ResApp Health announced on Thursday, that it will shortly commence a US-based clinical study to explore the relationship between cough and SARS-CoV2 “COVID-19” infection. ResApp has engaged Phosphorus, a US clinical testing company to provide at-home COVID-19 testing for the study.
ResApp will conduct a pilot clinical study to secure data to train an algorithm to identify COVID19 through cough sounds recorded on a smartphone, using an at-home saliva-based Polymerase Chain Reaction pathology test as a reference standard.
ResApp’s regulatory approved cough-based machine-learning technology requires a smartphone and is currently used to assist clinicians in the diagnosis of patients for a range of respiratory conditions.
The company will actively recruit patients from COVID-19 hotspot areas in the US that are either symptomatic or asymptomatic who have a high likelihood of having COVID-19. The study aims to recruit up to 1,500 subjects with data collection expected to take up to two months.
To support the study, ResApp has signed a laboratory services agreement, Phosphorus to provide at-home COVID testing for the study. Most recently, Phosphorus has been focused on the development and roll-out of COVID-19 tests for individuals, employers and organisations. The group has developed an at-home saliva collection test for COVID-19, which has Emergency Use Authorisation from the US Food and Drug Administration.
During the study, ResApp will collect cough sample and symptom data from participants who will then be sent a Phosphorous at-home saliva collection kit. After providing their saliva sample, participants will ship the completed test kit to Phosphorous’ CAP-accredited and CLIA-certified lab for PCR testing, allowing ResApp to detect and confirm whether or not a patient has COVID-19. A second cough sample will then be taken from patients to bolster the study dataset.
CEO and Managing Director Dr Tony Keating said: “While much progress has been made, the effects of COVID-19 are expected to continue well into the foreseeable future and we are confident that the development of this smartphone-based screening test will become an important and useful tool in many settings both within health systems and more broadly.
ResApp’s regulatory-approved and clinically validated products include ResAppDx, a smartphone-based acute respiratory disease diagnostic test for use in telehealth, emergency department and primary care settings; and SleepCheck, a smartphone application that allows consumers to self-assess their risk of sleep apnoea.
Both products are CE Marked in Europe and TGA approved in Australia, although to date, neither of the companies products have achieved any material level of commercial revenue.