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23andMe Inc., the Google Inc.-backed DNA analysis company co-founded by Anne Wojcicki, was told by U.S. regulators to halt sales of its main product because it's being sold without "marketing clearance or approval."

The Saliva Collection Kit and Personal Genome Service, or PGS, tells users whether they carry a disease, are at risk of a disease and would respond to a drug. Most of the uses fall into the category of a medical device and require Food and Drug Administration approval, the agency told the Mountain View, California-based company in a Nov. 22 letter made public today.

Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin, started 23andMe about six years ago to help people assess their risk of cancer, heart disease and other medical conditions. Brin used the saliva kit to determine he had a gene that makes him susceptible to Parkinson's.

"FDA is concerned about the public health consequences of inaccurate results from the PGS device," the agency said today. "The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work."

The FDA used candid language in the letter to outline the work the agency has done with 23andMe since 2009 to no avail, including more than 14 face-to-face and teleconference meetings and had hundreds of e-mail exchanges. The FDA said it has given the company feedback on study protocols, discussed regulatory pathways and provided statistical advice.

No Proof

"Even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions," the FDA wrote.

The agency said it hasn't heard from 23andMe since May and meanwhile the company has initiated new marketing campaigns, including television commercials, indicating 23andMe plans to expand the device's use without obtaining FDA marketing clearance.

The FDA decided in 2010 that services claiming to evaluate a customer's risk of disease must be cleared by regulators if the companies sell directly to consumers. Most FDA-cleared genetic tests are for a single disease while 23andMe's would be the first to test for multiple conditions.

"We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission," Catherine Afarian, a spokeswoman for 23andMe said in an e-mail. "Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."

FDA Submissions

23andMe submitted FDA applications in July and September of 2012 for the least stringent of two types of medical device reviews. The FDA said the company failed to address "the issues described during previous interactions."

UnitedHealth Group Inc., the largest publicly traded U.S. health insurer, raised concern in a March 2012 report about the accuracy and affordability of the tests. Such types of genetic tests may become a $25 billion annual market in the U.S. within a decade, highlighting the need to identify which work best, the insurer said at the time.

(Updates with FDA feedback to company in fifth paragraph.)

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FDA Tells Google-Backed 23andMe to Halt DNA Test Service

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23andMe Inc., the Google Inc.-backed DNA analysis company co-founded by Anne Wojcicki, was told by U.S. regulators to halt sales of its main product because it's being sold without "marketing clearance or approval." The Saliva Collection Kit and Personal Genome Service, or PGS, tells users whether they carry a disease, are at risk of a disease and would respond to a drug.

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I have been eager to find out my genetic predispositions for some time now. Thus, when 23andMe had an incredible one day sale for their phenotype DNA test, I just could not pass by such an opportunity to get what I wanted for me, while simultaneously doing a review of this new and interesting product for you.

The main question I was trying to answer was: Is it worth doing the phenotype DNA test?

In the end, my conclusion is that it is. However, for reasons listed below, other people may reach a different conclusion for themselves. Hopefully, after reading my review, you would be in a better position to make an informed decision whether such a product is right for you too. In order to accomplish that I will start with a brief video introduction to what is DNA in general and phenotype (or SNP) DNA in particular. Then, I will look at the process of taking the test and show you a video of how I did it myself. Consequently, I will proceed by looking at the associated costs as well as some of the issues surrounding the pro's and con's of getting the test done. Finally, I will end with my personal verdict of the product.

One of the really great things about 23andMe is the fact that they provide a sea of useful information for those who are interested in learning more about their genome and the interpretation of specific genes. For starters, you can visit the 23andMe YouTube Channel and watch some short educational videos about genetics. Here are the 3 most relevant and informative clips:
Genetics 101: What is DNA? Genetics 101: What is a SNP (Single Nucleotide Poliymorphism) What is Phenotype?
The Testing Process
During my Singularity 1 on 1 podcast interviews with a number of experts such as Aubrey de Grey, Terry Grossman and Andrew Hessel, I was told repeatedly that tests such as 23andMe 's personal genome service are among several tests that are worth doing. Given that, at best, I have a very limited knowledge of the field, I thought that I'd listen to their advice.

Here is how the process works:
The Saliva Sample DNA Test Kit Lab Processing of Saliva Samples The Costs
Recently, the price for 23andMe's personalized genome service went down from a one time fee of $199 to the current $99 USD. On top of that you have to pay kit shipping costs to and from your address plus $9 monthly on-line membership fee for one year. Thus, provided that you live somewhere in continental US and pay the full price, you should expect:

$99 + (12months X $9 each) + roughly $30 for shipping = $237 (total cost for the year)

In my case I took advantage of a one-day DNA Day Sale and thus had to pay only the shipping and the $9 monthly fee for 12 months. Since I am located in Canada my shipping was about $50 and hence my total yearly cost will end up being around $158.

Let me also say that in my opinion the $99 one time fee is a fair amount to pay for what you get so don't feel that you will be overpaying if you order your kit now. This way you can get your results in the fastest way possible. However, if you are interested in getting the best price possible, then I recommend that you start following the Spittoon - the 23andMe blog. There you can be among the first to hear about any future promotional discounts and sales you can take advantage of.
Full Genome Mapping vs. Phenotype (SNP) DNA Test

Now that we've covered the mechanics and the costs, it is time to mention at least some of the more important issues related to DNA testing in general and phenotype or SNP DNA testing in particular.

