good summary from @ScottGottliebMD. This is a complicated area where adaptive judgment is needed when times are stable to enable innovation and personalized care, but in this pandemic crisis, threading the needle is difficult. https://twitter.com/ScottGottliebMD/status/1297152402773233666

But like all areas of medicine, evidence for reliability and reproducibility of product performance is necessary. Most companies do a great job, but FDA oversight is necessary to set standards and deal proactively with problems. @DukeMargolis

The question of the operating characteristics of tests is not easy to grasp & an independent adjudicator is needed to assure quality when so much is at stake for patients. A "free for all" marketplace for such critical testing is dangerous. Flexible regulation is the way.