28 August 2026

GENinCode Plc

("GENinCode" or the "Company")

CARDIO inCode-Score® milestone clinical results for prevention of coronary artery disease

Primary prevention results presented at ESC Annual Congress 2026, Munich 

GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease ("CVD") and assessment of ovarian cancer risk, announces the presentation today of preliminary clinical results by the Institut Català de la Salut (ICS), Government of Catalonia, Spain at the 2026 European Society of Cardiology (ESC) Annual Congress. The results showed a major advance in the prediction and potential prevention of coronary artery disease ("CAD") using the Company's CARDIO inCode-Score® Coronary Artery Disease Polygenic Risk Score ("CAD PRS") test.

The results presented are from the real-world pilot implementation of CARDIO inCode-Score® undertaken by ICS over the past 18 months, with the objective of identifying patients whose cardiovascular (CV) risk was changed when the CARDIO inCode-Score genetic test results were integrated with their conventional clinical CV risk assessment. The pilot subsequently reviewed the patients at 6 and 12 month following testing to assess the change in their CV risk profile and any changes to the patient's modifiable CV risk factors, including smoking habit and LDL-Cholesterol, to assess the clinical utility of CARDIO inCode-Score®.

Study Overview

The ICS pilot implementation followed 584 patients from 14 primary care centres in Catalonia, Spain split across both sexes aged 45-65 years in a primary prevention setting. The patients had previously been assessed at 'moderate CV' risk using traditional clinical risk assessment. The CARDIO inCode-Score® polygenic risk score was then used to quantify each patient's inherited genetic risk of coronary artery disease which was integrated with their traditional clinical risk assessment to provide a more comprehensive risk assessment.

Key Findings

The results demonstrated that polygenic risk assessment personalises coronary artery disease risk assessment and has significant implications for primary care and preventive cardiology. A single ('once in a lifetime'), low-complexity genetic test delivered as part of routine clinical consultation can identify those patients assessed as moderate-risk by conventional risk factors who are likely to benefit most from intensified prevention treatment. Genetic testing can also support the safe de-escalation of those who are found to be at low genetic risk.  The results showed;

·     Genetic information changed the overall risk assessment in 42.6% of moderate-risk patients - 11.6% of patients were reclassified upward, 14.9% downward, with 6.8% on the upward reclassification threshold, and 9.2% with a high polygenic burden while retaining a moderate risk. One in four (26.5%) changed their risk category (low, intermediate, high) outright.

·     Disclosing the genetic risk result to patients and clinicians was followed by measurable improvement in CV risk after a mean follow-up of 8.5 months (SD, 1.24): with a mean CV risk at recruitment to the study of 7.30% being reduced to 6.04%, mean LDL-Cholesterol of 136.74 mg/dL reduced to 123.17 mg/dL, and sustained smoking abstinence of the study cohort increasing from 43.7 to 62.8% (all p values <0.0001).

·   The benefit of testing was greatest where the patient's genetic risk was highest; 49.6% of the high genetic risk group were reduced to a lower risk category, 33% reduced in the moderate genetic risk group and 28.6% reduced in the lowest quintile (p=0.0015).

These real-world findings provide further clinical evidence that polygenic risk acts as a powerful risk-enhancing tool in a primary care setting, supporting its broader use in clinical decision-making for preventive care. Effectiveness and cost-effectiveness analyses are ongoing.

Clinical and Preventive Implications

This study underscores the critical role that integrating genetic data with current clinical cardiovascular risk factors can play in revolutionising cardiovascular risk stratification and prevention, guiding earlier intervention in at-risk populations. It also follows the recent American College of Cardiology and American Heart Association inclusion of CAD PRS in the US guidelines for primary prevention of coronary heart disease.    

Moderate-risk individuals with high genetic risk may benefit from more proactive lipid management and lifestyle or therapeutic intervention, even where LDL-C cholesterol are at levels traditionally considered moderate (e.g.  130mg/dL), while in those with a low genetic risk de-escalation can be considered. In short, a combination of genetic and conventional risk factors allows a personalised approach to cardiovascular risk assessment.

By integrating polygenic risk assessment into existing clinical pathways, healthcare providers can more accurately identify individuals at heightened lifetime risk of CAD and personalise prevention strategies. Reducing CV risk can reduce the incidence of severe cardiovascular events, such as heart attacks and strokes, and potentially mitigate the economic costs associated with long-term heart disease. This approach can be seen as a significant step toward improving public health outcomes, particularly in addressing the global burden of cardiovascular disease.

Dr. Elisabet Descals, Primary Care Director, Institut Català de la Salut (ICS), Government of Catalonia, Spain said: "The ICS results provide further real-world clinical evidence for the inclusion of polygenic risk scores (PRS) in conjunction with clinical risk for improved risk assessment of CAD in primary care moderate-risk patients. The incorporation of polygenic risk has improved risk stratification, with a significant reduction in estimated CV risk and improved control of risk factors. Likewise, the strategy is expected to be cost-effective, and the results could have immediate applicability in primary care, facilitating more personalized medicine and shared decision-making, while optimizing the allocation of healthcare resources." 

For more information visit www.genincode.com

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Notes to editors: Key facts on Cardiovascular disease:

·      Cardiovascular diseases (CVDs) are the leading cause of death globally.

·      An estimated 19.8 million people died from CVDs in 2022, representing approximately 32% of all global deaths. Of these deaths, 85% were due to heart attack and stroke.

·      Over three quarters of CVD deaths take place in low- and middle-income countries.

·      Out of the 18 million premature deaths (under the age of 70) due to noncommunicable diseases in 2021, at least 38% were caused by CVDs.

·      Most cardiovascular diseases can be prevented by addressing behavioural and environmental risk factors such as tobacco use, unhealthy diet (including excess salt, sugar, and fats) and obesity, physical inactivity, harmful use of alcohol and air pollution.

·      It is important to detect cardiovascular disease as early as possible so that management with lifestyle changes, and consideration of potential medications and interventions can begin.

Overview of Cardiovascular disease:

Cardiovascular diseases (CVDs) are a group of disorders of the heart and blood vessels. They include:

·      Coronary heart disease - conditions caused by disease of the arteries supplying heart muscle; the most common type of heart disease and the single leading cause of death worldwide;

·      Cerebrovascular disease - conditions caused by disease of the arteries supplying the brain, such as strokes and some forms of dementia;

·      Peripheral arterial disease - a disease of arteries supplying the arms and legs;

·      Rheumatic heart disease - damage to the heart muscle and heart valves from rheumatic fever, caused by streptococcal bacteria;

·      Congenital heart disease - birth defects that affect the normal development and functioning of the heart caused by malformations of the heart structure from birth; and

·      Deep vein thrombosis and pulmonary embolism - blood clots, usually in the leg and/or pelvic veins, which can dislodge and move (embolise) to the heart and lungs.

Heart attacks and strokes are usually acute events and are mainly caused by blockage of an artery that prevents blood from flowing to the heart or brain. The most common reason for this is a build-up over time of fatty deposits, termed plaque, on the inner walls of the arteries (atherosclerosis) that supply the heart or brain. Strokes can be caused by bleeding from a blood vessel in the brain or from blood clots.

Atherosclerosis can start early in life and is an extremely common progressive condition. It can be detected in pathology specimens (histology) even in childhood and about half of adults aged 45 - 84 years have detectable plaque build-up in their arteries over their lifetime without knowing it, using investigative techniques such as CT scanning. Genetic testing enables individuals to be assessed for their risk of future heart disease well in advance of the clinical symptoms allowing physicians to advise on how to prevent the onset of atherosclerosis and heart disease.