A big part of arguing for or against any test comes from understanding its goals, its accuracy and its implications. Thus, the first step of deciding, if it is worth doing for you or not, consists in finding out what the test does and does not do.

For starters, make sure you are clear that this is not a complete mapping of your personal genome. What 23andMe offers is a SNP DNA test. This means is that it does not map and examine all your 3 billion genome base pairs but tests only what are arguably the most important 1 million snips of your DNA. While this may be a small part of your total genome it is supposed to be a rather revealing one. In fact, it is for this reason that the test is so affordable. Otherwise, you would be looking to pay upwards of many thousands of dollars rather than the mere couple of hundred you would be paying with 23andMe. In addition to cost, another advantage of the SNP test is that it is much faster while the main disadvantage is that it is less accurate. So, make sure you understand the differences and recognize the pro's and con's of each test.

In terms of general accuracy, having a specific gene does not necessarily guarantee a specific or certain type of (health) outcome. Though the exact importance of your genes is still very much a matter of scientific debate, currently the predominant opinion claims that genes determine only about 20-30% of the outcome. The other 70-80% are a result of your environment and life choices such as nutrition, sleep and stress patterns, physical activity etc. Thus no DNA test can or will ever predict your future. At best, what it can do is provide you with a good idea of your odds but how you play those is up to you.
Can you handle the truth?
While the issues mentioned above pertain to the accuracy of DNA testing, the bigger issues are moral ones. So even if we can have perfectly accurate DNA test results, for many, the biggest question, at least at the personal level, is:

"Do I really want to know that?"

For example, when I told my family that I have sent a saliva sample for testing, my sister-in-law said that she does not really want to know what are her chances of developing breast cancer. So if you feel the same way and prefer to not know, then, you definitely should not take the test. I start from the presumption that knowledge is always better than ignorance, even if many may adopt the "ignorance is bliss" attitude.

There is also a whole other spectrum of legal, practical, political and ethical issues related to DNA testing but I will not dwell on those here for this is not the purpose of my review. All I will say is that it may be good to think through all the potential implications of your results before you actually do the test. (Perhaps you can watch a couple of movies such as Gattaca)
The Results
One thing that surprised me pleasantly was the fact that, even though 23andMe says your results take between 6 and 8 weeks, I had mine ready and uploaded to my on-line profile only 2 weeks after sending my sample.

Below is a screen-capture of my health overview home page. Have in mind that this is only a small fraction of a sea of personal information that 23andMe provides you with. In fact, I still haven't had the chance to read even half of it.

For reasons of privacy I will not go into all the minute details of my personal results but you should know that your DNA results are grouped into four main areas: Disease Risks, Carrier Status, Traits and Drug Response.

Each of those has its own homepage with dozens, if not hundreds, of specific items within its respective group (e.g. disease risks), which are then given a percentage number representing your specific personal risk, as well as the respective average general population risk.

Furthermore, each of those items is also clickable and thus you can go to its specific home page (e.g. Alzheimer's Disease), where you can read more about your own data and how that disease works or get some technical reports and scientific citations used to compile the information. All in all, we are talking thousands of pages of relevant in-depth scientific information which is regularly updated with the latest research for the duration that you pay your $9 monthly membership fee.

Another interesting element of your results is the information provided about your ancestry along your maternal and paternal lines. Here is a screen-shot of the map representing my maternal line.

For those interested in your family tree, know that there is an optional free "Relative Finder" service on your profile page where you can look for and get in touch with other people who have also opted into the database and you share genes with. In this way you can actually find distant relatives you never knew existed. Interestingly, while I haven't had the time to use or examine that part of my profile yet, since I did opt into the service, I was already contacted by someone who is a naturalized American of Bulgarian origin. According to 23andMe that person is probably my fifth cousin.
The Verdict
A big part of your decision is what you expect to find out and how you view the usefulness of any such information.

While curiosity was certainly a part of my motivation for taking the test, I had some very real medical concerns too. I come from a family with a long and lethal history of cancer, diabetes and heart disease. That fact has motivated me to make (mostly) healthy life-choices with respect to nutrition and physical activity. Yet, since genes play an important role, I thought that knowing more accurately my genetic predispositions can provide useful new information and prioritize and focus my efforts on specific things that I should and should not do.

I was relieved to find out that my odds are pretty good because I am showing decreased risk for most major ailments such as Heart Disease, Diabetes, Prostate Cancer, Alzheimer's and Parkinson's disease. However, even if it were mostly bad news, it would not have been a reason to despair. In fact, I would have been even more motivated to take action and have as healthy a lifestyle as I possibly can.

In the end of the day I strongly believe that 23andMe provides an excellent product and great value for the money. You can say that, given my results, I didn't make any big discoveries about my genome for there was nothing that really jumped out at me. Yet I did discover and, with every profile update, will continue to find out many important and interesting things both about my genes and my family tree. (Not to mention that I got connected with a person who may turn out to be a distant cousin of mine.)

