Leading digital health company, ResApp Health Limited (ASX: RAP) has announced positive top-line results from its Australian Breathe Easy adult prospective, double-blind clinical study. Following the release of this news, the share price of the company increased by 24% during the intraday trade (AEST 12:26 PM).
The company has found that its smartphone-based algorithms are able to diagnose all respiratory diseases included in the study: lower respiratory tract disease, pneumonia, asthma exacerbations, chronic obstructive pulmonary disease (COPD) and COPD exacerbations. Further, the company is now having compelling data on the identification of exacerbations in patients with asthma and COPD.
As per the company’s CEO and Managing Director Tony Keating, these results are underpinning the commercialisation of a range of smartphone-based acute diagnostic and chronic disease management tools. He further told that the company is planning to use this data to support CE and TGA regulatory submissions.
The study had 979 subjects on which the performance of ResApp’s algorithms was evaluated. The algorithms were evaluated using positive percent agreement (PPA) and negative percent agreement (NPA) compared to a clinical diagnosis reached by expert clinicians with full examination and results of investigations.
In the first critical step in the clinical diagnostic pathway, i.e., identification of lower respiratory tract disease, 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. Moreover, similar levels of accuracy were demonstrated for pneumonia with an 86% PPA and an 87% NPA when compared to a clinical diagnosis. Pneumonia is the most common illness-related cause of adult hospital admission, usually caused by a bacterial, viral or fungal infection.
Around 339 million people are estimated to have asthma and around 251 million people are currently suffering from COPD. Both of these are having a major impact on patient quality of life. The ability to identify exacerbations early will help patients and their doctors better manage their disease. Further, the ability to identify asthma exacerbations and COPD in the early stages could improve patient outcomes and reduce healthcare costs. ResApp’s algorithms achieved an 89 percent PPA and an 84 percent NPA when compared to a clinical diagnosis for the identification of acute asthma exacerbations and they identified COPD with an 86 percent PPA and an 85% NPA compared to a clinical diagnosis which was confirmed by lung function testing.
COPD exacerbations are among the leading causes of adult hospital admissions and readmissions worldwide. For patients who were having a history of COPD, ResApp’s algorithms identified COPD exacerbations with an 83% PPA and a 91% NPA compared with a clinical diagnosis.
The company is planning to use these results to support CE and TGA regulatory submissions.
In the last six months, the share price of the company decreased by 40.48% as on 18 April 2019. RAP’s shares are trading at $0.155 (+24% intraday) with a market capitalization of circa $98.36 million as on 23 April 2019 (AEST 12:26 PM).
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