ResApp Health (ASX: RAP) has received Europe’s CE Mark approval for its latest smartphone-based respiratory disease diagnostic test for adults and children, paving the way for the company to sell the test throughout the region.
CE Mark approval for ResApp’s ResAppDx-EU version two test builds on the existing CE approval for the original ResAppDX-DU test, which was purely for children.
ResApp chief executive officer and managing director Tony Keating said securing CE Mark approval now allowed the company to commercialise its smartphone-based test for adults and children across the European Economic Area.
“A large percentage of general practitioner, emergency department and telehealth consultations are for respiratory disease and now, for the first time, clinicians in Europe will have access to a fast and accurate point-of-care diagnostic test that will improve care and reduce costs for patients of all ages,” Mr Keating said.
ResAppDx-EU version two
The company’s latest smartphone test allows clinicians to evaluate adults and children for lower respiratory tract disease, pneumonia, asthma exacerbation and chronic obstructive pulmonary disease exacerbation (adults), croup (children) and bronchiolitis (children).
The software uses machine learning algorithms to analyse a patient’s cough sounds to diagnose disease.
ResAppDX-EU does not require any additional hardware or accessories.
According to the company, most people will develop an acute respiratory tract infection at least once a year, with these infections the most common acute illnesses seen in primary care.
Traditional forms of diagnosing respiratory illnesses are complex and subjective using clinical judgement with diagnostic aids including stethoscope, imaging, blood and sputum tests.
ResApp’s technology has been successful in clinical studies in diagnosing common respiratory diseases among adults and children.
The company anticipates EU approvals will facilitate approvals in other regions including Australia, the US, Canada and Singapore.
On the back of this morning’s news, ResApp’s share price lifted almost 7% to reach $0.235 by mid-morning.