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GENinCode PLC on Wednesday said its polygenic risk score test for heart health has been approved by the New York Department of Health as it advances its US Food & Drug Administration assessment. Shares in GENinCode jumped 40% to 3.00 pence on Wednesday afternoon in London. The Oxford-based genetic testing company, focused on cardiovascular disease and ovarian cancer prevention, said the approval enables full state coverage for Cardio inCode-Score under US Centers for Medicare & Medicaid Services. The test will be included in the clinical laboratory fee schedule for 2025 at an average reimbursement of approximately $500 per test. Cardio inCode-Score is a polygenic risk score based on DNA extracted from a saliva or blood sample which identifies an individual’s inherited genetic risk of heart disease. GENinCode said it will collect patient samples from New York State physicians, clinics, and health institutions for testing at its Irvine, California lab facility, which has also received a New York State clinical test permit. The company added that its discussions with the US FDA are ongoing. It expects to submit additional data to complete its De Novo assessment application in the first quarter of 2026. ‘Following careful evaluation by the New York State Department of Health, we are delighted to receive Cardio inCode-Score test approval to commercially promote Cardio inCode-Score for genetic risk prediction of heart disease in the New York State. The approval also provides further support for our FDA De Novo assessment,’ said Chief Executive Matthew Walls. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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