CardiNor has announced that it has achieved CE marking according to IVDD for the CardiNor Secretoneurin ELISA test.
This new frontline biomarker for cardiovascular disease reflects the biological mechanism triggering arrhythmia. CardiNor has a clinical program to further strengthen and widening the clinical documentation of its novel biomarker, and the CardiNor Secretoneurin (SN) test is being trialled in patient selection for cardiac rhythm management using Implantable Cardiac Defibrillator (ICD) devices, the company states.
“We are delighted to achieve CE marking on this important new biomarker and are now looking forward to expanding our distribution network globally and to prepare for US market entry. The COVID-19 pandemic has further highlighted the need for improved cardiovascular disease risk markers. The CardiNor Secretoneurin ELISA assay will provide clinicians with a key tool for both more accurate risk prediction and patient management,” says Dag Christiansen, CEO, CardiNor.
SN is the only biomarker shown to be associated with biological processes linked to cardiomyocyte handling and has been described as the “missing link biomarker” in cardiovascular disease risk assessment. This biological function may explain why SN is an independent and strong predictor of mortality in all major patient cohorts tested, including patients with ventricular arrhythmia, acute heart failure, and acute respiratory failure patients with CVD and severe sepsis, the company states.
The CardiNor SN assay is based on work by Professor Torbjørn Omland and his research group at Akershus University Hospital in Norway.