23andMe & Ancestory.com DNA Shutdown

For weeks and weeks the TV had been showing commercials for 23andme DNA home test kits as well as Ancestory.com home DNA test kits. However, this past week the government stepped in and shut down the home kits and made the companies cancel all advertising for their products.

The government (FDA) claims they are doing this out of concern for the customer. But is that true? I doubt it. Nothing with the government is ever what they claim it is. I don't know if the FDA is just embarrassed because they are behind the times and aren't smart enough to keep up with the information provided in the home DNA test kits. I don't know if the government is nervous because the ground floor companies in the home DNA test kits stand to make a fortune. I don't know if the medical companies are pushing the FDA to stop the home test kits because they are so much LESS EXPENSIVE then the ones the same ones that doctors order through hospitals and medical offices. I don't know for sure but I'd bet it's all of the above reasons.

Huffington Post is calling for the FDA to 'get out of the way' of people taking control of their own health care and being informed about themselves. The FDA needs to 'get out of the way' of revolutionary change to the medical field - says the Huffington Post. I agree.

Huffington Post Reacts to Home DNA Kit Ban

Those of us who have already used the site know the real problem is that doctors themselves are behind the curve. When 23andMe sent us our results, we followed their advice: we asked our doctor to talk about them. Most doctors didn't know where to begin. But the more of us ask about 23andMe, the more the medical profession is catching up. Slowly but surely, they're brushing up on genomics, taking the time to understand the site, and talking to us about our results and what, if anything, to do about them.

By prompting such dialogue, 23andMe has sparked a revolution in how the medical profession uses genetic information. Change like that rarely, if ever, comes from within an industry; it's almost always driven by people on the outside with new approaches and technologies that disrupt old paradigms -- like the idea that genomics aren't something "ordinary" doctors need to understand or that patients shouldn't be active, informed participants in their healthcare.

We're urging the FDA not to short-circuit this revolution, and have launched a Change.org petition to rally those who agree. Our message is simple: "Please trust us -- and our doctors -- to make responsible use of our own genetic information. Instead of banning new technologies, the FDA should focus on educating doctors and patients about the benefits, and limitations, of genetic testing.

Genetic test maker 23andMe stops marketing after FDA warning

Home genetic test maker 23andMe, which is backed by Google Inc, stopped marketing its products last week after the U.S. Food and Drug Administration warned that it did not have regulatory approval to do so, a company spokeswoman said.

The company stopped television, radio and online advertising for its $99 DNA test which is supposed to detect a range of genetic variants and provide information about a person's health risks, the spokeswoman said.

The FDA said last week it had sent a warning letter to the company on November 22 stating that products designed to diagnose, mitigate or prevent disease were medical devices that required regulatory clearance.

Official 23andMe site

According to the founder of the company - the purpose of home genetic testing is to revolutionize health care. They also stand to make a fortune because they are in at the ground floor of this. (and that's not a bad thing ... it's actually rather smart and kudos to them )
How the Small Start Up Company Got Started

Wojcicki has been thinking deeply about this for years. A former Wall Streeter with a degree in biology, she has parlayed a personal interest in wellness into a thriving, potentially groundbreaking business. Since founding 23and­Me in 2006--with the backing of an impressive list of investors including her husband, Sergey Brin, and the company he then ran, Google--she has been working toward two goals: bringing the power of genetic testing to everyday consumers so they can better manage their own health care, and using the aggregated data from those tests to help doctors, scientists, hospitals, and researchers discover new cures for diseases that emanate from troublesome genetic mutations. (Wojcicki and Brin announced their separation in August. A 23andMe spokesperson says, "He remains committed to the company.") It has not been a business for the faint of heart--the three other similarly positioned startups in the field have changed course--but Wojcicki has deep pockets, having raised more than $126 million since 23andMe's inception, with Yuri Milner, the Russian billionaire who's invested in Facebook, Twitter, and Airbnb, joining as a backer last December.

Ancestory.com Home DNA Testing
Ancestry.com had the DNA home testing kits as well. I'm pretty sure theirs went a step further and would give you ancestry and relative connections ... part of their ancestry tree stuff.

You can see the kind of information given to the customer here -
An Independent Review of Ancestry.Com DNA kit

Vanessa Williams was able to trace her DNA/Ancestry back through the slave years.
it was surprising and important information for her.
Huffington Post - Vanessa Williams Ancestry Mail Order DNA Test Kit Results

I know that many here will say that people shouldn't be doing these home test kits because it gives away your DNA data to a company and you have no control over it afterwards. That's true. BUT ... these can also do the customer a whole lot of good and can be preventative medically. It puts power into the hands of the customer and out of the hands of the doctors/medical establishment. It also tells those who are adopted about their genetics and family medical history ... that's important. (in our case, we have no idea about our daughters birth family and it would be good to know if there are medical issues she'll have to be careful with in the future)

I think the fact that the home test kits are so much less expensive than what doctors order via hospitals and medical facilities is what is pushing the FDA to put a lid on them. Really. I think it's a $$$ thing.

