ELISA Blood Test Uses Innovative Biomarker to Detect Heart Disease and Sudden Cardiac Arrest

Cardiovascular disease (CVD) is the leading cause of death worldwide and a large proportion of these patients ultimately die from sudden cardiac death (SCD). Now, a new secretoneurin (SN) blood-based ELISA (enzyme-linked immunosorbent assay) cardiovascular risk test could provide clinicians with a key tool for both more accurate risk prediction and patient management.

The CardiNor SN assay from Cardinor AS (Oslo, Norway) is a blood-based cardiovascular risk test that detects SN, a small 33-amino acid neuropeptide detectable in the blood stream and produced by neuroendocrine and heart muscle cells. 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 CVD risk assessment. This unique 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. SN is thus addressing a vast and untapped market potential for CVD patient diagnosis, risk stratification and monitoring, complementary to BNP/NT-proBNP and cardiac troponins.

In addition to front line CVD testing, there is a potential major role for SN testing in patient selection for cardiac rhythm management. Current criteria both lack the desired sensitivity and specificity. As an example, as many as 70% of patients with an ICD (implantable cardioverter-defibrillator) will never need the device. Conversely, a large proportion of sudden cardiac death patients do not fulfill current criteria for ICD implantation. Thus, there is an urgent need to better target and select patients who will benefit from an ICD. CardiNor has a comprehensive clinical program to further strengthen and widening the clinical documentation of its novel biomarker, and the SN test is being trialed in patient selection for cardiac rhythm management using ICD devices. The CardiNor SN assay has achieved CE marking according to IVDD and the company is now planning to expand its distribution network globally and preparing for its US market entry.

“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,” said Dag Christiansen, CEO, CardiNor. “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.”

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Cardinor AS