Furthermore, even if it seems that I have been lucky genetically speaking, it does not mean that I did not benefit from the test. I would argue that the shorter the genetic straw you draw, the more important it is for you to be aware of it. Knowing about the existence of a potential problem is the only way that you can ever be proactive in avoiding it or, if necessary, be active towards resolving it. Indeed, it is a fact that cancer patients who get well educated about their medical condition have three times better chances of surviving than those who don't put any effort on their own but blindly follow their doctor's prescriptions.

While genetics is still a relatively new science in its early stages of development, we are already at the level where we can begin benefiting from it. DNA tests are not only here to stay but also a good example of a cutting edge application with serious potential benefits that you can access right now. So, even though in the future such tests will certainly be better, faster, cheaper and more accurate, at least until you are able to do a full mapping of your personal genome for a similar price, I will argue that this product is worth doing.

In short, based on the reasons above, I regularly recommend 23andMe 's Personal Genome Service to all my friends and relatives. In fact, my wife Julie will be next to send her saliva test.
Video Updates: 23andMe vs. the FDA in less than 4 minutes 23AndMe issues statement on FDA smackdown
Dear 23andMe Customers,

I wanted to reach out to you about the FDA letter that was sent to 23andMe last Friday.

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.

23andMe has been working with the FDA to navigate the correct regulatory path for direct-to-consumer genetic tests. This is new territory, not just for 23andMe, but for the FDA as well. The FDA is an important partner for 23andMe and we will be working hard to move forward with them.

I apologize for the limited response to the questions many of you have raised regarding the letter and its implications for the service. We don't have the answers to all of those questions yet, but as we learn more we will update you.

I am committed to providing each of you with a trusted consumer product rooted in high quality data that adheres to the best scientific standards. All of us at 23andMe believe that genetic information can lead to healthier lives.

Thank you for your loyalty to 23andMe. Please refer to our 23andMe blog for updates on this process.

Anne Wojcicki
Co-founder and CEO, 23andMe

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23andMe DNA Test Review: It's Right For Me But Is It Right for You?

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I have been eager to find out my genetic predispositions for some time now. Thus, when 23andMe had an incredible one day sale for their phenotype DNA test, I just could not pass by such an opportunity to get what I wanted for me, while simultaneously doing a review of this new and interesting product for you.

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After much consideration, research, and parental advice, I have drawn up my decision whether or not I would go forth with the personal DNA test. Even though there are positive reasons to get your DNA testing, I honestly feel that the negative reasons outweigh the positives. There are various factors that I do not feel comfortable with, thus making me side to go against the test. Even though it is drastically more affordable than that of the entire DNA genome, the other 2.9 billion genome base pairs are left unknown. What if I have an incredibly rare single-replacement illness that could be threatening? I do agree that this test is more accurate in terms of specificity than the test for the entire genome for its price, yet it still lacks in proof and accuracy. In such terms, having a certain gene in particular location does not automatically guarantee a specific type of health outcome. Currently, the genes determine only about 20-30% of the outcome of that health condition. The other 70-80% are a result of environment and life choices (such as nutrition, sleep schedules, stress levels, exercising etc.). Thus, no DNA test can accurately predict one’s definite future. Each consumer must be mentally prepared for the possibility of having a serious health risk. I certainly am the type to take things far too drastically and can let my imagination haunt over me, and there are many other people who would be scared of their results as well. Some results could be emotionally difficult to sink in, whether related to health risks or ancestry. Some people just prefer not to know what “is wrong with them”. There are a number of people who become psychologically terrified of what the test displays on the screen. Some people would rather suicide their way out of actually going through their future disease. In addition, some results may not even be true. 23andMe only shows the percentage chance of having such a disease in the near or far future. The knowledge of when is still unknown. It would not tell me how to help sustain such a condition, if there was even one, and what the condition is at minimum. I also feel uncomfortable knowing that this testing is not FDA approved. The Google-owned 23andMe was ordered by the FDA to stop all sales of the personal DNA test and Saliva Spit Samples due to lack of health and safety approval. The FDA agency stated that they were concerned about whether or not these tests actually worked, with the customers’ safety ensured. It’s unreliable to know that the product is not FDA approved, meaning that the customers are unaware that their spit sample could be infused or contaminated, thus altering the displayed DNA SNPs results. I feel unable to trust the results in the first place, thus, meaning that ordering the test would be a waste. I am not saying that I do not care for my health, because I do; it is just that, I would rather not take my chances on this personal genetic testing and continue living, not having that I may have a dangerous disease in unknown time.

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"Geek Dad's Experience with Personal Genetic Testing Through 23andMe"

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"Geek Dad's Experience with Personal Genetic Testing Through 23andMe"

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If your family is anything like mine you have a good deal of lore and uncertainty about where your ancestors come from. You might have a strong idea about some of your ancestors, e.g. your great grandmother on one side emigrated from Italy, but there are probably other lines that peter out into the obscurity of time. With the birth of our first child my wife and I thought it might be fun to get our DNA sequenced, both to better understand our son's heritage and to identify any risks lurking in the recessive recesses of our genetic codes. It turned out to be quite illuminating.

