Re:FDA Warning Letter to 23andMe
by unclebucknasty on Monday November 25, 2013 @04:01PM
(#6796976)
I think one can make a million hypothetical arguments against the testing. But, I just don't see people taking the test at face value and making major life decisions without further follow-up. I think most reasonable people would consider it a screen.
If the testing was wildly inaccurate, then that's another issue. It almost becomes more an FTC consumer protection-type matter at that point. But, there is no indication that this is the problem. They go on to state that their testing is done in CLIA-certified laboratories:
https://www.23andme.com/howitworks/ (near bottom of page) http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA...
BTW, I'm not really defending the service, per se. In fact, I have issues with it that are more along the privacy lines. I just don't see where there's any proof that it has an outsized chance of ruining lives any more than, say, in-home HIV testing.
Re:FDA Warning Letter to 23andMe
by Dylan16807 on Monday November 25, 2013 @03:17PM
(#6796648)
They'd probably feel a hundred times worse if they found out by observing the symptoms in those future children.
What if the gene essentially means "you and your husband shouldn't have children?"