GENI Genincode Plc

23 January 2025

GENinCode Plc

("GENinCode" or the "Company")

CARDIO inCode® inclusion in the US CMS 2025 Clinical Lab Fee Schedule

and launch in the Spanish region of Catalonia

Oxford, UK. GENinCode Plc (AIM: GENI), the genetics company focused on the prevention of cardiovascular disease, announces the inclusion of CARDIO inCode (for the polygenic risk assessment of coronary heart disease) in the US 2025 Clinical Lab Fee Schedule (CLFS) to enable reimbursement from Medicare and Medicaid across the US. The company also announces the implementation of CARDIO inCode for the prevention of coronary heart disease (CHD) in the Spanish region of Catalonia.

The CARDIO inCode-Score test is being clinically adopted across leading US healthcare institutions and has now been included in the Centers for Medicare and Medicaid Services (CMS) Clinical Lab Fee Schedule (CLFS) from 2025. The CARDIO inCode test (CPT code: 0401U) price varies on a state by state basis ranging from $450 - $570 with a median price of ~$500/test. The company is also progressing its FDA 'de novo' submission for CARDIO inCode and expects to provide an update on progress over the coming months.

Following earlier CARDIO inCode test pilots across Spain, the Catalonia ministry of health has agreed to implement CARDIO inCode to improve the risk assessment of cardiovascular disease in primary care through the Catalan Health Institute - ICS ("Institut Català de la Salut"). Catalonia is one of 17 Spanish regions providing state based health services to prevent CHD. Out of a total Spanish population of approximately 48 million, the Catalonia region has a population of 7.7m. CARDIO inCode will be provided to patients aged between 45 to 64 years targeting those at risk of CHD estimated at up up to 476,000 patients in the Catalonia region. Test volumes are expected to escalate up to approximately 1,000 patient tests through this year with volumes expanding as increasing numbers of physicians, community practices and regions are educated and onboarded for testing. The Company is also progressing pilot preparations for CARDIO inCode in other Spanish regions. 

GENinCode specialises in polygenic risk assessment for the prevention of CHD. CHD is the most common form of heart disease and the leading cause of death worldwide and in the United Kingdon and United States.

In the UK around 7.6m people live with heart and circulatory disease, which causes 25% of all deaths annually. CHD can be reduced by identifying and treating individuals at risk, and the NHS 10 Year Plan (2019) focused on addressing CVD prevention.

Matthew Walls, CEO of GENinCode PLC said: "The start of US revenues and inclusion in the CMS Clinical Lab Fee Schedule supports the US scale-up of CARDIO inCode for prevention of coronary heart disease. We anticipate an acceleration in adoption of CARDIO inCode across US states and health institutions post FDA approval. The success of the CARDIO inCode CHD prevention program in the Catalonia region of Spain marks a significant milestone allowing us to cross apply this state based primary care program to other Spanish regions."

For more information visit www.genincode.com

Enquiries:

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.

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 cardiovascular disease.

About Cardiovascular Disease (CVD):

Heart and circulatory disease known collectively as Cardiovascular disease (CVD) are the leading cause of death globally, taking an estimated 17.9 million lives each year. 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.

Coronary heart disease (CHD) is the most common type of heart disease. In 2021 in the US, coronary heart disease accounted for 375,476 deaths. About 1 in 20 adults age 20 and older have CHD (about 5%). In 2021, about 2 in 10 deaths from CHD happened in adults less than 65 years old. Globally it is estimated around 200 million people are living with coronary heart disease. Around 110 million men and 80 million women have coronary heart disease. Coronary heart disease kills an estimated nine million people each year - in 2019 it was the world's single biggest killer.

In the UK, cardiovascular disease causes a quarter of all deaths and is the largest cause of premature mortality in deprived areas and 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 NHS action on smoking and tobacco addiction, obesity, tackling alcohol misuse and food reformulation.

Aside from the genetic risk of cardiovascular disease, 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,  excess weight and obesity. These "clinical 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 coronary heart disease and ensuring they receive appropriate treatment can prevent premature deaths. Access to medicines and basic health technology in all primary health care facilities is essential to ensure that those in need receive treatment and counselling.

Early detection and treatment of CVD can help patients live longer, healthier lives is set out in the NHS 10 Year Plan. Too many people are still living with undetected, high-risk conditions such as raised cholesterol, high blood pressure and atrial fibrillation (AF). Globally, healthcare systems are making progress on identification and diagnosis of high genetic risk individuals and working towards people routinely knowing and understanding their 'ABC' (AF, Blood pressure and Cholesterol risk). Replicating this approach is now increasingly possible with advanced molecular testing and digital technology.