I hope the Huffington Post is successful in it's campaign to get these back on the market.
People should be able to find out about themselves and make their own decisions.
It's OUR DNA ... we should be allowed to access the information in it.

There is an online petition to stop the ban ... but I'm not sure if I'm allowed to post it so I won't.
You can google it up if you are interested.

Are these the same tests that you can use to determine paternity with as well? I actually know two people that have used those, and in both cases, of course it was cheaper than waiting for the courts to order it done.
It saved one fellow a lot of heartbreak.

I think it is ridiculous to ban them. Seriously, it is our choice to go this route, and use this test to find out all kinds of info about ourselves. What are they really afraid of?

FlyersFan


Ancestory.com Home DNA Testing
Ancestry.com had the DNA home testing kits as well. I'm pretty sure theirs went a step further and would give you ancestry and relative connections ... part of their ancestry tree stuff.

You can see the kind of information given to the customer here -
An Independent Review of Ancestry.Com DNA kit


maybe its because of this reason ? in the western world you have sperm donators as well as egg donators ( correct me if im wrong ) so in making these tests two married couples might find out that they are brother and sister and by finding out this info it will cause problems , i dont know maybe im wrong but just a thought .

I thought the ban was directed toward the specific company, 23andMe. Aren't there other companies beside 23andMe that offer genealogical y-DNA and mt-DNA testing that are not (yet) banned from selling the home kits?

chiefsmom
Are these the same tests that you can use to determine paternity with as well?

No that's a cheaper test. That one is $80.00 and only does paternity.
This one is DNA mapping for $100.00 for one person.
Ancestry.com will also map any dna relatives that are on their database for you.
You can discover cousins you didn't know you had ...

alphaether
I thought the ban was directed toward the specific company, 23andMe.

They are only talking about the ban for 23andMe. However, there are other companies who have the DNA test kits - including ancestry.com. They were advertising heavily on TV but now they are not. So considering that the DNA test kits are pretty much identical (ancestry.com connects you with dna relatives but I don't think 23andMe does), I'm thinking ancestry.com is also banned from advertising. Their ads have dropped off the TV even though a few weeks back they were on constantly.

I may be paranoid, but...

How does this play into companies ability to patent DNA?

The reason I ask is I seem to recall something of a poor man patent of sending your idea via certified snail mail.


Would having your own DNA result sent to you mean you just poor man patented your own DNA?

I haven't been following the GMO DNA patent thing to closely so don't know if I'm just wrongly speculating here.

reply to post by FlyersFan


Thanks for clearing that up. I have been researching my ancestry for the past few years and was planning to order a home DNA swab kit for my dad, whose paternal line I cannot trace back more than two generations. I'll be pretty frustrated if I can't move forward with this option.

reply to post by FlyersFan

I think the fact that the home test kits are so much less expensive than what doctors order via hospitals and medical facilities is what is pushing the FDA to put a lid on them. Really. I think it's a $$$ thing.

I agree that it's definitely a money thing. From the huff post article:

Today, the FDA shut down further sales of the saliva home-test kit, citing the "potential health consequences that could result from false positive or false negative assessments for high-risk indications... For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist."

This doesn't make sense since nobody is going to be able to get any of these treatments without a doctor anyway. I do think that there should be very clear explanations attached to the results but as long as the companies are accurately and ethically conveying the results, it's no different than any other diagnostic test.

I think an even scarier thought is that this is an attempt to force people to get genetic screening through health insurance companies who could later use the results to preemptively raise premiums.

Very silly thought here:

Maybe the government is afraid that (certain) people will find out that there is 'alien' DNA mixed in with their own, you know, "disclosure" by saliva?

lostgirl
Very silly thought here: Maybe the government is afraid that (certain) people will find out that there is 'alien' DNA mixed in with their own, you know, "disclosure" by saliva?

I don't think that's silly at all. The more we know, the less control 'they' have. If the general population suddenly understands DNA and all it implies ... who knows what we'll find out!

I'm more inclined to believe it's a $$$ thing ... the big companies pushed the FDA to shut down the less expensive private testing so that the big companies could keep the monopoly.

But you never know ....

reply to post by FlyersFan


This is a shame.

