genedrive
plc
("genedrive" or the
"Company")
Key CYP2C19-ID test
performance milestone achieved
genedrive plc (AIM: GDR), the point
of care pharmacogenetic testing company, is pleased to announce
that a key milestone has been met in The
Development and Validation of Technology for Time Critical Genomic
Testing ("DEVOTE") programme for its CYP2C19-ID kit. The programme
has now passed the patient numbers required for a subsequent
submission for an in vitro diagnostics CE certification ("CE-IVD"),
which is still anticipated in early 2025.
The Genedrive® CYP2C19-ID point of
care genetic test is UK Conformity Assessed ("UKCA") certified,
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 drug clopidogrel which can be
prescribed in Ischemic Stroke ("IS") and Transient Ischaemic Attack
("TIA"). The test automatically interprets the CYP2C19 DNA variant
information for the clinician and allows for prompt administration
of an alternative treatment plan for the circa 30% of individuals
that are less likely to respond favourably to
clopidogrel.
DEVOTE is an all-comer study in
which CYP2C19 DNA variants in patients presenting in the acute
emergency care setting are tested with the Genedrive® CYP2C19-ID test and results compared with those
obtained by reference laboratory platform testing, with testing on
a third laboratory platform in instances where there is
disagreement in test results. In the
tests run to date the Genedrive® CYP2C19-ID test has out-performed
the reference laboratory-based test with respect to coverage of LoF
variants and accuracy (correct identification of
variant).
The DEVOTE programme, through its
lead partner the University of Manchester ("UoM"), has supported
the Company's requirement for assessing performance in acute care
patients and provided valuable supporting infrastructure to assess
the real-world clinical performance of time-critical clinical tests
in NHS settings. The study addresses clinical requirements of
the In Vitro Diagnostic Medical Devices Regulation ("IVDR") for
CE-IVD submission and subsequent commercialisation in those
countries recognising CE-IVD, in addition to current UKCA
certification allowing UK commercialisation.
Approximately 30% of patients in the
cohort harboured CYP2C19 LoF variants as expected. The
Genedrive® CYP2C19
test outperformed the laboratory test with respect to accuracy of
identification of LoF alleles, and broader inclusion of LoF
alleles. Genedrive® CYP2C19-ID test results are available in ~70
minutes.
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 test of choice in the NHS before clopidogrel
administration in the management of IS and TIA patients
(https://www.nice.org.uk/guidance/indevelopment/gid-dg10054/documents).
The draft guidance is expected to be finalised on 10 July
2024.
James Cheek, CEO of genedrive plc, said:
"This study has
been invaluable in progressing our requirements for CE-IVD
certification to complement our existing UKCA certification.
Our CYP2C19 test is the only one we are aware of that can deliver
clinically actionable results for these DNA variants in the CYP2C19
gene in a rapid timeframe in emergency care settings at the point
of care. We are excited that the availability of this
intervention has the potential to make a difference to patients'
lives and we look forward to working with UK stroke networks in the
NHS to bring this vital test into day-to-day
use."
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: "It has been very positive working with genedrive as part of
the Innovate UK funded DEVOTE project to test clinical samples and
determine how well the assay performs in this setting. It is clear
that the test will offer an effective rapid solution to doctors and
pharmacists to guide effective prescribing for patients with
stroke."
Professor Ben Bridgewater, Chief Executive at Health
Innovation Manchester, said: "This is a great example of
how the GM Health Innovation Accelerator programme is supporting
development of our innovation ecosystem specifically in this case
through validation of a novel and valuable rapid diagnostics test.
Congratulations to genedrive for this achievement as they continue
to collaborate with academic strengths in the city region to
develop products to improve the health of our local population and
address inequalities in care."
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
|
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.
About
Clopidogrel
Clopidogrel is an antiplatelet drug
used after IS or TIA to reduce the risk of blood clots that can
cause further strokes and is metabolised into its active form by an
enzyme encoded by the CYP2C19 gene. The CYP2C19 gene in some
people has variations that reduce the enzyme's function which means
that clopidogrel does not work as well in these people (Loss of
Function "LoF"). 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.