We both signed up to have our DNA sequenced by a company called 23andMe. Co-founded and run by Anne Wojcicki, wife of Google Co-founder Sergey Brin, the company aims rather loftily to achieve breakthroughs in the genetics of human health by creating a vast database of genetic information from its customers and then cross-referencing that database against the health history of people that choose to opt into the company's genetic research (you can opt out of the company's database if you're worried about running into your evil clone). The company essentially harnesses the power of crowd sourcing for genetic research.

Of more immediate interest to me when I signed up, they provide personalized gene scans of certain relatively well-understood parts of the genome in order to provide each customer with an individualized assessment of his or her ancestry and health risks. The cost of this service is $99 / person. Once you sign up the rest is easy. The company sends you a tube to fill up with your spit, which you seal and mail back to their lab, and after about a month they send you an email that your results are in. You are prompted to create a login to the company's website, which you can then access on an unlimited basis to view your results.

Your results come in two broad categories: ancestry and health. The ancestry side is the fun part. I knew my family was mostly European, but there were tales about certain parts of my heritage that I wanted to confirm or deny. For instance, because of my maternal grandfather's dark complexion and his grandfather's work on Indian reservations, we always speculated that we had some Native American ancestry. We also speculated that we were part Jewish because my maternal great grandfather had a Jewish surname, though he was not known to ever practice the religion. I was hoping both would turn out to be true.

The family lore was half right. After logging into the website I clicked on the link to ancestry composition. My composition came back 99.5% European (the other 0.5% was unassigned), which breaks out as follows:

British and Irish: 11.9%
French and German: 1.5%
Nonspecific Northern European: 48.4%
Ashkenazi (Jewish): 11.7%
Nonspecific Southern European: 0.5%
Nonspecific European: 25.6%

So we were right about the Jewish ancestor, but wrong about the Native American. I was a bit disappointed with how much of it came out as "nonspecific," which is of course not very illuminating. But it's not too surprising. 23andMe aims to tell you where your ancestors were roughly 500 years ago, before intercontinental travel became common. But even 500 years ago travel within Europe was common enough to make it hard to parse out which specific country people came from. On the other hand I was pleasantly surprised with how much they can tell you. For instance they can tell you your percentage of Neanderthal DNA. I came in at 3%, which puts me in the 92nd percentile. My wife says that explains a lot.

The more sober side of the results is your health risks. With varying degrees of confidence they can tell you your risk factor for a number of diseases. None of it is presented as a certainty, but rather as a lifetime percentage risk. For instance, you might be told that you have a 47% chance of acquiring a certain disease over the course of your lifetime, whereas the average person has only a 23% chance of acquiring that disease. It can also tell if you are a recessive carrier of certain genetic diseases such as Cystic Fibrosis, which only expresses if a child inherits the harmful variant on both sides. Perhaps most usefully, it tells you your likely response to certain drugs. I was happy to learn that I am a "fast metabolizer" of caffeine. Given that my blood is often equal parts hemoglobin and coffee, I found that reassuring.

Some people might find the health results frightening, but I took the attitude that it was better to have advance warning of potential issues when there is still time to do something about it than to blindly hope for the best. That said, 23andMe is careful to disclose that much of the genetic research they rely on is of a preliminary nature. In other words, you shouldn't make major life decisions based on preliminary genetic testing results without seeking actual medical advice and further testing.

All in all I'm happy my wife and I did the test. It gives us something more to tell our son about his forbears, and it gave us some interesting insights into our health. It won't tell you everything, and it's not as detailed as I would like, but for $99 it tells you a lot. I would recommend the service to anyone that has an interest in their heritage, anxiety about their health risks, or both. The fact you might play a small part in helping advance genetic research is icing on the cake. As an armchair science geek I find that pretty cool. I also find it cool that I feel more legitimate saying "L'Chaim!"

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My Experience With Personal Genetic Testing Through 23andMe - GeekDad

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If your family is anything like mine you have a good deal of lore and uncertainty about where your ancestors come from. You might have a strong idea about some of your ancestors, e.g. your great grandmother on one side emigrated from Italy, but there are probably other lines that peter out into the obscurity of time.

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I signed up for 23andMe with an open mind. I emerged with deep concerns about privacy, among other issues.

Who Owns Your Data?

Thanks to the U.S. Food and Drug Administration (FDA), 23andMe was out of the genetic testing business as of December 2013-not that those genetic tests were all that practical to begin with. Unfortunately for consumers, as of October 2015, they were back in business again. But don't be too quick to sign up.

Prior to December 2013, 23andMe touted new age promises of direct-to-consumer genetic testing. At the time, eager users like me were provided with personalized information regarding:

Risks for 120 health conditions

Carrier status for 49 rare diseases

Standing on 57 traits

(The reports sound more useful than they really were, however.)

Amazingly, users paid $99 for:

Surveys that benefit the medical research community-companies pay 23andMe big bucks for access to your data.

Uninterpretable raw genetic data. (Why?)

Ancestry information and

Risk. Plenty of it.

There's No Going Back

If you're not feeling exposed yet, you should be.

In addition to the ancestry benefits that 23andMe touts, consumers of DNA testing should understand possible medical, legal, and personal risks of getting such testing. They should understand that once certain information is provided, it can Never Be Taken Back. This is the proverbial horse that's been let out of the barn. There's no going back on this information.

