4 ms·
The ignorance of, and/or disregard for regulatory standards is the common thread here. Also, How do you know they work? They got slapped for giving people risk
by dfsegoat 11y ago
The ignorance of, and/or disregard for regulatory standards is the common thread here.
Also, How do you know they work? They got slapped for giving people risks of disease using genetic data over the internet -- a method which was not peer-reviewed or shown to be accurate and precise. That is not bullshit - that is effective regulation.
The saddest thing is - even if you are right, all the FDA asked 23&Me to do was file a premarketing authorization -- something that many tiny companies do all the time to buy time to generate solid evidence.
- mattmcknight 11y ago"They got slapped for giving people risks of disease using genetic data over the internet -- a method which was not peer-reviewed or shown to be accurate and precise." So if they delivered the results by mail or phone call they would have been in the clear? That is bullshit.
- dfsegoat 11y agoNope. It doesn't matter if the results came by courier pigeon: The test has not been validated in controlled trials or even published in peer-reviewed literature -- let alone approved by the FDA. If it were so simple don't you think they would have obtained approval by now? The sad thing is any idiot can invent a glucose meter and file their PMA properly -- but a company essentially backed by Google blows it horribly.