“I didn’t think anyone was having a beef with the FDA, just asking why Promethease could release reports 23andme couldn’t.”
The short answer is that Promethease can release those reports because it is not selling a diagnostic test. 23&me cannot release those reports (without first validating them with their own test) precisely because it IS selling a diagnostic test.
FDA is empowered by congress to regulate not only drugs but also medical devices and diagnostic tests. The FDA also has law enforcement authority from congress. FDA officers literally carry a badge.
Currently 23&Me is selling a service to sequence your DNA and report the results. Promethease doesn’t test anything. It combs the medical literature and links up reported disease risks associated with having certain genes or DNA sequences. Prior to getting in trouble with the FDA 23&Me used to do both and tried to claim it was just supplying information and not making a medical claim. FDA didn’t buy it. 23&Me was saying in effect “Our test says that you have gene XYZ, and these scientists from Harvard have found that anyone with gene XYZ has a 10-fold increased risk of diabetes” or some such thing. The FDA was not fooled by this semantic sophistry. 23&Me clearly wanted you to conclude something about your health based on their test - in other words they were making a medical claim.
Faced with this clear violation of the regulations governing medical tests the FDA told them to stop making medical claims until they had properly validated them on their specific tests, as other medical test makers are required to do. And 23&Me at first enormously compounded its error by blowing the FDA off - completely ignoring them, So then the FDA really brought the hammer down. 23&Me quickly cried uncle and stopped reporting the medical claims and started playing nice with FDA. They have since validated their test for a few medical claims, and these are the “skimpy” medical reports you currently get with the 23&Me service. They are working with FDA to validate and add more.
In the meantime Promethease sprang up to fill the info gap created by the FDA punishing 23&Me. And they get away with it because they aren’t reporting results of a medical test. They are merely repeating what the medical literature says. They don’t make or sell a medical test or anything else that the FDA is empowered to regulate.
So for those who have the “old” 23andme reports, who have their results for Alz and breast cancer and high cholesterol and all the common diseases - are you suggesting what they have is nonsense and that 23andme overreached in their interpretations?
Pizzagirl, interpret those results as you would interpret anything Peomethease spits out - RUO.
My apologies for not being clear in my early post. I (again incorrectly) assumed that anyone who is engaging in the interpretation of their own genetic data would know the basics. BLAST is a database and a search tool that allows you to plug in a piece of genetic sequence (or a protein sequence) and see where else in the literature and patents that sequence appears, how similar it is to sequences reported in the literature, plus it also lets you do some other things.
As other posters explained, the data you get from 23andme is not a sequence of your genome, it is limited to only a few places in the genome where certain mutations/variation happen. There is no full sequence search needed, so a simplified database (containing data about those places or so-called SNPs and their frequencies etc.) and a search tool can be used. Apparently, this is what Promethease provides as their service. You, the consumer, get to interpret the data as you wish.
I was just proud enough of myself that I had a handle on haplogroups :-).
I didn’t think it was necessary for me to become an expert on genetics in order to order 23andme and find out my ancestry and a few things about my health, but I guess I do.
I kind of feel the same way I feel when I just want a computer to work and computer geeks insist on telling me that I need to learn all about the inner workings of computers. Oh well. Live and learn, I suppose.
For those interested, there’s a 23andMe Newbies group on Facebook. The introductory post includes a lot of helpful links but some of them are links to blogs so I can’t post those. You can join the group if you want those links, or maybe they’re searchable using Google. I didn’t check.
“So for those who have the “old” 23andme reports, who have their results for Alz and breast cancer and high cholesterol and all the common diseases - are you suggesting what they have is nonsense and that 23andme overreached in their interpretations?”
I wouldn’t call them nonsense so much as unproven. I suspect that the majority of them are correct. I also suspect that in the vast majority of cases the 23&Me technology accurately detects the SNP or gene. Where these things sometimes fall apart is in the validity of the association of the gene or sequence with the risk of disease. The side of the yellow brick road of biotechnology is littered with many hundreds of gene/disease associations that were published in the medical literature but didn’t hold up in later studies. To the extent your report is based on studies that didn’t hold up, the results could be inaccurate.
For the gene/disease associations that that have been solidly observed many times by different investigators, and especially those that have been validated in formal clinical trials, you are probably on safe ground to assume the result is correct. But even for correct 23&Me or Promethease results, the interpretation of what (if anything) to do about them is still up to you.
