No sequencer on its own will ever be certified. You always need a pipeline from sample to a clinically useful answer to be certified. The problem here is that

No sequencer on its own will ever be certified. You always need a pipeline from sample to a clinically useful answer to be certified. The problem here is that everything in that pipeline keeps improving at a fast base. Also the reference databases are updated all the time. Whereas sequencing will probably always give the right answer to the precise question it was given, I don't see any luck in certifying these methods any time soon.