FDA closes down 23andme Genetic testing.
 

Another blow to consumers who want to be proactive in their
own care and life:

http://www.usatoday.com/story/news/n...andme/3699329/

An interesting article if you read the whole thing.

Fda
 

Again our government who loves and protects us strikes again.
Remember what President Reagan said the scariest words you can hear are
"We're from the government and we're here to help"

I don't get it...
 

I think that the government regulating things like this is a good thing. I've been employed in the medical device industry for companies that work very hard to get FDA approval. Why should this company get a pass?

I would think all the tests that they run/ran are already proven, they didn't invent anything. I saw on another site, 4000$ quoted as the price for checking for the gene for breast cancer, how many of us can afford that?
frankly, I think it is "nanny state" strikes again! also, all those companies charging 4000 dollars, probably weren't too happy either, and had an in with the FDA.

Spitting into a small tube could be very unsafe. Yegads, what if someone missed the tube‽ :rolleyes: They—or someone else—might slip on the spittle and get injured!

...And monkeys could fly out my butt. Is the FDA acknowledging here that doctors/hospitals would perform chemo and/or surgery based on a mail-order test without due diligence?

I thought (but I could be mistaken) that cancer screening (e.g. Pap smears, mamograms) is pretty standard these days(?) :Dunno:

BINGO. There it is.
Doc

That is why the FDA reasons sound just like propaganda.

It seems to me that learning about MTHFR and then seeing your doctor would be a good idea. Have the test redone then, (the doctor would balk less than if you asked out of the blue), and then it would be in your record. I do think the MTHFR genetic issue will someday be linked to cancer etc. Better to know your status now and use methylfolate and methylB12 to become healthier and less at risk. (methylation is involved in cancer protection too but less is known at this time clinically about it).

Best to learn you have hemochromatosis so you can GO TO YOUR
DOCTOR for treatment and evaluation for organ damage etc. (BEFORE YOU DIE or end up on dialysis.)

As far as accuracy? Well Quest has TWICE sent out inaccurate Vit D test results over 1yr in the first case and MONTHS in the second case. Labs that do tests for medical places are known for errors etc. That is why doctors RETEST often!

The FDA is being pressured by some entity to stop these tests IMO.

My sister did that and it was fun but I couldn't see anything on the results that we didn't know from family history.

judi

OK, I guess what I'm really reacting to is the sentiment that the government can't or shouldn't do anything with regard to regulations. Are they perfect? No. Are there sometimes politics involved? Yes. My personal pet peeve is the goverment's crazy, obsessive war on marijuna use when there's little or no evidence that it's even a problem. And you want to talk about Quest and similar labs? It's nuts the amount of money they make from unnecessary drug testing that often yields faulty results and negatively affects real people's lives.

But even for all of that, I'd still rather live in a country where there are at least some (admittedly imperfect) rules that protect people. If the system isn't good enough, then I think the answer is to hold their feet to the fire to make it better, not absolve them of responsibility. </soapbox>

Interesting reading the actual letter the FDA sent 23&me

http://www.fda.gov/ICECI/Enforcement.../ucm376296.htm

I do wonder if we will ever know the real story behind this sudden "regulatory" move to stop a service that was doing no harm, and providing something beneficial at an affordable rate to many :rolleyes::rolleyes::rolleyes:

Funny. A couple days after I heard about this FDA action, I went to 23andme's web site, bought their kit and now it's sitting on my desk waiting for me to spit into it. I've been putting it off for ages. It looks like the FDA letter prevents them from marketing, but not selling. Fortunately, the news of the FDA letter is free marketing for them, for a while at least.

I saw one of their commercials on TV yesterday...so I guess the FDA did not shut them down after all?

there is also a class action lawsuit now

http://www.forbes.com/sites/danmunro...ainst-23andme/

Interesting piece in Businessweek
http://www.businessweek.com/articles...ber-and-airbnb


Here is a petition as well
https://www.change.org/petitions/fda...-genomics-kits

I just received a brochure from 23andme a few weeks ago. I put it on the side so I could do it after the holidays. Needless to say, I'm disappointed!

Another article on this talking about how the insurance companies view this.

http://www.fastcompany.com/3022224/i...ance-companies

NYTimes article about Genetic Testing
 

The author sent her required samples to three labs, with three DIFFERENT sets of results, some contradictory.

http://www.nytimes.com/2013/12/31/sc...ml?ref=science

"In the case of rheumatoid arthritis, though, the tests examined the same five markers, plus a few others, and delivered contradictory interpretations."

"J. Craig Venter, chief executive of his namesake institute and of Synthetic Genomics, was a pioneer in sequencing the human genome in 2000. Though he issued recommendations to genetic testing companies four years ago to help them improve their predictions, he remains skeptical of their clinical value."

“Your results are not the least bit surprising,” he told me. “Anything short of sequencing is going to be short on accuracy — and even then, there’s almost no comprehensive data sets to compare to.”

Buy Beware!

Hugs, Elaine

I had this done a few months ago and enjoyed the Ancestral History. The medical stuff was good to see as well and not a whole lot surprised of any findings.

I know my ancestral history and what I have. Lucky me. :( 23 & Me doesn't test for CMT anyway. That is through DNA blood testing, EMG/NCV for two types of it and family history can be helpful.