REG - 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
(https://www.youtube.com/watch?v=X6DAIuw9Dsk) ), 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
(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
(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
     (mailto: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
                                                   (mailto:genedrive@walbrookpr.com)
 Anna Dunphy                                       +44 (0)7876 741 001

 

 

About genedrive plc (http://www.genedrive.com (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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