Business
NICE recommends CYP2C19 genotyping
NICE recommends CYP2C19 genotyping.
About this update from Genedrive Plc
[{"type":"text","content":"\n\ngenedrive plc\n(\"genedrive\" or the \"Company\")\n \nNICE recommends CYP2C19 genotyping for clopidogrel treatment\nGenedrive® CYP2C19 ID test modelled to be a clinically and cost-effective option\n \ngenedrive plc (AIM: GDR), the point of care molecular diagnostics company, announces that the UK's National Institute for Health and Care Excellence (\"NICE\") has recommended in draft guidance that CYP2C19 genotyping should be used before clopidogrel administration in the management of ischemic stroke (\"IS\") patients.\n \nThe specialist NICE diagnostics assessment committee systematically reviewed the clinical and economic impact of genetic testing, including both laboratory-based and point-of-care (\"POC\") tests, concluding that CYP2C19 genetic testing strategies are likely to save costs and increase life expectancy compared with no testing. Screening patients to assess their clopidogrel resistance status allows for alternative treatments and better clinical outcomes.\n \nAlthough the Genedrive® CYP2C19 ID test is in development, the NICE Committee included its predicted performance and pricing in its clinical and economic models and a thorough review is included in the Committee Papers in the public consultation documents. The Genedrive POC test had the highest probability of being the most cost effective for all scenarios compared to lab based or other POC solutions. Since final performance data for the Genedrive® CYP2C19 ID test is not yet available; and the product has not yet been registered in the UK under UKCA marking, the NICE Committee reasonably comments that no recommendation can yet be made for clinical use. The Company is anticipating UKCA marking of the Genedrive CYP2C19 test prior to NICE's final report, currently scheduled for October. At that time, NICE will have the option to update the recommendation on the Genedrive CYP2C19-ID Kit.\n \nNICE's final guidance will follow the public consultation period which opens today, 19 May, and is scheduled to close on 9 June 2023. The public consultation documents and summary review of NICE's information can be found at: https://www.nice.org.uk/guidance/indevelopment/gid-dg10054/documents\n \nDavid Budd, CEO of genedrive plc, said: \"This is the second time we have had the opportunity to work with NICE on recommendations for ...