REG - Genedrive PLC - NICE recommends CYP2C19-ID Kit in final guidance

GenedriveAnnouncement

31/07/2024 07:00

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RNS Number : 5459Y  Genedrive PLC  31 July 2024

 

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS DEFINED IN ARTICLE 7 OF
REGULATION (EU) NO 596/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF
16 APRIL 2014 ON MARKET ABUSE (MARKET ABUSE REGULATION) AS RETAINED AS PART OF
UK LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 AS AMENDED.

 

genedrive plc

("genedrive" or the "Company")

 

NICE recommends the Genedrive® CYP2C19-ID Kit in final guidance

Genedrive® CYP2C19-ID test chosen as the preferred platform for point-of-care
genotype testing

prior to clopidogrel treatment for stroke patients in the NHS

 

genedrive plc (AIM: GDR), the point-of-care pharmacogenetic testing company,
is pleased to announce that following on from the draft guidance issued in
April 2024, the UK's National Institute for Health and Care Excellence
("NICE") has recommended in its final guidance that CYP2C19 genotyping should
be used to guide clopidogrel use after Ischaemic Stroke ("IS") or Transient
Ischaemic Attack ("TIA"), and that the Genedrive® CYP2C19-ID test should be
used as the test of choice for point-of-care strategies.

 

The guidance has been published today and can be found at:
https://www.nice.org.uk/guidance/dg59 (https://www.nice.org.uk/guidance/dg59)
.

 

With UKCA certification for the product already achieved, completion of the
DEVOTE clinical phase, and today's final guidance from NICE recommending the
Genedrive® CYP2C19 ID kit for use in point-of-care settings, the Company will
now actively pursue commercialisation in the UK and Middle Eastern countries
where device registration is enabled by UKCA certification, and is fully
prepared to supply and meet the anticipated demand.

 

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

 

Whilst positioned primarily for enabling near-patient testing, the Genedrive®
System is also suitable for traditional laboratory testing paradigms as a more
affordable alternative to laboratory platforms where sample throughput
requirements do not necessitate high-scale batch processing.

 

The specialist NICE diagnostics assessment committee systematically reviewed
the clinical and economic impact of CYP2C19 genetic testing, including both
laboratory-based and point-of-care tests, concluding that CYP2C19 genetic
testing strategies will be beneficial to people with loss-of-function CYP2C19
variants with alternative antiplatelet treatment and 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;

 

-      its greater coverage of genetic variants compared to the other
point-of-care system assessed, permitting increased equitable access to
healthcare across ethnic populations;

-      no requirement for cold-chain storage logistics and;

-      its ability to integrate with patient electronic healthcare
systems.

 

CE-IVD for CYP2C19-ID test

As previously communicated, the Company has an ongoing valued long-standing
partnership with clinical genetics collaborators in Manchester under the
DEVOTE programme, for which a key clinical milestone has been met for
requirements for CE-IVD submission as announced in May 2024. This will
supplement the Company's 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.  Receipt of CE-IVD certification in addition to UKCA
certification would enable the Company to penetrate markets which it estimates
are worth in excess of £100 million per annum.

 

James Cheek, CEO of genedrive plc, said: "We are delighted with this final
guidance from NICE recommending implementation of CYP2C19 genotype-guided use
of Clopidogrel in IS and TIA patients in the NHS to reduce risk of recurrent
strokes, and recommendation of our CYP2C19 ID-kit as the point-of-care
interventional platform of choice.  This represents a key milestone in our
commercialisation plans for the product, and further solidifies our business
strategy of leading provision of cost-effective solutions for pharmacogenetics
in time critical emergency healthcare situations. We are proud to be at the
forefront of the emergence of near-patient genetic testing in emergency
healthcare to facilitate optimal personalised therapeutic choices and
ultimately improve patient outcomes."

 

Professor Bill Newman, Professor of Translational Genomic Medicine at the
University of Manchester and Lead of the NHSE Network of Excellence in
Pharmacogenetics and Medicines Optimisation at Manchester University NHS
Foundation Trust, said: "To ensure that patients receive the correct treatment
to reduce the risk of them having a further stroke after an initial episode,
we need to use a rapid genetic test. The development of this new point-of-care
diagnostic has the potential to significantly improve care for tens of
thousands of patients after a stroke. As part of the DEVOTE project we have
been delighted to have worked with genedrive to generate the evidence for this
test to become available to patients."

 

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). 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.

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 Stroke

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 people who have strokes in
the UK each year(1), with these figures estimated to increase by 60% to
2035(2).  Globally, one in four people over the age of 25 will have a stroke
in their lifetime, and there are 1.3 million stroke survivors in the UK(3),
with current costs of care of approximately £26 billion(2).  Societal costs
are expected to increase 250% over the period to 2035 unless measures to
prevent strokes and reduce the disabling effects of strokes are successfully
developed and implemented(2).

 

About Clopidogrel

Clopidogrel is an antiplatelet drug used in clinical management of stroke.
It is metabolised into its active form by an enzyme encoded by the CYP2C19
gene which in some people has DNA variations that reduce the enzyme's function
which means that clopidogrel does not work as well in these people (Loss of
function).  Suboptimal response to clopidogrel is common, affecting up to 30%
of patients in the general population, which increases to approximately
50%-60% in certain ethnic groups.

For dual antiplatelet therapy including clopidogrel, the UK National Clinical
Guidelines for Stroke states that his should be considered in patients
presenting within 24 hours of TIA and minor stroke(4).

1.    https://www.stroke.org.uk/stroke/statistics
(https://www.stroke.org.uk/stroke/statistics)

2.    https://doi.org/10.1093/ageing/afz163
(https://doi.org/10.1093/ageing/afz163)

3.
https://www.world-stroke.org/assets/downloads/WSO_Global_Stroke_Fact_Sheet.pdf
(https://www.world-stroke.org/assets/downloads/WSO_Global_Stroke_Fact_Sheet.pdf)

4.    National-Clinical-Guideline-for-Stroke-2023.pdf (strokeguideline.org)
(https://www.strokeguideline.org/app/uploads/2023/04/National-Clinical-Guideline-for-Stroke-2023.pdf?_gl=1*17fau81*_up*MQ..*_ga*MjAyOTExNTQxNi4xNzE4MTA4NTgy*_ga_EE3BZMVLRT*MTcxODEwODU4MS4xLjEuMTcxODEwODU5MC4wLjAuMA..)

 

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