FDA Enters Genetic Testing

Since there are lots of genetic testing companies, and this particular one happens to be backed by Google, one has to wonder if there might be a little arm twisting going on.

Don't mess with us.

http://www.policymic.com/articles/48679/nsa-prism-program-google-may-have-refused-to-cooperate-with-the-nsa-but-even-that-s-a-secret

Hmmm....coincidence?

http://idebate.org/blog-post/google-%E2%80%9Coutraged%E2%80%9D-nsa

It's in the wording of their advertizing. Which gets the FDA involved. Because they claim that the results can lead to prevention.

The FDA has been beating on their doors for years to get the information necessary to comply with their standards. With no results from the company. The kicker that started the ball rolling on the ban was when they place and ad on national TV.

Not saying that the aim of this was not against Google. But Google has investments in another DNA test lab that doing the same work. With no problems from the FDA.

http://www.theverge.com/2013/11/25/5144928/how-23andme-brought-down-fda-wrath-personal-genetics-wojcicki

I watched the ad, and I don't see any false advertising, nor do I consider it to be a medical product.

Can the FDA produce anyone that has been hurt by this company?

At least this test is based in science...what about people that believe in horoscopes?

Should we ban those also?

If people are misunderstanding the results of these tests, it looks to me like they are making healthier choices based on those results. So if the results are accurate, and some stupid person takes steps to reduce their risk of diabetes, (based on a misunderstanding), is it bad?

The company should just have to provide a disclaimer that says that the test is not intended to diagnose or predict future illness, and that it doesn't replace regular checkups with a doctor. Period.

Just for the heck of it, I did a search to find out if Google had done anything to piss off "big brother" recently. That's where the NSA link came from.

From their web site

"A simple DNA test led to an unexpected diagnosis for a mother and daughter, changing their lives forever."

The product is a collection tool for biological agents. Which can carry disease. Which are being sent though the mail. There needs to be some control there. What if the spit in the cup carries an infectious disease.

The test which you have not referring to. The sample is sent to a lab. Which cost $999.00. Is a diagnostic tool. It can't diagnose anything just the possibilities. In which you need a medical professional to get involved.

All the FDA want is accuracy test. Which they have not provided.

With out accuracy you may have a whole lot of healthy people running to their doctor for problems that don't exist. For farther test and treatment. Which in the long run will push medical coverage up for us all.

You ask whether anyone been hurt. The FDA into prevention. So you want someone to be hurt first! What about you and me? I pay my medical insurance.

Hey you got a grand you can throw away for a test of possibilities on your health that may not be accurate because no one is insuring it is? Sounds like a scam doesn't it!

The test is $99, not $999.

...and if the testing facility is unable to prove 100% accuracy, then we have a responsibility to stop using DNA in criminal trials...where the same risks exist, except people end up with death penalties and prison time based on tainted samples.

http://www.themacdonaldcase.org/accuracy.html

If anyone has hurt anybody with sloppy lab work, it would be the government.

http://abcnews.go.com/WN/fbi-north-carolina-crime-lab-buried-blood-evidence/story?id=11431980

If they cannot comply with the exacting standards that they are demanding of this company, then it ALL must be shut down. They can't have it both ways.

http://www.deathpenaltyinfo.org/accuracy-dna-matches-definitively-identify-suspects-questioned

The $999 came from an old article.

So you want to stop all use of DNA because one lab won't produce the results of tests for their accuracy. Where all the other labs have complied.

To me your link to the NC crime lab is criminal behavior not sloppy lab work. To omit evidence more likely to get prosecutions. I would be looking at the DA at the time. I wonder what political office the DA hold now.

Interesting link to shared DNA markers that were found shared. Seem the FBI needs to better the test.

So how does all the wrong doing and possible problem with DNA testing justify the FDA not to do their job. All they ask are reports of test for accuracy. Since none were provided they shut a proportion of the work they do down. Their $99 public testing.

I'm up at 4 AM, and use the time to drink coffee and check on things I've heard. Just delved into this, this morning, after hearing about it on the radio yesterday.

