ResApp’s smartphone app works by using algorithms to analyse the sound of a patient’s cough and provide a diagnosis.
The multi-site clinical study in the U.S. aims to recruit up to 1,111 patients between the ages of 29 weeks and 12 years.
The primary endpoint of the study is the diagnosis of pneumonia compared to radiologic and clinical diagnosis.
The secondary endpoint is the diagnosis of other common childhood respiratory diseases such as upper respiratory tract infection, croup, bronchiolitis and asthma compared with a clinical diagnosis.
Worldwide, pneumonia is the leading cause of death of children under 5 years of age and is the most common reason for U.S. children to be hospitalised.
Today, respiratory disease diagnosis is based on a combination of auscultation, imaging and laboratory tests.
An instant, accurate diagnostic test delivered via a smartphone could greatly improve patient management, expand access to healthcare and reduce costs.
The U.S. study builds on ResApp’s highly successful Australian paediatric clinical study which demonstrated accurate diagnosis of pneumonia, asthma/viral wheeze, bronchiolitis, croup and upper respiratory tract infections.
Analysis of the Australian study data is progressing well and ResApp will release enhanced results in early 2017.
The company’s share price has more than tripled in 2016, last trading at $0.33.