Corporate News

MedStar to start clinical use of CARDIO inCode-Score® polygenic testing to prevent cardiovascular disease

Oxford, UK. GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease, announces its collaboration with MedStar Health (“MedStar”), a ten-hospital health system in the Washington, D.C. area, to use its CARDIO inCode-Score® (“CIC-SCORE”) test in primary care for the risk assessment of coronary heart disease (“CHD”). Results of the CIC-SCORE test will be combined with the standard American College of Cardiology Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator to identify patients who could benefit from earlier preventive treatment.

The CIC-SCORE test assesses an individual’s polygenic (DNA) risk of CHD which, together with their clinical risk, provides a comprehensive risk assessment of CHD. It also addresses the well-recognised need for improvement in CHD standard of care practices.

As the largest healthcare provider in the Mid-Atlantic, MedStar is an effective incubator for evaluating new clinical applications and through this study, MedStar physicians will provide valuable feedback on the clinical utility of CIC-SCORE in the primary care setting. The clinical utility data generated will support coverage determination and reimbursement for CIC-SCORE with the Centers for Medicare and Medicaid Services (CMS). William Weintraub, MD, Director of Population Health Research at MedStar Health Research Institute and Kristen Miller, PhD, Scientific Director for the National Center for Human Factors in Healthcare at MedStar Health Research Institute, are co-Primary Investigators and Christina Schreiber, DO, a family medicine primary care provider with MedStar, is the physician lead for the study.

The collaboration with MedStar represents the first major US institution to begin clinically assessing CIC-SCORE, forming part of the Early Access commercial programme now underway.

Clinicians have for many years recognised the importance of prior CHD events (e.g. heart attack) within 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 advance of genomics, it has become possible to add genetic profiling to conventional CHD risk factors. The combination of genetics and conventional clinical risk factors will enhance the predictive capability of a patient’s risk resulting in a more ‘personalised’ approach to preventive care.

The CIC-SCORE test is a patent protected in-vitro diagnostic polygenic test used to assess the risk of CHD. GENinCode procesess the CIC-SCORE test at its laboratory in Irvine, California and delivers online reports to physicians via its proprietary cloud-based ‘SITAB’ platform.

Matthew Walls, CEO of GENinCode Plc said: “We are pleased to announce our first major US clinical collaboration with MedStar, which will focus on use of CIC-SCORE to identify patients at high risk of heart disease, the largest cause of death in the US. We look forward to working closely with the MedStar team to identify patients at risk, inform personalised treatment and prevent coronary heart disease.”

William S. Weintraub Director of Population Health Research MedStar Health Research Institute and Professor of Medicine at Georgetown University commented: “We are delighted to collaborate with GENinCode to implement CIC-SCORE for the prevention of cardiovascular disease. This collaboration marks a major step in primary care practice for the risk assessment of CHD and we welcome this approach to help advance our clinical practice and 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-genetic algorithms and bioinformatics to provide advanced patient risk assessment to predict disease onset.

About MedStar Health:

MedStar Health combines the best aspects of academic medicine, research, and innovation with a complete spectrum of clinical services to advance patient care. As the largest healthcare provider in Maryland and the Washington, D.C., region, MedStar Health’s more than 300 care locations include 10 hospitals, 33 urgent care clinics, ambulatory care centers, and primary and specialty care providers. MedStar Health is also home to the MedStar Health Research Institute and a comprehensive scope of health-related organizations all recognized regionally and nationally for excellence. MedStar Health has one of the largest graduate medical education programs in the country, training 1,150 medical residents annually, and is the medical education and clinical partner of Georgetown University. MedStar Health is a $6.7 billion, not-for-profit, regional healthcare system based in Columbia, Maryland, and one of the largest employers in the region. MedStar Health’s team of more than 31,000 includes physicians, nurses, and many other clinical and non-clinical associates who together support MedStar Health’s patient-first philosophy that combines care, compassion, and clinical excellence with an emphasis on customer service. Visit MedStarResearch.org for more information.

About Cardiovascular Disease (CVD):

GENinCode specializes in polygenic risk assessment of CVD, the leading cause of death and disability worldwide. CVD is a broad disease classification which encompasses coronary heart disease (“CHD”) (causing angina, heart attack and heart failure), cerebrovascular disease (causing stroke, and some dementia), peripheral vascular disease (causing limb ischaemia, and some chronic kidney disease) and venous thromboembolism. CHD is the most common type of heart disease in the US and is often referred to as coronary artery disease or ischemic heart disease. For some people, the first sign of CHD is a heart attack. CHD is caused by plaque build up in the walls of the arteries that supply blood to the heart (coronary arteries) and other parts of the body.     

CVD accounts for an estimated 17.9 million deaths globally each year and accounts for 1 in every 4 deaths in the United States. 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. 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 current standard of care for assessing cardiovascular risk is based on traditional clinical risk factors such as age, sex, smoking, blood pressure and cholesterol levels from which individuals are categorized as being at low, borderline, intermediate or high risk of a CHD event. This categorization is imperfect as CHD events frequently occur in those thought to be at low or intermediate risk. The size of the populations classified at low through to intermediate risk are much larger than those at high risk so whilst the relative risk of a CHD event may be small, the absolute number of CHD events in low and moderate risk populations is much greater than the number of events in higher risk categories.

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, overweight and obesity. These “behavioural risks factors” can be measured in primary care facilities and indicate an increased risk of heart attack, stroke, heart failure and other complications. Genetic risk assessment helps to identify individuals in low or moderate risk populations who are at higher risk of a CHD event than their traditional clinical risk categorisation would suggest. This allows earlier in-life preventative measures to be put in place to lower their future risk.

Identifying those at highest risk of CVDs and ensuring they receive appropriate treatment can prevent premature death. 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 US and is the largest cause of premature mortality in deprived areas and is typically the single biggest area of national health care strategy where lives can be saved. CVD is largely preventable, through lifestyle changes, education and a combination of public health strategy for treatment and action on smoking and tobacco addiction, obesity, tackling alcohol misuse and food reformulation.