heck,
our govt really lets us do almost anything we want to do from owning assault weapons to pornography to bungee jumping to gambling to smoking to gluttony to letting companies collect whatever data they want on us - google google, , etc,, etc,, etc.

they let us smoke but only if there is a big scary warning label. my impression is the FDA wants 23andME to put a bigger warning label on their product as far as interpreting the results. DNA analyzers will be cheap enough that they will be standard procedure when you are born or on every cancer, this is a multibillion dollar industry that can't be stopped, the benefits are enormous.

from what i've read 23ANDME and the FDA have been discussing this for years and the FDA finally said they're tired of their dragging their feet. i could be wrong.

when i had my DNA analyzed, i had 2 sisters and 3 nieces very interested in the results since there is breast cancer in my family, they were wanting to know what the difference was between my $99 test and the $4300 test they were being quoted.

the implications are enormous in terms of marriage - is your potential spouse going to require you have your DNA analyzed, to life insurance costs, employment, having children, knowing your disease risk so you can prepare/choose lifestyles. i'm happy as a clam the FDA is looking at this, downside is minimal imho, upside is 23ANDME gets their blessing and sales increase. i can't believe they are doing the actual procedure wrong, they just have to clean up their presentation to customers(?)

I think you've have asked a great question and I think soccertese is 100% correct in his impression of what the FDA wants. I'll answer your question with a question of my own. Is it too much to ask that if a company sends you a detailed report on your risks for various illnesses and diseases that they have some validated basis that supports their risk assessment? I don’t know the answer but I can offer a suggestion for now. I see no reason why 23andMe, and the other DTCs, shouldn't be allowed to continue offering their DNA testing services to the public. They should be allowed to give you your raw data as well as your individual results on common genetic markers, like BRCA, LRRK2, PARK16, etc….. What they shouldn't be allowed to do, until they can validate their data, is provide disease risk assessment odds. They should try to standardize the markers that are tested among the companies. The current inconsistencies between the companies is because there is no consensus on which markers to test and the number of markers which should be tested. Finally, they can also focus their results on areas of high-risk predictions where there has been ample research and validation. BRCA would be an example of this. The DTCs seemed to have very consistent results when dealing with high risk markers. However, most of the diseases predicted in the reports by these companies have extremely low population risk. One report I read was that 80% of the diseases 23andMe reported on had average population risk of about 1%. So, if your markers put you at a 2.0 ratio, it would only increase your actual disease risk to 2% from the general population's 1%. Yet, your report would still classify you at High Risk. It's all relative. Sort of reminds me of some of the statin statistics Olsen gave us the other day, where the numbers are sort of meaningless.

Madelyn made another statement regarding 23andMe which is relevant. They are very well funded. Co-founders Sergey Brin and Anne Wojcicki (currently separated) have a net worth of about 24 billion. Their largest investor, Google, has a market cap over 350 billion. I would imagine they would be able to find the funds to conduct the research required to validate their reports and make everyone happy.

Thanks,

Gary

I personally think the 23andme testing would impel people to take the results to their doctors and get further testing.

The basic core is the methylation aspect which is impacting now about 40% of Americans. Getting this information on MTHFR at a reasonable price, is very important IMO. Several of our PN posters have done this and switched to methyl forms of folate and B12, already.

Remember the discoverer of Homocysteine problems was fired from MGH when he published. Took 20 yrs to get his credit on this topic!
http://www.chiro.org/nutrition/FULL/...Cully_MD.shtml

Let's see ... our sterling FDA allows toxic statins on the market to poison millions daily. Those taking those statins also have significant diabetes risk now from them...FDA acknowledges that. So the FDA has allowed Avandia back on the market to treat diabetes ...and Europeans are spared. (not allowed there). So in addition to cell death by statins, Americans can have heart failure as well from Avandia!

Good going FDA!

I hope soccertese is right. But... if the only goal the FDA had was to modify the way 23andMe reports risk, I have to wonder why their warning letter halts sales.... not risk reporting.


Exactly and well put. Maybe the FDA will require all 23and Me customers to pass a statistics course before testing !

i can go online an view my lab tests after a doctor's visit and it shows the normal ranges for each compound being measured but i know my doctor will tell me if anything concerns him. of course if something does, it also means more tests and more out of pocket costs.
just like there is this totally artificial seperation between doctors and pharmacists, it's a good idea there is available seperation between genetic testing and healthcare organizations which could really benefit from using your genetic results to make money.
as an aside, that's the reason doctors aren't allowed to replace pharmacies except in isolated areas, the potential conflict of interest. but it sure makes for a screwed up system where pharmacists and doctors often don't work together - few pharmacists are going to tell a doctor they prescribed a drug that really isn't going to help. plus doctors often don"t know what drugs cost when they prescribe them.

we get get all sorts of wrong advice on everything, some intentional - real estate bubble, supplements at times, healthcare, investing - some unintentional, FDA can always be improved, just requires voters to express their wishes.

wonder how european countries requlate DNA analysis?

first complete human genome sequencing cost $3billion
now costs less than $3000

only 1/1000 of DNA is different between 2 people but that still represents 3million base pairs

chimps and humans are 99% similar

humans and broccoli are 1/3 similar

we pass on about 30mutations to our offspring.

Here's the letter that the FDA sent to 23&me
http://www.fda.gov/ICECI/Enforcement.../ucm376296.htm

Dear Mister and Mizz FDA,

I hereby wish to inform you that me and my DNA have a personal thing going.

Me and my DNA have had some great times together, and some bad times too. But through thick and thin, for better and for worse, me and my DNA hung together. Any information about my DNA is mine, not yours.

If the information about my DNA is faulty, with false positives and positive falsies, it is still MY information. Not YOURS. Do you see the distinction there?

When I received my DNA report I immediately called the doctor to arrange a fecal transplant AND a brain transplant, but the doc mixed up the two, and now when people say I have s*it for brains, it is an objective fact.
But I have become very creative in the toilet.

Me and my DNA are big buddies, and nobody gets between us. Go check out your own DNA and get your greedy paws off mine.
Your sin-sear-ly and all that.