No hidden agenda, just opening it up for conversation. I'm still looking around, but I haven't found exactly what the demand for accuracy means.

Yeah, the NC case was criminal, and a massive mess.

I'm trying to find the standard for accuracy that the FDA wants.

Is it the same standard that the government uses when trying criminal defendants, and in which mistakes are made, or is it a higher standard?

This article states that they use certified testing labs.

http://www.sfgate.com/health/article/23andMe-asks-FDA-for-some-test-approval-3748013.php

If the labs are certified, wouldn't they be certified by a government agency?

23andme is the testing lab. They also do DNA research. This lab is the lab the FDA has the problem with. It all maybe just records on equipment calibration.

Maybe so, but it looks like the lab is in compliance.

http://blog.23andme.com/23andme-and-you/sorry-for-the-delay-a-message-from-23andme-founders-anne-wojcicki-and-linda-avey/

that article is 5 years old.

http://blog.23andme.com/news/an-update-regarding-the-fdas-letter-to-23andme/comment-page-1/#comment-358664

Not that this article informs us of what the real issue is with the FDA. Just there seems to be one.

here seem to be the problem

http://qz.com/151202/23andmes-problem-isnt-the-fda-its-that-no-one-knows-if-it-works/

Good find.

Here's a problem, (for me).

The FDA has concerns that 23andMe genetic tests could have serious consequences, in the form of false positives resulting in unnecessary treatments (like preventative mastectomies) or false negatives resulting in ignored conditions.

How in the world is anyone going to get unnecessary procedures without a doctor being involved?

A woman can't just walk into a hospital and tell them to cut her boobs off, because her spit test showed a higher risk.

False negatives that result in ignored conditions?

I don't know about anyone else, but I don't go to the doctor unless I feel bad...which is rare. So I may be ignoring all kinds of conditions.

If I were 23andMe, I would just change my entire message to, "For entertainment purposes only; Not to be used as a diagnostic tool."

Problem solved.

Hypochondria

Sure she can it's done everyday. Breast augmentation for a score or more reasons. Too large. Too small. I want to be a girl. I want to be a guy. Plastic surgeon will cut you for what ever reason you want to give him. Look at some of those ridiculous face jobs people have had done. And they even paid for it. All elective surgery.

More anti-government propaganda.....give it a rest....

I wasn't aware that the Washington Post was an anti-government propaganda machine.

Is this story false, or is there a better source?

Should the government be able to block people from getting genetic testing? I guess your answer would be yes.

You must have had many imaginary playmates as a child, I'd say. That quality seems to have carried over into adulthood as a means of manufacturing a conspiracy when anything having to do with the government comes into the news.

If you would have us believe that sending away a bolb of spit to some unknown start-up business (about which you know absolutely NOTHING) and then making decisions about healthcare and maybe even medical treatments based on unknown "tests" supposedly carried out by anonymous "teshnicians" that may or may not be qualified you,re bonkers.

You are willing to put your life, and the lives of your family, in the hands of TOTAL strangers, who CLAIM to be running some unknown "tests" while distrusting the big, bad government? Really? Really?

Get serious.

First of all...my imaginary friends are still with me.

Secondly, I'd like to see some links showing that this company has misled customers.

How would I be risking my life by sending them some spit?

I'd agree that a lot of people wouldn't be able to make heads or tails out of the results...but where's the fraud?

This looks pretty comprehensive to me:

https://www.23andme.com/about/tos/

For starters, form your cited website:

"The website bills the service as a "first step in prevention," to help users in "mitigating serious diseases." "those are medical claims "

"including occasionally threadbare scientific data"

"detailing the hundreds of emails and 14 face-to-face meetings that led up to the block. As of January, the company still had not completed the studies it would need to make a marketing submission, despite operating for more than five years"

"Is a genetics professional involved in ordering or interpreting the test?" No.

This is no different than going to a drug store, hooking up some electrodes, running an EKG strip and interpreting the results of your self administered EKG.

Laypersons DO NOT know enough to essentially practice e-mailed medical results!!