I’ve used 23andme since 2009. Since then, the price of the kits has changed many times. They even had a subscription model (monthly fee) for a while, but it was not too popular. I think when I got it it was like $299 or $399. It seems it often goes on sale around the holidays.
Promethease has been around for a while too, since before the FDA cracked down on 23andMe. It used to be free, and i think you used to have to install and run a copy on your own computer. Or something complicated like that! I know that I used it back in 2010. It used to have info on some SNPs that did not have reports on 23andMe. It seems a lot more polished now!
I just used it - $5 and less than 20 minutes and I now have thousands of pages to scroll through. It’s an ugly interface but searchable. I can filter by things that are good, things that are bad, and things that are neutral (e.g., eye color).
My husband has taken both 23andme and the Ancestry test. They differ a bit on the ethnicity estimates. 23andme shows 17% French and German where Ancestry shows very little “Europe West”. Ancestry shows a lot more British and Irish than 23andme does. Both show his Native American DNA in the same range.
I like that 23andme shows the DNA segments with color so you can see where the different types (ethnicity) segments are. Our whole family took the 23andme tests back when we could get full health reports so we have that too.
For genealogy purposes I’d recommend Ancestry because their circles feature is awesome. For health and ethnicity I’d recommend 23andme.
@TatinG “Have any of you tried any of these DNA testing companies. Were you satisfied with your results?”
Me! I have taken Ancestry, 23andme, and FTDNA. I have also spent a lot of time working on my ancestry/family tree. I was adopted but have been able to construct my family tree with the help of these tests.
In my opinion, there is a very clear answer to this:
If you are primarily interested in learning more about your ancestry and investigating, verifying or developing your family tree, then Ancestry is much better. I should add that in my experience, most people know very little about this more than two or three generations back, and a reasonable portion of what they think they know proves to be wrong. Before you take this test, and dig into your ancestry, be prepared to be calm if you uncover a few family secrets. Almost all families have them to varying degrees.
If you have no interest in ancestry, but are interested in medical DNA information, then 23andme is better. You can use it for Ancestry a little bit, but in reality the database and functionality is not very useful for this purpose.
FTDNA is by far the least useful of the three in my experience. They don't have the scale of the other two.
I sent in my 23andMe kit about a week ago. It was very easy to use. After going without eating, drinking or toothbrushing for half an hour, I spit into a tube up to a fill line. Then I flipped the cap over which added some fixative. Put it back in the same box and send it back. They notified me that they got it. So now I just have to wait 6 weeks.
My most recent example is that I have been helping a friend with her family tree, and she has gotten several family members (her, both of her parents, and her cousin) to test on Ancestry.
From comparing her mother’s DNA test results to her cousin’s DNA test results, I can tell that her mother and her aunt (the cousin’s mother) do not have the same father. No one in the family has any idea about this.
My friend has decided not to tell her mother or anyone else in the family about that portion of the result, but is interested in learning who her DNA grand father (who is almost certainly not living) actually was. Using the DNA matches and their family trees on Ancestry we are working on it. We haven’t solved that yet, but we will. We have found a few definite ancestors of the father and are in the process of working forward to him.
These types of things happen from time to time in most families. Often the surprises are not so immediate as in this case, but sometimes they are. You just have to realize that anything is possible and DNA does not care about family secrets. To me, it is an interesting, fun puzzle to solve, but some people find it upsetting.
H and I are planning on 23andMe, soon, particularly because CF runs in his family. We are hoping H is not a carrier. Several of the nieces, on his side, were found to be CF carriers during (routine?) tests during pregnancy. One niece married a man who, unexpectedly, turned out to also be a carrier, so their baby has CF. It is a horrible, heart-breaking disease that is all-consuming to the immediate family.
My D is approaching child-bearing years and it would be comforting to know that she is not a carrier via H or me. That said, the usual tests only reveal about 40 CF markers and there are many more, including the marker of our niece’s H.
We thought of gifting 23andMe to D and her husband, but don’t want to put pressure on for them to produce grandchildren. We decided to test ourselves to, hopefully, give us piece of mind.
I’ve always wanted to do 23andme, but didn’t think it was worthwhile for genetic results alone. I already have an excellent idea what those results would be, but thought I missed the boat on the health related info. It’s interesting to see how people have used the report as a baseline for other services. I didn’t realize you could do that.
We have a child who is deaf due to a recessive gene. It is one that 23andMe tests for. Our child had the real (MD ordered) genetic tests done for deafness genes, but through 23andMe, we learned our other child is not even a carrier, though my husband and I are, as expected. It gave me confidence in the 23andMe results.
