It would seem that clarification and further information is...

It would seem that clarification and further information is needed regarding the statistical significance and what FDA really need/want.
But just to give another view, the potential to use this as a diagnostic tool in conjunction with clinical assessment surely carries more weight than simply a quick diagnositic test.
To compare, consider EEG for epilepsy. Sensitivity is often quoted around 50%, but used with clinical suspicion is a very useful test. And used ridiculously often.
The specificity is higher, but again not exactly perfect.
Clinicians often require multiple EEG’s to help with manage my and they can take weeks or months to order and obtain a full report.
Maybe this type of use is more suited for MEB.
IMHO of course.