Genincode Regulatory News (GENI)

GENinCode Plc

("GENinCode" or the "Company")

Positive results for Lipid inCode® in NHS clinical study

Lipid inCode® offers greater diagnostic information for hypercholesterolemia sufferers over current NHS standard

Oxford, UK. GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease, announces the successful completion of its NHS clinical study and positive results for its Lipid inCode® test ("Lipid inCode®") for hypercholesterolemia (high levels of cholesterol), including Familial Hypercholesterolemia (FH), undertaken at Royal Brompton and Harefield Hospitals ("RB&H"), recently merged with Guy's and St Thomas' NHS Foundation Trust ("GSTT") the largest specialist heart and lung centre in the UK.

Piers McCleery, Director of strategy, RB&H hospitals: "The study results mark a breakthrough for hypercholesterolemia sufferers and preventative care practice and we are delighted that the Lipid inCode test can help support the NHS 10-Year plan to identify and address patients suffering with Familial Hypercholesterolemia."

The peer reviewed study, which has been published in Global Cardiology Science and Practice[1], involved DNA samples from 40 index cases who had been referred for FH testing in an ISO15189-accredited NHS genetic screening service. These samples were then retrospectively tested using the Lipid inCode® assay with the results compared with those from the initial NHS testing.

The positive results showed an "absolute concordance in variant detection between both diagnostic tests for monogenic and polygenic FH, the only difference being in the interpretation and classification of DNA variants based on ACMG guidelines, which did not differ by more than one classification class." The Lipid inCode® test was "equivalent to the NHS test in providing comprehensive genetic analysis that included the assessment of both monogenic (FH) and polygenic determinants of blood cholesterol and including a pharmacogenomic assessment of predisposition to statin-related myopathy".

The study concluded that "the Lipid inCode® diagnostic test can be undertaken with rapid turnaround and gave the same results as those reported by standard NHS genetic laboratory testing." This is expected to increase diagnostic efficiency and support timely clinical management. Furthermore, the study found that Lipid inCode® offers additional genetic information such as a polygenic risk score (PRS) for hypercholesterolemia, pharmacogenomic testing for statin intolerance, and genetic predisposition to raised Lp(a), an important independent cardiovascular risk factor. Lipid inCode® also provides a coronary Genetic Risk Score which indicates the genetic contribution to an individual's overall risk of future coronary heart disease events, based on the genetic variants analysed.

In the UK around 7.6m people are living with heart and circulatory disease causing 25% of all deaths annually in the UK. Cardiovascular disease (CVD) can be reduced by diagnosing and treating individuals at risk, and the NHS 10 Year Plan (2019) sets out significant ambitions to address the prevention of CVD, including identifying individuals with hypercholesterolemia and particularly those with FH. Lipid inCode offers genetic testing for the causes of high cholesterol, with rapid results and a comprehensive report to clinicians. Lipid inCode® will be offered at a reduced cost to the NHS to help support the NHS meet its declared ambition to detect 25% of people with FH by 2024.

Familial Hypercholesterolemia 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. 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 as possible, often requiring medicines such as statins or more aggressive treatment to help better control cholesterol levels.

GENinCode specialises in polygenic assessment to identify those at risk of developing CVD, with the aim of preventing future cardiovascular events. 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 and RB&H have a shared 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, GENinCode said: "We are delighted with the published results and what this will mean to patients suffering with dyslipidemia and familial hypercholesterolemia in the UK. The results further strengthen our ability to deliver significant clinical improvement in the diagnosis of hypercholesterolemia and will help support the NHS reach its goals to diagnose patients with hypercholesterolemia and personalise treatment to prevent the onset of CVD."

'Evaluation of a novel rapid genomic test including polygenic risk scores for the diagnosis and management of familial hypercholesterolaemia' by Neves, E. et al. Global Cardiology Science & Practice, No 4 (2021), DOI: 10.21542/gcsp.2021.31, https://globalcardiologyscienceandpractice.com/index.php/gcsp/article/view/545

For more information visit www.genincode.com

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About GENinCode:

GENinCode Plc is a UK based company specializing 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 Royal Brompton and Harefield hospitals and Guy's and St Thomas' NHS Foundation Trust:

Royal Brompton and Harefield Clinical Group, part of Guy's and St Thomas' NHS Foundation Trust since February 1st, 2021, is the largest specialist heart and lung centre in the UK and among the largest in Europe. Clinical teams at the RB&H care for patients with a wide range of complex cardiac conditions including congenital (present at birth), inherited, and acquired.

Guy's and St Thomas' NHS Foundation Trust (GSTT) is one of the largest hospital Trusts in the UK. RB&H's Genetics & Genomics Laboratory provides specialist cardiovascular and respiratory clinical genetic testing as part of the South London Genomics Laboratory Hub consortium, which is led by GSTT. As a clinical group within GSTT, RB&H is also a member of the South East Genomic Medicine System Alliance.

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).