests too.

    June 15, 2010 at 13:00 | Report abuse | Reply
  5. Dora Smith

    I tested at 23andMe. I wanted to identify "the gene" for type 2 diabetes that runs in our family. 23andMe provides a report of risk of type 2 diabetes (and a long list of other conditions), based on 9 genes, which is a small number of those that cause type 2 diabetes. It told my brother and me we have a typical risk despite a family full of diabetes, and we both have diabetes. 23andMe does collect data on most known genes for diabetes, and because I have the research skills I was able to identify the genes and pull their values from my raw data. I found that like everyone I have many gene
    s for type 2 diabetes, my brother differs on the most important of them, and science cannot discern who is genetically at risk of developing type 2 diabetes.

    23andMe tests for serious health problems, from its one gene risk for kidney failure (there are alot of genes), to its eight gene risk for heart disease (there are thousands of genes), to its completely deceptive report on your risk for breast cancer.

    What 23andMe purports to want to do is both get extensive data that scientists can research health conditions, and enable consumers to have the genetic information we increasingly want pertinent to their health. Unfortunately their glitsy marketing approach to delivery has created a service that is basically pure fraud, and can falsely scare or lull people regarding their real genetic risks. I'm glad that I could see my actual genes regarding type 2 diabetes; on the other hand, the data most people see is outright deceptive.

    June 15, 2010 at 13:14 | Report abuse | Reply
  6. jib

    The purpose of the FDA (very briefly) is to protect consumers from products which may be dangerous. This includes unsafe drugs and misleading advertising.

    There are some products which are not within the purview of the FDA. These include herbal products. Look for the "not FDA approved" or similar language. These products can contain any old crap and do not have to actually work. The advertising on these products is protected by the FDA to prevent the manufacturers from making inaccurate or unsubstantiated claims.

    Drugs, Medical Devices, Testing and Diagnostic products are within the FDA mandate. Anyone using a test for some diagnostic purpose (determining paternity or diagnosing diseases) should want these products evaluated by the FDA before use.

    While no government agency is perfect, or often worthwhile, the FDA is an agency with the interest of the population in mind. For example, without the FDA thalidamide would have been readily available in the US, not just in Europe.

    June 15, 2010 at 13:21 | Report abuse | Reply
  7. james

    Until the FDA gets control of the completely fake medicines on the market now, they should shut up.

    June 15, 2010 at 13:31 | Report abuse | Reply
  8. Tony

    The FDA will have some credibility when they act like this towards the Pharmaceutical companies that are selling products that literally kill people in some cases. The scary part is those products have been approved by the FDA. The worse that can happen from these test is someone could get incorrect information which any sane doctor would verify before treatment anyway.

    June 15, 2010 at 13:34 | Report abuse | Reply
  9. Bill

    If consumers could get the test results directly, you could submit samples from anyone you have contact without too much difficulty.

    June 15, 2010 at 13:37 | Report abuse | Reply
  10. anon1

    excuse me FDA... I dont need YOU telling me what kind of information I can view about myself. And what I chose to do with that information is MY prerogative not yours

    June 15, 2010 at 13:54 | Report abuse | Reply
  11. CRA1

    The FDA's job is to regulate all drugs, devices and cosmetics. Depending on what the test employs, it will likely fall under the device category. The do this to prevent harm to the public. Typically there isn't any tampering with the product from the FDA side. The FDA just wants the companies to prove that it's (1) safe and (2) effective. The company must prove to the FDA just that. Now if the companies can prove with pre-clinical and clinical data that they are as good as, say, a pregnancy test, then they'll pass. However, the FDA cannot regulate the ethics involved in such a test.

    Some of the people responding questioned why this needs to be regulated. Basically, because people like to sue. It's our consitutional right to sue. And this is not only the pharmaceutical companies (monitary) safeguard, but the public's (health) safeguard too.

    Herbal products are not regulated by the FDA. See the requred label stating such items on the containers/bottles.

    Almost everything we use on a daily basis from band-aids to tooth-brushes to defibrillators are FDA approved. See FDA.gov for more info.

