NEW ORLEANS, LOUISIANA / ACCESS Newswire / November 12, 2025 / American Heart Association ("AHA") Conference 2025, GENinCode the predictive genetics company focused on the prevention of cardiovascular disease ("CVD"), announces the presentation by Kaiser Permanente of a major clinical utility study on CARDIO inCode-Score Polygenic Risk Score ("PRS") for the prevention of coronary heart disease ("CHD").

• Cardiovascular disease ("CVD") is the leading cause of death in the US and worldwide with over 82 million Americans living with CVD.

• CVD accounts for one in every three deaths in the US, or more than 900,000 deaths per year.

• The estimated annual cost of CVD to US healthcare is over $400Bn with a consequential productivity loss of over $350Bn per annum which is forecast to exceed $1Trillion by 2035.

The presentation titled ‘Enhancing the PREVENT Equation with a Polygenic Risk Score: Clinical Utility' showed the latest ASCVD clinical prediction tool ‘PREVENT' was significantly enhanced by the inclusion of CARDIO inCode-Score (PRS), improving the predictive accuracy in personalised risk assessment for prevention of CHD.

CARDIO inCode-Score is a clinically validated, commercially available polygenic risk score based on DNA extracted from a simple saliva or blood sample. The risk score has been designed and optimized for multi-ethnic population-based risk prediction and primary prevention of CHD in healthcare systems.

GENinCode has worked with Kaiser Permanente Departments of Research and Cardiology on the clinical research and development of CARDIO inCode-Score for over 15 years. The multi-ancestry population study based on the Northern California GERA cohort studied over 60,000 individuals, 30-74 years of age, with follow up of 14 years and represents the latest in a series of CARDIO inCode-Score clinical utility publications.

• The AHA presentation showed that integrating CARDIO inCode-Score with the PREVENT equation improves prediction of CHD events with statistical significance.

• The benefit was particularly evident among borderline and intermediate PREVENT risk individuals, where there is uncertainty in clinical decision-making regarding statin initiation or intensification.

• Combining CARDIO inCode-Score PRS with the PREVENT equation improves the ability to detect those most likely to develop ASCVD (NRI of 10.7%).

• In addition, there was incremental risk stratification by CARDIO inCode-Score within each PREVENT risk group, more evident in borderline and intermediate risk categories. Notably, event rates for those at intermediate PREVENT risk with high PRS were higher than those at high PREVENT risk but low PRS (14.4% vs 12.4%).

• Moreover, 50.2% of individuals in the borderline/intermediate PREVENT risk group with a high PRS were not on statin treatment. These individuals represent 9.2% of all people in the borderline/intermediate group.

The clinical utility of CARDIO inCode-Score has also been validated in the Framingham Risk Score and the Pooled Cohort Equations, and now the PREVENT equation. CARDIO inCode-Score has also been assessed with the interplay between lifestyle and family history of CHD. Individuals with a high PRS can prevent incidence of CHD by as much as 52% by changing their lifestyle. A high PRS has also been shown to increase CHD risk greater than a positive ‘family history' alone (64% higher vs 42% higher). The joint effect of a positive family history and a high PRS increases the hazard ratio by 2.3x, considerably improving CHD risk assessment based on family history. In addition, CARDIO inCode-Score has been shown to modulate the association of LDL-C with CHD, showing significantly increased risk from LDL-C levels of 100 mg/dL and above among individuals with a high PRS.

Dr. Richard Kovacs, Q.E. and Sally Russell Professor of Cardiology at the Indiana University School of Medicine and Chief Medical Officer of the American College of Cardiology and Past President of the American College of Cardiology said: "These results provide further compelling clinical evidence for the inclusion of polygenic risk scores (PRS) in conjunction with clinical risk for improved risk assessment of CHD. The polygenic risk score is especially important in relation to patients clinically classified at borderline/intermediate risk and younger patients with a family history of CHD. The recent scientific statements and acknowledgment of the value of PRS by the American College of Cardiology and American Heart Association is also welcome."

Our thanks to Dr. Jamal Rana and Dr. Carlos Iribarren for leading this clinical research and to co-authors Dr. Meng Lu, Dr. Martha Gulati, Dr. Nathan Wong and Dr. Roberto Elosua and our clinical advisory team for advocating the inclusion of genetic risk assessment in CHD risk assessment.

SOURCE: GENinCode US inc