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ResApp Health set to begin U.S. study of its app to diagnose respiratory diseases

An important step towards the commercialisation of ResAppDx in the U.S.
a smartphone
The app uses cough sounds to diagnose respiratory conditions

ResApp Health Ltd (ASX:RAP) has secured its third institutional review board (IRB) approval in the U.S. for a study that will evaluate the efficacy of the ResAppDx smartphone application.

The prospective double blind study is aimed at evaluating the efficacy of the ResAppDx app in diagnosing childhood respiratory diseases from cough sounds.

Planning to enrol up to 1,667 patients

Three hospital sites in the U.S. have now received IRB approval for the study – Massachusetts General Hospital, Texas Children’s Hospital and Cleveland Clinic Children’s.

The SMARTCOUGH-C-2 study plans to enrol up to 1,667 patients aged 29 days to 12 years of age who present to one of the three participating sites in the U.S. with signs or symptoms of respiratory disease.

ResApp’s co-primary endpoints from the study are positive and negative percent agreement with clinical diagnosis for various respiratory diseases.

These include pneumonia, lower respiratory tract disease, viral lower respiratory tract infection, bronchiolitis, asthma/reactive airways disease, upper respiratory tract disease and croup.

READ: Resapp Health embarking on new study to evaluate efficacy

The clinical diagnosis will be made by an independent, centralised clinical adjudication committee using all available clinical data, including radiology and microbiology.

Importantly, this represents another step towards the commercialisation of ResAppDx in the U.S.

The refined study includes major improvements over previous studies in the U.S., which is expected to deliver results that are more representative of ResAppDx’s performance.

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