REG - Genedrive PLC - Genedrive® CYP2C19-ID Kit performance published

GenedriveAnnouncement

27/12/2024 07:00

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RNS Number : 3526R  Genedrive PLC  27 December 2024

genedrive plc

("genedrive" or the "Company")

 

Genedrive® CYP2C19-ID Kit clinical performance published

Superior performance to laboratory test and alternative available point of
care platforms

 

genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company,
announces that the clinical performance of its CYP2C19-ID Kit has been
published in the Journal of Molecular Biology. The publication is available at
https://www.jmdjournal.org/article/S1525-1578(24)00312-X/fulltext
(https://www.jmdjournal.org/article/S1525-1578(24)00312-X/fulltext) .

 

Background to the Genedrive® CYP2C19 test

The Genedrive® CYP2C19 ID point of care genetic test is UK Conformity
Assessed ("UKCA") certified and is recommended by The National Institute for
Health and Care Excellence ("NICE") as the Point of Care ("PoC") test of
choice for use in the NHS for CYP2C19 genotype guided prescribing of
Clopidogrel in Ischaemic stroke (IS) and Transient Ischaemic Attack (TIA).
It uses a single, non-invasive cheek swab sample, and rapidly identifies
several important genetic variants of the CYP2C19 gene (Loss Of Function
("LOF")), which are instrumental in an individual's response to the
antiplatelet drug clopidogrel which can be prescribed in Ischemic Stroke
("IS") and Transient Ischaemic Attack ("TIA"). Some of these important LOF
variants are more prevalent in specific ethnic groups and are not included in
targets in any other point of care CYP2C19 genotyping platform.  The test
reports CYP2C19 DNA variant information to the clinician and allows for prompt
consideration of an alternative treatment plan for the circa 30% of
individuals carrying CYP2C19 DNA variants which result in them being less
likely to respond to clopidogrel.

 

Study Results

In the clinical study, CYP2C19 DNA variants in patients presenting in the
acute emergency care setting were tested with the Genedrive® CYP2C19-ID test
and results compared with those obtained by reference laboratory platform
testing, with testing on a separate laboratory platform in instances where
there was disagreement in test results.

In summary, in a cohort of 202 patients, in addition to being substantially
less expensive than the laboratory platform, the Genedrive® CYP2C19 ID Kit
outperformed laboratory testing with respect to (1) speed to result, (2)
accuracy of LOF identification and (3) test fail rate.  Sensitivity and
specificity of the CYP2C19 ID Kit was 100%, with failure rate of 0.98% (three
times lower than laboratory testing).  In addition, the laboratory test
platform returned incorrect results for eight samples (4%).  Importantly, the
Genedrive® CYP2C19 ID Kit identified seven patients harbouring LOF variants
that would not have been detected using an alternative POC CYP2C19 genotyping
platform which focuses on two specific LOF variants compared to five targeted
by the Genedrive® test, or laboratory genotyping methods which also focus on
these two LOF variants.  Requirement for freezer storage of reagents of this
alternative platform is also an implementation barrier in acute clinical
settings that the Genedrive® technology circumvents.

 

This study confirms "that the Genedrive® System is able to provide an
accurate, rapid, non-invasive alternative to standard laboratory testing and
can be used as a point of care test in the clinical environment."

 

Gino Miele, CEO of genedrive plc, said: "We are delighted with the clinical
performance of our CYP2C19 ID Kit reported in this publication.  With
recommendation by NICE as the PoC test of choice for CYP2C19 genotyping in
IS/TIA in NHS England, dominant health economic modelling by NICE, positive
value assessment by the Scottish Health Technology Group, together with this
study evidencing superior performance compared to laboratory testing and by
extrapolation our nearest competitor product, we are well positioned to
capitalise on the emerging clinical pharmacogenetics area of point of care
CYP2C19 genotyped-guided clopidogrel treatment both domestically and
internationally, ultimately enabling better patient outcomes, improving
equitable access to healthcare and positively impacting healthcare financial
burdens."

 

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.

 

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).

 

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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