No matter how curious you are, the benefits that 23andMe provides should pale in comparison to its risks. Yes, welcome to the brave new world of

spit in a test tube

pay $199 plus shipping (they raised their rates but occasionally offer specials)

answer loads of intrusive personal questions about your health and lifestyle (known medical conditions, pesticide exposure, sexuality, family background, drug use, etc.)

then turn over your medical and personal data so big companies like Pfizer and Genetech can use it for their own financial gain. (Yes, folks, this is where Big Pharma steps in.)

My recommendation: Think very carefully before you do this.

Direct-to-Consumer Genetic Testing Becomes Widely Accessible

The possibility of learning about one's personal genetic unknowns has intrigued the public since 2008, when 23andMe's direct-to-consumer (DTC) genetic test was named Time Magazine's Invention of the Year. ¹

At the time, however, the company's price tag for personal DNA analysis was $999, placing the service out of reach for many. (For those willing to pay attention, there's a lesson in there about being an "early adopter.")

The Google-backed company has dropped its price several times since then in an effort to attract more customers. In December 2012, the fee was permanently reduced to $99, plus shipping ($9.95 in the United States)-permanently, I guess, until the rate increase to $199 in October 2015. 2

At these lower price points, many people find themselves at a decision point: " Should I get at-home genetic testing?" I was one of them.

I signed up before the December 2013 FDA involvement. I went in with an open mind, enthusiastic to discover more. However, I have emerged with deep concerns about privacy, the ability to withdraw from medical research, and who really owns one's data. Following is my opinion, based on my experience.

A Cautionary Tale for Anyone Interested In Genetic Testing

The Immortal Life of Henrietta Lacks

Registration Was So Easy

Signing up was so easy, but that's often the thing about mistakes-they're easy to make and tough to undo. As someone who was curious about my health risks and carrier status, I decided to take the chance and enroll.

I registered online with 23andMe and provided the required personally identifying information. This included my name, address, email address, and credit card information for payment of the service. The option to be tested anonymously does not exist. Don't think I didn't want that option.

The company subsequently mailed me a "spit kit" to collect a small amount of saliva. They had to do it twice because I didn't understand how to properly use it the first time around.

I subsequently returned the sample to the contracted laboratory for processing. (To promote privacy with the third-party testing lab, the consumer uses a registration number instead of his or her name.) Then, after 6-8 weeks, I received the information I had been waiting for.

Have You Checked Their BBB Rating?

Better Business Bureau ratings are general barometers of how a business tends to interact with customers. Rating reflect a variety of factors, including complaint history, governmental and licensing issues, type of business and time in business, business transparency, and advertising issues.

Why Is A Spit Sample So Valuable?

Personal genotyping consists of genetic analyses conducted on a small sample of a person's DNA. Although the company now provides only ancestry information. 23andMe is the largest company in the direct-to-consumer genetic testing market.

Saliva is used because our spit is a genetic window to who we are. Saliva samples contain DNA cells for analyzing single nucleotide polymorphisms, or SNPs (pronounced "snips"). SNPs are patterns of DNA cells that contain small changes, or copying errors. ⁴ These errors occur when cells reproduce. As a result, SNPs contribute to both observable and unobservable variations in health, physical appearance, and other aspects of what makes each person unique.

SNPs are inherited from one's parents. Therefore, they can be used as an index of genetic similarity. The more closely related you are to someone, the more likely you are to share SNPs. For example, you share more SNPs with a sibling than a third cousin. 5

When you turn over access to your DNA, combine it with personally identifiable information (e.g., name), then provide survey data (e.g., questionnaires on sexuality, personality, drug use, lifestyle), you hand over the keys to not only your own identity but that of your relatives. Why? Thanks to publicly available records, you have provided information about not just yourself but also your relatives. And there's no going back.

Who knows how this information will be used in the future?

More than 10 million SNPs exist across the human genome, and prior to the FDA's involvement 23andMe tested for about one million of these coding variations. ⁶ This coverage of only a portion of the genome was one of the major criticisms of 23andMe even before the FDA became involved.

In contrast, competitor companies such as Gene by Gene Ltd. offer consumers an analysis of their entire genome (called "whole genome sequencing"). However, such comes at the hefty price tag of $7,395 or more and requires the involvement of a personal physician. ⁷

Nothing Is More Personal Than Genetic Analysis

Like hundreds of thousands of other people, I took the testing before the FDA put a halt to 23andMe's personal health analytics. The U.S.Food and Drug Administration (FDA) intervened in late 2013 because of concerns that this service eliminated the physician as consultant or middleman by offering testing services directly to consumers.

During the entire process, rather than relying on a personal physician to request testing, deliver results, and answer questions I communicated directly with 23andMe. Diagnoses were never involved-just potential risk factors and carrier statuses. Imagine, however, the personal impact of discovering that your results include Parkinson's or another serious illness. That physician as middleman sounds more necessary than ever.

23andMe Testing: You're Putting Yourself At Personal Risk

Do you care about this information so much that you could risk not being able to get life insurance or long term care insurance? If an insurance company gains access to your data, then these could be the consequences not only for you but potentially also for your relatives who did NOT consent to having their DNA tested.

Is genealogy information so important to you that you could risk a possible data breach? Regardless of what 23andMe says about their security and privacy protocols, think about hackers and the value of all that data in one place.

