Genedrive Regulatory News (GDR)

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;

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:

For further details please contact:

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.