I recently had my genome done by ancestry in hopes of finding my father's birth family. (my brother is getting his y dna done as well)

There is a program called Promethease (which is associated with 23andme) where you can download your genome data and it gives you all genetic traits that are known within your genome.

I found I had a double defect on a gene that is responsible for the breakdown of Folic Acid to folate.
It seems 20% of people of Central European ancestry has this double defect. One defect makes the process 35% less efficient which causes a gradual build up of homocysteine. The other defect effects the breakdown of Folic Acid to the components that make serotonin, epinephrine, dopamine, etc. I also found I was 7 times less likely to respond to antidepressants.

I have struggled with depression my whole life and now have an answer to why (aside from the stress).

I wondered about my life long increase in MCV (mean corpuscular volume) and MCH (mean corpuscular hemoglobin) that doctors have blown off...'for some reason you make big fat red blood cells'. Increased homocysteine is known to be one of the causes of this.

Elevated homocysteine is inflamatory and people have a 50% increased chance of developing cardiovascular disease besides a host of other diseases/disorders.

I have found a work around by taking methyl folate, methyl B-12 and B complex without folic acid.

No dr. has seen cause to investigate any of this so they would have only treated the symptoms and not the cause.

I always believed people have to take responsibility, to the degree they are able, for their own health. Who is more interested in your health than you? This takes one tool out of our hands and gives it to the medical/drug industry.

reply to post by liveandlearn


Sounds like you got good information that you could have worked with.

One week before 23andMe got shut down, our daughter sent her DNA sample in for testing.
She is adopted and we have no way of knowing anything about her family health history.
It would have been helpful to have SOMETHING for her to know about and to watch for.
So we are in limbo. Her test sample is in their lab. I don't know if we'll get the info or not.

The gov't is screwing with something they shouldn't be.
(no surprise, eh?)

I wonder if there might not be more to the story. I went off to see what prompted all this, since the FDA normally moves at a snails pace but does at least make a warped kind of Government sense on what it does.

err.. There definitely is a bit more to it..

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.”

Who is Anne Wojcicki, one might wonder? Well.. It would be clearer if she'd taken on the traditional married name of Brin.

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.

23andme isn't just google backed, like it's run by an employee or something. It's the personal project of the wife of a Google co-founder. That same google that has working relationships with the NSA and those nasty folks. Same google out collecting everything about everyone, everywhere.

People have been willingly..and even paying, to send DNA to google for years. We also know the FDA has been at this since 2009.

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.

Source

The story is interesting in explaining what some of the logic has been. I don't know how much I agree with, but before I knew who backed it, I was wondering if I might want a scan myself. Now? Well... err... I'm glad I looked. Wow.. Google is everywhere.

FlyersFan
reply to post by liveandlearn

 

Sounds like you got good information that you could have worked with.

One week before 23andMe got shut down, our daughter sent her DNA sample in for testing.
She is adopted and we have no way of knowing anything about her family health history.
It would have been helpful to have SOMETHING for her to know about and to watch for.
So we are in limbo. Her test sample is in their lab. I don't know if we'll get the info or not.

The gov't is screwing with something they shouldn't be.
(no surprise, eh?)

Well, hopefully since it is paid for and in process you will get your results. I checked my results and they are still available thru Promethease who apparently analyzes it through 23andme info.

It seems the company could easily get by the complaint that some of the information may not be correct by recommending specific testing via a physician for the particular gene concerned.

The thing is, the genome is still a work in progress. My particular defect has been studied for many years. More often than not I found I had some bad genes balanced by more or less good ones. What to make of that? It also said that I should be able to tolerate lactose...I can't. There could be one or more that says I can't but it hasn't been identified as yet.

So when you get your results you will have an enormous amount of research to determine the relevance of any particular risk of concern.

Best wishes

FlyersFan

One week before 23andMe got shut down, our daughter sent her DNA sample in for testing.
The gov't is screwing with something they shouldn't be.
(no surprise, eh?)

Well there is still hope. The FDA letter does NOT shut them down, it merely states that until they can bring their claims up to compliance they cannot market it. Complete shut down is alot different than stopping all marketing campaigns. Here is a copy of the FDA letter to 23andMe . In the letter it does not call for a shut down at all, but states:

Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.

The fact that you are still able to purchase the test kit from 23andMe's Website tells me that they are still operational and I would think for those who have already submitted samples, results will follow. I was able to complete their online purchasing form all the way up to the billing section, and since I've no intent on purchase, that is where I stopped. (By the way, the kit offered by Ancestry.com is also still available for purchase)

Per 23andMe's own blog they admit that they have not met the requests of the FDA:

We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.