    June 15, 2010 at 14:16 | Report abuse | Reply
  12. Ano3042

    I remember a (what I found to be) scary story a while back where most of the children in the country have had DNA samples unknowingly taken and genetic disease tests ran on them for years. I suppose these tests were FDA reviewed and approved? Why is it that when the government wants to do something it has little to no regulation/oversight but when private individuals want to do something it needs massive bureaucratic systems put in place over it to "protect the people".

    June 15, 2010 at 14:23 | Report abuse | Reply
  13. STUFF

    FAIL. Our genes cannot tell us anything about illness. That is a bold faced LIE told by who else but old white men who are angry that this country is more mixed then ever and need a platform of ALLEGED SCIENCE to spew their hate. It obviously stems from a lack of something downstairs. Aww, poor old white men. So weak, so frail. I am so glad they are dying out.

    June 15, 2010 at 14:37 | Report abuse | Reply
  14. San

    Only a small handful of diseases are known to be caused by a specific mutation. The majority of diseases these companies claim to diagnose are done using genome wide association studies on single gene mutations. A game of statistics, they are fishing in two pools of samples, one with a disease and one without, looking for differences in genes and reporting any genes found in greater number in the disease group as being disease causing without any clinical evidence of the gene actually being disease causing, most diseases are thought to be caused by a combination of many genes which we as of yet know very little about.

    The fact is, a majority of these genes are also present in the healthy population, in people that never go on to develop the disease. The FDA is right not to allow these companies to publish preliminary findings without conclusive evidence and create undue panic.

    June 15, 2010 at 14:39 | Report abuse | Reply
  15. Agiani

    Jay said, "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."

    There was a story recently about a law that went into affect. Basically, it said that you cannot be denied insurance due to a genetic predisposition for a disease.

    Also, there are some companies that do make their living selling retail paternity kits. (I'm thinking of Identigene at http://www.dnatesting.com.) I notice that identigene isn't mentioned in the article ... probably because they have a) been selling kits at retail for at least 5 years (and you have to send it to the lab), and b) they obviously have FDA approval, or they would have been mentioned.

    June 15, 2010 at 14:44 | Report abuse | Reply
  16. Nathan Peterson

    Next thing you know parents will be testing their children for gay genes, genetic disease predispositions, and then putting them up for adoption if they're not perfect.

    June 15, 2010 at 14:47 | Report abuse | Reply
  17. andy

    reminds me of when drug testing at home came out. its not the product its the people who don't use it properly(and there are a lot) neither are perfect one just needs to keep that in mind.

    June 15, 2010 at 14:52 | Report abuse | Reply
  18. Don

    I see no legitimate reason why the FDA should be regulating this product. Do they regulate pregnancy tests: I do not believe they do. Just because consumers could do the test wrong or the test may or may not be accurate does not warrant their involvement.

    June 15, 2010 at 15:00 | Report abuse | Reply
  19. Jessica

    Rest assured everyone, all the stupid humans are already doing stupid, disasterous things...this test will not make anything worse than it already is. DEEP BREATHS EVERYONE...JUST TAKE DEEP BREATHS

    June 15, 2010 at 15:07 | Report abuse | Reply
  20. bluepen61

    Another intrusion into our private decision making. Apparently we cannot be allowed to take responsibility for our own actions.

    June 15, 2010 at 15:21 | Report abuse | Reply
  21. Lara

    Recently Genetic Medicine thought leaders – all familiar with the DTC companies – discussed the key themes, questions, opportunities and barriers surrounding the promise of Genetic Medicine.

    Out of that discussion came the realization that very little of the genetics that is known today will provide any yes or no answers about our health in the future. Another notable finding is that to be informed health consumers and to make sense of our own genetic information, we better learn statistics.

    Quality of info from DTC companies was discussed – seems that they test only for the most common mutations – not all. There is concern that a negative result may be falsely reassuring.

