ResApp Health (ASX:RAP) has announced positive top-line results from its Australian Breathe Easy adult clinical study.
The digital health company is developing smartphone applications for the diagnosis and management of respiratory disease.
The company said its smartphone-based algorithms were found to accurately diagnose all respiratory diseases included in the study - lower respiratory tract disease, pneumonia, asthma exacerbations, chronic obstructive pulmonary disease (COPD) and COPD exacerbations.
“The breadth of these results is exciting. Not only do we have outstanding results for the diagnosis of acute respiratory disease in adults, we also have compelling data on the identification of exacerbations in patients with asthma and COPD, as well as the ability to screen for COPD in the general population,” said CEO and managing director Tony Keating.
“These results underpin the commercialisation of a range of smartphone-based acute diagnostic and chronic disease management tools, and we intend to use this data to support CE and TGA regulatory submissions.”
The study recruited a total of 979 subjects.
According to the company, the performance of its algorithms was evaluated using positive per cent agreement (PPA) and negative per cent agreement (NPA) compared to a clinical diagnosis reached by expert clinicians with full examination and results of investigations.
"For identification of lower respiratory tract disease, the first critical step in the clinical diagnostic pathway, ResApp’s algorithms achieved an 88% PPA and an 89% NPA when compared to clinical diagnosis in patients with acute respiratory symptoms or clinical normalcy," said the company in a statement.
"Similar levels of accuracy were demonstrated for pneumonia, the most common illness-related cause of adult hospital admission, with an 86% PPA and an 87% NPA when compared to a clinical diagnosis."
It continued, "In patients with a history of asthma, ResApp’s algorithms achieved an 89% PPA and an 84% NPA when compared to a clinical diagnosis for the identification of acute asthma exacerbations."
“Asthma and COPD exacerbations have a major impact on patient quality of life and the ability to identify exacerbations early will help patients and their doctors better manage their disease,” said Dr Scott Claxton, respiratory physician, GenesisCare, one of the study's principal investigators and a member of ResApp’s scientific advisory board.
“COPD screening in primary care has the potential to reduce the significant number of people who have undiagnosed, untreated COPD and provide them with treatment that can help improve their quality of life and reduce their risk of death.”