The company can't get good enough adjudication in a US trial to demonstrate accuracy for individual diseases. So clearly they have pulled back to a broader target in order to get greater confidence.
This is a serious erosion of the company's aspirations. Forget any near or medium term prospects of ResappDx becoming a diagnostic tool for specific conditions in the USA.
The new certification, when it eventually is granted, will allow ResappDx to be used to indicate that a LRTI exists. This is something any medical practitioner can do in 90 seconds with a stethoscope. The only advantages of ResappDx under those conditions are:
- Patient doesn't have to take off their shirt.
- Symptoms can be measured at a distance, without direct contact.
