Genincode Regulatory News (GENI)

GENinCode Plc

("GENinCode" or the "Company")

CARDIO inCode® study for risk of incident Coronary Heart Disease

to be presented at European Society of Cardiology Annual Meeting in Amsterdam

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

The study investigated a subset of over 60,000 adult individuals with no history of Coronary Heart Disease (CHD) from the Genetic Epidemilogy 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 follow-up of 6.5 years, using CARDIO inCode-Score® (CIC-SCORE) to assess the polygenic risk of CHD, the interplay with lifestyle and incidence of CHD. Coronary heart and circulatory disease known collectively as Cardiovascular disease (CVD) is the leading cause of death globally, taking an estimated 17.9 million lives each year.

GENinCode specialises in polygenic risk assessment of CHD which is the most common form of heart disease and the leading cause of death in the United States.

CARDIO inCode-Score® or CIC-SCORE is now entering Early Access Programs with leading US healthcare institutions and has been granted its CPT PLA code from the American Medical Association for health insurance coverage and reimbursement. The CPT PLA Code will enable increased access to the CIC-SCORE test for those patients with clinical risk factors and/or a family history of risk of CHD.

CIC-SCORE is an 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 scoring. CIC-SCORE provides a major step change in patient risk assessment for CVD enabling improvement in risk assessment, preventive care and personalised treatment resulting in a lower incidence of major adverse cardiovascular events, such as heart attack or stroke.

In the UK around 7.6m people live with heart and circulatory disease, which causes 25% of all deaths annually1. 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 progress the Kasier Permanente team have made to complete this milestone study. This communication represents the first of a series of publications showing the clinical utility of polygenic risk assessment to identify individuals at high genetic risk of coronary heart disease, thereby enabling targeted treatment and a breakthrough in primary preventive care."

For more information visit www.genincode.com

Enquiries:

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 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 known collectively as Cardiovascular disease (CVD) are the leading cause of death globally, taking an estimated 17.9 million lives each year. 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.

Coronary heart disease is the most common type of heart disease. In 2021 in the US, coronary heart disease accounted for 375,476 deaths. About 1 in 20 adults age 20 and older have CHD (about 5%). In 2021, about 2 in 10 deaths from CHD happened in adults less than 65 years old. Globally it is estimated around 200 million people are living with coronary heart disease. Around 110 million men and 80 million women have coronary heart disease. Coronary heart disease kills an estimated nine million people each year - in 2019 it was the world's single biggest killer.

In the UK, cardiovascular disease causes a quarter of all deaths and is the largest cause of premature mortality in deprived areas and 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 NHS action on smoking and tobacco addiction, obesity, tackling alcohol misuse and food reformulation.

Aside from the genetic risk of cardiovascular disease, 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, excess weight and obesity. These "clinical 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 coronary heart disease and ensuring they receive appropriate treatment can prevent premature deaths. Access to medicines and basic health technology in all primary health care facilities is essential to ensure that those in need receive treatment and counselling.

Early detection and treatment of CVD can help patients live longer, healthier lives is set out in the NHS 10 Year Plan. Too many people are still living with undetected, high-risk conditions such as raised cholesterol, high blood pressure and atrial fibrillation (AF). Globally, healthcare systems are making progress on identification and diagnosis of high genetic risk individuals and working towards people routinely knowing and understanding their 'ABC' (AF, Blood pressure and Cholesterol risk). Replicating this approach is now increasingly possible with advanced molecular testing and digital technology.

1. https://www.bhf.org.uk/-/media/files/for-professionals/research/heart-statistics/bhf-cvd-statistics-uk-factsheet.pdf?rev=e771367bf0654a4dae85cbc9dbefae17&hash=76C0182379BB6EE118EC6F76FA35A158#:~:text=There%20are%20around%207.6%20million,these%20numbers%20rise%20still%20further.