Corporate News

De Novo approval will enable a new regulatory class for the commercial distribution of CARDIO inCode-Score medical device

Oxford, UK. GENinCode Plc (AIM: GENI), the polygenics company focused on the prevention of cardiovascular disease (“CVD”), announces it has agreed with the Food and Drug Administration (FDA) to create a new regulatory class for polygenic risk scores and transition its premarket notification 510(k) submission to a De Novo submission. The new regulatory class clearance of CARDIO inCode will enable GENinCode to commercially advance US national distribution of the CARDIO inCode-Score polygenic test kit (medical device) for the risk assessment and prevention of Coronary Heart Disease (“CHD”).

Following the CARDIO inCode-Score 510(k) medical device submission in August 2023, the FDA has reviewed the submission and recently noted CARDIO inCode-Score’s ‘first in class’ position and the deep clinical evidence for polygenic risk assessment of CHD. Based on these factors and the novel position of CARDIO inCode-Score, the FDA has requested the Company to transition to a De Novo pathway for market approval. The crossover to a De Novo pathway enables the Company to work with the FDA to establish a new polygenic regulatory class for the CARDIO inCode-Score medical device based on its favourable benefit-risk profile and associated special controls thereby setting a new regulatory standard for future polygenic tests in this class. Following the FDA request, the Company has now submitted its De Novo submission for market clearance and expects a timeline to clearance broadly in line with earlier the earlier 510(k) submission forecasts of late Q1/early Q2 2024.

CARDIO inCode-Score or CIC-SCORE is an in-vitro diagnostic test used to assess an individual’s polygenic risk of CHD based on DNA analysis. Published clinical evidence amassed over the past 15 years shows that the test when combined with traditional clinical risk assessment, provides a comprehensive risk assessment of CHD for use in primary preventive care. GENinCode processes and delivers the CIC-SCORE test results to physicians via its online ‘SITAB’ cloud based reporting system.

The CIC-SCORE test addresses the well-recognised need to improve the CHD standard of care by providing a genetic (polygenic) risk assessment for CHD, thereby improving preventive care, patient management, and personalised treatment.

GENinCode has commenced Early Access Programs for CARDIO inCode-Score with leading institutions in the United States to provide an improved estimation of an individual’s risk of heart attack over their lifetime. The test is currently being delivered from the GENinCode CLIA and CAP approved laboratory in Irvine, California.

Matthew Walls, CEO of GENinCode PLC said: “The Board are delighted with FDA recognition of the advanced clinical position of CARDIO inCode-Score and their decision to create a new regulatory class for polygenic risk assessment. We expect the De Novo pathway to provide an improved route to gaining US regulatory approval of CARDIO inCode-Score for the polygenic risk assessment of Coronary Heart Disease.”

This announcement contains inside information.

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, 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 preventive care and treatment strategies. GENinCode genetic tests combine clinical algorithms and bioinformatics to provide advanced patient risk assessment for coronary heart disease.

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.

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 preventive approach to CVD.