Yeah, but a person can also jump on the internet, and have themselves talked into having all kinds of ailments.

I know some of those people.

Should all medical sites be closed...just in case someone mistakenly thinks they have something that they don't?

Why doesn't the FDA get some of their employees to take the test, and do an identical test at a government lab?

If the results don't match, bust them; if they are identical, leave them alone.

Is that too easy?

That wouldn't solve the problem of false advertising.

False advertising isn't the claim being made by the FDA.

From your article, once again, "The FDA said the company repeatedly has failed to provide the scientific data necessary to prove that its test works as advertised."

What is that, if not false advertising?

That's a stretch. What, exactly, is the data that the FDA wants?

...and what constitutes the test "working"? It's a DNA panel; it's not intended to do anything but provide information.

They are using peer reviewed studies to disseminate the information, which hasn't been proven, but serves as an indicator of certain conditions. Is that bad?

If the FDA has a problem with the advertising, they should just change it. Maybe hire the firm that's running the ACA ads on TV....it sounds great!!!!

Not at all.

"The website bills the service as a "first step in prevention," to help users in "mitigating serious diseases." "those are medical claims"

Don't be so thick.

So the FDA shut them down because they wouldn't remove those words from their ads?

They should just take them out.

Although, if I go to any medical website, look up the causes and prevention of heart disease...wouldn't that be considered a first step in prevention and mitigation?

Here's one just for you. But women should be especially scared.

https://www.mayoclinic.com/health/fecal-incontinence/DS00477/DSECTION=risk-factors

You just don't read these things, do you?

detailing the hundreds of emails and 14 face-to-face meetings that led up to the block. As of January, the company still had not completed the studies it would need to make a marketing submission, despite operating for more than five years"

What's a marketing submission?

If the tests are fine, is it okay for the FDA to shut down a company due to their marketing strategy?

Again...if I were the company, I would use this opportunity to shine a spotlight on the marketing of the ACA, and use that as an example of honesty and integrity, that has been fully vetted by the US government.

Any practice that has been deemed appropriate in the marketing of the ACA, should be appropriate for any private company...and I would fashion my marketing after that.

We're covered!!!!!!

There's just no hope for you.

This kind of clears things up.

http://www.foxnews.com/health/2013/11/27/23andme-what-really-wrong-with-personal-genetic-tests/

If the company makes it very clear that the tests are an incomplete evaluation, the FDA should leave them alone.

This shutdown doesn't seem to be about the test results, but that people are too stupid to understand them, and must be protected by the government.

I don't think so. This is a voluntary test, taken by adults that are willing to pay for it.

Should we stop online IQ tests...so stupid people don't get their feelings hurt or misunderstand the results?

Fox news? FOX NEWS????? FOX NEWS?????????

YOU'VE GOT TO BE KIDDING!

Fox "news" is so incredibly biased and Exceptionally RADICAL that I will not even open your offering!

I won't believe anything they say, so why bother!

Easy there Skippy...you're running the risk of a heart attack and fecal discharge.

Copyright 2013 LiveScience, a TechMediaNetwork company. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

You didn't read it to the bottom.

Fecal discharge?

If I grunt really, really hard can I discharge you????

That might cure the giant pain in the a$$ that you are!

Sometimes I scare myself with my spontaneous humor.

You scare a lot of people...just like the little man in the booth, in The Wizard of Oz.

Face it. This isn't about the company; it's about the American people being so stupid, that they are willing to put their full faith in a $100 DNA spit test.

If we've truly reached that point, this country is screwed anyway.

I don't even know why people would want these things. I want my cancer or heart disease to be a surprise.

"If we've truly reached that point, this country is screwed anyway." We're there already, and sinking rapidly up to our collective chinny chin chins.

10 year old kids spend thousands of dollars a year on smart phones and games, Twitter, hulu, YouTube, List of Internet phenomena - Wikipedia, the free encyclopedia.

We're doomed to destruction. The stock market is over 16,000 for no logical reason, except the insane reason you disclosed in another thread. Government subsidies? It HAS TO FAIL!

