Hacker News Reader

Comment by dekhn | Hacker News Reader

That's not correct. The FDA made them stop doing something they were doing illegally. Their genetic test is a medical device and they didn't have federal approval.

Further, when the FDA informed them they needed approval, they didn't respond. The FDA finally had to invoke the law.

Also, I don't think 23&Me's test results have enough medical value to be used for evaluating health risks.

Further, 23&me's database has serious problems; for exmaple, they still report tongue rolling as a Mendelian trait. That alone shows that they aren't being careful with their analysis.

View on HN

Also, I don't think 23&Me's test results have enough medical value to be used for evaluating health risks.

For some things they do, like they test for mutations related to Alzheimer's that can drastically alter risk, ranging from "you're probably never going to get it" to "you're probably going to get it, and there's a good chance it'll be much earlier than you would have imagined".

But their marketing material was vastly overstating the value of their results, which is near 0 for most diseases. And it was misleading people into thinking it was more comprehensive than it really was (like, it's not a full genome, and it doesn't include every SNP that we know matters like most BRCA mutations).

Do they actually still show the Alzheimer's information? If so, I'd be very interested in doing that...

They don't show any medical information for new customers, but you can analyze it yourself with stuff like https://www.promethease.com/

All of those diseases that 23&Me reported on have existing single-purpose genetic tests which are far more accurate.

I've done full-genome too. The report (first from Illumina, then from another site I uploaded my VCFs) was medically useless: I read all the top risks, then did additional research, and found that the risks they reported were contradicted by other SNPs (for example, they'll say you are at risk for X, but only if you have Y SNPs and Z SNPs, and if you check Y and Z you don't have it).

In general, you need a genius/expert to analyze these results right now.

I think it's kinda bullshit that there seems to be no limit on the information that the government, Facebook et. al. can gather on me, but somehow I can't be trusted with information about my own genetic code unless it's been vetted by the FDA. It's not like I could go have a medical procedure solely on the basis of this information. Yet supplements and diet pills can make all kinds of bogus claims with impunity.

>I think it's kinda bullshit that there seems to be no limit on the information that the government, Facebook et. al. can gather on me, but somehow I can't be trusted with information about my own genetic code unless it's been vetted by the FDA.

All the FDA did was prevent them from making unsubstantiated medical claims from the results of their test, in the same way that they would for, say, a new pharmaceutical. 23&Me could always go and perform the necessary clinical trials and submit the evidence to prove their results to the FDA. FDA is doing what the FDA was designed to do. What's the problem?

>Yet supplements and diet pills can make all kinds of bogus claims with impunity.

That's because the supplement lobby launched a huge political campaign and got congress to change the law barring the FDA from investigating supplements, after the FDA tried to regulate them.

Relevant news report from when the FDA took regulatory action.

http://www.cbsnews.com/news/fda-warns-23andme-tells-genetic-...

> Also, I don't think 23&Me's test results have enough medical value to be used for evaluating health risks.

Insurance companies would have another view.

That's probably the reason why the FDA wants them to get approval before making such evaluations.

The FDA wants them to get approval becaue what 23&Me was doing was illegal and then when the FDA informed them, 23&Me didn't respond (this is all clearly documented!). The FDA has a requirement to enforce the law.

Do they? What evidence do you have of that? Insurance companies typically reimburse for actual genetic tests, and they are legally prevented by GINA from discriminating against you for the test results.

Reply on news.ycombinator.com