If data systems can be breached at the IRS, Target, Home Depot, Anthem, AOL, Heartland, Ebay, JPMorganChase, and other large organizations, what makes 23andMe and their corporate partners immune? If you think you're not at risk, you're fooling yourself.

Risk Assessment for Health Conditions

I received the full "benefit" of 23andMe services prior to the December 2013 FDA involvement, when they were supposedly unimpeded by government intervention. I was left with a big "so what?" Today's consumers who grasp at the even more watered down health reports should consider that carefully.

The so-called health information was of varying usefulness. Some conditions tested only one or two genes associated with a disease or condition known to involve multiple genes. ( What's the real value in that?) Other results were based on findings of questionable validity (e.g., preliminary research studies involving less than 100 people). This is scientifically meaningless.

Still other reports were marginally interesting but of no practical value: hair curl and earwax type. Finally, there were other results that seemed to be issued based on what I had reported to 23andMe already in a survey. They were reporting back to me what I had reported to them. Duh!

A Word To the Wise

I became alarmed with 23andMe in the Spring of 2015 when I attempted to confirm with the customer care department that they had my status as OPTING OUT of research participation. The company's recent partnerships with 12 big pharmaceutical companies had triggered concern about privacy, security, who owned my data, and how it would be used.

I had completed some but not all of their exhaustive battery of surveys and had not logged on for a very long time. In response to my clearly worded request that I withdrew my consent from research, the customer care replied that "23andMe may still use the information for internal purposes." 23andMe was the door that, once opened, can never be shut.

I'm not done with 23andMe yet, however I am left to wonder what "internal purposes" means? Who has access to my data? What are they using it for? How many other people have made similar requests and had them unheeded?

Is it worth $199 to reveal your genetic code to a private company with big links to Big Data for the mere benefit of perhaps connecting with fifth-degree cousins. In the future will we be able to Google our DNA code?

My advice: If you're curious about your family tree, look to genealogy, not genetics.

A good family tree/geneology service will NOT require you to provide a biological sample

What's In Those Surveys?

23andMe survey topics include a variety of topics. Examples include:

personality measures

commonly used medications

sexual orientation survey

questions about tobacco and caffeine usage

pesticide exposure and

which toe is the longest.

Although 23andMe indicates that 90% or more of its consumers do participate in their survey research, users can opt out of surveys they consider overly intrusive or decline to participate in surveys altogether.

Sources

1. Hamilton, Anita. "1. The Retail DNA Test - Best Inventions of 2008 - TIME." Breaking News, Analysis, Politics, Blogs, News Photos, Video, Tech Reviews - TIME.com. Last modified October 29, 2008. Accessed March 15, 2013. http://www.time.com/time/specials/packages/article/0,28804,1852747_1854493_1854113,00.html.

2. Rochman, Bonnie. "Good Genes - TIME." Breaking News, Analysis, Politics, Blogs, News Photos, Video, Tech Reviews - TIME.com. Last modified August 20, 2012. Accessed March 17, 2013. http://www.enhancedmedicalcare.com/portfolio-items/time-magazine/.

3. Neff, Gina. "23andMe vs. the FDA: Both are wrong." Slate Magazine. Last modified December 13, 2013. http://www.slate.com/blogs/future_tense/2013/12/13/_23andme_vs_the_fda_both_are_wrong.html?wpisrc=burger_bar.

4. National Center for Biotechnology Information. "SNPs: Variations on a Theme." National Center for Biotechnology Information. Last modified September 20, 2007. Accessed March 16, 2013. http://www.livingnaturally.com/ns/DisplayMonograph.asp?StoreID=3ED1FF6A18BD42979FFF73C8E8CD4512&DocID=genomic-snp.

5. 23andMe. "What are SNPs?" 23andMe. Accessed March 15, 2013. http://www.23andme.com.

6. 23andMe. "Genotyping Technology." 23andMe. Accessed March 15, 2013. http://www.23andme.com.

7. GenebyGene. "Products." DNA DTC. Accessed October 17, 2014. http://www.dnadtc.com/products.aspx.

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The Risks and Benefits of 23andMe DNA Analysis

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I signed up for 23andMe with an open mind. I emerged with deep concerns about privacy, among other issues. Thanks to the U.S. Food and Drug Administration (FDA), 23andMe was out of the genetic testing business as of December 2013-not that those genetic tests were all that practical to begin with.

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- information released can ruin chances of getting good insurance

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- you will be able to detect health risks early and change your lifestyle accordingly

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- some people can not handle the emotional results

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- 23andMe's personal DNA test is not FDA approved

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- Your own DNA has the possibility of being sold, bought, or transferred to others

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Although my health is very important to me, I would not take the 23andMe genetic test. 23andMe is not FDA approved and their results have no scientific evidence meaning the results given to you are meaningless. DNA is your identity and is very personal, after the genetic test 23andMe keeps your DNA for other unknown purposes. Lastly, not all the results for the genetic testing are optimistic and positive and most people do not react well to bad news. Knowing that you have a high chance of a disease in the future causes unnecessary stress and may cause physiological health conidtions. I do not want to know if I have a risk of having an incurable disease in the future, I want to live my life and let things play out naturally.

