GENinCode shares jumped on Friday after releasing results showing its cardiovascular test can meaningfully change how patients at moderate risk of heart disease are assessed and treated.
The results are a major validation of the firm’s approach, and shares rose 20% in early trade.
The data, from an 18-month pilot run by the Institut Català de la Salut in Catalonia and presented at the European Society of Cardiology congress in Munich, tested GENinCode’s CARDIO inCode-Score, a polygenic risk score that gauges a patient’s inherited risk of coronary artery disease.
The score was layered on top of conventional clinical assessment for 584 patients aged 45 to 65 across 14 primary care centres, all previously judged to be at moderate risk.
Adding the genetic reading changed the overall risk assessment for 42.6% of those patients, with just over a quarter (26.5%) moving to a different risk category outright.
This matters because the test flags moderate-risk patients who would benefit from earlier, more intensive prevention, while allowing those found to be at low genetic risk to be safely stepped down.
After a mean follow-up of about 8.5 months, patients’ average cardiovascular risk fell from 7.3% to 6.0%, bad cholesterol dropped from 136.7 to 123.2 mg/dL, and sustained smoking abstinence rose from 43.7% to 62.8%.
The gains were largest among those with the highest genetic risk, nearly half of whom moved to a lower risk category.
Dr. Elisabet Descals, Primary Care Director, Institut Català de la Salut (ICS), Government of Catalonia, Spain
said: “The ICS results provide further real-world clinical evidence for the inclusion of polygenic risk scores (PRS) in conjunction with clinical risk for improved risk assessment of CAD in primary care moderate-risk patients.
“The incorporation of polygenic risk has improved risk stratification, with a significant reduction in estimated CV risk and improved control of risk factors. Likewise, the strategy is expected to be cost-effective, and the results could have immediate applicability in primary care, facilitating more personalized medicine and shared decision-making, while optimizing the allocation of healthcare resources.”
Effectiveness and cost-effectiveness analyses are still underway. But the combination of real-world evidence and guideline recognition is exactly what GENinCode needs as it works to embed genetic testing into everyday cardiovascular care.
Further developments will be eagerly awaited by investors.