Meaning, the experiments didn’t have the type of oversight necessary to ensure that they were performed in stringent, controlled ways that would consistently provide accurate results and wouldn’t harm the test subjects. The company says that it “recognized” that some of its data was gleaned before the needed protocols were in place.
Theranos plans to appeal the Food and Drug Administration’s ruling, of course, and collect the extra information requested by the FDA before trying the certification process again. Same goes for when the company attempts certification for its Ebola test as well.
The miniLab itself was a way to sidestep founder Elizabeth Holmes’ two-year ban from owning or running a lab or her own, precisely because the device was made for outside use. All of this raises the question of how long Jennifer Lawrence will have to wait for a final script for Theranos: The Movie. Seriously, this saga just keeps getting better.