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23andMe hit with lawsuit over "meaningless" gene testing

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23andMe hit with lawsuit over "meaningless" gene testing

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A class-action lawsuit claims 23andMe misled customers over its $99 genetic test.--Courtesy of 23andMe

Amid scorn and scrutiny from the FDA, 23andMe is facing a class-action lawsuit claiming the company misled customers by selling genetic tests with no real scientific value, and plaintiffs want at least $5 million in damages.

In a California lawsuit filed last week, Personal Genome Service (PGS) customer Lisa Casey said that 23andMe billed its test as a resource for verifiable information like drug response, carrier status and health risks, marketing claims she argues are false and misleading because they came without the FDA's sign-off. The lawsuit also calls into question 23andMe's stated goal of amassing users' genetic data, saying the company intends to market that information to third parties "even though the test results are meaningless."

Casey invites all of 23andMe's customers, assumed to be in the hundreds of thousands, to join the suit, seeking $99 in damages for each in what amounts to a refund for PGS.

The lawsuit came just days after the FDA fired off a sternly worded warning letter chiding 23andMe for its deadbeat regulatory strategy and demanding PGS be taken off the market. This week, the company confirmed that it had pulled all of its TV, web and radio ads, but, as of Tuesday evening, would-be customers can still order the test on 23andMe.com.

23andMe isn't commenting on the lawsuit and, outside of a fairly vague blog post by CEO Anne Wojcicki, has remained tight-lipped about the FDA issue. That said, the company has essentially spelled out its counterargument elsewhere: 23andMe maintains that PGS is not a diagnostic service but is instead "intended for research and educational purposes only," a distinction that would theoretically exempt the test from the rigors usually required of legally defined medical devices.

The FDA, of course, disagrees, arguing in its letter that PGS's listed uses dovetail perfectly with its definition of a diagnostic device, thus requiring clinical validation before marketing. The agency worries that unverified PGS results could motivate patients to take drastic measures like undergo elective surgery or alter their drug regimens, and, after years of sporadic contact with 23andMe, the FDA has apparently run out of patience in demanding that the tests come off the market.

For its part, 23andMe stands by the accuracy of the data it returns to customers, and while Wojcicki acknowledges that the company is "behind schedule" with its FDA submissions, she has seemed to suggest a compromise with the agency in regulating the "new industry" of personal genetic testing.

- check out the lawsuit (PDF)

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23andMe hit with lawsuit over 'meaningless' gene tests

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A class-action lawsuit claims 23andMe misled customers over its $99 genetic test.--Courtesy of 23andMe Amid scorn and scrutiny from the FDA, 23andMe is facing a class-action lawsuit claiming the company misled customers by selling genetic tests with no real scientific value, and plaintiffs want at least $5 million in damages.

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I believe that 23 and Me is beneficial to its customers. I would take this genetic test because it will help me life a healthier life in the future. For only $99, 23 and Me will help me detect health problems and change my lifestyle accordingly. The test will also help me save money in the future if I were to have a health disease because I could have prevented it early on. In addition, I can learn about my ancestry and even learn about relatives that I may not have known. Many people say that 23 and Me is not trustworthy, however, 23 and Me is a very popular genetic testing company and has been featured on many famous media groups such as CNN and The New York Times.

However, I would take it when I am older because taking it now can lead to high levels of stress if the test results were to show that I had a life threatening disease. I think that young people can not handle the results, if they were bad, and will cause a lot of stress. School can already be stressful and knowing bad information that you might have a life-threatening disease would be psychologically devastating. In addition, I would be able to pay for it myself and in the future, it may become even more accurate and inexpensive.

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- only costs $99, compared to the prices before, which cost up to $2500

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- could help prevent any diseases

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- can learn about ancestry and discover new relatives

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-reports of over 240 different health conditions and traits

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-23 and Me is trustworthy and has been reviewed on many popular media.

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23 and Me is a genetic testing facility that will test someone's DNA to see if they have any health risks with just a small sample of DNA. It will also tell someone about their ancestry  and if their children are at risk of an inheritable disease by their carrier status. For only $99, this service can help people detect and take action against life threatening diseases before it happens.

Steps:

- Make an account to 23andMe

- Order your genetic testing kit for just $99

- provide a saliva sample and mail it to 23andMe

- In about 6-8 weeks an email will be sent to you with your genetic results

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Reports and features that are "Powered by 23andMe Research" are developed by 23andMe scientists using data and insights gathered from thousands of customers who have consented to participate in our research.

Skin Cancer (Basal and Squamous Cell Carcinomas) and Skin Cancer (Melanoma) reports (Powered by 23andMe research)

Reports and features that are "Powered by 23andMe Research" are developed by 23andMe scientists using data and insights gathered from thousands of customers who have consented to participate in our research.

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23andMe has rigorous standards that ensure high-quality results. Our team of scientists and medical experts use a robust process to develop genetic reports for our customers. Here are specific examples:

With one of the largest reference datasets in the world, 23andMe provides customers with one of the most detailed and accurate ancestry breakdowns on the market. Our algorithms make ancestry estimates based on probabilities and they're generally very accurate, but your results are not set in stone. We are always trying to improve and refine these estimates.

Our Genetic Health Risk*, Carrier Status*, Pharmacogenetics** reports meet FDA requirements. This means that each variant in those reports demonstrated >99% accuracy and reproducibility when tested under different laboratory conditions. This article provides additional information.

