UK-based GENinCode PLC unveiled a wide-ranging commercial partnership with Thermo Fisher Scientific Inc (NYSE:TMO) to manufacture, sell, and distribute its CARDIO inCode-Score test.
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Agreement Details
The agreement covers the U.S., Europe, the Middle East, and the African region.
CARDIO inCode-Score is a clinically validated, commercially available polygenic risk score (PRS) based on DNA extracted from a simple saliva or blood sample. The extracted DNA is scored to identify an individual’s inherited genetic risk of heart disease, thereby enabling prevention through lifestyle change and/or treatment.
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Before the U.S. Food & Drug Administration (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 U.S.
The company will adopt a similar approach in the EMEA market.
With the U.S. and EU cardiovascular devices market estimated at $22.8 billion and 12.5 billion euros, 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 SITAB system for clinical testing, AI bioinformatics, and risk reporting.
The 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 test included in the 2025 Clinical Laboratory Fee Schedule at an average reimbursement of ~$500 per test.
GENinCode continues to progress discussions with the FDA and expects to submit additional data requested to complete its De Novo assessment in the first quarter of 2026.
Matthew Walls, GENinCode CEO, said, “We are delighted to announce this milestone collaboration with Thermo Fisher Scientific to scale CARDIO inCode-Score across the U.S. 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.”
Recent Deal
In October, Thermo Fisher inked a deal to acquire Clario Holdings for $8.875 billion in cash, plus potential future earnout and other performance-based payments.
The acquisition enhances Thermo Fisher’s digital and data capabilities, leveraging AI to accelerate clinical research, improve data insights, and boost efficiency in drug development, helping pharma and biotech customers bring therapies to patients faster and maximize R&D returns.
TMO Price Action: Thermo Fisher Scientific shares were down 2.00% at $568.87 at the time of publication on Thursday, according to Benzinga Pro data.
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