CARDIO inCode-Score 510(k) FDA submission update

De Novo approval will enable a new regulatory class for the commercial distribution of CARDIO inCode-Score medical device

Oxford, 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").

Following 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.

CARDIO inCode-Score or CIC-SCORE is an in-vitro diagnostic test used to assess an individual's polygenic risk of CHD based on DNA analysis. Published clinical evidence amassed over the past 15 years shows that the test when combined with traditional clinical risk assessment, provides a comprehensive risk assessment of CHD for use in primary preventive care. GENinCode processes and delivers the CIC-SCORE test results to physicians via its online 'SITAB' cloud based reporting system.

The CIC-SCORE test addresses the well-recognised need to improve the CHD standard of care by providing a genetic (polygenic) risk assessment for CHD, thereby improving preventive care, patient management, and personalised treatment.

GENinCode has commenced Early Access Programs for CARDIO inCode-Score with leading institutions in the United States to provide an improved estimation of an individual's risk of heart attack over their lifetime. The test is currently being delivered from the GENinCode CLIA and CAP approved laboratory in Irvine, California.

Matthew Walls, CEO of GENinCode PLC said: "The Board are delighted with FDA recognition of the advanced clinical position of CARDIO inCode-Score and their decision to create a new regulatory class for polygenic risk assessment. We expect the De Novo pathway to provide an improved route to gaining US regulatory approval of CARDIO inCode-Score for the polygenic risk assessment of Coronary Heart Disease."