    And then, besides quality, what info is safe to share? The promise of the genome is that someday we’ll be able to interpret the information in a way that will save lives and improve quality of life. This means that genetic information has to be “actionable.” To the medical establishment, actionable typically translates as prevention. But, if your genetic profile shows a risk for a disease and there is no treatment, why should anyone bother to tell you? There is a debate going on about what information is actionable, and what is safe to tell people. And how about activism, fundraising, and planning for the future... aren’t these also valuable actions?

    read more of the recap:

    June 15, 2010 at 15:36 | Report abuse | Reply
  22. Kevin

    Do I really even need to go into the "revolving door" at the FDA? Process a big company's new drug application then get hired for several years as a highly paid "consultant"..then go back to the FDA and repeat.

    We need to clean house.

    June 15, 2010 at 15:36 | Report abuse | Reply
  23. Ronnie Harper

    I think the real problem here is the FDA is in the pockets of the drug companies. The drug companies don't want these products on the market because it will interfere with all the commercialization of pharmaceuticals they have been doing lately, by giving consumers more, accurate information. This is all about business, and the right-wing fat cats that sit on and populate the FDA panels – same problem with all our government agencies.

    June 15, 2010 at 15:41 | Report abuse | Reply
  24. Tgr

    The FDA does mostly good things. But, this issue smells of over reaching of Big government.

    June 15, 2010 at 15:48 | Report abuse | Reply
  25. Paul

    Response to "Anonymous"

    Anonymous said: "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."

    >>Then allow the companies to detect the SNP's and provide the data to the customer without explanation.<<

    June 15, 2010 at 15:49 | Report abuse | Reply
  26. JBPhD

    As scientist with a PhD in Molecular Biology, at home DNA tests worry me. Most people people do not realize that even a tiny amount of DNA that is not yours getting into your sample can have drastic effects on the results. Also, as someone mentioned above, different genes have different sensitivity levels of detection, which further increases the chances of incorrect results. Further, some form of regulation is needed to ensure that these labs are performing the tests under the most sterile of conditions to prevent contamination. You cannot compare DNA testing to something like a home pregancy test. These are completely different technologies that require different considerations. You can argue you that it is about money all you want but being falsely diagnosed for a serious disease from an at home test is not something I am willing to gamble on.

    June 15, 2010 at 15:57 | Report abuse | Reply
  27. wenmich

    The FDA definition of a drug or device is in part that the product; diagnosis, cure, mitigation, treatment, or the prevention of disease. Therefore it falls under the scope of the FDA. The companies are required to prove to the FDA that their product does not fall under any of these categories. That is why some natural products are not regulated by the FDA.

    June 15, 2010 at 16:01 | Report abuse | Reply
  28. Nick


    There are already at home paternity tests on the market... stop by your local walgreens....this is for GENETIC testing that will tell you if you are at a high risk for medical conditions. I agree that the FDA should regulate these tests because there are a lot of people that sit on WebMD all day long obsessing about possible diseases they have. Inaccurate genetic tests could lead these people to self diagnose themselves and seek medical attention for conditions they don't have.

    June 15, 2010 at 16:30 | Report abuse | Reply
  29. AB

    People: the tests are not done at home. You don't have to do anything more than spit and mail. To those of you saying these consumer tests should be regulated because people are too stupid to do the test at home – you have nothing to worry about, except your own misunderstanding. The tests are analyzed at labs, not at home.

    Then, you log on to a website and get your results such as whether or not you react typically to a certain drug or not. This is what the government thinks you will need to be regulated on. They think you will stop taking, never take or refine your medicine dosage based on having this information. (and what is wrong with this? well, it makes you more knowledgeable than your doctor which they do not like).

    Information is freedom but some people would like you not to have access except through a medical professional. This increases their bottom line and takes the power from you and gives it to them which is what control and regulation is all about. The tests are not going to be any more reliable because the FDA is involved. They are based on already conducted science – but these facts seem to be overlooked by the FDA. This is a HUGE industry and $ are to be made and doctors want to control this rather than letting people do it themselves.

    June 15, 2010 at 20:02 | Report abuse | Reply
  30. DP

    Dear FDA,

    Make Me.

    Free Enterprise

    June 16, 2010 at 00:23 | Report abuse | Reply
  31. Duh

    I've done the 23&Me test and while 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 it's clear from what is provided in FAQ's on their site that they are not like a pregnancy test, they mostly don't give a yes/no result on any disease or condition. In being on there since 2008 I know of anyone on the site who has made any important medical decissions as a result. One decission I have made it to eat much more healthily and detox myself from junk and over-refined mass produced foods something many Governemts around the World now promote. Clearly thats a positive result and for me the FDA is barking up the wrong tree on this one.

