Reading the FDA notice, a lot of them will probably get FDA approval soon given this accelerated pathway. Looks like they just want 99% sensitivity and < .01%

Reading the FDA notice, a lot of them will probably get FDA approval soon given this accelerated pathway. Looks like they just want 99% sensitivity and < .01% false positives on the targeted genes/regions, and as long as you can show your WGS coverage you don't need to do trials or whatever.