The need for a better test to predict Sudden Cardiac Death
Sudden cardiac death (SCD) is caused by an abruptly abnormal heart rhythm that results in the heart stopping and subsequent death. Preventive Implantable Cardioverter Defibrillator (“ICD”) implantation is often recommended for high-risk patient populations. People at high risk may have advanced heart failure, a history of ventricular arrhythmia, genetic mutations that predispose to SCD, or a prior heart attack with scarred heart tissue. Nevertheless, the majority of people that receive preventive ICD implantations every year never have an SCD event. At the same time, the vast majority of people who die from SCD will not have had an ICD implanted.
For these reasons, an important medical need exists for improved SCD risk determination.
The Company’s technology is based on the discovery that people at greater risk for SCD and, thereby likely candidates to receive an ICD, also often have a truncated form of a protein encoded by a gene known as SCN5A. This gene encodes for a portion of the sodium channel that is believed to be very important for orchestrating normal electrical activity of the heart. Under stressful conditions to the heart, like heart failure, the SCN5A gene produces truncated forms, or “variants”, of the protein leading to malfunctioning sodium channels. These SCN5A abnormal proteins are known as SCN5A variant C (“VC”) and SCN5A variant D (“VD”). Scientists at 3PrimeDx have discovered a strong correlation between VC and VD levels, and an increased risk of SCD. This is the basis of 3PrimeDx’s PulsePredic™ blood test.
3PrimeDx is further developing and seeking to commercialize the PulsePredicTM, test. Early identification of individuals who have abnormal levels of the SCN5A VC and VD variants could enable more personalized approaches to preventing future SCD. This type of diagnostic test could help identify “at risk” patients and in need of an ICD or other prevention measures. It could also prevent needless and costly implantations of an ICD. In particular, the PulsePredic™ test applies to all patients and does not represent a screen for a DNA mutation, but rather the variant levels (possibly indicating certain stressful heart conditions).