My wife's financial advisor gives us a year to get (at least some of) our money out of the market and into a safer place.

And, don't wait until the surprise becomes a shock. I did.

There's something to be said for "If I'd known I was going to live this long, I'd have taken better care of myself".

Happy Holidays.

If I'd known I was gonna live this long, I would have tried harder for an early grave.

I just went out for smokes, and the cops are huddled up getting ready to set up roadblocks.

I just got my spit test back, and they said that I'm inclined to become fearful of an all intrusive government.

Happy Holidays to you.

You smoke????

You premiums will be a lot higher when you sign up for Obamacare!!

I pay a higher premium now.

I'm transitioning to one of those E-cigs. They work pretty good. The juice I got for it is actually stronger than the ultralight cigarettes that I smoke.

Paranoid tendencies revealed by a spit test....sounds like the spit test administered on the spot by traffic police for cannabis intoxication (whilst driving) in Oz.

FOX NEWS????? Don't like Fox News? You should check out the Blaze, or would you rather listen to the ED SHOW for facts? Or maybe MSNBC? Or maybe facts directly from the president himself, he's heard often in all 57 states, and makes well thought out appointments and decisions.

Stuff it!

I still don't really care for Glenn Beck...he's an emotional basket case that thinks he's fighting a holy war.

But....The Blaze is a good information source. Everything is checked multiple times for accuracy, before it's released. I only check the website for stories that never get reported by anyone else. I haven't found any lies on there.

"Everything is checked multiple times for accuracy, before it's released."

You can't be serious! By what stretch of faith can you even say that????

How would you possibly know???? Because they say it is so????

That's the same as repeating lies until the gullible among you believe them.

I laugh in your general direction.

Care to make a wager that you can't find a fabricated story on the Blaze?

http://www.theblaze.com/

I don't bother with the opinion pieces...which is the same reason I don't watch Fox news. Too much opinion and not enough news.

First, the FDA has been infiltrated by Monsanto. The head chief is their lawyer.

So, anything they have to say, FDA is not worthy of listening to.

As for the US Government, they also need to be ignored. Obama as not a freakin clue ow to run , fix, or make policy in any way. A complete moron

Don't hold back. Go ahead and let it all out. You'll feel better.

Anybody ever looked at you sideways when you tell them where you live???

Yeah, Taylor is our food safety czar, (appointed by Obama), but Monsanto's influence within our government goes way back.

I found a chart online one time, that listed at least 100 individuals, (probably going back 20 years), that had held positions at both Monsanto and the federal government, and moving back and fourth between the two.

I wish I knew the details, and why there are no FDA studies or bans on glyphosate or high fructose corn syrup...but there aren't; and it can't be pinned on Obama.

I would agree that the FDA can't be trusted, and I would add every other government agency.

But rather than bashing individuals, I think we have a responsibility to look at the things the government does, under a microscope, and discuss them. For the FDA to single out this one company, when there are hundreds, indicates, (to me), that there is some kind of ulterior motive. I just don't know what it is...yet.

Edit: They are the biggest; and something else that's notable, is that they are building a massive, (voluntary), genetic database; complete with names and addresses.

Total speculation here, but I wouldn't be surprised to find that the government is looking to have exclusive rights to any genetic data, and has a way to get it through the ACA.

BINGO!!!!

Did anybody realize that the government maintains it's own, (voluntary), DNA gathering and testing site?

Well, they do.

Here is the disclaimer:

IMPORTANT NOTE: NIH does not independently verify information submitted to the GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in the GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.

And here is the site:

https://www.ncbi.nlm.nih.gov/gtr/

Here are the people that the government contracts with:

https://www.acmg.net/ACMG/Terms_and_Conditions/ACMG/Terms_and_Conditions.aspx?redirect=https://www.acmg.net/ACMG/Sign_In.aspx?

The legalese looks very similar to what 23andMe uses. My guess would be that this is about eliminating competition, and funneling people into the government sponsored testing and gathering site.

Bastards!

Who wants to bet me that 23andMe chose not to sign up for the government's "approved" list of testing facilities?

