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23andMe meets FDA standards, adds back wellness reports

blog.23andme.com

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Re: 23andMe meets FDA standards, adds back wellness reports

#71

Post by methou »

chaud wrote: post #2

I would like to know how the new report compares to the old one. 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…

The price in Europe is 99% and 20% off for additional kits. Shipping cost would be 42.99/62.99 for std/express shipping that takes weeks.

Re: 23andMe meets FDA standards, adds back wellness reports

#72

Post by Hydraulix989 »

This news of their FDA approval came right after news of their latest $155mm funding round which tells us that their new investors DEFINITELY knew about this before the public. [1]

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...

Re: 23andMe meets FDA standards, adds back wellness reports

#73

Post by unclebucknasty »

toomuchtodo wrote: post #61
op00to wrote: post #37

23andMe can do whatever they want with your data. It totally boggles my mind that someone would give a private company legal, full, and complete access to what makes you, you. We're still in the infancy of understanding what we can do with our genomes. Giving all our information over to an entity without a fiduciary responsibility to protecting your personal data is just idiotic.

> It totally boggles my mind that someone would give a private company legal, full, and complete access to what makes you, you. My genome is public on Harvard's Personal Genome's Project [+]; why would I care what 23andme does with my data? [+] http://www.personalgenomes.org/

Which one makes the other a good idea?

Re: 23andMe meets FDA standards, adds back wellness reports

#74

Post by nitrogen »

adenadel wrote: post #64
op00to wrote: post #37

23andMe can do whatever they want with your data. It totally boggles my mind that someone would give a private company legal, full, and complete access to what makes you, you. We're still in the infancy of understanding what we can do with our genomes. Giving all our information over to an entity without a fiduciary responsibility to protecting your personal data is just idiotic.

There is no concept of "genome security" because you leave your genome everywhere you've ever been. If someone wants your genome and is willing to spend the money to sequence it, they've got it. Let's estimate 6pg of DNA per cell and that we need 100ng of DNA for sequencing. Rounded up that means 20000 cells left behind. That means you cannot leave a single hair, fingernail clipping, feces, etc anywhere that you do n…

There's a massive difference between chasing down one person's DNA and gaining unwarranted access to a consolidated database of millions of genomes.

Re: 23andMe meets FDA standards, adds back wellness reports

#75

Post by boulos »

brianbarker wrote: post #4
ska wrote: post #3

Earlier quoted context omitted.

I don't know anything about this particular filing, but the FDA is primarily concerned with you having demonstrated safety and efficacy. 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.

I just like knowing I have the trait for smelling asparagus in urine.

Wait; I thought you didn't...

Re: 23andMe meets FDA standards, adds back wellness reports

#76

Post by xirdstl »

devonEnlis wrote: post #65
chaud wrote: post #2

I would like to know how the new report compares to the old one. 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…

I'm preparing a blog post on the differences between the old and new 23andMe reports, and how they compare to a raw data analysis with Enlis Genome Personal. 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…

Not speaking to the price, this makes sense. To achieve FDA approval, their reporting is much more conservative. That's probably for the best.

Re: 23andMe meets FDA standards, adds back wellness reports

#77

Post by superkuh »

travisp wrote: post #49
mtgx wrote: post #33

I wonder if this is why they finally got their approval: http://fusion.net/story/215204/law-enforcement-agencies-are-...

Probably not: https://www.23andme.com/transparency-report/

If a US national security letter with a gag were used it wouldn't show up here.

Re: 23andMe meets FDA standards, adds back wellness reports

#78

Post by sskates »

op00to wrote: post #37

23andMe can do whatever they want with your data. It totally boggles my mind that someone would give a private company legal, full, and complete access to what makes you, you. We're still in the infancy of understanding what we can do with our genomes. Giving all our information over to an entity without a fiduciary responsibility to protecting your personal data is just idiotic.

People said the same thing about putting their photos on the internet in the early days and now there are massive companies dedicated to it.

Re: 23andMe meets FDA standards, adds back wellness reports

#79

Post by greggman »

xirdstl wrote: post #76
devonEnlis wrote: post #65

Earlier quoted context omitted.

I'm preparing a blog post on the differences between the old and new 23andMe reports, and how they compare to a raw data analysis with Enlis Genome Personal. 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…

Not speaking to the price, this makes sense. To achieve FDA approval, their reporting is much more conservative. That's probably for the best.

I'm not saying you're wrong but would you mind explaining why you think that's for the best?

Re: 23andMe meets FDA standards, adds back wellness reports

#80

Post by calgoo »

darkmighty wrote: post #50
cryoshon wrote: post #29

Earlier quoted context omitted.

Probably. Unfortunately, this precludes someone who is privacy-conscious from using these products, as cool as they may seem. I can't imagine how the government would put this information to anything other than malicious use. 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.

If the gov't really want a DNA sample from you is it that hard to obtain? I understand this allows them to do it en masse though.

What happened was that the police was using some publicly available data to cross reference with cold cases. Then when they found a familiar match, the produced a warrant to get the identity of the family member that was registered. The main issue was that the info was available, so some tech just ran the comparison. However, it feels like it would be way to easy to request the information directly with a warrant and that's it. Using something like: "We need to save the women and children, here is a list of unidentified DNA samples, please compare them to all your database."
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