REG - Genedrive PLC - Key CYP2C19-ID test performance milestone achieved

GenedriveAnnouncement

21/05/2024 11:00

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RNS Number : 2973P  Genedrive PLC  21 May 2024

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
(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
                                                   (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.

 

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.

 

 

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