FDA Orders 23andMe to Stop Providing Genetic Analysis.

[wdb]

DNA Testing Startup 23andMe Hits A Snag As FDA Shuts Down Sales Of Home Testing Kit

The U.S. Food and Drug Administration has ordered 23andMe, the genomic startup co-founded by Anne Wojcicki, Linda Avey and Paul Cusenza in 2006, to stop selling its at-home DNA testing kits as of November 22. As Bloomberg reports, a letter from the FDA sent to the company made public today classifies the kit as a medical device and outlines that it required regulatory approval before being sold.

http://techcrunch.com/2013/11/25/23andme-fda-block/

 

[jeffrez]

AMA doesn't like people helping themselves, apparently.

http://blogs.marketwatch.com/health...e-backed-23andme-to-stop-selling-99-dna-test/

 

[Seven7]

I just bought mine

 

[barbc56]

Genetic testing can be an important part of medical care. I'm glad the FDA want tests that are reliable. The 23me may or may not be reliable or valid , but the onus is on 23andme to prove this.

IMHO, this seems like someone wanted to make a fast buck without waiting to havie the science behind what was being claimed and then take advantage of patients who have concerns about their health.

The adage of if it sounds too good to be true, it probably is.

In a warning letter posted online Monday, FDA regulators say that the Silicon Valley firm has not shown that its tests are safe or effective despite "more than 14 face-to-face and teleconference meetings" and "hundreds of e-mail exchanges." The agency orders 23andMe to stop marketing its test immediately, warning that erroneous results could cause customers to seek unnecessary or ineffective medical care.

http://www.usatoday.com/story/news/nation/2013/11/25/23andme/3699329/

Arguments rage all over the place on this one, but the short answer is that
SNP tests—which is the kind of DNA scan 23andme relies upon— don’t tell us
all that much (yet). They analyze a million genes out of three billion total and
the impact those million play in long term-health outcomes is still in dispute.
For example, the nature/nurture split is normally viewed at 30/70—meaning
environmental factors play a far more significant role in long-term health
outcomes than genetics.

http://www.forbes.com/sites/stevenk...nter-of-the-personalized-genomics-revolution/

It's about quality control and the FDA needs to come down hard on these bogus tests that many who don't have a lot of money we end up spending because we have a chronic illness that sometimes makes us desperate. Shame on them!!

 

[Sea]

I just bought mine

Just in time! Hopefully the ban is only on new sales and they can continue to process what's already been sold.

The accuracy of the testing (raw data) is not the problem. It's the interpretation of the data the FDA is looking for evidence for. 23andme are making predictions based on a snp or 2 when sometimes there's a whole interplay of many snps that would contribute to risk for certain conditions. They're basically giving medical advice without approval. I hope it gets sorted quickly. The FDA is concerned people will make radical decisions without complete information. For example having an unnecessary mastectomy because 23andme says your risk of breast cancer is high, or forgoing important checks like a mammogram if they say your risk is low.

 

[barbc56]

I think people should start asking for refunds!! Look how the WPI, (or was it an affiliated lab?) profited from the original xmrv test. Sigh. Don't get me started!!!

 

[Valentijn]

I don't know if they're actually making predictions. They're just showing calculations of odds based on research. Granted, a lot of people might not understand exactly what that means, but really they're just providing data.

I think it's also fairly clear that false positives and false negatives are possible ... but is there any sort of test where that isn't the case?

 

[Waverunner]

The FDA is concerned people will make radical decisions without complete information. For example having an unnecessary mastectomy because 23andme says your risk of breast cancer is high, or forgoing important checks like a mammogram if they say your risk is low.

Who would be so stupid to have a mastectomy because of 23andMe results? It's not like you go to a doctor and say "Good day to you, Sir. I'd like to have a mastectomy." "Oh sure, please sign here and we get you started."

The FDA is way past the point of their mandate and now entering the realm of the absurd. The FDA bureaucrats think that they know better than you how to handle your genetic information. This is outrageous.

 

[barbc56]

Who would be so stupid to have a mastectomy because of 23andMe results? It's not like you go to a doctor and say "Good day to you, Sir. I'd like to have a mastectomy." "Oh sure, please sign here and we get you started."

The FDA is way past the point of their mandate and now entering the realm of the absurd. The FDA bureaucrats think that they know better than you how to handle your genetic information. This is outrageous.

I think you might be surprised at what people will do if they are desperate enough.

All the FDA is asking is that the test be valid. I don't think that's asking a lot.

 

[Sea]

Who would be so stupid to have a mastectomy because of 23andMe results? It's not like you go to a doctor and say "Good day to you, Sir. I'd like to have a mastectomy." "Oh sure, please sign here and we get you started."

