genedrive's test for stroke treatment nears NHS introduction
Used in conjunction with the genedrive® System, Genedrive’s CYP2C19 test is a molecular point-of-care test for rapid CYP2C19 genotyping, used to identify which patients may or may not respond to mainline antiplatelet therapy (blood clot prevention drugs) following ischemic stroke. Clopidogrel is a drug that is often given to ischemic stroke patients to prevent further clot formation but is less effective in individuals with certain genetic CYP2C19 variants because they do not metabolise clopidogrel fully.
Following the test, the Genedrive® System automatically interprets the information for the clinician, allowing prompt administration of an optimised treatment plan. In its performance evaluations, the test achieved 99% accuracy in detecting the variants that underpin loss of metabolism function.
Following the UKCA marking, genedrive can now begin commercialisation in the UK, and actively engage in the DEVOTE programme - previously announced in May 2023 - which will generate additional performance data.
This data is essential for CE marking submission, allowing for commercialisation in the EU, which is anticipated in H1 2024 after genedrive's engagement with DEVOTE concludes. In the UK, the product will be sold directly, with adoption influenced by anticipated positive final NICE recommendations for CYP2C19 testing in December 2023.
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The news today builds on genedrive’s announcement in May, when it received draft guidance from the UK's National Institute for Health and Care Excellence (NICE) for the use of CYP2C19 genotyping before administering the drug clopidogrel to ischemic stroke patients.
The demand for genedrive's CYP2C19 test is incredibly high due to its critical importance in addressing a significant health crisis. In the UK alone, there are over 100,000 cases of strokes, 60,000 transient ischaemic attacks, and a staggering 38,000 associated deaths each year. Moreover, on a global scale, there is a substantial market opportunity for genedrive as strokes rank as the second leading cause of death worldwide.
genedrive's test also offers huge cost-saving benefits, as evidenced by the significant financial impact of strokes on the NHS, with the annual cost of strokes alone surpassing £3 billion within the healthcare system. However, when considering broader factors such as the societal cost, including the loss of productivity among stroke survivors of working age and the extensive hours dedicated by unpaid caregivers, the overall economic burden escalates to £26 billion per year.
During a time of unprecedented pressure on the NHS, stripping out the cost of ineffective prescriptions and reducing the burden of avoidable illness and adverse drug reactions could present a substantial cost-saving opportunity, in addition to optimising the desired outcome and safety of the care each individual patient receives.
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