Results presented re. NHS CYP2C19 Genotype Testing
Genedrive plc announced that data underpinning the NHS implementation guide for CYP2C19 genotype testing to guide Clopidogrel use after ischaemic stroke or TIA was presented at the UK Stroke Forum. The pilot programme found a higher prevalence of patients unlikely to respond to clopidogrel in the near-patient arm (33%) versus the laboratory arm (29%), with the Genedrive® CYP2C19 ID Kit potentially identifying an additional 4,200 stroke patients annually. Test results significantly impacted prescription practices, with 100% of patients in the Genedrive point-of-care arm having results available on-ward compared to 88% discharged in the laboratory arm. The Genedrive® CYP2C19 ID kit demonstrated a low test failure rate of 0.49% and was deemed feasible, scalable, and effective in acute clinical settings, with CYP2C19 interventional testing estimated to offer £160 million in value annually to the UK NHS.
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Pilot Programme Study Results underpinning NHS Implementation Guide for CYP2C19 Genotype Testing Presented at the UK Stroke Forum
genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, notes the presentation of two posters by authors from NHS England ("NHSE") Network of Excellence in Pharmacogenomics, the NHSE Genomics Unit, NHSE National Stroke Programme, and Manchester Centre for Genomic Medicine at the UK Stroke Forum, Aberdeen, 25-27 November 2025. Data presented in these posters underpinned the recently published "NHS implementation guide for CYP2C19 genotype testing to guide Clopidogrel use after ischaemic stroke or transient ischaemic attack ("TIA")" to support prescribing decisions in stroke.
As outlined in the online presentation (Personalising Medicines with Genomics), the National Pilot Programme was conducted at four geographically diverse NHS stroke units across England. The results included laboratory CYP2C19 testing assessed at Doncaster, St. George's and Exeter (December 2024 - April 2025), and Point-of Care ("PoC") rapid CYP2C19 genetic testing assessed using the Genedrive® CYP2C19 ID kit at Salford Royal Hospital's Hyper Acute Stroke Centre (March 2025 - April 2025).
Key findings and conclusions from these were;
| Ÿ | "A higher prevalence of patients unlikely to respond to clopidogrel identified in the near-patient arm (33%) versus the laboratory arm (29%)." The Company estimates that an additional c. 4,200 stroke patients benefitting from alternative prescribing decisions could be identified annually using the Genedrive® CYP2C19 ID Kit due to its increased target coverage and ethnic inclusivity. |
| Ÿ | "Test results impacted prescription practices, guiding prescription changes and aligning treatment with patients' genetic profiles for better outcomes." Notably, 100% of patients in the genedrive PoC arm requiring clopidogrel prescription had their results available whilst on-ward, whereas 88% of patients in the laboratory arm had been discharged (requiring follow-up activities for prescription change activities). |
| Ÿ | Genedrive® CYP2C19 ID kit "test failure rate of 0.49%" in the acute clinical setting. |
| Ÿ | "Implementation of Genedrive® CYP2C19 testing was feasible, scalable and effective in providing immediate availability of results during acute clinical settings. Moreover, the findings substantiate the clinical utility of CYP2C19 genotype-guided antiplatelet therapy in the management of patients with ischemic stroke or TIA, particularly with diverse British and European populations." |
Dr Gino Miele, CEO of genedrive plc, said:
"We are pleased to report the presentation of the data underpinning the NHS CYP2C19 testing implementation guidelines, clearly highlighting the positive case for implementation of our rapid CYP2C19 testing platform. Rapid availability of test results enables actionable prescription choices and reduces the risk of less effective medications being prescribed for secondary prevention of stroke. CYP2C19 interventional testing is estimated to offer £160M of value annually to the UK NHS, with rapid CY2C19 testing estimated to release 62,500 bed days and 235,000 healthcare professional hours annually and aligns perfectly with NHS 10-year plan ambitions for realising the patient and financial benefits of shifting spending to prevention from treatment. We look forward to progressing with Integrated Care Boards (ICBs) and the Dynamic Procurement System (DPS) team to deliver our cost-saving, life-changing transformational solution to stroke patients nationally."
| Ÿ | Applying translational research into clinical practice: Implementing point of care CYP2C19 testing for clopidogrel resistance in stroke care. Nourhan Soliman et al . Poster A7. |
| Ÿ | Real-World NHS Implementation of NICE DG59 Recommended CYP2C19 Testing to guide Clopidogrel Prescribing after Acute Stroke and TIA. David Hargroves et al . Poster i11. E-mail: england.clinicalpolicy@nhs.net |
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