GENinCode Plc, the Oxford-based predictive genetics company which floated on the London Stock Exchange’s AIM in July when it raised £17 million, has filed a pre-submission for its Cardio inCode-SCORE with the USA’s Food and Drug Administration (FDA).
GENinCode Plc focuses on the prevention of cardiovascular disease. Cardio inCode-SCORE is an in-vitro diagnostic test which assesses an individual’s combined genetic and clinical risk to predict and prevent cardiovascular disease.
The pre-submission for Cardio inCode-SCORE marks the commencement of the regulatory pathway for US market approval, which is anticipated later this year. The FDA views pre-submission as a structured process for managing and tracking interactions between manufacturers and the FDA about the application for approval or clearance, prior to final submission. It is an interactive process designed to give the opportunity to obtain FDA feedback on the application with the goal of making the end submission process more efficient.
Matthew Walls, CEO of GENinCode Plc, said: “Recognition of inherited genetic contribution to the onset of cardiovascular disease continues to grow. We are well placed to improve the Cardio Vascular Disease (CVD) standard of care by identifying individuals at high genetic risk who can be advised on lifestyle choices and access to personalised treatment to improve future health outcomes.”
GENinCode specialises in polygenic risk assessment of CVD, the leading cause of death and disability worldwide. CVD is a broad disease classification which encompasses conditions such as coronary artery disease (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.
CVD accounts for an estimated 17.9 million deaths globally each year.
The Cardio inCode-SCORE test assesses an individual’s inherited genetic (DNA) risk of cardiovascular disease together with their clinical risk to provide a comprehensive risk assessment of CVD for use in primary preventative care. It also addresses the well-recognised need for improvement in CVD standard of care practices. The test provides a greatly improved estimation of an individual’s risk of a CVD event (e.g. heart attack) particularly within a 10-year period following the test. Cardio inCode-SCORE provides a step change in patient risk assessment for CVD thereby providing a major improvement in preventative care, patient management, diagnosis, and personalised treatment.
The current standard of care for assessing cardiovascular risk is primarily based on traditional clinical risk factors such as age, sex, smoking, body mass, blood pressure and cholesterol levels from which individuals are categorised as being at low, moderate or high risk of a CVD event. This categorisation is imperfect as CVD events frequently occur in those thought to be at low or moderate risk. The size of the populations at low or moderate risk are much larger than those at high or very high risk so whilst the relative risk of a CVD event may be small, the absolute number of CVD events in low and moderate risk populations is much greater than the number of events in higher risk categories.
Genetic assessment will help to identify individuals in low or moderate risk populations who are at higher risk of a CVD 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.
Clinicians have for many years recognised the importance of prior CVD events within the 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 advances of genomics, it has proved possible to add genetic profiling to conventional CVD risk factors, the combination of the two (genetics and conventional clinical risk factors) enhancing the predictive capability of patient risk thereby resulting in a more ‘personalised’ approach to patient care.
The GENinCode Cardio inCode test is a patent protected in-vitro diagnostic genomic test system used to assess the risk of onset of CVD and recurrent myocardial events. The test provides a comprehensive CVD risk assessment by combining both genetic and clinical risk factors using GENinCode’s proprietary software and algorithms to produce a personalised CVD risk score. GENinCode processes and delivers the Cardio inCode-SCORE test via its online ‘cloud based’ portal to physicians.
Over the past 15 years GENinCode has invested significantly in its research, bioinformatic data, technology and product development to assess disease risk to prevent CVD.