Secretoneurin (SN): the first blood biomarker to accurately stratify mortality risk in patients with cardiac arrhythmia

Cardiovascular disease (CVD) is the no. 1 killer worldwide. At least half of CVD deaths is caused by ventricular arrhythmias that lead to sudden cardiac death (SCD). The diagnosis of arrhythmias is difficult but crucial for accurate decision-making and patient survival, being more frequent and carrying greater risk in heart failure (HF) patients. When managing HF patients, cardiologists currently prescribe an ECG (which may detect an arrhythmia) and an echocardiogram to measure the blood ejection from the left ventricle (LVEF), since there is a correlation between LVEF and risk of ventricular arrhythmias. If LVEF is < 35%, the patient is eligible for implantable cardioverter-defibrillator (ICD) surgery, which costs at least 20K€. Still, around 51 % of victims of SCD have normal LVEF. In addition, 67% of all implemented ICDs are never activated because those patients were (unknowingly) at low-risk for arrhythmias, which represents a 1.34 B€ overtreatment cost/year in the EU alone. Cardiologists urgently need an accurate biomarker that helps to better stratify patients’ risk for life-threatening arrhythmia. Existing cardiac biomarkers do not provide that info, keeping under or overtreatment. CardiNor has IPR rights and is bringing to market a new in vitro diagnostic (IVD) test to measure blood levels of Secretoneurin (SN), a new biomarker that provides unmatched insight into the mechanisms of arrhythmia, with a prognostic capacity to accurately stratify the patients into risk categories. With SN data, cardiologists will be able to rightly pinpoint high-risk patients and select those patients to ICD surgery. For every 10% of ICD-eligible patients that are diverted from surgery more than 134M€ are saved every year. First sales will be in 2020 as an ELISA kit and over time added to other IVD platforms to increase exploitation potential. CardiNor and its value chain partners have been working together on the SN assay for 24+ months, having reached TRL6 in Q3 2018.