Genedrive PLC - Results presented re. NHS CYP2C19 Genotype Testing
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RNS Number : 5753J
Genedrive PLC
01 December 2025
genedrive plc
("genedrive" or the "Company")
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."
Further details are available at:
Implementation guide - genetic_testing_to_support_prescribing_decision_in_stroke: https://www.nw-
gmsa.nhs.uk/about-us/our-projects/genomic-networks-excellence/pharmacogenomics-and-medicines-optimisation-
genomic-network-excellence/clopidogrel-pilot-project-cyp2c19-genetic-testing-stroke-and-tia-patients
Personalising Medicines with Genomics; What Pharmacy Professionals Need to Know About Clopidogrel
Testing: https://www.youtube.com/watch?v=X6DAIuw9Dsk
UK Stroke Forum 2025 Poster Presentation Citations:
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
For further details please contact:
genedrive plc +44 (0)161 989 0245
Gino Miele: CEO / Russ Shaw: CFO
Peel Hunt LLP (Nominated Adviser and Broker) +44 (0)20 7418 8900
James Steel
Walbrook PR Ltd (Media & Investor Relations) +44 (0)20 7933 8780 or genedrive@walbrookpr.com
Anna Dunphy +44 (0)7876 741 001
About genedrive plc (http://www.genedrive.com)
genedrive plc is a pharmacogenetic testing company developing and commercialising a low cost, rapid, versatile
and simple to use point of need pharmacogenetic platform for the diagnosis of genetic variants. This helps
clinicians to quickly access key genetic information that will aid them make the right choices over the right
medicine or dosage to use for an effective treatment, particularly important in time-critical emergency care
healthcare paradigms. Based in the UK, the Company is at the forefront of Point of Care pharmacogenetic testing
in emergency healthcare. Pharmacogenetics informs on how your individual genetics impact a medicines ability to
work for you. Therefore, by using pharmacogenetics, medicine choices can be personalised, made safer and more
effective. The Company has launched its two flagship products, the Genedrive® MT-RNR1 ID Kit and the
Genedrive® CYP2C19 ID Kit, both developed and validated in collaboration with NHS partners and deployed on
its point of care thermocycler platform. Both tests are single-use disposable cartridges which are ambient
temperature stable, circumventing the requirement for cold chain logistics. The Directors believe the Genedrive®
MT-RNR1 ID Kit is a worlds-first and allows clinicians to make a decision on antibiotic use in neonatal intensive
care units within 26 minutes, ensuring vital care is delivered, avoiding adverse effects potentially otherwise
encountered and with no negative impact on the patient care pathway. Its CYP2C19 ID Kit which has no
comparably positioned competitor currently allows clinicians to make a decision on the use of Clopidogrel in
stroke patients in 70 minutes, ensuring that patients who are unlikely to benefit from or suffer adverse effects from
Clopidogrel receive an alternative antiplatelet therapeutic in a timely manner, ultimately improving outcomes.
Both tests have undergone review by the National Institute for Health and Care Clinical Excellence ("NICE") and
have been recommended for use in the UK NHS. The Company has a clear commercial strategy focused on
accelerating growth through maximising in-market sales, geographic and portfolio expansion and strategic M&A,
and operates out of its facilities in Manchester.
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