ResApp’s smartphone app works by using algorithms to analyse the sound of a patient’s cough and provide a diagnosis.
ResApp is extending the study through to the end of May and is increasing maximum recruitment to 1,500 patients.
Enrolment in the study has progressed well across eleven recruitment locations, however the incidence of pneumonia and croup among study patients has been unseasonably low.
The primary endpoints of the U.S. study are the diagnosis of pneumonia compared to clinical and radiologic diagnosis.
Increasing the recruitment target is to ensure that the study generates statistically strong results and maximize the range of diseases included in ResApp’s de novo submission to the FDA.
ResApp remains on-track to complete enrolment, release topline results and submit its de novo submission to the FDA in the first half of CY2017.
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.
Currently, respiratory disease diagnosis is based on a combination of auscultation, imaging and laboratory tests.
An instant, accurate diagnostic test delivered via a smartphone is expected to greatly improve patient management, expand access to healthcare and reduce costs.