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FDA Pre-Submission Filed for Cardio inCode-SCORE

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GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease, announces the filing of its Pre-Submission for Cardio inCode-SCORE with the Food and Drug Administration (FDA). Cardio inCode-SCORE is an in-vitro diagnostic test that assesses an individual’s combined genetic and clinical risk to predict and prevent cardiovascular disease (“CVD”).

Following an extensive exchange of information and constructive discussions with the FDA, GENinCode has been invited by the FDA to file its Pre-Submission for Cardio inCode-SCORE. This marks the commencement of the regulatory pathway for U.S. market approval, which is anticipated later this year. The FDA views Pre-Submission as a structured process for managing and tracking interactions between manufacturers and the FDA about the application for approval or clearance, prior to final submission. It is an interactive process designed to give the opportunity to obtain FDA feedback on the application with the goal of making the end submission process more efficient.

Matthew Walls, CEO of GENinCode Plc, said: “Despite the delays driven by the pandemic, the filing of the Cardio inCode FDA Pre-Submission marks the start of the U.S. regulatory approval pathway and ongoing preparation for the launch of Cardio inCode-SCORE later this year. Recognition of inherited genetic contribution to the onset of cardiovascular disease continues to grow. We are well placed to improve the CVD standard of care by identifying individuals at high genetic risk who can be advised on lifestyle choices and access to personalized treatment to improve future health outcomes.”

GENinCode specializes in polygenic risk assessment of CVD, the leading cause of death and disability worldwide. CVD is a broad disease classification that encompasses conditions such as coronary artery disease (causing angina, heart attack, and heart failure), cerebrovascular disease (causing stroke, and some dementia), peripheral vascular disease (causing limb ischemia, and some chronic kidney disease) and venous thromboembolism. CVD accounts for an estimated 17.9 million deaths globally each year and accounts for one in every four deaths in the United States. By 2030, the global cost of CVD is set to rise from approximately US$863 billion in 2010 to US$1,044 billion and is both a major health issue and global economic burden.

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