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.

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 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‽ 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(?)

BINGO. There it is.
Doc

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

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