How does 23andMe DNA testing work?

After you provide a saliva sample, 23andMe uses genotyping to analyze your DNA. This means we look at specific locations in your genome that are known to differ between people. We then turn those results into personalized genetic reports on everything from ancestry composition to traits to genetic health risks. Note that genotyping is different from DNA sequencing, which looks at every letter in a particular stretch of DNA.

Who can use 23andMe?

Most adults who are able to provide saliva samples can use the 23andMe kit. However there are some considerations that can complicate the DNA accuracy. Check out our Terms of Service for more info on those cases.

How do I get my 23andMe reports and how long does it take?

To begin, visit www.23andme.com/start. Once you have successfully registered your DNA testing kit, provided a saliva sample and put the kit in the mail, you can use the return tracking link available on your profile homepage to track your kit's progress to the lab. Once your sample reaches the lab, it is typically processed within a few weeks, with results then delivered to your secure online account.

Do 23andMe DNA test kits expire?

We encourage customers to provide their sample before the "Collect saliva by" date on the side of the collection tube. If your sample collection kit is lost or damaged, or if it has expired, please contact customer care to assist you with getting a replacement kit.

Why should I choose 23andMe?

There are many benefits of DNA testing, including finding relatives, learning whether you have genetic variants you could pass onto your children, and receiving personalized insights into your health and ancestry. 23andMe Health + Ancestry Service offers 150+ DNA reports that do just that. In addition to taking greater control of your own health and digging deeper into your ancestry, you can also opt in to participate in research that could help fuel scientific discoveries that benefit the larger community.

We're also committed to providing you with a safe place where you can learn about your DNA knowing your privacy is protected. 23andMe has sold 12+ million kits, and with each and every one of those, privacy has been our number one priority. You may learn more about our commitment to privacy here.

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*The 23andMe PGS test includes health predisposition and carrier status reports. Health predisposition reports include both reports that meet FDA requirements for genetic health risks and reports which are based on 23andMe research and have not been reviewed by the FDA. The test uses qualitative genotyping to detect select clinically relevant variants in the genomic DNA of adults from saliva for the purpose of reporting and interpreting genetic health risks and reporting carrier status. It is not intended to diagnose any disease. Your ethnicity may affect the relevance of each report and how your genetic health risk results are interpreted. Each genetic health risk report describes if a person has variants associated with a higher risk of developing a disease, but does not describe a person's overall risk of developing the disease. The test is not intended to tell you anything about your current state of health, or to be used to make medical decisions, including whether or not you should take a medication, how much of a medication you should take, or determine any treatment. Our carrier status reports can be used to determine carrier status, but cannot determine if you have two copies of any genetic variant. These carrier reports are not intended to tell you anything about your risk for developing a disease in the future, the health of your fetus, or your newborn child's risk of developing a particular disease later in life. For certain conditions, we provide a single report that includes information on both carrier status and genetic health risk. Warnings & Limitations: The 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is indicated for reporting of the 185delAG and 5382insC variants in the BRCA1 gene and the 6174delT variant in the BRCA2 gene. The report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer. The three variants included in this report are most common in people of Ashkenazi Jewish descent and do not represent the majority of BRCA1/BRCA2 variants in the general population. This report does not include variants in other genes linked to hereditary cancers and the absence of variants included in this report does not rule out the presence of other genetic variants that may impact cancer risk. The PGS test is not a substitute for visits to a healthcare professional for recommended screenings or appropriate follow-up. Results should be confirmed in a clinical setting before taking any medical action. For important information and limitations regarding each genetic health risk and carrier status report, visit 23andme.com/test-info/

**23andMe PGS Pharmacogenetics reports: The 23andMe test uses qualitative genotyping to detect 3 variants in the CYP2C19 gene, 2 variants in the DPYD gene and 1 variant in the SLCO1B1 gene in the genomic DNA of adults from saliva for the purpose of reporting and interpreting information about the processing of certain therapeutics to inform discussions with a healthcare professional. It does not describe if a person will or will not respond to a particular therapeutic. Our CYP2C19 Pharmacogenetics report provides certain information about variants associated with metabolism of some therapeutics and provides interpretive drug information regarding the potential effect of citalopram and clopidogrel therapy. Our SLCO1B1 Pharmacogenetics report provides certain information about variants associated with the processing of some therapeutics and provides interpretive drug information regarding the potential effect of simvastatin therapy. Our DPYD Pharmacogenetics report does not describe the association between detected variants and any specific therapeutic. Results for DPYD and certain CYP2C19 results should be confirmed by an independent genetic test prescribed by your own healthcare provider before taking any medical action. Warning: Test information should not be used to start, stop, or change any course of treatment and does not test for all possible variants that may affect metabolism or protein function. The PGS test is not a substitute for visits to a healthcare professional. Making changes to your current regimen can lead to harmful side effects or reduced intended benefits of your medication, therefore consult with your healthcare professional before taking any medical action. For important information and limitations regarding Pharmacogenetic reports, visit 23andme.com/test-info/pharmacogenetics/

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DNA Genetic Testing For Health, Ancestry And More - 23andMe

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23andMe offers DNA testing with the most comprehensive ancestry breakdown, personalized health insights and more.