Which devices and drugs were 23&Me selling? I thought it was just crowd-sourced information about traits.
Think how ridiculous it would be if the FDA just shut down a crowd-sourced database about trait correlations. But suddenly when a company like 23&Me correlates the two, it becomes pure, concentrated evil that must be subject to regulation.
They were marketing their genetic testing kits and related services for diagnosing genetic diseases and risks. That made it a "medical device" within the scope of the Food and Drug Act, which means that they needed to actually have specified level of testing establishing the validity of the things its was being used to assess.
The FDA noticed the violation, notified 23andMe, said, if you want to keep doing this, you need to meet the requirements, and please tell us how you plan to come into compliance. And 23andMe blew them off for quite a while, so the FDA enforced the law.
It's not a stretch to imagine someone acting on that information with potentially dangerous results; taking extra unneeded supplements, having elective surgery, dramatically changing their lifestyle to reduce the risk of some condition, etc.
The difference is that Illumina did things legally (including hiring clinical genetics analysts who pored over the details and made a number of calls about what was significant).
23&Me did not. They were doing something that they would have known was illegal. The FDA explained this to them, and 23&Me blew them off. Failing to respond to an accusation from the government is an amateur move and 23&Me deserved what they got. They only went back and negotiated afterwards.
You're complaining the government was restricting your freedoms but we have more than adequate evidence that 23&Me was acting irresponsibly.
Then I promptly uploaded my genome including the VCF files they used for risk screening, https://my.pgp-hms.org/profile/hu80855C
Anybody on the internet is free to analyze my genome.
What's been your experience with analysis? Something that can be picked up, or something that the professional insights you got were far more useful?
Personally I found it less than useless, since I can't reasonably conclude I have no risks. I know enough genomics to conclude that beyond a few well understood cases, genomes have little medical predictive ability.