GENinCode (AIM:GENI), the AIM-listed predictive genetics company focused on cardiovascular disease and ovarian cancer risk, presented preliminary results on Thursday from an 18-month real-world pilot of its CARDIO inCode-Score coronary artery disease polygenic risk score.
The Institut Català de la Salut, Catalonia's regional health service, ran the study across 14 primary care centres, testing 584 patients aged 45 to 65 who had been classed at moderate cardiovascular risk under conventional assessment.
Genetic testing changed the overall risk assessment in 42.6% of these patients, with 26.5% shifting outright between low, intermediate and high categories.
After a mean follow-up of 8.5 months, mean cardiovascular risk fell from 7.30% to 6.04%, LDL-cholesterol dropped from 136.74 mg/dL to 123.17 mg/dL, and smoking abstinence rose from 43.7% to 62.8%.
The benefit scaled with genetic risk: 49.6% of the high genetic risk group moved to a lower risk category, against 33% in the moderate group and 28.6% in the lowest quintile.
The findings follow the American College of Cardiology and American Heart Association's recent inclusion of polygenic risk scores in US guidelines for primary prevention of coronary heart disease.
"The incorporation of polygenic risk has improved risk stratification, with a significant reduction in estimated CV risk and improved control of risk factors", said Dr Elisabet Descals, Primary Care Director at ICS, adding that the strategy is expected to be cost-effective with immediate applicability in primary care.
Effectiveness and cost-effectiveness analyses are ongoing.
News Intelligence what this means for the company
GENinCode's CARDIO inCode-Score reclassified cardiovascular risk in 42.6% of moderate-risk patients in a real-world Catalonia pilot, with measurable clinical gains: mean estimated CV risk fell from 7.30% to 6.04%, LDL-cholesterol dropped 13.5 mg/dL, and smoking abstinence rose from 43.7% to 62.8% over 8.5 months. The result validates the test's ability to refine risk stratification in primary care and arrives as US guidelines now endorse polygenic risk scores for coronary heart disease prevention, positioning GENinCode ahead of regulatory approval timelines.
Real-world evidence of clinical utility and risk reclassification strengthens GENinCode's case for US regulatory approval and reimbursement, though the company remains cash-constrained at £0.8m (31 Dec 2025) and dependent on the Q3 2026 De Novo PMA submission and end-Q4 2026 approval target. Cost-effectiveness analyses are still ongoing, and the pilot's 8.5-month follow-up is too short to measure hard clinical outcomes (events, mortality), leaving the ultimate health economic case incomplete.
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