REG - Genedrive PLC - NICE recommends the Genedrive CYP2C19-ID Kit

GenedriveAnnouncement

03/04/2024 07:00

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RNS Number : 0366J  Genedrive PLC  03 April 2024

genedrive plc

("genedrive" or the "Company")

 

NICE recommends the Genedrive® CYP2C19-ID Kit

Genedrive® CYP2C19-ID test for genotype-guided clopidogrel treatment in the
NHS

chosen as the preferred platform for UK point-of-care genotype testing

 

genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company,
announces that the UK's National Institute for Health and Care Excellence
("NICE") has recommended in draft guidance that the Genedrive® CYP2C19-ID
test should be used as the point-of-care ("POC") test of choice before
clopidogrel administration in the management of Ischemic Stroke ("IS") and
Transient Ischaemic Attack ("TIA") patients.

 

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, which are instrumental in the loss of metabolism
function. The Genedrive® System automatically interprets the information for
the clinician, allowing prompt administration of an optimised treatment plan.

 

According to the World Stroke Organization, there are over 77 million people
globally who currently have experienced ischaemic stroke and it is estimated
by the Stroke Association that there are 100,000 strokes in the UK each year.
 Suboptimal response to antiplatelet treatment following stroke is common,
affecting about 20%-30% of patients in the general UK population, which
increases to about 50%-60% in certain ethnic groups.

 

NICE recommended in the May 2023 draft guidance that people who have just had
an IS or TIA should have a CYP2C19 genetic test prior to antiplatelet
treatment. Following a public consultation of this draft guidance, which ends
on 26 April 2024, final recommendations are expected to be published by NICE
on 10 July 2024. The public consultation documents and summary review of
NICE's information can be found at:

https://www.nice.org.uk/guidance/indevelopment/gid-dg10054/documents
(https://www.nice.org.uk/guidance/indevelopment/gid-dg10054/documents)

 

The specialist NICE diagnostics assessment committee systematically reviewed
the clinical and economic impact of genetic testing, including both
laboratory-based and POC tests, concluding that it would be beneficial for
people with loss-of-function CYP2C19 alleles to receive alternative
antiplatelet treatment to clopidogrel and CYP2C19 genotype testing is also
cost effective compared with not testing regardless of which alternative
antiplatelet therapy people have.

 

In addition to being dominant in cost effectiveness models, NICE recommends
the Genedrive® as the point-of-care platform of choice for CYP2C19 genotyping
strategies in the NHS.  The decision was based on several differentiating
features of the Genedrive® technology; (1) its greater coverage of genetic
variants compared to the other point-of-care system assessed, permitting
increased equitable access to healthcare across ethnic populations, (2) no
requirement for cold-chain storage logistics, (3) its ability to integrate
with patient electronic healthcare systems.

 

As previously communicated, the Company's ongoing valued long-standing
partnership with clinical genetics collaborators in Manchester under the
DEVOTE programme will supplement our existing clinical performance data used
for UKCA certification and lead to anticipated CE-IVD certification and
commercialisation within the European Union, and those additional countries
that recognise CE-IVD, in early 2025.  Following the completion of the DEVOTE
clinical performance, together with final NICE recommendation due on 10 July
2024, the Company would intend to actively pursue commercialisation in the UK.

 

James Cheek, CEO of genedrive plc, said: "We are delighted to receive this
recommendation from NICE for our CYP2C19 point of care pharmacogenetic test.
The NHS has done significant work on both strokes and mini strokes, with
campaigns for FAST (Face, Arms, Speech, Time) and promoting changing
lifestyles to prevent a stroke. This guidance is just the next step in stroke
management, ensuring that if you have a stroke, specifically related to a
disruption of the blood flow, that the medicine given has a positive effect.
Clopidogrel is the NICE recommended front line treatment for these types of
strokes. However, if you are one of the estimated 20%-30% who are unable to
metabolise Clopidogrel effectively you have the opportunity to be identified
quickly and given an alternative medication. We are delighted to be part of
this change which is in line with our strategy to deliver point-of-care
pharmacogenetic testing to positively impact patient outcomes. With MT-RNR1
getting a NICE EVA conditional recommendation last year, further funding
applied for to achieve a full recommendation this year, a strategy in place to
achieve Food and Drug Administration ("FDA") approval and sales being realised
from new customers in 2024 we feel there is growing momentum within the
Group's POC  pharmacogenetic testing strategy."

 

Professor Bill Newman, Clinical Head of Division and Senior Lecturer in
Clinical Genetics at Manchester University NHS Foundation Trust, said: "The
DEVOTE Programme funded by Innovate UK has brought together academic, industry
and clinical partners from across Manchester to deliver novel genomic
diagnostics to make medicine prescription safer and more effective for
patients. We have been delighted to work with genedrive to develop their point
of care test which will ensure that rapid results are available to reduce the
risk of patients having further strokes."

 

For further details please contact:

 

 genedrive plc                                     +44 (0)161 989 0245
 James Cheek: 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, simple to
use and robust point of need pharmacogenetic platform for the diagnosis of
genetic variations. This helps clinicians to quickly access key genetic
information that will help them make the right choices over the right medicine
or dosage to use for an effective treatment. Based in the UK, the Company is
at the forefront of work on Point of Care pharmacogenetics. Pharmacogenetics
looks at how your genetics impacts a medicines ability to work for you.
Therefore, by using pharmacogenetics, medicines can be made safer and more
effective. The Company has launched its flagship product, the Genedrive®
MT-RNR1 ID Kit, which is a single-use disposable cartridge that circumvents
the requirement for cold chain logistics by providing temperature stable
reagent test kits for use on their proprietary test platform. This test allows
clinicians to make a decision on antibiotic use within 26 minutes; ensuring
vital care is delivered with no negative impact on the patient pathway.

 

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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