Comment · Tue, December 3, 2013 · Ceretropic
The Methylation cycle, Methylation analysis, and the 7 days you have left to get tested (cheaply) thru 23andme.
Original post in this thread
Rage_Boner · 82 points
It’s estimated that 45% of the population have a methylation cycle dysfunction. The [methylation cycle]( http://i.imgur.com/kRb0G3R.jpg) is one of the most important biochemical pathways in the body. It’s a chemical process that happens billions of times per second in our bodies and is responsible for many things, including:
* To produce vital molecules such as Co Q-10 and carnitine.
* To switch on DNA and switch off DNA. This is achieved by activating and deactivating genes by methylation. This is essential for gene expression and protein synthesis. Proteins of course make up the hormones, neurotransmitters, enzymes, immune factors and are fundamental to good health. When viruses attack our bodies, they take over our own DNA in order to replicate themselves. If we can't switch DNA/RNA replication off then we will become more susceptible to viral infection.
* To produce myelin for the brain and nervous system.
* To determine the rate of synthesis of glutathione which is essential for detoxification.
* To determine the rate of synthesis of glutathione which is an essential anti-oxidant as glutathione-peroxidase. Furthermore oxidative stress blocks glutathione synthesis - yet anot…
What they were answering
EnLilaSko · 0 points
No, they are saying that 23andme has not clinically verified that their interpretation of the results are accurate. They are not stipulating that the SNP test itself is inaccurate. If they were, they would be going after the other genetic testing companies using the same method as 23andme.
But they wrote this:
As discussed above, FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.
How can they mean "Your interpetations of the results" by that and not "That the machine is working"?
Some people have even done a much more expensive whole genome sequencing, then compared their results to the raw 23andme data. They found it to have around a .03% error rate. So the raw SNP data from 23andme seem to be very accurate
I really don't think the FDA cares about what some random persons (or cmpanies) have done, they want actual studies afaik. If 23andme had just worked with them all the way there would be no problem, that's atleast what I think.
u/MisterYouAreSoDumb · Ceretropic
The inaccurate results they are referring to are the ones on the "My Results" page of the site. The FDA is saying that the interpretation 23andme is giving are the results of the PGS, rather than just an interpretation of the actual results. I consider the raw SNP data to be my actual results, and merely use the resources 23andme gives as a starting point. The FDA is saying that 23andme is marketing the "My Results" interpretations as the product, and has not empirically shown those "results" to be accurate.
I have not seen anything from the FDA stating that they think the raw SNP results are inaccurate. Even if they were, that is not under the FDA's purview. They are interested in the scientific proof that something being marketed as a medical device is accurate. They are stating that since 23andme is providing interpretations of the data and linking recommendations based on that interpretation, that they are selling a medical device. As such, 23andme's product does fall under the FDA purview, and they are required to provide scientific proof of the accuracy of those claims. It is 23andme's stance that they are not selling a medical device, and that they do not fall under FDA guidelines. I suppose the courts are going to have to decide one way or the other.
So yes, it would be nice if they had just done everything that the FDA asked from the beginning. However, they do not feel they are required to by law. Also, I know how rigorous the FDA can be on certain guidelines. It might have been extremely cost prohibitive to provide the type of information that the FDA was requesting. If they want 23andme to run trials for every recommendation they make, that would be billions of dollars in research costs. I do think 23andme could have handled things differently. However, we may not be getting all the information on what was promised between them and the FDA.
If you are looking for the accuracy of the raw SNP data, there was a study run on the matter. http://www.clinchem.org/content/57/3/518.short