enzamatic

People need to realize their authority comes from regulating sale. They couldn't regulate the device because it was not for sale. At the point that they began selling tests, they could regulate the nanotainer because it's a consumable, essentially sold to the customer with each test. I think they were probably involved as early as they could be.

There are other companies who followed the rules and do have a successful test for Zika. A company with Theranos history should have been following the rules, knowing they had already screwed up. They're currently, unless their appeal succeeds, going to be barred from performing ANY testing for 2 years. Actually the fact that they are under appeal makes failure to follow procedures even more astounding.

The question is, why is this bar a problem for them and not others? Inability to follow a basic protocol is a good sign of their incompetence with regard to deeper issues I suspect.

You're also talking about telling someone they either do or do not have a disease. The finger stick alone is not all the damage that you can do. Is that person pregnant? Is their spouse? Are they going to act on what you told them?