Genincode Regulatory News (GENI)

GENinCode Plc

("GENinCode" or the "Company")

NHS accelerates implementation of LIPID inCode® testing of patients

suffering with hypercholesterolemia and familial hypercholesterolemia

NHS earmarks budget to expand GENinCode's LIPID inCode® polygenic testing to prevent Cardiovascular Disease

Oxford, UK. GENinCode Plc (AIM: GENI), the genetics company focused on the prevention of cardiovascular disease, announces the expansion of its collaboration with the Academic Health Science Network for the North East and North Cumbria ("AHSN NENC") to use the LIPID inCode® polygenic test in Primary Care for the diagnosis of familial (inherited) hypercholesterolemia ("FH") with available information to physicians for polygenic hypercholesterolemia (high levels of cholesterol) and coronary heart disease risk.

NHS funding to accelerate LIPID inCode® testing has been earmarked to improve the diagnosis and treatment of FH to prevent cardiovascular disease ("CVD"). Expanding access to genetic testing for FH, which causes early onset of heart attacks (myocardial infarction or "MI"), will enable the identification, earlier diagnosis and treatment of patients at high genetic risk of a heart attack. Improved detection of patients at genetic risk supports better treatment and preventative care to avoid a heart attack. The acceleration of LIPID inCode® testing will support the delivery of the NHS 10 Year Plan to identify at least 25% of those individuals suffering with FH by 2024 as part of the NHS genomics programme. The NHS 10 Year Plan for FH is at the forefront of cardiovascular clinical improvements to reduce CVD mortality in the UK. 

LIPID inCode® is the first commercial polygenic test to prevent CVD to be implemented by the NHS. LIPID inCode® provides a comprehensive diagnosis of FH and assesses an individuals inherited genetic risk of hypercholesterolemia and coronary heart disease. GENinCode will deliver LIPID inCode® using its proprietary SITAB 'cloud based' system and datasets enabling a rapid turnaround of test results (10-15 days) at reduced cost to the NHS.

The NHS funding follows the positive results of the LIPID inCode® NHS clinical study1 and successful completion of the AHSN NENC pilot. The NHS have now commenced LIPID inCode® testing in the Darlington Primary Care Network (PCN) and community practice representing over 100,000 patients in the North of England. The collaboration will diagnose patients with genetic disorders giving rise to high levels of cholesterol an important risk factor leading to the development of CVD.

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, including identifying individuals with hypercholesterolemia and particularly those with FH. FH is an inherited monogenic condition which affects an individual's ability to regulate and remove cholesterol from their blood. FH affects approximately 1 in 250 people in the UK population and globally.

Matthew Walls, CEO of GENinCode PLC said: "The collaboration with the AHSN NENC continues to expand the use of LIPID inCode testing to identify patients at high risk of heart disease representing the largest cause of death in the UK and globally. We are now extending implementation of LIPID inCode to other UK AHSN's marking a further NHS milestone for the roll-out and adoption of our leading polygenic test. We look forward to supporting the NHS in reaching its long term goal to diagnose patients with hypercholesterolemia and provide earlier risk assessment of CVD to improve health outcomes."

Professor Julia Newton, Medical Director at AHSN NENC commented: "We are delighted to accelerate the implementation of LIPID inCode® for the diagnosis and treatment of hypercholesterolemia and familial hypercholesterolemia. The added benefit of easy sample collection, improved test turnaround times at a reduced costs to the NHS, continues to help us deliver the Lipid inCode test in our primary care practice and we welcome this approach to help us deliver the NHS 10-Year plan to reduce the onset of cardiovascular disease."

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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 disease onset.

About Academic Health Science Network for the North East and North Cumbria (AHSN NENC):

The AHSN NENC is focused on building and maintaining strong relationships and partnerships which is fundamental to its success. Member organisations and stakeholders include NHS, academia and industry partners in the North East and North Cumbria.

By developing and maintaining strong relationships with members and practitioners, the Network continually shares knowledge and translates ideas into practice. The Network benefits from harnessing the expertise and experience of clinical staff, for example, to act as change agents to adopt and diffuse new practice across organisations and support the research community to develop knowledge.

To deliver against what is a broad remit, the Network works in close collaboration with The AHSN Network across the UK as well as with other national organisations, such as NIHR Clinical Research Network. Other partnerships are developed where appropriate, for example, with the third sector and with industry.

There are 15 Academic Health Science Networks ("AHSN") across England, established by NHS England in 2013 to spread innovation at pace and scale - thereby improving health and generating economic growth. Each AHSN works across a distinct geography serving a different population in each region. The AHSN NENC leads the national AHSN programme to better identify FH in collaboration with the Accelerated Access Collaborative (AAC) and the National Institute for Health & Care Excellence (NICE).

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. 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.

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.

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

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.

Expanding access to genetic testing for Familial Hypercholesterolemia (FH), which causes early heart attacks will enable the diagnosis and treatment of those patients at genetic risk of sudden cardiac death. The NHS set out in the 10 Year Plan to identify at least 25% of those individuals suffering with FH by 2024 through the NHS genomics programme.