    June 16, 2010 at 07:34 | Report abuse | Reply
  32. NA

    I'm a 23andme user and an Ancestry DNA user and I may also do FTDNA .. I like the services, it is my money. They are services not medical providers. It is still in pioneering stages I don't expect it to be perfect but I like what I have. Yes I print out all my 23andme findings and showed them to my Dr. who was not interested – I still go to my Dr. I still respect my Dr. and I still do what my Dr. feels is best regarding my medical needs. But the percentages that show what the average person is and what my possible risk or not risk is pretty interesting and also vauge .. but do I exercise more now .. YES .. do I buy healthy organic foods and grow my own organic vegetables .. YES .. do I cook more instead of buy out .. YES .. FDA – please there is not harm here .. I am not a patient of 23andme .. I am a buyer of a service that gave me adaquate not misleading information about the services. And there is a law that your genetics can not be used against you for insurance or job .. Go look at the required work poster in your business GINA since 2008 .. there is no harm and no foul here. The government is over reaching again and I will not be voting for my Congressman Waxman because of his letter to 23andme. Seriously we need to vote government out that feels they have a right to our DNA and we do not.

    June 16, 2010 at 12:47 | Report abuse | Reply
  33. TM

    I don't work for the FDA, but I do work in life sciences. I thought a few points on the FDA would be helpful. So for the record:

    1. The FDA is responsible for regulating medical devices. So the blood glucose meter and the pregnancy test that have been mentioned actually do fall under their remit and have to be approved.
    2. Homeopathic remedies that make claims that they cannot medically prove do get warning letters and get pulled from the shelves. (Though there are still tons of them.)
    3. The FDA always places the burden on a manufacturer/service provider to prove that their product does not require regulatory compliance.

    Personal genomics is relatively new as a discipline. As long as a supplier does not claim to diagnose or to treat an illness, the suppliers of this service and the FDA should be able to reach an agreement. Trained laboratory professionals actually administer these tests and have to conform with regulations like Good Laboratory Practices (GLP).

    The fact that incorrect results were sent to patients does imply that the conversation is worth having. The FDA policies are designed to ensure that samples are correctly tracked and managed.

