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NICE recommends CYP2C19-ID Kit in final guidance
NICE recommends CYP2C19-ID Kit in final guidance.
About this update from Genedrive Plc
[{"type":"text","content":"\n\n \nTHIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS DEFINED IN ARTICLE 7 OF REGULATION (EU) NO 596/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 16 APRIL 2014 ON MARKET ABUSE (MARKET ABUSE REGULATION) AS RETAINED AS PART OF UK LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 AS AMENDED.\n \ngenedrive plc\n(\"genedrive\" or the \"Company\")\n \nNICE recommends the Genedrive® CYP2C19-ID Kit in final guidance\nGenedrive® CYP2C19-ID test chosen as the preferred platform for point-of-care genotype testing\nprior to clopidogrel treatment for stroke patients in the NHS\n \ngenedrive plc (AIM: GDR), the point-of-care pharmacogenetic testing company, is pleased to announce that following on from the draft guidance issued in April 2024, the UK's National Institute for Health and Care Excellence (\"NICE\") has recommended in its final guidance that CYP2C19 genotyping should be used to guide clopidogrel use after Ischaemic Stroke (\"IS\") or Transient Ischaemic Attack (\"TIA\"), and that the Genedrive® CYP2C19-ID test should be used as the test of choice for point-of-care strategies. \n \nThe guidance has been published today and can be found at: https://www.nice.org.uk/guidance/dg59.\n \nWith UKCA certification for the product already achieved, completion of the DEVOTE clinical phase, and today's final guidance from NICE recommending the Genedrive® CYP2C19 ID kit for use in point-of-care settings, the Company will now actively pursue commercialisation in the UK and Middle Eastern countries where device registration is enabled by UKCA certification, and is fully prepared to supply and meet the anticipated demand.\n \nThe Genedrive® CYP2C19-ID point-of-care genetic test uses a single, non-invasive cheek swab sample, and rapidly identifies six important genetic variants of the CYP2C19 gene, five of which are instrumental in the loss of metabolism function. The Genedrive® System automatically interprets the information for the clinician, allowing prompt administration of an optimised treatment plan. \n \nWhilst positioned primarily for enabling near-patient testing, the Genedrive® System is also suitable for traditional laboratory testing paradigms as a more affordable alternative to laboratory platforms where sample throughput requirements do not necessitate high-scale bat...