Business
CARDIO inCode-Score 510(k) FDA submission update
CARDIO inCode-Score 510(k) FDA submission update.
About this update from Genincode Plc
[{"type":"text","content":"\n\nGENinCode Plc\n(\"GENinCode\" or the \"Company\")\n \nGENinCode to transition CARDIO inCode-Score (CIC-SCORE) 510(k) FDA submission to De Novo pathway \nDe Novo approval will enable a new regulatory class for the commercial distribution of CARDIO inCode-Score medical device\n \nOxford, UK. GENinCode Plc (AIM: GENI), the polygenics company focused on the prevention of cardiovascular disease (\"CVD\"), announces it has agreed with the Food and Drug Administration (FDA) to create a new regulatory class for polygenic risk scores and transition its premarket notification 510(k) submission to a De Novo submission. The new regulatory class clearance of CARDIO inCode will enable GENinCode to commercially advance US national distribution of the CARDIO inCode-Score polygenic test kit (medical device) for the risk assessment and prevention of Coronary Heart Disease (\"CHD\").\n \nFollowing the CARDIO inCode-Score 510(k) medical device submission in August 2023, the FDA has reviewed the submission and recently noted CARDIO inCode-Score's 'first in class' position and the deep clinical evidence for polygenic risk assessment of CHD. Based on these factors and the novel position of CARDIO inCode-Score, the FDA has requested the Company to transition to a De Novo pathway for market approval. The crossover to a De Novo pathway enables the Company to work with the FDA to establish a new polygenic regulatory class for the CARDIO inCode-Score medical device based on its favourable benefit-risk profile and associated special controls thereby setting a new regulatory standard for future polygenic tests in this class. Following the FDA request, the Company has now submitted its De Novo submission for market clearance and expects a timeline to clearance broadly in line with earlier the earlier 510(k) submission forecasts of late Q1/early Q2 2024.\n \nCARDIO inCode...