REG - Genedrive PLC - UKCA marking achieved for new CYP2C19 test

GenedriveAnnouncement

06/09/2023 07:00

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RNS Number : 4792L  Genedrive PLC  06 September 2023

genedrive plc

("genedrive" or the "Company")

 

UKCA marking achieved for new Genedrive® CYP2C19 test

 genedrive Point of Care test that helps manage treatment in stroke patients
is now readying for NHS introduction

 

genedrive plc (AIM: GDR), the point of care molecular diagnostics company,
announces it has achieved UKCA marking registration for its new Genedrive®
CYP2C19 System. It is a point of care pharmacogenomic test that can
differentiate between patients that could respond to clopidogrel treatment and
those that will not, allowing more effective drug treatment to be prescribed
on a personalised basis. The test can be performed at the bedside or in a
ward, and can deliver a clinically actionable result in about one hour.

 

Poor response to treatment following stroke is common, effecting up to 30% of
patients in the general population and in a recent report up to 50% in certain
ethnic groups. In the UK, the National Institute for Health and Care
Excellence ("NICE") recommended in May 2023 draft guidance that people who
have had an ischaemic stroke or transient ischaemic attack ("TIA") should have
a CYP2C19 genetic test prior to treatment. It's estimated that there are over
60 million ischaemic strokes per year globally and over 100,000 in the UK each
year.

 

The Genedrive® CYP2C19 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 and poor activation
of clopidogrel in a patient. The Genedrive® System automatically interprets
the information for the clinician, allowing prompt administration of an
optimised treatment plan. Like all genedrive products, the tests are presented
in a temperature stable, freeze-dried format, allowing testing to be performed
by healthcare workers, away from laboratory locations. In its performance
evaluations, the test achieved 99% accuracy in detecting the variants that
underpin loss of metabolism function.

 

UKCA marking now allows the Company to begin commercialisation in the UK, and
actively engage in the DEVOTE programme (previously announced in May 2023),
which will generate additional performance data in an acute care setting. This
expanded dataset is required for CE marking submission, which will allow for
commercialisation in the EU. Submission is expected in the first half of 2024
once genedrive's engagement with DEVOTE has completed. In the United Kingdom,
the Company will be selling the product through its direct sales team, and
momentum for adoption is expected to be influenced by positive final NICE
recommendations for CYP2C19 testing, which are expected in December 2023.

 

David Budd, Chief Executive Officer of genedrive plc, said: "UKCA marking of
the Genedrive® CYP2C19 test is a milestone for the Company as we formally
register our second pharmacogenomic test for use in emergency medicine. As we
begin commercialisation and look to registration activities more globally, we
will benefit from a rapidly evolving well documented clinical understanding
and guidance for the use of genetic testing for stroke management. The use of
point of care testing allows patients to be put on an optimised treatment plan
as quickly as possible. The risk of recurrent stroke in the week after a TIA
or minor stroke is up to 10%, so routine laboratory testing which can take
many days or weeks is unlikely to be as appropriate as a point of care
solution returning results in about one hour."

 

For further details please contact:

 

 genedrive plc                                       +44 (0)161 989 0245
 David Budd: CEO / Russ Shaw: CFO

 Peel Hunt LLP (Nominated Adviser and Joint Broker)  +44 (0)20 7418 8900
 James Steel / Patrick Birkholm

 finnCap (Joint Broker)                              +44 (0)20 7220 0500
 Geoff Nash

 Walbrook PR Ltd (Media & Investor Relations)        +44 (0)20 7933 8780 or genedrive@walbrookpr.com
                                                     (mailto:genedrive@walbrookpr.com)
 Paul McManus / Anna Dunphy                          +44 (0)7980 541 893 / +44 (0)7876 741 001

 

 

About genedrive plc (http://www.genedriveplc.com
(http://www.genedriveplc.com/) )

genedrive plc is a molecular diagnostics company developing and
commercialising a low cost, rapid, versatile, simple to use and robust point
of need molecular diagnostics platform for use in patient stratification
(genotyping), pathogen detection and other indications in emergency care.

 

About DEVOTE

The Development and Validation of Technology for Time Critical Genomic Testing
(DEVOTE) Programme is a collaboration between academics, clinicians, and
industry partners. It aims to accelerate the adoption of genomic technology
into clinical practice by supporting companies through each aspect of the
translational pathway.

 

For more information contact info@devoteprogramme.com
(mailto:info@devoteprogramme.com) .

 

 

 

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