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

Oxford, UK. GENinCode Plc (AIM: GENI), the genetics company focused on the prevention of cardiovascular disease (“CVD”), announces the Amercian Medical Asscoiation (AMA) grant of a Current Procedural Terminology (CPT) Proprietary Laboratory Analyses (PLA) code for its CARDIO inCode-SCORE (“CIC-SCORE”) polygenic test for the risk assessment of Coronary Heart Disease. The new code 0401U, has been approved and published by the AMA CPT Editorial Panel1 and is scheduled to become effective on July 1st 2023.

A payment rate for the new code will be established for Medicare patients through the Clinical Lab Fee Schedule (CLFS) Annual Public Meeting process. GENinCode will commence discussions with Medicare and recommend an appropriate basis for establishing a national Medicare price for the CIC-SCORE code.

CIC-SCORE is entering Early Access Programs with leading institutions in the United States over the coming months and the grant of the CPT PLA code is an important step in preparing CIC-SCORE for insurance coverage and reimbursement. The CPT Code will enable increased access to the CIC-SCORE test for patients at genetic risk of Coronary Heart Disease.

The grant of the CPT PLA code follows an extensive program of work to gain California State Licensing and CLIA approval for the CIC-SCORE test at the Company’s Irvine, CA Laboratory together with the clinical and analytical validation of the CIC-SCORE lab diagnostic test. CPT coding and terminology is widely used across the United States providing doctors and health care professionals with a uniform language for coding medical services and procedures to streamline reporting, increase accuracy and efficiency.

CIC-SCORE is a in-vitro diagnostic test used to assess an individuals inherited (DNA) genetic risk of Coronary Heart Disease. The test is based on published clinical evidence amassed over the past 15 years and combined with traditional clinical risk provides a comprehensive risk assessment of Cardiovascular Disease (CVD) for use in primary preventative care. GENinCode processes and delivers the CARDIO inCode-SCORE test to physicians via its online ‘SITAB’ cloud based reporting system.

CIC-SCORE also addresses the well-recognised need for improvement in the CVD standard of care. The CIC-SCORE test provides an improved estimation of an individual’s risk of heart attack over their lifetime and particularly within a 10-year period following the test. CIC-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.

GENinCode specialises in polygenic risk assessment of CVD, the leading cause of death and disability worldwide.

Matthew Walls, CEO of GENinCode PLC said: “The grant of the CPT PLA code is an important step as we prepare CARDIO inCode-SCORE to enter Early Access Programs in the United States. The code is instrumental to obtaining insurance coverage and reimbursement, and will help increase access to CARDIO inCode-SCORE testing for patients at genetic risk of Coronary Heart Disease.”

  1. https://youtu.be/mB7xgRcpgsc

For more information visit www.genincode.com

GENinCode Plc

Matthew Walls, CEO                                               www.genincode.com or via Walbrook PR

Paul Foulger, CFO

Stifel Nicolaus Europe Limited (Nomad and Joint Broker)

Alex Price / Ben Maddison / Richard Short                           Tel: +44 (0)20 7710 7600

Cenkos Securities Plc (Joint Broker)

Giles Balleny                                                                                  Tel: +44 (0)20 7397 8900

Dale Bellis / Michael Johnson (Sales)

Walbrook PR Limited

Anna Dunphy / Louis Ashe-Jepson / Phillip Marriage       Tel: 020 7933 8780 or genincode@walbrookpr.com

Mob: +44 (0)7876 741 001 / +44 (0)7747 515 393

+44 (0) 7867 984 082

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 and accounts for 1 in every 4 deaths 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.