Digital health company ResApp Health (ASX: RAP) is a step closer to clinically proving the capabilities of its proprietary ResAppDx app after announcing the completion of enrolment in its SMARTCOUGH-C-2 study.
The study is evaluating the efficacy of the ResAppDx smartphone application for the diagnosis of childhood acute respiratory disease using cough sounds, which are then analysed for indications of respiratory disease.
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 clinical diagnoses of the same patients to see if its ResApp’s technology can make accurate clinical diagnoses.
With enrolment finished, the study now enters the “data verification phase” in which final quality assurance, clinical and radiologic adjudication will be conducted for the remaining patients, and final source data verification site visits will be performed.
Following data verification, the independent analysis team will prepare top-line results, which are expected “within a month”, according to ResApp chief executive officer and managing director Dr Tony Keating.
Dr Keating explained to Small Caps that if ResApp’s technology can demonstrate at least a 75% success rate in diagnosis accuracy, the study would be deemed successful and its technology could be on a fast-track to FDA approval in the US and a further study also being done in Australia.
Dr Keating also explained that ResApp intends to deliver its technology to patients via a business-to-business (B2B) model whereby healthcare providers licence the technology and offer it via “telehealth consultations” as well as being integrated into existing facilities used by healthcare providers.
Telehealth consultations are doctor appointments made via video conferencing tools and allow for greater interaction between doctors and patients – especially for people in remote areas.
Integrating ResApp’s technology into screening for respiratory disease could potentially save existing healthcare operators large sums of money currently spent on complex tests and invasive sampling. Therefore, ResApp’s top-line results in the coming weeks could serve as a clear indicator regarding the efficacy of ResAppDx and its ultimate commercial viability.
Studying acute respiratory disease
SMARTCOUGH-C-2 is a multi-site, prospective, double-blind study evaluating the efficacy of the ResAppDx smartphone application in the diagnosis of childhood acute respiratory disease using cough sounds.
The study enrolled almost 1,500 patients less than 12 years of age with signs or symptoms of acute respiratory disease and recorded their cough sounds for analysis. These recordings will now be interpreted to form diagnoses and then compared with clinical diagnoses given to the patients by doctors.
ResApp intends to prove that ResAppDx accurately detects the early-warning signs (and clinically diagnoses) common ailments such as pneumonia, lower respiratory tract disease, viral lower respiratory tract infection, bronchiolitis, asthma, reactive airway disease, upper respiratory tract disease and croup.
If commercialised, ResApp hopes its technology can replace stethoscope, x-ray and CT scans, spirometry, as well as blood and sputum tests in offering a rapid respiratory disease diagnosis.
Full enrollment means the SMARTCOUGH-C-2 study can deliver a clear conclusion regarding the efficacy of ResAppDx. ResApp has also said that its app underwent a revised version of the study with “significant improvements made to training and processes”.
ResApp says that improvements in hospital staff training and an improved audio recording application have produced higher quality cough audio data in the SMARTCOUGH-C-2 study.
Furthermore, the health company said that its data is subsequently verified by a rigorous quality assurance process that has ensured a successful recording rate of 97%, to date.
Given the sensitive nature of diagnoses and the potential for misdiagnosis when detecting respiratory issues via smartphones, ResApp is also supplementing existing study guidelines with an independent, centralised clinical adjudication panel to ensure consistent clinical diagnosis.
“We are grateful once again to all the patients who participated in the revised study, as well as the investigators and their teams for their hard work and considerable skill that have made this study possible,” said Dr Keating said.
“With higher quality audio data throughout the study, and a consistent, less subjective clinical adjudication process we are confident that we have mitigated the issues that we identified in our earlier SMARTCOUGH-C study. We now look forward to receiving top-line results which will form the basis of our de novo premarket submission for ResAppDx in the US,” Dr Keating added.
Today’s news of ResApp completing enrolment for its medical study helped its shares to reach a high of A$0.16 by early afternoon, up around 11% from yesterday’s close.