GENinCode Partners with US-based Thermo Fisher to Commercialize Heart Disease Test

MT Newswires · 3d ago
07:34 AM EST, 12/04/2025 (MT Newswires) -- GENinCode (GENI.L) partnered with US-based clinical research company Thermo Fisher Scientific to commercialize the former's polygenic risk score test for coronary heart disease. Under the collaboration, Thermo Fisher Scientific will manufacture and distribute the CARDIO inCode-Score test device across the US, Europe, and the Middle East, and Africa regions, according to a Thursday filing. The predictive genetics company expects to submit additional data requested by the US Food and Drug Administration to complete its De Novo assessment on the test in the first quarter of 2026. Initially, the test will be introduced to laboratories as a lab-developed test for the disease. However, after receiving the US FDA's approval, the partners will begin manufacturing and selling the device to laboratories and testing centers in the US and EMEA.