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GenedriveAnnouncement

04/11/2024 13:30

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RNS Number : 8551K  Genedrive PLC  04 November 2024

genedrive plc

("genedrive" or the "Company")

 

Scottish Health Technology Group publishes two Technology Assessments
including genedrive's CYP2C19 ID and MT-RNR1 and kits

 

genedrive plc (AIM: GDR), the point-of-care pharmacogenetic testing company,
announces that in response to a referral from the Accelerated National
Innovation Adoption ("ANIA") collaborative the Scottish Health Technologies
Group ("SHTG") has carried out two technology assessments which included both
the Genedrive® CYP2C19 ID Kit and the Genedrive® MT-RNR1 ID Kit.

 

The Genedrive® CYP2C19 ID Kit is included in the Technology Assessment
"Genotype testing to guide clopidogrel use after an ischaemic stroke or
transient ischaemic attack ("TIA")" which will be used to form an ANIA value
case and will 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/)

 

Key conclusions of the SHTG assessment relevant to the Genedrive® CYP2C19 ID
kit were as follows:

 

·    Using the Genedrive® CYP2C19 ID Kit to identify clopidogrel
resistance was resource saving from year two onwards and would also prevent
961 recurrent strokes over a 5-year period and save NHS Scotland approximately
£18 million;

·    The benefits of antiplatelet therapy are maximised when the patient
is started on treatment within 24 hours of the initial stroke or TIA.
Laboratory-based testing, which can take up to one week to provide results,
could result in patient harm if treatment is delayed until the test results
are available and many patients could be discharged from hospital by the time
laboratory test results are available;

·    Smaller hospitals serving remote and rural areas would experience
problems accessing laboratory-based genotype testing;

·    There are four regional genetic testing centres in Scotland and they
are under pressure to deliver urgent cancer genetic testing priorities.
There was concern that using regional genetic testing centres would result in
inequalities in care across Scotland; and

·    The Genedrive® CYP2C19 ID Kit had low test failure rate and can
identify more targets, which is a crucial consideration for the inclusion of
more patients from a wider range of ethnic backgrounds and therefore aids
addressing inequalities in healthcare.

 

In addition, the Technology Assessment "Genotype testing to guide antibiotic
use and prevent hearing loss in neonates" is for the Genedrive® MT-RNR1 ID
Kit and concludes 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/)

 

Dr Gino Miele, CEO of genedrive plc, said: "Following positive recommendations
by The National Institute for Clinical Care and Excellence (NICE) for both our
MT-RNR1 and CYP2C19 ID products, we are delighted with these additional
positive independent assessments of the SHTG, and look forward to further
decisions of ANIA regarding potential national rollout plans in Scotland.  We
are proud to be at the forefront of near-patient pharmacogenetic testing and
of the potential for our products to be significantly impactful in delivering
improved patient outcomes in these vulnerable groups as well as offering
significant savings to healthcare systems."

( )

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 / Patrick Birkholm

 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

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.

 

About ANIA

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.

 

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