Genincode Regulatory News (GENI)

GENinCode Plc

("GENinCode" or the "Company")

Collaboration with University Clinic Dresden for implementation of LIPID inCode®

LIPID inCode® becomes first polygenic test for CVD implemented in Germany

Oxford, UK. GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease, announces its collaboration with the University Clinic Dresden, Department of Internal Medicine and Department of Human Genetics, based in Germany, to use its LIPID inCode® test in primary care for the diagnosis of hypercholesterolemia (high levels of cholesterol) and familial hypercholesterolemia ("FH"). LIPID inCode® is the first polygenic product to be introduced in Germany to improve the diagnosis and treatment of hypercholesterolemia to prevent cardiovascular disease ("CVD"). This new endeavour is based on a long-standing clinical research collaboration of GENinCode with the Department of Medicine (Prof. Dr. S. Bornstein).

The University Clinic lipid centre treats over 6000 patients with lipid disorders and constitutes the largest academic lipid apheresis centre globally. In Germany, 60% of the population suffer from high levels of cholesterol and it is estimated that over a quarter of a million of these cases relate to FH1. The collaboration also builds on the Transcampus Initiative between Technische Universität in Dresden and Kings College London, providing a translational model of best practice and patient care across borders.

LIPID inCode® testing will initially support the lipid centre in the region of Saxony to deliver its preventative care plans to identify individuals at risk of CVD. The lipid centre, will handle the regional roll-out of testing and may extend testing to other regions of Germany. LIPID inCode® improves the diagnosis and treatment of familial hypercholesterolemia with rapid turnaround of test results to prevent the onset of CVD. It is also the first commercially available polygenic test for CVD to be implemented in Germany. 

The collaboration follows the positive results of the LIPID inCode® Dresden clinical study and pilot. LIPID inCode® testing in the Saxony region will cover a primary care population and community practice in the region. Testing will diagnose patients with genetic disorders giving rise to high levels of cholesterol, an important risk factor for the development of CVD. Improved detection supports better treatment and preventative care.

In the Germany around 6 million people live with cardiovascular disease, which causes 25% of all deaths annually, with the disease rate particularly high in the region of Saxony2. CVD can be reduced by identifying and treating individuals at risk and the collaboration will focus on addressing 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. For individuals suffering with FH, it is important to lower 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.

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 University Clinic in Dresden will focus on the use of Lipid inCode® testing to identify patients at high risk of heart disease, the largest cause of death in the Germany. The Dresden hub will handle regional testing and extend testing to other regions of Germany for the adoption of our globally leading polygenic test. We look forward to supporting the Dresden Lipid Centre in reaching its plans to provide early diagnosis of patients with hypercholesterolemia and prevent CVD."

Professor Stefan Bornstein, Chair and Director of Medicine of the University Hospital and Transcampus Dean Kings College London, commented: "We are delighted to collaborate with GENinCode to implement Lipid inCode® for the diagnosis and treatment of hypercholesterolemia and familial hypercholesterolemia. This collaboration marks a major step to improve our primary care practice for the identification of FH sufferers and we welcome this approach to work together with our UK colleagues as part of the German and UK Transcampus programme 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 University Clinic Dresden, Department of Medicine and Department of Human Genetics:

The University Clinic Dresden, Department of Internal Medicine III, under the direction of Clinic Director Prof. Dr. Stefan R. Bornstein - with more than 250 employees in medical, nursing, technical and administrative services as well as in research - is one of the leading centres in Germany and Europe in the field of treatment and research of diabetes mellitus type 1 and 2 as well as its secondary diseases and lipid disorders. The clinic is home to the only active islet cell transplantation programme in Germany at present, the interdisciplinary vascular centre and the special outpatient clinics for rheumatology, metabolism, diabetic foot, insulin pumps, angiology, nephrology, endocrinology as well as the emergency room and the intensive care unit of internal medicine. The department of human genetics has extensive expertise in the analysis of common and rare genetic diseases and is also an integral part of the cancer centre.

About cardiovascular disease (CVD)

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 burden3.

1 Prevalence of dyslipidemia among adults in Germany: results of the German Health Interview and Examination Survey for Adults (DEGS 1)] - PubMed (nih.gov)

2 Regional Differences in the Prevalence of Cardiovascular Disease - PMC (nih.gov)

3 Data-driven quality improvement program to prevent hospitalisation and improve care of people living with coronary heart disease: Protocol for a process evaluation - PMC (nih.gov)