Genincode Regulatory News (GENI)

10 January 2022

GENinCode Plc

("GENinCode" or the "Company")

FDA Pre-Submission filed for Cardio inCode-SCORE

Commencement of regulatory pathway for US market approval

Oxford, UK. GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease, announces the filing of its Pre-Submission for Cardio inCode-SCORE with the Food and Drug Administration (FDA). Cardio inCode-SCORE is an in-vitro diagnostic test which assesses an individual's combined genetic and clinical risk to predict and prevent cardiovascular disease ("CVD").

Following extensive exchange of information and constructive discussions with the FDA, GENinCode has been invited by the FDA to file its Pre-Submission for Cardio inCode-SCORE. This marks the commencement of the regulatory pathway for US market approval, which is anticipated later this year. The FDA views Pre-Submission as a structured process for managing and tracking interactions between manufacturers and the FDA about the application for approval or clearance, prior to final submission. It is an interactive process designed to give the opportunity to obtain FDA feedback on the application with the goal of making the end submission process more efficient.

Matthew Walls, CEO of GENinCode Plc, said: "Despite the delays driven by the pandemic, the filing of the Cardio inCode FDA Pre-Submission marks the start of the US regulatory approval pathway and ongoing preparation for the launch of Cardio inCode-SCORE later this year. Recognition of inherited genetic contribution to the onset of cardiovascular disease continues to grow. We are well placed to improve the CVD standard of care by identifying individuals at high genetic risk who can be advised on lifestyle choices and access to personalised treatment to improve future health outcomes."

GENinCode specialises in polygenic risk assessment of CVD, the leading cause of death and disability worldwide. CVD is a broad disease classification which encompasses conditions such as coronary artery disease (causing angina, heart attack and heart failure), cerebrovascular disease (causing stroke, and some dementia), peripheral vascular disease (causing limb ischaemia, and some chronic kidney disease) and venous thromboembolism. CVD accounts for an estimated 17.9 million deaths globally each year and accounts for 1 in every 4 deaths in the United States. 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.

The Cardio inCode-SCORE test assesses an individual's inherited genetic (DNA) risk of cardiovascular disease together with their clinical risk to provide a comprehensive risk assessment of CVD for use in primary preventative care. It also addresses the well-recognised need for improvement in CVD standard of care practices. The test provides a greatly improved estimation of an individual's risk of a CVD event (e.g. heart attack) particularly within a 10-year period following the test. Cardio inCode-SCORE provides a step change in patient risk assessment for CVD thereby providing a major improvement in preventative care, patient management, diagnosis, and personalised treatment.

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.

Genetic assessment will help to identify individuals in low or moderate risk populations who are at higher risk of a CVD event than their traditional clinical risk categorisation would suggest. This allows earlier in-life preventative measures to be put in place to lower their 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 more 'personalised' approach to patient care.

The GENinCode Cardio inCode test is a patent protected in-vitro diagnostic genomic test system used to assess the risk of onset of CVD and recurrent myocardial events. The test provides a comprehensive CVD risk assessment by combining both genetic and clinical risk factors using GENinCode's proprietary software and algorithms to produce a personalised CVD risk score. GENinCode processes and delivers the Cardio inCode-SCORE test via its online 'cloud based' portal to physicians.

Over the past 15 years GENinCode has invested significantly in its research, bioinformatic data, technology and product development to assess disease risk to prevent CVD. Using the predictive capability of genomics, GENinCode has a vision to assist clinicians and inform patients of their cardiovascular risk and improve public health.

For more information visit www.genincode.com

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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, in the United States through GENinCode U.S. Inc and in Europe through GENinCode S.L.U.

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 disease onset.

About Cardiovascular Disease

Cardiovascular disease (CVD) is 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 and 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.

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.

Cessation of tobacco use, reduction of salt in the diet, eating more fruit and vegetables, regular physical activity and avoiding harmful use of alcohol have been shown to reduce the risk of cardiovascular disease. Health policies that create conducive environments for making healthy choices affordable and available are essential for motivating people to adopt and sustain healthy behaviours.

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.

CVD 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 NHS action on smoking and tobacco addiction, obesity, tackling alcohol misuse and food reformulation.

Genetic risk assessment can help early detection and treatment of CVD to help patients live longer, healthier lives. Many people are still living with undetected, high-risk conditions such as high blood pressure, raised cholesterol, and atrial fibrillation (AF). Progress continues in the NHS to identify and diagnose people routinely knowing their 'ABC' (testing and monitoring of AF, Blood pressure and Cholesterol) set out in the NHS 10 Year plan.