GENinCode Plc (AIM: GENI) shares climbed 33% after the company announced a major collaboration with Thermo Fisher Scientific to commercialise its CARDIO inCode-Score® Polygenic Risk Score test for predicting and preventing coronary heart disease.
The agreement covers manufacturing, sales, and distribution across the US and EMEA, with the test to be offered first as a Lab Developed Test ahead of expected FDA approval. The partnership will use Thermo Fisher’s QuantStudio™ 5 Dx Real-Time PCR System and is aimed at tapping into the sizeable cardiovascular devices markets, worth about US$22.8 billion in the US and €12.5 billion in Europe.
CARDIO inCode-Score® already holds New York State licensure and is set to appear on the 2025 Clinical Laboratory Fee Schedule with an average reimbursement of around $500 per test. GENinCode said it plans to submit the remaining data required for its FDA De Novo process in the first quarter of 2026.
Matthew Walls, GENinCode Chief Executive Officer said; “We are delighted to announce this milestone collaboration with Thermo Fisher Scientific to scale CARDIO inCode-Score across the US and EMEA markets. The collaboration advances our commercial pathway and will accelerate the adoption of CARDIO inCode-Score well beyond our current capabilities. The collaboration also underpins our US-FDA and EU-IVDR Medical Device 2026 expansion plans.”
For more information visit www.genincode.com
