Business
Collaboration with Thermo Fisher
GENinCode Plc has announced a significant collaboration with Thermo Fisher Scientific to commercialize its CARDIO inCode-Score® Polygenic Risk Score test for coronary heart disease prediction and prevention. This agreement includes manufacturing, sales, and distribution across the US and EMEA regions, with the test initially available as a Lab Developed Test before US FDA approval. The collaboration leverages Thermo Fisher's QuantStudio™ 5 Dx Real-Time PCR System and aims to address the substantial US$22.8 billion and Euro€12.5 billion cardiovascular devices markets. The CARDIO inCode-Score® test has secured New York State licensure and will be included in the 2025 Clinical Laboratory Fee Schedule with an average reimbursement of approximately $500.00 per test, while GENinCode expects to submit additional data to the FDA in Q1 2026. Disclaimer*
About this update from Genincode Plc
[{"type":"text","content":"\n\n4 December 2025\nGENinCode Plc\n(\"GENinCode\" or the \"Company\")\n \nCARDIO inCode-Score® collaboration with Thermo Fisher Scientific\nCommercialisation agreement to sell, distribute and manufacture CARDIO inCode-Score®\nfor the genetic risk prediction and prevention of coronary heart disease\n \nGENinCode Plc (AIM: GENI), the Oxford based predictive genetics company focused on the prevention of cardiovascular disease (\"CVD\") and risk assessment of ovarian cancer, announces today a collaboration with Thermo Fisher Scientific to sell, distribute and manufacture the CARDIO inCode-Score® Polygenic Risk Score (\"PRS\") test for the prediction and prevention of coronary heart disease (\"CHD\" or \"heart disease\").\n \nCollaboration\nThe GENinCode and Thermo Fisher Scientific collaboration includes manufacturing of CARDIO inCode-Score® and sale and distribution across the US and Europe, Middle East and Africa (EMEA) regions. Prior to US FDA approval, laboratories will be introduced to CARDIO inCode-Score® as a Lab Developed Test (LDT) for the prevention of heart disease. Following FDA Medical Device approval, the collaboration will extend to manufacturing and sale of the device to laboratories and test centres across the US. A similar approach will be adopted in the EMEA market.\n \nWith the US and EU cardiovascular devices market estimated at US$22.8 billion and Euro€12.5 billion respectively, and 80% of heart disease and stroke being preventable, the collaboration will provide the CARDIO inCode-Score® test to assess an individual's genetic risk of heart disease. The test process will use GENinCode's proprietary 'SITAB' system for clinical testing, AI bioinformatics and risk reporting.\n \nThermo Fisher Scientific has been chosen as the preferred partner based on the design and development of the CARDIO inCode-Score® test on the QuantStudio™ 5 Dx Real-Time PCR System. The QuantStudio™ 5 Dx Real-Time PCR System is globally available with significant coverage across the US and EMEA region. Increasing demand for CARDIO inCode-Score® will be met by Thermo Fisher Scientfic scale up of the test manufacturing. \n \nThe CARDIO inCode-Score® test recently received New York State licensure to complete its US Centers for Medicare and Medicaid Services (CMS) state coverage with the te...