If I really wanted to do some detective work, I would go to the list of companies, (that are doing exactly what 23andMe is doing, but submitting the data to the government), find the owners of those companies, and look up their political donation records.

With a couple of hours of time, I could probably name the names of the people in Washington that are behind this shutdown.

Well, until my search is stopped, which is happening more frequently.

YouTube videos go dark when I attempt to watch them, Google searches give me a message that says, "What you are looking for does not exist. That's all we know."

For anybody that isn't following along, let me spell it out...

23andMe is the single largest DNA testing company, and they do not share their data with the government.

The "approved" DNA testing companies that can be found at the government link, are open for business and ready to take your money for a spit test and resulting DNA panel.

Here is ACMG, (the government's gateway to genetic testing data), actively promoting another testing company.

http://careers.acmg.net/news/Quest-Diagnostics-Introduces-BRCAvantage-Broadly-Expanding-Patient-Access-to-BRCA-Genetic-Testing-for-Inherited-Breast-and-Ovarian-Cancers/OtwJR4RDIciulQmVDkLeTTsmu8f3PWNzEbC9q71zgYxS1ga7TZHdjylHLZPFKzGd/?utm_source=jobseeker-index&utm_medium=news&utm_campaign=news&utm_term=American%20College%20of%20Medical%20Genetics&type=association

A smart investor would dump some money into Quest...or maybe the money has already been made. Notice the spike in early to mid November. You have to hit the 6m button, and the outlook for this company is bearish.

http://www.marketwatch.com/investing/stock/dgx

There's a place for your wife to put some money Lyn. If she holds it for a year, she would probably do quite well. The future looks bright.

The plot thickens:

The government DNA database uses ACMG exclusively> ACMG recommends Quest Diagnotics> Quest Diagnostics is tied directly to...wait for it.....Microsoft HealthVault. MS HealthVault is a place where doctors and patients are encouraged to upload medical records online.

https://www.healthvault.com/us/en

HealthVault is tied directly to Healthit.gov.

http://www.healthit.gov/patients-families/video/health-it-you-giving-you-access-your-medical-records

How cozy!

It's coming, like it or not. Your medical records will end up somewhere in the cloud, if you live long enough.

There's good and bad to it. It costs initially and continually, but it can cut the number of unnecessary tests and duplication of treatment.

My wife's up on all things medical.

Yes, Big Brother is closing his net around guys like you.

One of these days you'll just quit posting, and then we'll know you have been "disappeared".

Did you look at all of the links?

This is more than just big brother; the net is being drawn by the government, working hand in hand with a few corporate interests...with Bill Gates at the top of the feeding frenzy.

If we don't stop our silly squabbling about Fox news or Obama, nothing will be able to stop or challenge these people...they will be in COMPLETE control.

Oh, and the leadership of both political parties is completely onboard.

"They" are already in COMPLETE control. They just have chosen not to draw the noose too tightly, yet!

I'll have to admit that your paranoia is beginning to rub off on me. I'm beginning to worry about our young children and grandchildren and what their lives will be like.

It's not paranoia. We can stop this...and it's not about liberals vs conservatives.

Between data harvesting, (for the government), and masterminding the common core curriculum, (for the government), the amount of, (taxpayer), money that Bill Gates stands to make, will make his Windows platform look like a lemonade stand.

It's not the money that worries me...it's the power.

The FDA has just shut down 23andMe, which is the largest of it's kind. The companies that do the same thing, and run their data through the government DNA collection site, are green lighted and allowed to carry on. I just submitted the proof.

Closing this company was a warning to anyone that doesn't want to "play ball" with the US government. They won't reopen...and if they do, they will be connected to the government DNA site.

PS- I meant it when I said to dump some money into Quest Diagnostics.

The grass just got a whole lot greener. I wish I had some laying around to invest.

I just picked a disease at random, from the government's site.

A person can look at their DNA panel, locate the abnormal genes, and do a self diagnosis. If a person found an abnormal gene in this group, would it prevent them from having children?

http://ghr.nlm.nih.gov/condition/diamond-blackfan-anemia