…which would be plenty of info for the primary endpoint of "saving lives".

The government's desire for a legible set of stats should take a backseat to the urgent need to inform people how to protect themselves. Let's help people save themselves by not making useful tools illegal. Pretty charts for bureaucracies can wait.

Yes, ideally that's what would happen. But it's hard for the FDA to approve any new medical device that's worse along a metric the FDA cares about than existing methods. Honestly, the FDA has basically never cared about price and availability before so I'm really surprised they're even letting this one through given that it's less sensitive than a standard PCR. Given how disastrous the FDA's (and CDC's) actions around testing were in February and March I'm relieved things are currently going as well as they are.