Ann: Voluntary Suspension, page-429

You do know the last Australian clinical trial results used process to match the US-centric clinical case definitions and followed published guidance by the US FDA.......????

"The dataset and machine learning algorithms have been optimised to match the design of ResApp’s US SMARTCOUGH-C study as closely as possible. The clinical diagnosis, used as a comparator, has been adapted to match the SMARTCOUGH-C US-centric clinical case definitions.

The algorithms have been fine-tuned to differentially diagnose disease from all patients recruited to the study, as required by the SMARTCOUGH-C endpoints. Following published guidance by the US FDA, the key measures of positive percent agreement (PPA) and negative percent agreement (NPA) are reported instead of sensitivity and specificity. ResAppDx achieved between 90% and 100% PPA and between 89% and 96% NPA with clinical diagnosis of primary upper respiratory tract infection (i.e. with no comorbidities), croup, lower respiratory tract involvement, asthma/reactive airways disease (RAD) and bronchiolitis.

For pneumonia, ResAppDx demonstrated 89% PPA and 79% NPA with clinical diagnosis. The lower NPA reflects the higher uncertainty in the current method of clinical diagnosis of pneumonia and in particular the clinical overlap between pneumonia, bronchiolitis and asthma/RAD, which can occur at the same time. In many of these cases ResAppDx provides a diagnosis of both pneumonia and the other condition which accurately reflects the clinical situation. "