REG - Genedrive PLC - Scottish Government testing programme investment

GenedriveAnnouncement

17/03/2025 11:15

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RNS Number : 9539A  Genedrive PLC  17 March 2025

genedrive plc

("genedrive" or the "Company")

 

Scottish Government announcement of investment to support national
pharmacogenetic testing of CYP2C19 in Stroke patients and MT-RNR1 in newborn
babies in NHS Scotland.

 

genedrive plc (AIM: GDR), the point-of-care pharmacogenetic testing company,
is pleased to note an announcement by the Scottish Government of investment
into phased delivery of two national scale pharmacogenetic testing programs
utilising genedrive's MT-RNR1-ID and CYP2C19-ID kits in NHS Scotland.  The
public announcement is available at
https://www.gov.scot/news/improving-health-through-innovation/
(https://www.gov.scot/news/improving-health-through-innovation/) .

 

The initial deployment of these programmes is through funding being provided
to the Accelerated National Adoption ("ANIA") pathway following referral from
ANIA to the Scottish Health Technologies Group ("SHTG") which carried out two
technology assessments that included both the Genedrive® CYP2C19 ID Kit and
the Genedrive® MT-RNR1 ID Kit.  Subsequently, Scotland's First Minister John
Swinney delivered a speech on NHS Renewal & Recovery on 27 January 2025
(https://www.youtube.com/live/-tWX1ESlpSs
(https://www.youtube.com/live/-tWX1ESlpSs) ) during which he stated (38:40),
"The latest innovations in genetic testing will be harnessed to enable better
targeting of medications, in cases ranging from recent stroke patients to
newborn infants with bacterial infections.  Smarter care, better care".

 

As outlined in the Scottish Government announcement, approximately £800,000
will fund testing newborn babies with genedrive's MT-RNR-ID kit, in a phased
national roll out over 18 months with first clinical testing beginning in
October.  Once fully implemented it is expected that over 3,000 babies per
year will receive the MT-RNR1-ID test throughout Scotland.  A total of £1.1
million will support interventional CYP2C19 testing in recent stroke patients
and whilst primarily focused on laboratory based testing with substantially
slower turnaround times, Genedrive's CYP2C19-ID kit will be included for
assessment against laboratory testing pathways in Transient Ischaemic Attack
("TIA") clinics.

 

Dr Gino Miele, CEO of genedrive plc, said: "This announcement from the
Scottish Government is a welcome commitment to the strategic implementation of
pharmacogenetic testing into clinical pathways at national scale in NHS
Scotland.  Aside from enabling significantly better patient outcomes, these
interventional testing paradigms offer substantial financial value to
pressured healthcare systems.  Against a backdrop of increasing paradigm
shifts from treatment to prevention and speedier, less centralised
diagnostics, and also recent UK government announcements to abolish NHS
England as an organisation and loss of 9,000 jobs with accompanying savings of
£500m per year, it is noteworthy that CYP2C19 interventional testing alone is
estimated to offer one-third of this at approximately £160m per year of value
to NHS England.  We look forward to working with colleagues in ANIA, and are
grateful for their integrated efforts and forward strategic thinking in
progressing these programs at national level, and we welcome other UK nations
adopting a similar integrated national approach to such avoid introduction of
regional healthcare inequalities.  Genedrive are proud to be at the forefront
of enabling the impact of near-patient pharmacogenetic testing and we look
forward to updating the market in due course as the contractual and
operational planning phases of these programmes are confirmed".

 

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.genedriveplc.com (http://www.genedriveplc.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.

 

About Clopidogrel

Clopidogrel is an antiplatelet drug used after IS or TIA to reduce the risk of
blood clots that can cause further strokes. Clopidogrel is metabolised into
its active form by an enzyme encoded by the CYP2C19 gene which in some people
has variations that reduce the enzyme's function which means that clopidogrel
does not work as well in these people. The Genedrive® CYP2C19-ID point of
care genetic test uses a single, non-invasive cheek swab sample, and rapidly
identifies six important genetic variants of the CYP2C19 gene, five of which
are instrumental in loss of metabolism function. The Genedrive® System
automatically interprets the information for the clinician, allowing prompt
administration of an optimised treatment plan, and whilst positioned for
near-patient testing is equally amenable to use in laboratory settings.

 

About Genedrive® MT-RNR1 Kit

The Genedrive® MT-RNR1 kit is the world's first rapid point-of-care test to
screen infants in an urgent care setting for a genetic variant that can cause
life-long hearing loss when carriers of the variant are given certain
antibiotics. Those infants identified by the Genedrive® MT-RNR1 ID kit as
carrying the variant can then be given alternative antibiotics.  It has the
potential to save thousands of children from lifelong hearing loss, whilst
providing a net positive financial outcome case to healthcare systems.

 

About SHTG & ANIA

The Scottish Health Technology Group (SHTG) is a national health technology
assessment agency that provides advice to NHS Scotland on the use of new and
existing health technologies (excluding medicines), likely to have significant
implications for people's care.  NHS Scotland is required to consider the
advice of the SHTG.

 

The Accelerated National Innovation Adoption (ANIA) brings together partners
from across NHS Scotland and Scottish Government with complementary
capabilities to identify, triage, develop and deliver high impact innovations
for deployment at scale, for the benefit of patients across NHS Scotland.

 

The Genedrive® CYP2C19 ID Kit was included in the Technology Assessment
"Genotype testing to guide clopidogrel use after an ischaemic stroke or
transient ischaemic attack ("TIA")" was used to form an ANIA value case inform
decision making on the roll out of CYP2C19 genotype testing in NHS Scotland.
The report is available at
https://shtg.scot/our-advice/clopidogrel-genotype-testing-after-ischaemic-stroke-or-transient-ischaemic-attack-tia/
(https://shtg.scot/our-advice/clopidogrel-genotype-testing-after-ischaemic-stroke-or-transient-ischaemic-attack-tia/)

 

The Technology Assessment "Genotype testing to guide antibiotic use and
prevent hearing loss in neonates" for the Genedrive® MT-RNR1 ID Kit concluded
that genetic testing will be considered for national rollout to hospital wards
that care for newborn babies.
https://shtg.scot/our-advice/genotype-testing-to-guide-antibiotic-use-and-prevent-hearing-loss-in-babies/
(https://shtg.scot/our-advice/genotype-testing-to-guide-antibiotic-use-and-prevent-hearing-loss-in-babies/)

 

 

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