Genincode Regulatory News (GENI)

GENinCode Plc

("GENinCode" or the "Company")

NHS implementation of Lipid inCode® testing of patients suffering with hypercholesterolemia and familial hypercholesterolemia

Lipid inCode® becomes the first commercial polygenic test for CVD to be implemented by the NHS

Oxford, UK. GENinCode Plc (AIM: GENI), the predictive 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 implement the use of its Lipid inCode® test in the AHSN NENC Primary Care Network (PCN) for the diagnosis of hypercholesterolemia (high levels of cholesterol) and familial hypercholesterolemia ("FH"). This marks the introduction of GENinCode's first UK polygenic product aimed at improving the diagnosis and treatment of hypercholesterolemia and preventing the onset of cardiovascular disease ("CVD").

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

The NHS implementation of Lipid inCode® marks the introduction of GENinCode's first UK genetic product aimed at improving the diagnosis and treatment of familial hypercholesterolemia and preventing the onset of cardiovascular disease ("CVD"). Lipid inCode® is the first commercial polygenic test for CVD to be implemented by the NHS.

Following the positive results of its Lipid inCode® NHS clinical study1 and recent successful completion of the Lipid inCode® AHSN NENC pilot, the AHSN NENC will now implement the use of Lipid inCode® in the Darlington PCN and community practice representing over 100,000 patients in the North of England. Within this population, Lipid inCode will detect and diagnose people with high cholesterol, a known important risk factor for the development of CVD. Improved detection supports better treatment and preventative care. Lipid inCode® offers genetic testing for the causes of high cholesterol, with rapid results and comprehensive reporting for clinicians. Lipid inCode® will be offered at a reduced cost to the NHS, to help support the ambition it declared in its Long Term Plan to detect 25% of people with FH by 2024.

In the UK around 7.6m people live with heart and circulatory disease, which causes 25% of all deaths annually in the UK. CVD can be reduced by identifying and treating individuals at risk, and the NHS 10 Year Plan (2019) sets out significant ambitions to address the 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 one in 250 people in the UK population and globally. The NHS Long Term Plan sets out to expand access to genetic testing for FH, which causes early heart attacks and sudden cardiac death. Individuals suffering with FH have a higher risk of heart disease and death at a younger age. For individuals suffering with FH it is important to lower their cholesterol to healthy levels as early in life as possible, often requiring medicines such as statins or more aggressive treatment to help better control cholesterol levels.

CVD is a broad disease classification which encompasses conditions such as coronary artery disease (causing angina, heart attacks, heart failure), cerebrovascular disease (causing stroke, and some dementia), peripheral vascular disease (causing limb ischemia, and some chronic kidney disease) and venous thromboembolism. CVD is the leading cause of death and disability worldwide accounting for one in every four deaths in the United States. According to the US National Institutes of Health (NIH), by 2030, the global cost of CVD is set to rise to US$1,044 billion, from approximately US$863 billion in 2010, and is both a major health issue and global economic burden.

GENinCode has a vision to assist clinicians and inform patients in interpreting cardiovascular risk, and to improve public health using the predictive capability of genomics. High genetic risk patients are assisted in making lifestyle choices and can receive targeted treatment to improve outcomes. Over the past 15 years GENinCode has made a substantial investment in its research, bioinformatic data, technology, and product development to assess disease risk, in order to help clinicians and patients prevent the onset of CVD.

Matthew Walls, CEO of GENinCode PLC said: "The collaboration with the AHSN NENC continues to advance our Lipid inCode test to identify patients at high risk of heart disease and stroke representing the largest cause of death in the UK. The implementation of Lipid inCode marks the beginning of our NHS diagnostic testing for hypercholesterolemia and familial hypercholesterolemia sufferers and we look forward to supporting the NHS in reaching its long term plan to diagnose patients with hypercholesterolemia."

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

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 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.

About Cardiovascular Disease (CVD):

Heart and circulatory disease, also known as 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. 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' (AF, Blood pressure and Cholesterol).