CEO MI:RNA Ltd Edinburgh, Scotland, United Kingdom
Abstract: Background - Cardiac disease is common and challenging to diagnose in primary care. MicroRNA diagnostics could fill this unmet clinical need. Hypothesis/Objectives - In companion animals, to answer the question: can analysis of a blood sample by a novel microRNA based platform, when compared to the current gold standard of echocardiography, effectively distinguish between animals with cardiac disease and healthy controls? Animals - One hundred and fifty-nine client-owned animals; 52 cats (34 hypertrophic cardiomyopathy (HCM) and 18 controls) and 107 dogs (36 myxomatous mitral valve disease (MMVD), 30 dilated cardiomyopathy (DCM) and 41 controls). Methods - A prospective case-control study was performed to obtain blood samples, surplus to clinically indicated testing, from cats with HCM, dogs with DCM or MMVD and healthy cat and dog controls. Cardiac diagnoses were made by a cardiology specialist after a cardiac evaluation including echocardiography. Blood samples were sub-analysed by diagnostic group for the expression profile of 15 microRNA markers using machine learning algorithms. Model classification accuracy was assessed and sensitivity and specificity for each pathology was reported with 95% confidence intervals. Results - For HCM, diagnostic sensitivity was 0.89 [0.74-0.96] and specificity was 0.77 [0.52-0.92]. For diagnosis of DCM, sensitivity was 0.87 [0.70- 0.95] and specificity was 0.59 [0.43-0.72]. For MMVD, diagnostic sensitivity was 0.83 [0.69-0.91] and specificity was 0.92 [0.78-0.97]. Conclusions and clinical importance - This proof-of-concept study demonstrates the capability of a novel microRNA platform to identify companion animals with cardiac disease and its potential for use in primary care.