Genedrive PLC UKCA marking achieved for new CYP2C19 test (4792L)
06 September 2023 - 4:00PM
UK Regulatory
TIDMGDR
RNS Number : 4792L
Genedrive PLC
06 September 2023
genedrive plc
("genedrive" or the "Company")
UKCA marking achieved for new Genedrive (R) 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(R) 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May 2023 draft guidance that people who have had an ischaemic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(R) 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(R) 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 (R) 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 +44 (0)20 7933 8780 or genedrive@walbrookpr.com
Relations)
+44 (0)7980 541 893 / +44 (0)7876
Paul McManus / Anna Dunphy 741 001
About genedrive plc ( 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 .
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