Shares in GENinCode PLC (AIM:GENI) jumped 34% to 4.02p after the predictive genetics group unveiled a wide-ranging commercial partnership with Thermo Fisher Scientific to manufacture, sell and distribute its CARDIO inCode-Score test.
The agreement covers the US and the Europe, Middle East and Africa region.
Before full US regulatory clearance, laboratories will be offered the test as a Lab Developed Test, a route that allows hospitals and clinics to run their own versions while the food and drug regulator completes its review.
Once GENinCode secures FDA medical-device approval, Thermo Fisher will begin manufacturing and selling the kit directly to laboratories and testing centres. A similar roll-out is planned in EMEA.
The tie-up is significant for a company of GENinCode’s size. Thermo Fisher’s QuantStudio 5 Dx real-time PCR system, on which the test is designed, is already widely installed, giving the test immediate reach. The partners expect to scale manufacturing as demand grows.
CARDIO inCode-Score uses a polygenic risk score to estimate a person’s inherited likelihood of coronary heart disease from a saliva or blood sample.
GENinCode says stronger genetic insight allows clinicians to target lifestyle advice or treatment earlier, helping to prevent severe events such as heart attacks. The test recently secured New York State licensure and is listed on the 2025 US clinical laboratory fee schedule at an average reimbursement of about $500.
GENinCode said it intends to submit further data to US regulators early next year to complete its De Novo assessment.
Chief executive Matthew Walls said the Thermo Fisher partnership “advances our commercial pathway and will accelerate the adoption of CARDIO inCode-Score well beyond our current capabilities”.