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GENinCode Gets New York State Approval for Coronary Heart Disease Test

MT Newswires·12/03/2025 06:30:48
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06:30 AM EST, 12/03/2025 (MT Newswires) -- GENinCode (GENI.L) received approval from the New York State for its Cardio inCode-Score polygenic risk score to predict and prevent coronary heart disease, according to a Wednesday release. The New York State Department of Health, Clinical laboratory Evaluation Program's approval allows for full state coverage of the test under the US Centers for Medicare and Medicaid Services. It also enables the predictive genetics company to collect patient samples from physicians, clinics, and health institutions across New York for laboratory testing at its Irvine, California, facility. In addition, GENinCode is in ongoing discussions with the US Food and Drug Administration, with plans to submit additional data to finalize its De Novo assessment in the first quarter of 2026.