Okay, I've read your posts and the debate primarily with @Tech goose and it looks to me like you're arguments are based on incomplete information/
1) The current trial is not testing ResappDx to see if it agrees with a clinician. If it agrees only with a clinician then the applicability of the product would be limited to those circumstances where a clinician isn't available. The test is against whether the patient actually turned out to have the condition predicted by ResappDx. The fact that the results have taken so long to be released after the last patient was enrolled is an indication of how long the traditional tests/procedures take to produce a result. Perhaps the doctor imagined by @dougfr might ditch his stethoscope, but it's more likely that he will ditch the traditional tests in the first instance. Those ResappDx won't be an additional cost, it will be a cost reduction as well as a response improvement. It will also be applicable where the traditional tests can't be done or will cost more than the patient is able to afford. The doctor might reserve traditional tests for cases where the patient fails to respond to treatment based on a ResappDx diagnosis.
2) I don't recall seeing anybody suggest prescriptions will be given over the phone!
3) The whole point of conducting the current trial and subsequently obtaining FDA approval is surely to show that using ResappDx aligns with current best practice, isn't it? The whole point of measuring NPA is to ensure that if the patient doesn't have a condition then ResappDx won't say they do.
You're citing examples of marginal, complex, borderline or combination cases where a clinician would be cautious and would gather additional information to make a diagnosis. In such a situation ResappDx is likely to return no diagnosis at all. The doctor would then make a judgement about what this clearly sick patient actually has and then work to eliminate or confirm various conditions. Similarly ResappDx could diagnose multiple conditions, in which case the doctor would decide whether that mix matches the symptoms, or whether there is some other condition afflicting the patient.
This is why ResappDx will be used by doctors! I suspect that if the results are in line with previous studies then most doctors will welcome ResappDx as a powerful, fast and efficient additional tool.
Ann: Voluntary Suspension, page-244
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #