in this case Roche was fast-tracked because of a critical and life threatening unmet need in community health. Product approval in the US in not driven by foreign health agencies. It's driven by unmet need, burden of illness, product effectiveness, product affordability, etc. To create this story you need clinical trials, real world evidence, etc. The approval process is also limited by red tape and other regulations that make the product approval process very slow (and expensive).

I think in this case it's desperate times = desperate measures. In fact, I'm surprised Roche gained approval to test so quickly.