Standard devices, or proprietary devices developed (and kept) in-house. The New Yorker profile suggests that FDA device approval only becomes necessary when devices are sold.
That is quite a loophole! If these blood tests are proved to be inaccurate, the lawsuits will be a plenty?
I have followed her career. In every Interview, she talks about the huge about of funding the company has received.
Why not perform double blind studies? Blood is sent to Quest Labs. Blood is sent to her companies machines. The results are collated by a third party. It seems like one of the easier studies to set up? It seems like a cheap way of proving her machine works as described? Plus, the company Lawyers could sleep at night?
What if they did just that, then chose to not publish the results? That would be a really good strategy, you play your cards when you need to, on your terms rather than on the terms of your competitors.
