FDA orders 23andMe to halt DNA test service

[Genohub]

My opinion is that the FDA's move was a significant overreach. Personal genetic information should be freely accessible to anyone without the interference of government. Interpretation of this data should be open access just as any other scientific result or finding. With this latest move, expect personal genetic testing to move offshore.

- Genohub

[dpryan]

See also the thread on Biostars. I'm of a somewhat different opinion, it would seem. I know too many people who would jump at the opportunity to do this but would completely misunderstand the results. As the Spiderman saying goes, "with great power comes great responsibility".

[rhinoceros]

It looks to me like Big Pharma lobbying bought this outcome from the FDA but what do I know..

p.s. I did 23andMe some time ago and found the results fascinating. I would have paid the same $99 just for the ancestry information alone..

[Genohub]

I think a strong disclaimer when you receive your results saying something like, "these results are for research only, open to interpretation and are not clinically actionable or do not meet clinical standards", should be enough for people to realize that these are for research only. Stating that false positives are possible/common and supplying the names of a few geneticists should alleviate any consumer concerns.

Has anyone received a gross false positive in their 23andMe genotype results?

- Genohub

[rskr]

I think a strong disclaimer when you receive your results saying something like, "these results are for research only, open to interpretation and are not clinically actionable or do not meet clinical standards", should be enough for people to realize that these are for research only. Stating that false positives are possible/common and supplying the names of a few geneticists should alleviate any consumer concerns.

Has anyone received a gross false positive in their 23andMe genotype results?

- Genohub

23andme just looks stupid. It isn't like the FDA hasn't told other businesses to cease and desist for these types of genetic tests, just because they have a really nice Google backed web page and well though marketing strategy doesn't matter.

[dpryan]

I think a strong disclaimer when you receive your results saying something like, "these results are for research only, open to interpretation and are not clinically actionable or do not meet clinical standards", should be enough for people to realize that these are for research only. Stating that false positives are possible/common and supplying the names of a few geneticists should alleviate any consumer concerns.

Has anyone received a gross false positive in their 23andMe genotype results?

- Genohub

Apparently yes. It seems that their web guys had a little too much input into the display algorithm. At least they fixed things quickly, but that's a rather troubling bug.

[beatnk96]

This is from 2010

http://www.youtube.com/watch?v=YI-m2Cucdoo

[Khen]

Does anybody know about the relative acuracy of the Illumina OmniExpress Plus? That is apparently what they use at 23andme but I have not seen any publications on this technology.

[Genohub]

23andme just looks stupid. It isn't like the FDA hasn't told other businesses to cease and desist for these types of genetic tests, just because they have a really nice Google backed web page and well though marketing strategy doesn't matter.

I have no particular interest in 23andMe they just happen to make big splashes in the news. What I am concerned about is limiting public access to genetic data. To me, saying the "public can't handle it" and then just limiting access to everyone seems irresponsible. Also on the research end, it seems 23andMe was getting access to particularly large data sets that would have normally not been available.

- Genohub

[rskr]

I have no particular interest in 23andMe they just happen to make big splashes in the news. What I am concerned about is limiting public access to genetic data. To me, saying the "public can't handle it" and then just limiting access to everyone seems irresponsible. Also on the research end, it seems 23andMe was getting access to particularly large data sets that would have normally not been available.

- Genohub

Your argument isn't very good, kind of like the data/analysis they were producing, and the other businesses they told to quit marketing invalid genetic tests. It is irrelevant whether or not people can handle the data, because they never proved the data were good.

On another level, I can somewhat agree with the sentiment that I would like access to my own genetic data. However, realistically an individual's genetic data are of limited value on its own, which is why 23andMe was providing a service to interpret the data, but then they were providing diagnostics, which is squarely within FDA's authority to regulate.

[Genohub]

Letter below is what was sent out to 23andMe customers:

Dear 23andMe Customers,

I wanted to reach out to you about the FDA letter that was sent to 23andMe last Friday.

It is absolutely critical that our consumers get high quality genetic data that they can trust. We have worked extensively with our lab partner to make sure that the results we return are accurate. We stand behind the data that we return to customers - but we recognize that the FDA needs to be convinced of the quality of our data as well.

23andMe has been working with the FDA to navigate the correct regulatory path for direct-to-consumer genetic tests. This is new territory, not just for 23andMe, but for the FDA as well. The FDA is an important partner for 23andMe and we will be working hard to move forward with them.

I apologize for the limited response to the questions many of you have raised regarding the letter and its implications for the service. We don't have the answers to all of those questions yet, but as we learn more we will update you.

I am committed to providing each of you with a trusted consumer product rooted in high quality data that adheres to the best scientific standards. All of us at 23andMe believe that genetic information can lead to healthier lives.

Thank you for your loyalty to 23andMe. Please refer to our 23andMe blog for updates on this process.

Anne Wojcicki
Co-founder and CEO, 23andMe

[ymc]

Can they just market a new test that is only with traits unrelated to medicine?

[ymc]

It looks to me like Big Pharma lobbying bought this outcome from the FDA but what do I know..

p.s. I did 23andMe some time ago and found the results fascinating. I would have paid the same $99 just for the ancestry information alone..

We all know $99 is below cost. Their goal is to run a google of DNA, so they don't mind burning money.

[gringer]

We all know $99 is below cost. Their goal is to run a google of DNA, so they don't mind burning money.

I'm not convinced about that. I see prices of about $98 per sample for the HumanOmniExpress kit, and that's without any "friend" discounts [can't get a price for Express+]. I would expect that 23andMe would have a frequent flyer discount for Illumina, and most of the sample prep should be robot-driven at the scale I'd expect them to be working at.

Based on a single discussion I heard at a small ethics conference a few years back, I'd expect that 23andMe will keep on trucking on and chasing the money, regardless of what the FDA says. Sure, they'll work with FDA as much as possible (or as much as necessary), but it's not likely to stop them from doing the tests.

If they can't market directly to US consumers, they'll find some other way to get that testing done (see Tesla in Texas), or just skip the US market entirely if it stops being profitable (unlikely).

[rskr]

I'm not convinced about that. I see prices of about $98 per sample for the HumanOmniExpress kit, and that's without any "friend" discounts [can't get a price for Express+]. I would expect that 23andMe would have a frequent flyer discount for Illumina, and most of the sample prep should be robot-driven at the scale I'd expect them to be working at.

Based on a single discussion I heard at a small ethics conference a few years back, I'd expect that 23andMe will keep on trucking on and chasing the money, regardless of what the FDA says. Sure, they'll work with FDA as much as possible (or as much as necessary), but it's not likely to stop them from doing the tests.

If they can't market directly to US consumers, they'll find some other way to get that testing done (see Tesla in Texas), or just skip the US market entirely if it stops being profitable (unlikely).

X billion where X>1 is a pretty hefty speeding ticket. Several of the big Pharma companies were nailed for marketing medicines for treatments that weren't approved, maybe Brin has pockets that deep, but I doubt it. Also there aren't too many places like Nazi Germany left in the educated computer literate world, the primary market for such casual lab testing consumers.