Cardiovascular disease (CVD) is the leading cause of death worldwide (2). A large proportion of these patients ultimately die from sudden cardiac death (SCD). The predominant causes of SCD – ventricular tachycardia and ventricular fibrillation (VT/VF) – have been shown to be key determinants of survival in patients both with CVD and the general population.
Cardiomyocyte Ca2+ imbalance is at the core of most triggered arrhythmias in CVD, but current biomarkers (troponins and BNP) do not reflect Ca2+ regulation. Accordingly, methods to identify and monitor patients with cardiomyocyte Ca2+ imbalance and increased risk of VT/VF are highly warranted. As the only biomarker associated with Ca2+ status, SN is ideally suited for this purpose. Moreover, high SN concentrations are also a strong indication of the need to follow up with ECGs, echocardiography, and other examinations (angiography, cardiac MRI, PET-CT, etc.) to determine whether there are signs of structural or functional heart disease.
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 fulfil current criteria for ICD implantation. Thus, there is an urgent need to better target and select patients who will benefit from an ICD. The arrhythmia- ICD market is massive: It is estimated that > 30 million people suffer from arrhythmias and >100.000 ICDs are implanted in the EC alone with yearly device treatment costs exceeding €2 billion.
Facts and figures
- Heart disease is the leading cause of death for both men and women.1
- About 610,000 Americans die from heart disease each year—that’s 1 in every 4 deaths.1
- Coronary heart disease is the most common type of heart disease, killing more than 370,000 people annually.1
- In the United States, someone has a heart attack every 43 seconds. Each minute, someone in the United States dies from a heart disease-related event.2
- Coronary heart disease alone costs the United States $108.9 billion each year.2 This total includes the cost of health care services, medications, and lost productivity
- Heart disease is the leading cause of death for both men and women. More than half of the deaths due to heart disease in 2009 were in men.1
- Most cardiovascular diseases can be prevented by addressing behavioral risk factors such as tobacco use, unhealthy diet and obesity, physical inactivity and harmful use of alcohol using population-wide strategies.
Key risk factors for heart disease include: hypertension, diabetes and hyperlipidemia
Arrhythmia, also known as cardiac dysrhythmia or irregular heartbeat, is conditions in which the heartbeat is irregular, too fast, or too slow. A heartbeat that is too fast – above 100 beats per minute in adults – is called tachycardia and a heartbeat that is too slow – below 60 beats per minute – is called bradycardia.
The majority of CVD deaths are caused by cardiac arrhythmias leading to sudden cardiac arrest.
Current cardiac rhythm management is effective and includes anti-arrhythmic drugs and the use of device-based therapy such as implantable cardioverter-defibrillators (ICDs). The introduction of treatment with ICD’s in cardiovascular disease has proved lifesaving. However, current criteria lack the desired sensitivity and specificity for proper patient selection, as does the electrocardiogram (ECG) and existing cardiac biomarkers.
Arrhythmias affect more than 30 million people around the world. Arrhythmias may occur at any age but are more common among older people where the prevalence may by > 20%.
Market – the opportunity:
The market for CVD biomarkers exceeds USD 5 billion, with BNP and troponin both selling for approx. 2 billion annually. Our forthcoming ELISA, as mentioned, will be designed in such a way that it easily can by adopted to these platforms.
This unique biological function explains why SN acts as an independent and strong predictor of mortality in several patient cohorts, including, ventricular arrhythmia, acute heart failure, 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.
The biomarker market for CVD is dominated by the major IVD companies such as Siemens, Roche and Abbott with their proprietary high-throughput platforms. Our forthcoming ELISA, as mentioned, will be designed in such a way that it easily can by adopted to these platforms.
References and use full links:
- «Who Is at Risk for an Arrhythmia?». http://www.nhlbi.nih.gov/. July 1, 2011. Retrieved 7 March 2015.
- WHO (2017) The top 10 causes of death, fact sheet. Available at: who.int/mediacentre/factsheets/fs310/en/