REG - Genedrive PLC - NHS implementation guide published for CYP2C19

GenedriveAnnouncement

27/11/2025 10:15

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RNS Number : 2766J  Genedrive PLC  27 November 2025

genedrive plc

("genedrive" or the "Company")

 

NHS implementation guide published for CYP2C19 genotype testing

 

genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company,
notes the publication of the "NHS implementation guide for CYP2C19 genotype
testing to guide Clopidogrel use after ischaemic stroke ("IS") or transient
ischaemic attack ("TIA")" to support prescribing decisions in stroke.

 

Following the National Institute for Health and Care Excellence ("NICE")
recommendation for CYP2C19 genotyping in TIA and IS including the Genedrive®
CYP2C19 ID Kit as the preferred rapid testing platform, and a national pilot
implementing both laboratory and "rapid testing" approaches, the
implementation guide encourages stroke services to use the guide to plan how
CYP2C19 genotype testing could be integrated locally.  Interim presentation
of the pilot results highlighted that the vast majority of stroke patients had
moved further down the care pathway by the time results were available from
laboratory testing (which takes several days to weeks), whereas actionable
results were available from rapid testing within just over one hour.

 

The guide notes that;

 

·    Patients at hyperacute stroke units typically have a short length of
stay, which may be more suitable for rapid testing.

·    In the context of TIA and non-disabling stroke, clopidogrel is
typically started immediately.  Turnaround time of laboratory testing means
patients may require an additional appointment to change their prescription.
This group of patients may be receiving less effective secondary prevention
for the days between the test and until an alternative medicine is started.

·    Rapid testing may reduce the need for follow-up appointments or
additional communication to other services to action a prescribing decision.

·    Rapid testing devices can be housed within local pathology
laboratories in addition to frontline clinical areas.

·    Hyperacute stroke units, or centres with high volume TIA admissions
may benefit from rapid testing.

·    As Point-of-Care (rapid) testing provides real-time results,
treatment decisions can be made immediately.

·    Laboratory based testing is under review for national commissioning
and if included in the NHS National Genomic Test Directory then the cost of
the test (excluding logistics) will be funded centrally. Whereas funding for
rapid testing must be met at trust or Integrated Care Board (ICB) level.

·    Rapid testing devices from different providers may test for different
genetic variants, therefore it is recommended to undertake a local equality
impact assessment to understand the prevalence of variants across local
diverse populations.

 

Further details are available at:

 

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)

 

Dr Gino Miele, CEO of genedrive plc, said: "The publication of the NHS
implementation guide for delivery of CYP2C19 genotype testing is well-overdue,
having been expected earlier this year.  Whilst light on detail, publication
of it is welcome, confirming the value of rapid testing solutions to stroke
patients, particularly in enabling more immediate prescribing decisions to TIA
patients.  As expected, laboratory-based testing funding is likely to fall
within Genomic Test Directory commissioning, whereas rapid testing procurement
is likely to be required to be met at trust and ICB level, where our focus has
been predominantly placed commercially in recent months."

 

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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