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UKCA marking achieved for new CYP2C19 test
UKCA marking achieved for new CYP2C19 test.
About this update from Genedrive Plc
[{"type":"text","content":"\n\ngenedrive plc\n(\"genedrive\" or the \"Company\")\n \nUKCA marking achieved for new Genedrive® CYP2C19 test\n genedrive Point of Care test that helps manage treatment in stroke patients is now readying for NHS introduction\n \ngenedrive plc (AIM: GDR), the point of care molecular diagnostics company, announces it has achieved UKCA marking registration for its new Genedrive® CYP2C19 System. It is a point of care pharmacogenomic test that can differentiate between patients that could respond to clopidogrel treatment and those that will not, allowing more effective drug treatment to be prescribed on a personalised basis. The test can be performed at the bedside or in a ward, and can deliver a clinically actionable result in about one hour.\n \nPoor response to treatment following stroke is common, effecting up to 30% of patients in the general population and in a recent report up to 50% in certain ethnic groups. In the UK, the National Institute for Health and Care Excellence (\"NICE\") recommended in May 2023 draft guidance that people who have had an ischaemic stroke or transient ischaemic attack (\"TIA\") should have a CYP2C19 genetic test prior to treatment. It's estimated that there are over 60 million ischaemic strokes per year globally and over 100,000 in the UK each year. \n \nThe Genedrive® CYP2C19 test uses a single, non-invasive cheek swab sample, and rapidly identifies six important genetic variants of the CYP2C19 gene, which are instrumental in the loss of metabolism function and poor activation of clopidogrel in a patient. The Genedrive® System automatically interprets the information for the clinician, allowing prompt administration of an optimised treatment plan. Like all genedrive products, the tests are presented in a temperature stable, freeze-dried format, allowing testing to be performed by healthcare workers, away from laboratory locations. In its performance evaluations, the test achieved 99% accuracy in detecting the variants that underpin loss of metabolism function.\n \nUKCA marking now allows the Company to begin commercialisation in the UK, and actively engage in the DEVOTE programme (previously announced in May 2023), which will generate additional performance data in an acute care setting. This expanded dataset is required for CE marking submission, which wil...