SN ELISA CE IVDR marking

Offentlig prosjektsammendrag

CardiNor AS is a Norwegian diagnostic 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. The test was CE marked according to IVDD 98/79/EC in December 2021 and is now commercially available in the US (research only) and in key markets in Europe through our network of distributors. We are conducting further clinical documentation and testing to gain regulatory approval in Europe according to the new IVDR (EU) 2017/746.