Genincode Regulatory News (GENI)

GENinCode Plc

("GENinCode" or the "Company")

CARDIO inCode® study on risk of incident Coronary Heart Disease

presented at European Society of Cardiology Annual Meeting in Amsterdam

Oxford, UK. GENinCode Plc (AIM: GENI), the polygenics company focused on the prevention of cardiovascular disease, announces the presentation by Kaiser Permanente, US on the 'Utility of the CARDIO inCode-Score® CHD polygenic risk score for incident coronary heart disease interplay with lifestyle in a multi-ethnic cohort of more than 60,000 individuals'. The presentation was made at the Annual Meeting of the European Society of Cardiologists Congress over 25-28 August 2023 in Amsterdam.

The study investigated over 60,000 adult individuals with no history of Coronary Heart Disease (CHD) from the Genetic Epidemiology Resource in Adult Health and Aging (GERA) multi-ethnic cohort of the Kaiser Permanente Medical Care plan of Northern California, USA. The GERA cohort followed the membership over an average of 14 years, using CARDIO inCode-Score® to assess the polygenic risk of CHD, interplay with lifestyle and the incidence of CHD.

The study found that genetic and lifestyle factors are independently associated with the incidence of CHD and for individuals with a high polygenic risk measured by CARDIO inCode-Score®, a favourable lifestyle was associated with a 52% lower rate of CHD compared with an unfavourable lifestyle. The study also found that CARDIO inCode-Score® can identify individuals at the highest risk of CHD. These individuals should then be prioritized for lifestyle advice and where appropriate therapeutic intervention as they will benefit the most. By stratifying patients based on their polygenic risk score and targeting treatment to those with the highest risk score, the number of patients needing to be treated to prevent a CHD event were almost halved. CHD 'event' includes: non-fatal AMI, angina and coronary revascularization procedures (coronary by-pass or percutaneous intervention or CHD death. The study confirmed the earlier in life preventative measures can be put in place the lower the future risk underlining the need for 'polygenic risk score' lifetime risk assessment to be used in conjunction with traditional clinical risk assessment.

Other recently announced news

As previously announced, GENinCode is commencing Early Access Programs for CIC-SCORE (or CARDIO inCode-Score®) with leading healthcare institutions in the United States to provide an improved estimation of an individual's risk of heart attack over their lifetime. CIC-Score is now being commercially delivered from the GENinCode CLIA and CAP approved laboratory in Irvine, California.

As also announced, the Company has recently filed its CIC-Score pre-market notifification (510k) medical device filing with the FDA. The Company expects to receive FDA approval for the CIC-SCORE medical device over the next 6 months enabling scale up and processing by CLIA labs across the United States.

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

Matthew Walls, CEO of GENinCode PLC said: "We are delighted with the results from this latest Kaiser Permanente milestone study. The ESC presentation represents the first of a number of publications showing the clinical utility of the CARDIO inCode-Score® (polygenic risk score) to identify individuals at high genetic risk of coronary heart disease, thereby enabling targeted, personalised treatment and a breakthrough in preventive care."

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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 (clinical + genetic) 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 a online cloud based algorithmic 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 or stroke.

About Kaiser Permanente:

Founded in 1945, Kaiser Permanente is one of the United States largest not-for-profit health plans, serving more than 9 million members, with headquarters in Oakland, California.

It comprises: Kaiser Foundation Hospitals and their subsidiaries Kaiser Foundation Health Plan, Inc. The Permanente Medical Groups.

Kaiser Permanente physicians are responsible for medical decisions. The Permanente Medical Groups, which provide care for Kaiser Permanente members, continuously develop and refine medical practices to help ensure that care is delivered in the most efficient and effective manner possible.

Kaiser Permanente's creation resulted from the challenge of providing Americans medical care during the Great Depression and World War II, when most people could not afford to go to a doctor. Among the innovations it has brought to U.S. health care are:

· Prepaid health plans, which spread the cost to make it more affordable

· Physician group practice to maximize their abilities to care for patients

· A focus on preventing illness as much as on caring for the sick

· An organized delivery system, putting as many services as possible under one roof.

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.