SN-CE marking

Offentlig prosjektsammendrag

CardiNor AS is a Norwegian biotech company established in June 2015 to develop and commercialise assays for secretoneurin (SN), an important new biomarker for cardiovascular disease (CVD). SN is the only biomarker shown to be associated with biological processes linked to heart Ca2+ handling. This unique biological function explains why SN presents as an independent and strong predictor of mortality in major patient cohorts, including ventricular arrhythmia, acute heart failure, acute respiratory failure patients with CVD and severe sepsis. We have developed an easy to use ELISA (enzyme-linked immunosorbent assay) blood test to address the vast and untapped market potential in CVD patient diagnosis, risk stratification and monitoring. We are conducting further clinical documentation and testing to gain regulatory approval in Europe, CE marking. The CardiNor easy-to-use blood test SN ELISA will help to identify patients with heart disease who will benefit from ICD treatment. The current technology available for measuring SN is an RIA (radioimmunoassay) not suitable for routine or clinical use. Our new test based on ELISA technology that is very well established in both clinical research and routine and can easily be adopted on platforms such as Cobas by Roche and Architect by Abbott.