Premarket Notification 510(k) medical device filing for CARDIO inCode-Score (CIC-SCORE)  

Premarket Notification 510(k) medical device filing for CARDIO inCode-Score (CIC-SCORE)  

510(k) approval will enable US expansion and commercial distribution of CARDIO inCode-Score medical device


Oxford, UK. GENinCode Plc (AIM: GENI), the polygenics company focused on the prevention of cardiovascular disease (“CVD”), announces it has filed its Premarket Notification (510k) with the Food and Drug Administration (FDA) to expand its US commercial distribution of the CARDIO inCode-Score (“CIC-SCORE”) polygenic test for the risk assessment and prevention of Coronary Heart Disease (“CHD”). 


CIC-SCORE is a in-vitro diagnostic test used to assess an individual’s polygenic risk of CHD based on DNA analysis. The test is based on published clinical evidence amassed over the past 15 years which combined with traditional clinical risk provides a comprehensive risk assessment of CHD for use in primary preventative care. GENinCode processes and delivers the CIC-SCORE test results to physicians via its online ‘SITAB’ cloud based reporting system.


The CIC-SCORE test addresses the well-recognised need to improve the CHD standard of care by providing a step change in patient risk assessment for CHD thereby improving preventative care, patient management, and personalised treatment. 


GENinCode has commenced Early Access Programs for CIC-SCORE with leading institutions in the United States to provide an improved estimation of an individual’s risk of heart attack over their lifetime. The test is currently being delivered from the GENinCode CLIA approved laboratory in Irvine, California. The Company expects to receive FDA approval of the premarket notification for the CIC-SCORE kit/medical device over the next 6 months enabling scale up and processing by CLIA labs across the United States.


The Company also announces that it has received the College of American Pathologist (“CAP”) laboratory accreditation for the CIC-SCORE test delivered from the Company’s US laboratory based in Irvine, California.  This follows receipt of California State Licensing and CLIA approval earlier this year. 


The 510k filing follows the recently announced CPT PLA code (0401U) for CIC-SCORE which was approved and published by the AMA CPT Editorial Panel. A payment rate for the new code will be established for Medicare patients through the Clinical Lab Fee Schedule (“CLFS”) Annual Public Meetings with a pricing decision on CIC-SCORE expected in October.


Matthew Walls, CEO of GENinCode PLC said: “Approval of the 510k kit/medical device filing will complement our US laboratory testing enabling GENinCode to accelerate commercial growth of CIC-SCORE in the US market. Our Early Access Program is seeing strong demand for use of our CIC-SCORE CLIA lab test to identify patients at high genetic risk, personalise treatment and prevent CHD.”


This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014, as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018. The person responsible for arranging the release of this announcement on behalf of GENinCode Plc is Matthew Walls, Chief Executive Officer.


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Matthew Walls, CEO 



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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 Cardiovascular Disease (CVD): 

Heart and circulatory disease also known as cardiovascular disease (CVD) is the leading cause of death globally, taking an estimated 17.9 million lives each year, with Coronary Heart Disease (CHD) representing the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. CVD is a group of disorders of the heart and blood vessels that include coronary heart disease, cerebrovascular disease, rheumatic heart disease and other conditions. 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. 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.


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 action on smoking and tobacco addiction, obesity, tackling alcohol misuse and food reformulation. 


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, and overweight and obesity. These “intermediate risks factors” can be measured in primary care facilities and indicate an increased risk of heart attack, stroke, heart failure and other complications.


Identifying those at highest risk of CVDs and ensuring they receive appropriate treatment can prevent premature deaths. 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.


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. 


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 personalised and preventative approach to CVD.