23andMe meets FDA standards, adds back wellness reports
blog.23andme.com
blog.23andme.com
Also of note, the price has gone up from $99 (as of earlier this week) to $199.
edit: This NYTimes article has more details: http://www.nytimes.com/2015/10/21/business/23andme-will-resu...
Now, after nearly two years, 23andMe is announcing on Wednesday that it will begin providing customers with health information again, though much less than before and with F.D.A. approval.
The new health-related information 23andMe will provide is called carrier status. That relates to whether people have genetic mutations that could lead to a disease in their offspring, presuming the other parent has a mutation in the same gene and the child inherits both mutated genes. There will be information on 36 diseases, including cystic fibrosis, sickle cell anemia and Tay-Sachs.
For this reason, I would suspect the new reports will not include anything that they could not provide scientific evidence for effective differentiation, as well as anything without convincing argument that a report would not increase workup rates, etc. with some inherent risk.
[1] https://promethease.com/ and athletigen are two I've used that were pretty cool
I guess the US version has been priced differently?
Here are the headline numbers-
Number of health-related traits reported: Old: 201 New: 36 RawData: 2109
Number of health-related variants reported: Old: 1283 New: 100 RawData: 13,537
I will also note that while they increased the price, they are still using the same genotyping chip that they released in December 2013
To go to the extreme, a 0.001% chance of genetic disease can drive a person to make emotional decisions.
It seems to indicate a high level of naivety on the part of 23&Me in terms of the regulatory requirements around genetic testing.
What Hibbs found was that 23andMe and the FDA were not even speaking the same language. The FDA is guided by laws and regulations that limit what it can say, and 23andMe wasn’t picking up on the agency’s cues. FDA officials would leave 23andMe an opening to change the way carrier testing was regulated, for instance, and 23andMe would ask an unrelated question.
A part of me thinks it wasn't naivety and it was more "move fast and break things".
[1]http://www.forbes.com/sites/matthewherper/2015/10/21/23andme...
Or "I did a jerkish move (like playing dumb), and they didn't call me out on it. I've discovered a mind hack!"
Seems to be working ok for them. Perhaps the nature of genetic testing changes things.
We're still in the infancy of detecting disease through microbiome analysis, yet some foolish people still meet in person without signed contracts not to collect that information.
We're still in the infancy of analyzing video to detect mental state, yet people routinely go out into public without comprehensive agreements not to record or analyze their behavior.
I understand your concern about genetic information, as it's easy to understand the impact and the potential information gleaned. That said, the cost v.s. risks v.s. benefit of the 23andme service work for me - though I would not say that they should work for anyone else. It's good to think about potential future risks, but believing too much in the malevolence and competence of people from the future is often a mistake (see: lots of cold war policies).
It would be very unfortunate if this turns into Gattaca though.
My genome is public on Harvard's Personal Genome's Project [+]; why would I care what 23andme does with my data?
We can have the benefits of statistical research on our private information without handing the keys to the kingdom over to malicious actors.
This isn't correct. 23andMe are quite expliict about how genomic data may be used in their [privacy policy](https://www.23andme.com/about/privacy/#jump-link-content-con...).
Research using your genetic data only occurs with your permission, and it's stripped of personally identifying information (i.e presented in aggregate) when delivered to third parties. 23andMe can't, for example, sell your genome to an insurance company.
23andMe don't have a fiduciary responsibility to protect your data, they have legal one. If you still find this overly concerning, you could just use 23andMe's genetic sequencing, which when I last checked was priced at below cost, download the data and tell 23andMe to delete all personal information.
Once you have the genetic data, there are many options for performing analytics. For example https://www.promethease.com/ which uses SNPedia and isn't under the same FDA scrutiny as 23andMe and doesn't have to self-censor.
From their privacy policy:
>How is my privacy protected? >We will not share your individual-level information with any third party without your explicit consent
Both "individual-level" and "third-party" still leave a LOT of room for things to be shared. - At what level is the data allowed to be shared if not "individual-level"?
- Exactly who are third parties (is Google a third party?) and who decides that? Can it change tomorrow?
- What happens in the case they are bought out by some one? If they go bankrupt? What happens to the data?
Still too many unexplained items
I've been waiting to unlock the Alzheimer's results for ages, but it always tells me that "upgrading to the latest platform is unavailable".
http://www.snpedia.com/index.php/Promethease https://promethease.com/
https://github.com/cslarsen/dna-traits
The test for Alzheimers is here: https://github.com/cslarsen/dna-traits/blob/master/py-dnatra... (the algorithm used to be patented, by the way). By closely reading the algorithm, you can probably find out yourself, given that 23andMe still lets you browse your genome.
