Acarix has announced the results from a new multi-center trial of its handheld CADScor System for non-invasive, non-radiation acoustic detection of Coronary Artery Disease.
The results were presented at the American College of Cardiology 2017 Annual Scientific Meeting held in Washington on 17-19 March 2017 and showed that the handheld CADScor System rules out CAD with 97% negative predictive value. The results confirm the company’s previously announced figures which, prior to this study, was unconfirmed.
The trial involved 1,675 patients from two Danish hospitals with a low to intermediate likelihood of CAD referred for Cardiac CTA and showed that the handheld CADScor System rules out CAD with 97 % negative predictive value. Acarix believes this opens the possibility of use as a frontline test, reducing patient anxiety and waiting times, as well as improving triage for patients needing more expensive and invasive diagnostic modalities.
The CADScor System combines acoustic detection of turbulent arterial flow and myocardial movement with advanced algorithms in a handheld device to provide a patient specific CAD-score in less than 10 minutes.
“Despite the availability of improved risk stratification algorithms, the incidence of normal investigations such as nuclear or CT imaging remains high. We therefore tested the diagnostic accuracy of the CADScor System for ruling out CAD to see if it could be used to reduce demand for more advanced diagnostic modalities. We have concluded that, with its ability to rule out CAD with a 97% negative predictive value, this advanced, easy to use, stethoscope like device could indeed be deployed as a frontline test,” said Principal Investigator Morten Böttcher, MD PhD FESC and by Simon Winther, MD PhD, Department of Cardiology, Aarhus University Hospital, Denmark.
“We are delighted with the results of the trial. Coronary Artery Disease affects more than 120 million people worldwide but the current diagnostic pathway, which can rapidly escalate to expensive imaging and coronary angiography, is inefficient. For example, a recent Danish study showed that more than 90% of patients presenting with chest pain symptoms to their general practitioner do not have CAD. If adopted, the CADScor®System can provide rapid frontline assessment which could translate into a potential reduction in patient referrals by ~50%. – a win-win for patients, payers and physicians,” commented Acarix CEO Søren Rysholt Christiansen.