The FDA is way past the point of their mandate and now entering the realm of the absurd. The FDA bureaucrats think that they know better than you how to handle your genetic information. This is outrageous.

True, although it does concern me how many people misunderstand the risk calculations. 23andme does make it clear that it's based on preliminary research, that not having a certain mutation they test for does not rule out having other mutations they don't test for and that all information needs to be discussed with your doctor.

Still when you read in their community forums what people say about their results they obviously do not understand. Many are convinced the test is useless because they have a condition that their report says they have a low risk for.

 

[Waverunner]

I think you might be surprised at what people will do if they are desperate enough.

All the FDA is asking is that the test be valid. I don't think that's asking a lot.

"Arm your doctor with information on how you might respond to certain medications."
"Understand your genetic health risks. Change what you can, manage what you can't."
"Find out if your children are at risk for inherited conditions, so you can plan for the health of your family. "

I don't see anything about them promising that you can be cured by taking the test. I see them saying to talk to your doctor, and to try to stay healthy and look for warning signs. How deadly, better shut them down!

 

[barbc56]

"Arm your doctor with information on how you might respond to certain medications."
"Understand your genetic health risks. Change what you can, manage what you can't."
"Find out if your children are at risk for inherited conditions, so you can plan for the health of your family. "

I don't see anything about them promising that you can be cured by taking the test. I see them saying to talk to your doctor, and to try to stay healthy and look for warning signs. How deadly, better shut them down!

In a perfect world, I would agree.

 

[Waverunner]

Still when you read in their community forums what people say about their results they obviously do not understand. Many are convinced the test is useless because they have a condition that their report says they have a low risk for.

If 23andMe lies to you, please sue them. It is not my problem if someone is not able to understand or interpret his test results. We are adults and at one point in your life you should take responsibility for yourself. What the FDA didn't mention was, that 23andMe according to comments throughout the internet saved thousands of lives. There are hundreds if not thousands of people who found out about their genetic disorders (e.g. g6pd deficiency) through 23andMe. Were these people taken into account by the FDA?

 

[South]

Hello, I'm a long time lurker, and had planned on registering on Phoenix Rising soon - then suddenly today I got a push to do so when I read the following. This news blurb worries me that soon the FDA will block services like 23andme, either partly or entirely, from being used without "doctor involvement" or some such rules, adding high costs that could keep the service out of reach for many.

Anyone else concerned about this? If you-all already have your 23andme results, what about relatives/friends who do not yet have their own results, who might not be able to easily get them affordably via 23andme anymore?

And, the other services out there I've read about but haven't used yet, like genetic genie, that for fairly low cost will analyze a person's genetic data, I wonder if the FDA will try to block that? Really worried here.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm

 

[Waverunner]

Hi South,

welcome to the forum. There already is a thread about this topic. Please look here:

http://forums.phoenixrising.me/inde...-to-stop-selling-their-99-genetic-test.26668/

Moderator Note: Threads now merged

 

[barbc56]

This will be my last retort, so to speak, but how do we know these people were saved if the test isn't valid in the first place? Should I start retroviral medications if I had a positive xmrv tests?

While you can't discount them completely, anecdotal reports are not necessarily accurate and I haven't seen the same stories that you say you are seeing on the internet.

Not everyone has critical thinking skills whether it be from illness, ignorance, circumstances or exposure to the process. That's how scam artists become rich.

Everyone wants to make a buck but trying to get that money on something that has not been proven, nor taking the time to find out, IMHO, is greedy.

 

[Creekee]

Methinks the potential for big money is attracting this attention. Per Bloomberg:

"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."


Everything in healthcare is now ALL about the money.

Sigh.

 

[Waverunner]

@barbc56: A patient has to decide himself if he/she spends the money for 23andMe or not. You are right of course, the 23andMe test could be a false positive. It's the same with HIV and many other tests. False positive are always possible. In the end however there probably is no doctor on this whole planet who would use a 23andMe result to start treating a genetic disorder.

All patients with positive 23andMe results go to a doctor and will run a validated new test to confirm their results. The advantage of 23andMe is, that they check for several genetic diseases and have a very low price. In addition to this, we, the patients, can order 23andMe ourselves while for many other tests you will need a doctor to sign up for you.

 

[SickOfSickness]

Sign the petition if you support 23andme. Registration is quick.

https://petitions.whitehouse.gov/pe...entially-life-saving-diagnostic-kits/96BRCYNB

 

[Dreambirdie]

I stopped trusting the FDA long ago. Look what they did to Burzynski. They accused him of being a dangerous quack, while at the same time trying to steal the patent for his cancer treatments.

They are prostitutes for "the man" with the biggest doo-hickey full of cash.

Not that I have any strong opinions about this.