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CARDIO inCode 510k filing
CARDIO inCode 510k filing.
About this update from Genincode Plc
[{"type":"text","content":"\n\n\nGENinCode Plc\n(\"GENinCode\" or the \"Company\")\n \nPremarket Notification 510(k) medical device filing for CARDIO inCode-Score (CIC-SCORE) \n510(k) approval will enable US expansion and 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 filed its Premarket Notification (510k) with the Food and Drug Administration (FDA) to expand its US commercial distribution of the CARDIO inCode-Score (\"CIC-SCORE\") polygenic test for the risk assessment and prevention of Coronary Heart Disease (\"CHD\").\n \nCIC-SCORE is a in-vitro diagnostic test used to assess an individual's polygenic risk of CHD based on DNA analysis. The test is based on published clinical evidence amassed over the past 15 years which combined with traditional clinical risk provides a comprehensive risk assessment of CHD for use in primary preventative care. GENinCode processes and delivers the CIC-SCORE test results to physicians via its online 'SITAB' cloud based reporting system.\n \nThe CIC-SCORE test addresses the well-recognised need to improve the CHD standard of care by providing a step change in patient risk assessment for CHD thereby improving preventative care, patient management, and personalised treatment.\n \nGENinCode has commenced Early Access Programs for CIC-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 approved laboratory in Irvine, California. The Company expects to receive FDA approval of the premarket notification for the CIC-SCORE kit/medical device over the next 6 months enabling scale up and processing by CLIA labs across the United States.\n \nThe Company also announces that it has received the College of American Pathologist (\"CAP\") laboratory accreditation for the CIC-SCORE test delivered from the Company's US laboratory based in Irvine, California. This follows receipt of California State Licensing and CLIA approval earlier this year.\n \nThe 510k filing follows the recently announced CPT PLA code (0401U) for CIC-SCORE which was approved and published by the AMA CPT Edit...