Digital health company ResApp Health (ASX: RAP) is a step closer to making history and developing a clinically-proven means of detecting a swathe of respiratory diseases – with the use of a mobile phone app.
Earlier today, ResApp confirmed that its Breathe Easy study indicated that ResApp’s algorithms accurately diagnose a broad range of childhood respiratory diseases when compared to clinical diagnoses.
In what may sound as science fiction to sceptics, ResApp has been steadily providing scientific facts regarding its “machine-learning algorithms” that use sound to diagnose and measure the severity of respiratory conditions without the need for additional hardware.
The technology opens the door for doctors to diagnose respiratory diseases that do not require invasive and expensive surgical procedures, with military applications also being looked into.
ResApp has already launched into conducting clinical studies at several leading hospitals in the US and Australia, with a view of proving beyond all reasonable doubt that its technology can diagnose respiratory illness to the same standard as diagnoses conducted by highly qualified doctors and physicians.
So far so good
Studies to date have demonstrated that ResApp’s technology is capable of accurate diagnosis of pneumonia, asthma, bronchiolitis, croup, chronic obstructive pulmonary disease and upper respiratory tract infections.
ResApp has also obtained excellent results when screening for obstructive sleep apnoea in a proof-of-concept clinical study.
Today’s results from ResApp’s ‘Breathe Easy’ paediatric double-blind study are therefore a key checkpoint on the company’s journey to delivering a final product healthcare providers in the quickly emergent “telehealth” market, as well as emergency departments, urgent care and primary care settings as well as humanitarian organisations in the developing world.
Telehealth is defined as the “use of telecommunication techniques for the purpose of providing telemedicine, medical education, and health education over a distance”.
According to ResApp, it wants to provide suitable point-of-care diagnostic solutions for telehealth that are easily integrated into existing platforms and actively working on applications to provide “instant clinical quality diagnostic tests” to healthcare providers.
For the time being, ResApp has passed up the chance to launch a direct consumer-facing product, instead preferring to integrate and unify the existing treatment pathway, as opposed to disrupting the process entirely and trying to treat patients directly.
Early results suggest high accuracy
In total, ResApp collated data from 585 patients aged from 29 days to 12 years. Around 60% of the patients were male while 28% were less than two years old.
For all predefined study endpoints, ResApp says its algorithms performed “very well”, achieving a positive per cent agreement (PPA) between 79% and 97% and a negative per cent agreement (NPA) between 80% and 91% when compared to a clinical diagnosis. The results for asthma/reactive airway disease (RAD) were “exceptional”, with a PPA of 97% and an NPA of 91%.
For pneumonia – a disease that is responsible for the death of more children under five than any other disease – ResApp’s algorithms delivered a PPA of 87% and an NPA of 85%.
For lower respiratory tract disease, a key diagnosis for telehealth consultations in particular, ResApp’s algorithms yielded a PPA of 83% and an NPA of 82%.
Regarding its detection of bronchiolitis, ResApp said that “while a shortage of patients under two without bronchiolitis limited the statistical robustness of the study’s bronchiolitis results, the algorithm’s performance was again excellent with PPA and NPA both above 80%.”
“Even with all the information available to us in a modern, well-equipped hospital we still face difficulties in diagnosing childhood respiratory diseases. These excellent prospective results, obtained without the need to examine the patient or perform investigations, will give clinicians significantly more confidence in their diagnosis of respiratory disease, especially in telehealth and emergency department settings,” said Dr Paul Porter, principal investigator at Joondalup Health Campus and Princess Margaret Hospital, and the principal investigator on ResApp’s study.
“The outstanding results delivered by the ‘Breathe Easy’ prospective study are consistent with our expectations, and for diseases such as pneumonia and asthma have even exceeded our expectations. This formal confirmation of ResApp’s algorithms’ robust performance will allow us to provide key diagnostic products in an array of clinical settings, especially in telehealth – one of the fastest growing segments in healthcare – where up to 50% of consultations are respiratory related”, said Tony Keating, CEO and managing director of ResApp.
“We now have a solid dataset to underpin our forthcoming CE mark and TGA submissions which will propel the commercialisation of our products in Europe, Australia and the rest of the world outside the US. The successful completion of ‘Breathe Easy’ also gives us additional data, experience and confidence as we finalise our US SMARTCOUGH-C-2 study,” added Mr Keating.
ResApp is also expecting a final result from its US-based SMARTCOUGH-C-2 study later this year with the study currently at the data verification phase.
ResApp has enrolled a total of 1,470 patients at three hospital sites in the United States and has now completed the necessary recordings that will be analysed to infer diagnoses.
The data collected by ResApp will be compared to diagnoses made by accredited doctors for the same patients, to see if its digitally-powered detection algorithms can deliver what may have seemed like science fiction merely a few years ago.
From the results published so far, ResApp has a fighting chance of seeing its technology make the grade and open up to a potential wider market in future.
Today’s news helped ResApp’s share price to stage a 30% rally in morning trade, up to $0.225 per share.