GENinCode Plc

("GENinCode" or the "Company")

CARDIO inCode-Score® presentation at

European Society of Cardiology Preventive Cardiology Congress

Oxford, UK. GENinCode Plc (AIM: GENI), the polygenics company focused on the prevention of cardiovascular disease and ovarian cancer, announces  a presentation by Kaiser Permanente at the European Society of Cardiology (ESC) Preventive Cardiology congress in Athens, Greece, on the 'Joint consideration of low-density lipoprotein cholesterol ("LDL-C") and polygenic risk for incident coronary heart disease in a multi-ethnic cohort of 48,881 individuals' using CARDIO inCode-Score®.¹

The Kaiser Permanente Division of Research study investigated individuals who were part of the Northern California Genetic Epidemiology Resource in Adult Health and Aging (GERA) multi-ethnic population-based cohort. The GERA cohort followed the membership over an average of 14 years, using CARDIO inCode-Score® to assess the polygenic risk of coronary heart disease ("CHD") and the incidence of CHD events in association with LDL-C. A CHD event was defined as non-fatal heart attack, coronary revascularisation procedures or CHD death.

The study found that LDL-C and polygenic risk are independently associated with incident CHD, and that CARDIO inCode-Score® identifies individuals at the highest risk of CHD across LDL-C levels. Whilst all patients with elevated LDL-C ought to be treated, the data indicated that lipid lowering therapies may be more effective among those with high polygenic risk, as the number needed to treat (NNT) to prevent one CHD event was much lower in the high polygenic risk group. The data also indicated that subjects with a high CARDIO inCode-Score® should not have LDL-C levels above 130 mg/dL, as their CHD risk is similar to those with LDL-C =>190 mg/dL and a low polygenic risk.

The presentation follows the American Journal of Preventive Cardiology publication earlier this month indicating individuals with a high polygenic risk score should be prioritised for lifestyle advice and where appropriate therapeutic intervention as they will benefit the most. Previous data with CARDIO inCode-Score® has shown that, for individuals with a high genetic risk, a favourable lifestyle is associated with a 52% lower rate of CHD compared with an unfavourable lifestyle.

The study underlines the need for 'polygenic risk score' lifetime risk assessment in conjunction with traditional clinical risk assessment to optimise preventive care strategies to lower the future risk of CHD. Polygenic risk assessment can be undertaken in younger people, before conventional clinical risk factors (such as high LDL-C levels, high blood pressure, diabetes etc.) have developed and can be combined with conventional risk scoring in older people. By doing this clinicians can better identify those most likely to benefit from lifestyle and therapeutic intervention.

In the UK around 7.6 million people live with heart and circulatory disease, which causes 25% of all deaths annually. Cardiovacular disease (CVD) can be reduced by identifying and treating individuals at risk, and the NHS 10 Year Plan (2019) sets out to address CVD prevention.

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About GENinCode:

GENinCode Plc is a UK based company specialising in genetic risk assessment of cardiovascular disease. Cardiovascular disease is the leading cause of death and disability worldwide.

GENinCode operates business units in the UK, Europe through GENinCode S.L.U, and in the United States through GENinCode U.S. Inc.

GENinCode predictive technology provides patients and physicians with globally leading preventative care and treatment strategies. GENinCode CE marked invitro-diagnostic molecular tests combine clinical algorithms and bioinformatics to provide advanced patient risk assessment to predict cardiovascular disease.

About CARDIO inCode-Score® (CIC-SCORE)

CIC-SCORE is a first in class in-vitro diagnostic test used to assess an individuals genetic risk of CHD. The test is based on published clinical evidence amassed over 15 years which, combined with traditional clinical risk factors, provides a comprehensive risk assessment of CHD for use in primary preventive care. GENinCode labs process patient DNA samples and deliver the CARDIO inCode-Score® test results to physicians via an online cloud based algorithmic (AI) reporting system ('SITAB').

CIC-SCORE also addresses the well-recognised need for improvement in the cardiovascular disease (CVD) standard of care across ethnicities where individuals from certain racial and ethnic groups face higher risks of CVD. The CIC-SCORE test provides an improved estimation of an individual's risk of heart attack over their lifetime, particularly within a 10-year period post testing when combined with traditional clinical risk assessment. The CIC-SCORE polygenic risk score enables a major improvement in patient CVD risk assessment, preventive care and personalised treatment to reduce the incidence of major adverse cardiovascular events (MACE), such as heart attack.

About Cardiovascular Disease (CVD):

Heart and circulatory disease also known as cardiovascular disease (CVD) is the leading cause of death globally, taking an estimated 17.9 million lives each year, with Coronary Heart Disease (CHD) representing the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. CVD is a group of disorders of the heart and blood vessels that include coronary heart disease, cerebrovascular disease, rheumatic heart disease and other conditions. More than four out of five CVD deaths are due to heart attacks and strokes, and one third of these deaths occur prematurely in people under 70 years of age. By 2030 the global cost of CVD is set to rise from approximately US$863 billion in 2010 to US$1,044 billion and is both a major health issue and global economic burden.

Cardiovascular disease, causes a quarter of all deaths in the UK and is the largest cause of premature mortality in deprived areas and is the single biggest area where the NHS can save lives over the next 10 years. CVD is largely preventable, through lifestyle changes and a combination of public health and action on smoking and tobacco addiction, obesity, tackling alcohol misuse and food reformulation.

The most important behavioural risk factors of heart disease and stroke are unhealthy diet, physical inactivity, tobacco use and harmful use of alcohol. The effects of behavioural risk factors may show up in individuals as raised blood pressure, raised blood glucose, raised blood lipids, and overweight and obesity. These "intermediate risks factors" can be measured in primary care facilities and indicate an increased risk of heart attack, stroke, heart failure and other complications.

Identifying those at highest risk of CVDs and ensuring they receive appropriate treatment can prevent premature deaths. Access to noncommunicable disease medicines and basic health technologies in all primary health care facilities is essential to ensure that those in need receive treatment and counselling.

The current standard of care for assessing cardiovascular risk is primarily based on traditional clinical risk factors such as age, sex, smoking, body mass, blood pressure and cholesterol levels from which individuals are categorised as being at low, moderate or high risk of a CVD event. This categorisation is imperfect as CVD events frequently occur in those thought to be at low or moderate risk. The size of the populations at low or moderate risk are much larger than those at high or very high risk so whilst the relative risk of a CVD event may be small, the absolute number of CVD events in low and moderate risk populations is much greater than the number of events in higher risk categories.  It is clear that the earlier in life preventative measures can be put in place the lower the future risk. 

Clinicians have for many years recognised the importance of prior CVD events within the families of their patients because genetic factors contribute to the development of atherosclerosis and a patient's family history has become a surrogate for their inherited genetic risk. In recent years, with the advances of genomics, it has proved possible to add genetic profiling to conventional CVD risk factors, the combination of the two (genetics and conventional clinical risk factors) enhancing the predictive capability of patient risk thereby resulting in a personalised and preventative approach to CVD.