This is something I know a little bit about. And Obamacare does nothing for diagnostics - clinical data does. I don't know what that broker is on about. And that is an area (clin data) that PEB seem to be a little bit lacking in. They are getting much better and it is coming, but they need to show 1) efficacy and accuracy compared with current best practice ie. scopes etc. I know they have done some work on this but 2) they need a multi-centre, multi-disease status trial , split into two groups that pay attention or ignore the PEB results and then calculate outcomes up to two years after the last participant is enrolled. If the BladderCx or whatever outperforms, or at least adds significant improvement, to current clinical practice, then they cannot be ignored for much longer.
However, the biggest hurdle is the urologists themselves. They WILL NOT change practice from charging USD$1100 per scope to a test that is just as good but they only receive $200 at best. Yes, its all about the money (a very close second after the patient) for them. PEB need to change their business model based on the above study(s) and promote their tests as an adjunctive that costs USD$150 (MAXIMUM) on top of the scope. Volumes will then come their way as the urologists are happy, PEB is happy and revenue will go through the roof. This is precisely what Paul Ridker and colleagues achieved with CRP measurements and statins some years ago.
They also need to think of off-label use. What happens to the BladderCx or other markers in acute kidney injury? Diabetic TII whom seroconvert to TI? Pancreatic cancer sufferers? Long shots maybe but need to look to expand indications. Its what Shire, Gilead, Roche, Siemens, Abbott, Quest etc. do all the time.