Having said that, I also hope that this can be resolved because I do think that this service is a valuable one for anyone that is at all concerned with their own health and wants to be able to possibly prevent future health problems. (Although I have to confess to not exactly being comfortable with turning over my DNA to a company that in the future could then hand it over to a government agency to do with as they see fit..... hey what can I say... this IS after all a conspiracy website )

I dont know about the other website, ancestory, but a article I was reading yesterday on cnet about 23andMe says that they only cancelled the marketing, you can still buy the kits but you just wont see advertising for them.

CNET - 23andMe halts advertising amid FDA demands

People can still buy the genetic-testing startup's popular at-home testing kits, but they won't see any marketing for these products.

reply to post by Wrabbit2000


Nicely done, Wrabbit. Google really does involve themselves with some very creepy things. Remember that Motorola neck tattoo from a few weeks ago? Well, Motorola is owned by Google as well. www.google.com...

There is no other company or entity that frightens me more than Google does. At least the NSA does what it does under the banner of national security. Google just wants to sell us and they seem to want to know everything about us and be with us at every step of the way whether it be an eyepiece, a neck tattoo or what our DNA looks like.

Other interesting Google related patents (courtesy of Google, lol):

Facial recognition obscuring technology. Basically deters facial recognition by applying blurs to certain portions of the face that are used in facial recognition technology. Doesn't sound creepy at all and pretty great but patents can also be used to control technology. www.google.com...

Object tracking in videos with visual constraints such as lighting, blurring. "Once an object is tracked in the video, an object recognition algorithm may be used to identify the object. In an example, a face recognition algorithm can use the position of the face in each frame to determine the face's identity."
www.google.com...

Age estimation based on facial image. This software basically identifies the image of a user's age, which could help with user identification: www.google.com...

Kind of bizarre when you think about it but apparently, Google is into television, too: www.google.com...

23andMe is the subject though so let's see what they've got filed with the patent office to help clear up just what is their game.

This patent is on figuring out a way to connect the consumer of 23andMe DNA testing with a third-party for the sale of services or products related to the DNA results. The first example that they give seems fairly noble--a doctor perhaps or insurance provider. However, screw nobility because Google and its affiliates make their biggest bucks through revenue streams for advertising/marketing. In the case the individual is a consumer, and the third party a food provider (Nestle, Danone...), the food provider might benefit from gathering specific information of this individual/consumer. For instance, an analysis of this individual for his susceptibility of tasting cilantro as a fresh spice rather than as soap, might make the individual amenable to be part of a test panel for a novel pre-prepared meal containing cilantro. This way the food provider could recruit/invite the individual based on its specific 'predisposition' of cilantro taste. Basically when you use the 23andMe service, they will inform third parties that may be interested in your genetically related preferences of those preferences. www.google.com...

Want life insurance? Well 23andMe also has a patent on determining life expectancy based on genomic information that can be utilized by life insurance providers. Ponder that one for a moment. You could be as fit as a fiddle but have predispositions for certain ailments later in life that could influence any life insurance policy that you try to obtain in the future. The rather humorous thing about this one is the fact that Goog--I mean 23andMe--complains about monopoly issues. Cute... www.google.com...

This one is curious and is from 2009. The inventors/inassignees aren't linked with any entity; however, it specifically uses information gleaned from "scientific segments", mentions 23andMe as one of those segments, to basically provide a very in-depth profile of an individual for marketing purposes. www.google.com...

There are serious third-party issues with using 23andMe's services. Given that Google's primary intent seems to be collecting information about individuals for the purpose of selling that information to all sorts of entities (NSA, marketers, manufacturers), it should be zero surprise that 23andMe is loaded precisely for that as well. If any of you have used 23andMe, I hope you're comfortable with the idea that Nestle may have been notified of some of your genetic information, too.

I wasn't specifically looking for this, but here is a whole new chapter to the 23andme story....

SAN DIEGO (CN) - A California company is selling a bogus $99 DNA saliva test that it falsely claims can identify 240 health conditions and risks, a class action claims in Federal Court.

Lead plaintiff Lisa Casey sued 23andMe Inc., a Delaware corporation based in Mountain View, Calif.

Casey claims the company - apparently named for the 23 human chromosomes - "falsely and misleadingly advertises their Saliva Collection Kit/Personal Genome Service 'PGS') as providing 'health reports on 240+ conditions and traits,' 'drug response', 'carrier status', among other things, when there is no analytical or clinical validation for the PGS for its advertised uses."

Courthouse News

I'm thinking the FDA ruling helped clear the way for this lawsuit being filed, among other things.

Typical government agency, they ban something as harmless as a home DNA kit but allow things like cigarettes,which kill millions of people a year, to continue to be sold.yep, the FDA is doing a bang up job, that`s tax money well spent funding those clowns.