    June 17, 2010 at 11:27 | Report abuse | Reply
  34. karen

    The comments here demonstrate to me a general lack of understanding of genetic testing. First of all testing of genes (DNA) is done for different reason and is in need of clarification of some of the basic concepts. There are several ways/reasons to test DNA: 1)DNA testing for parternity and for use in criminal cases. This does not require a knowledge of exactly what genes are being screened or what any of the genes do and basically involves determining how closely the DNA of one person matches another known person (i.e. paternity testing) or an unknown person (sample from a crime scene). It is very precise testing but just involves comparing one DNA "fingerprint" to another 2) testing to see if there are an abnormal number of chromosomes (such as in Trisomy 21 or Down's Syndrome) or if there are abnormalities of the chromosomes themselves (as in some types of cancer in which a part of a chromosome may be missing, too long, or broken). This type of chromosome testing has been around the longest of any DNA testing 3)Testing for mutations – these are known changes in the DNA that are known to cause disease. Diseases such as Cystic Fibrosis, Huntington's Disease, and Sickle Cell Anemia are classic examples of conditions where a genetic test can tell whether someone carries the mutation for those conditions or they do not carry these mutations. This type of DNA testing been around for over 20 years and new disease-causing mutations are being discovered practically every day. However, this type of testing requires that you know exactly what mutations in genes are being looked for and yields a "yes or no" answer. 4)Testing for single nucleotide polymorphisms or SNPs (also called allelic variations). This is the newest type of genetic testing and only became possible on a large scale when the human genome project was completed. The human genome project basically created a huge library of little pieces of DNA (SNPs) that can be used to search genes. SNPs are minor variations in genes and are basically what makes each of us a different. Scientists used to think SNPs were not important in disease but within the last 5 – 7 years it has been realized that differences in some SNPs do matter and the association between variations in certain SNPs and an increase (or decrease) in the risk of various chronic diseases is the focus of a great deal of research. Scientists studying a common disease associated with aging (such as macular degeneration, Alzheimer's disease, or type II diabetes) collect DNA samples from hundreds or thousands of people who have the disease (affected subjects) and people who do not appear to have the disease (control subjects), study their DNA using the SNP based technology and the SNP library as a reference, and then use powerful computer processing programs to analyze millions of pieces of data to detect the probability that a particular SNP will be associated with a particular disease. Rather than a "yes or no" answer, such testing yields a probablilty answer. For example if one SNP shows up 10X more often in people with diabetes than in people without diabetes then that SNP is probably associated with diabetes. However, it doesn't say that a person who has that SNP will definitely develop diabetes – only that they probably at some increased risk compared to a person who doesn't have the SNP. Tthere are other factors that could affect the outcome – the researchers have to make sure their study subjects were not collected in a biased fashion and that there were not other diabetes risk factors that influenced the outcome (such as differences in average age, diet, weight, and exercise habits). Also, when studying a disease that shows up later in life (such as Macular Degeneration or Alzheimer's) scientists have to be careful that they don't enroll control subjects which are too young (i.e. they don't have the disease when they enter the study but would have the disease if they were 5 – 10 years older so including them in the control group artifically change the study result) Based on my reading what is online (I don't have any personal knowledge of any of these companies) the tests that all of these companies are doing appear to be based on the SNP technology. If so, the test results don't tell people that they have or will get a disease – they just suggest a probability that someone will or will not develop a disease. Also, different SNPs influence each other. Sometimes several SNP's are additive to make the likelihood of a disease worse, other times they can cancel each other out. Not all SNPs associated with risks of particular diseases have been discovered and, since SNP's can affect each other, knowing some of the SNP's for a disease doe not necessarily give you much more information than not knowing any SNPs. Also, the discovery that a particular SNP is statistically linked to a particular disease is "Intellectual Property" ie. patented information and since only one entity can technically hold a patent for a particular test, two companies technically cannot test for exactly the same information in exactly the same way without at least one of them violating a patent. Because it is always possible that the actual patent holder for a particular SNP/disease association is someone other than any of the companies that are doing the testing, none of the companies may be doing the exact testing that the initial discoverer of the association found so the test being offered may not yield the same results as the initial research that discovered a SNP/disease association. So you may not even know if you are getting the same test test for a probability of a disease from one company to the next. Two companies testing for the same thing could, hypothetically, be doing the testing in different ways to get around a patent restriction and may not actually be providing the same information. Bottom line – this technology is very exciting and promising but also very, very new and still evolving. Most, possibly all, of the tests on the market to date have not yet been "validated" which is why the FDA is concerned. It has nothing to do with "conspiracy theories". Before getting a genetic test you should make sure that the test has been independently validated and that the test results are reproducible – that is true for any kind of test and genetic testing is no different in that regard. Anyone undergoing genetic testing should also consider what they are going to do with the information. If there is no known cure or treatment or know preventative measure to take for a disease some people might still want to know they are at some risk, others would not. The results of genetic testing for something a person might not develop for decades could potentiallyinfluence their ability to get insurance or may make their premiums higher. The testing and uncertainty about the results might cause unnecessary anxiety – especially if the test results are ambiguous.

    June 17, 2010 at 17:13 | Report abuse | Reply
  35. dna paternity test

    results provided from a dna-kit to be used at home depends on how the sample is collected and the quality of the reagents. it is important to consider both factors before making important conclusions.

    November 11, 2010 at 19:00 | Report abuse | Reply
  36. dna paternity test

    results provided from a dna-kit to be used at home depends on how the sample is collected and the quality of the reagents. it is important to consider both factors before making important conclusions.

    November 11, 2010 at 19:02 | Report abuse | Reply
  37. Arcpoint Labs of Greenville, SC

    I agree with the warning it does seem like this shouldn't be something that people attempt at home. Would be more reliable to have the security of lab based results.

    May 3, 2012 at 11:08 | Report abuse | Reply
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