CARDIO inCode Lab Fee Update & Catalonia Launch

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."