To see all health reports, run this file on the downloaded genome: https://github.com/cslarsen/dna-traits/blob/master/py-dnatra... (you have to compile the C++ code first)
Actually was playing with the idea of monetizing off this project, but the laws in my country prohibit me from doing so. In fact, just using the program I made is illegal unless its my own genome.
Of course, you should be pretty careful with interpreting results as a hobbyist (as I am). But probing your genome with a parser, like the one I've made, is a great vehicle for piquing your intellectual curiosity.
[1] http://www.forbes.com/sites/matthewherper/2015/03/12/23andme...
While I could never bring myself to spend the $199, I was a very early adopter when it went on sale for DNA day (maybe the first DNA day sale), and the rest of my family bought the next time it went on sale for DNA day a year later. Now that medical results are back, I think it is worth either price, particularly if you have any concerns about genetic health issues being passed down to you.
In my case, my father was schizophrenic (and a couple of other relatives on the same side of the family likely suffered from undiagnosed mental illness based on what I know of their behavior and the details of their violent deaths), so I was more than a little curious about whether I had any of the genetic hints that I might suffer the same fate. I don't, and knowing that I don't have the couple of markers known to 23andme was worth at least $99.
A few years after we all signed up for 23andme, my father passed away of pancreatic cancer, which can also be a genetic condition, and so I was able to check for the risk factors that are known (though my father also lacked those markers, so it's either a marker that is unknown to 23andme, or he was not genetically predisposed to pancreatic cancer in his case). That was, again, worth at least $99, to me.
I know in either case, the ability of 23andme to predict those diseases is low, and it shouldn't replace hands-on medical care and paying attention to warnings signs, but it does provide some predictive power. And, for a while they were doing original research (polling their customers and comparing data to produce reports), which was really cool and fun to see happening. I don't think they're still doing that, maybe because of the FDA ruling.
When the medical stuff went away, I stopped recommending 23andme to friends and family, as it no longer held any interest for me. The family tree functionality is neat, I guess, but I'm not Mormon, and don't have a huge amount of interest in whether I'm related to somebody interesting 200 years ago (I'm probably not; I come from very poor white trash stock).
In short, the fact that we're arguing over whether a genetic profile is expensive at $199 or at $99 is a laughable first world problem. I'd like it if more of the world could afford it, and my signing up early was part of my encouragement for that to happen; I want it to be possible for everyone to look at their genetic predispositions and such, and take some of their medical care into their own hands with more informed choices. So, I opted in early. I would have bought eventually at $199, if they hadn't ever offered the $99 deal.
But, I too, would like to see it getting cheaper. It's been many years now, since I bought in at $99. At some point, they've gotta be thinking in terms of making it more accessible to more people. There are huge swaths of people for whom $199 is not chump change.
Many of those medical genetic tests are more expensive because they directly sequence the region of the gene associated with the disorder, providing much more data (for example, for some BRCA tests, a 'marker' consists of thousands of genomic positions, where 23andme might provide only several SNPs). This is important because a lot of disease-causing mutations are private to a single individual or a very closely-related group of individuals, and would not turn up in the population-level GWASes behind the construction of the present 23andme assay.
http://fusion.net/story/215204/law-enforcement-agencies-are-...
There must be a lab located outside the US (and with no US footprint or marketing) that will nonetheless provide full results to anyone providing a sample.
https://customercare.23andme.com/hc/en-us/articles/202907670...
The iffy part was the medical advice.
I can't imagine Fidelity Capital pouring millions into a company that got blocked by the FDA, and I was shocked to hear the news that they raised that much money until today when I found out that the FDA approved their DNA screening. I mean, they were dead as in last nail in the coffin status before that.
Not only that, recent news just broke that law enforcement now have access to members' DNA from 23andMe -- the federal government must have been appeased. [2]
As Saul Goodman says: "There's always a way to oil everyone's lock."
[1] http://venturebeat.com/2015/10/14/23andme-raises-115m-to-gro...
[2] http://thinkprogress.org/justice/2015/10/19/3713666/police-t...
SNP sequencing is the ultimate fingerprint, far more individually identifying than anything else as of yet. Imagine having 900,000+ criterion to cross reference to determine identity.
Notably, "Percentage of Requests Where Some Data Produced" is all 0%.
Now, obviously, you're asking them to sequence your genome, so they're getting personally identifiable information. If you have relatives who have done their 23 and me work-up, then they'll be able to tell that "John Doe" is related to Gunther Kumar, or whatever. In my friend's case, that's not likely to be an issue as they have few living relatives, most of whom are very old and would have no interest in 23 and me. YMMV.