GENinCode (AIM: GENI), a provider of genetic tests and predictive technology for Coronary Heart Disease (CHD) assessment, announced on Wednesday that it has agreed with the FDA to transition its CARDIO inCode-Score (CIC-SCORE) 510(k) submission to the De Novo pathway. The move will establish a new regulatory class for polygenic risk scores, facilitating the commercial distribution of the CARDIO inCode-Score polygenic test kit for CHD risk assessment and prevention in the US.

Following FDA's recognition of CARDIO inCode-Score's 'first in class' position, the De Novo pathway offers an improved route to market approval. The submission forecasts clearance in late Q1 to early Q2 2024.

CARDIO inCode-Score is an in-vitro diagnostic test providing polygenic risk assessment of CHD through DNA analysis. The FDA's request for De Novo pathway reflects the test's advanced clinical position and novel features. GENinCode expects the transition to set a new regulatory standard for future polygenic tests in this class.

GENinCode specializes in genetic risk assessment for cardiovascular disease (CVD). The company's CARDIO inCode-Score test, part of early access programs in the US, aims to enhance CHD preventive care, patient management, and personalized treatment. The genetic test combines clinical algorithms and bioinformatics for advanced patient risk assessment.

The current standard for assessing cardiovascular risk relies on traditional clinical risk factors, leading to imperfect categorization. Genetic factors play a crucial role, and recent advancements in genomics allow the integration of genetic profiling with clinical risk factors. This combined approach enhances the predictive capability of patient risk, enabling a more personalized and preventive approach to CVD.

GENinCode operates in the UK, Europe (through GENinCode S.L.U), and the US (through GENinCode U.S. Inc). The company's focus on preventive care aligns with global efforts to reduce the impact of cardiovascular disease on public health and healthcare systems.