Genedrive PLC NICE recommends CYP2C19 genotyping (9399Z)
19 May 2023 - 4:00PM
UK Regulatory
TIDMGDR
RNS Number : 9399Z
Genedrive PLC
19 May 2023
genedrive plc
("genedrive" or the "Company")
NICE recommends CYP2C19 genotyping for clopidogrel treatment
Genedrive(R) CYP2C19 ID test modelled to be a clinically and
cost-effective option
genedrive plc (AIM: GDR), the point of care molecular
diagnostics company, announces that the UK's National Institute for
Health and Care Excellence ("NICE") has recommended in draft
guidance that CYP2C19 genotyping should be used before clopidogrel
administration in the management of ischemic stroke ("IS")
patients.
The specialist NICE diagnostics assessment committee
systematically reviewed the clinical and economic impact of genetic
testing, including both laboratory-based and point-of-care ("POC")
tests, concluding that CYP2C19 genetic testing strategies are
likely to save costs and increase life expectancy compared with no
testing. Screening patients to assess their clopidogrel resistance
status allows for alternative treatments and better clinical
outcomes.
Although the Genedrive(R) CYP2C19 ID test is in development, the
NICE Committee included its predicted performance and pricing in
its clinical and economic models and a thorough review is included
in the Committee Papers in the public consultation documents. The
Genedrive POC test had the highest probability of being the most
cost effective for all scenarios compared to lab based or other POC
solutions. Since final performance data for the Genedrive(R)
CYP2C19 ID test is not yet available; and the product has not yet
been registered in the UK under UKCA marking, the NICE Committee
reasonably comments that no recommendation can yet be made for
clinical use. The Company is anticipating UKCA marking of the
Genedrive CYP2C19 test prior to NICE's final report, currently
scheduled for October. At that time, NICE will have the option to
update the recommendation on the Genedrive CYP2C19-ID Kit.
NICE's final guidance will follow the public consultation period
which opens today, 19 May, and is scheduled to close on 9 June
2023. The public consultation documents and summary review of
NICE's information can be found at:
https://www.nice.org.uk/guidance/indevelopment/gid-dg10054/documents
David Budd, CEO of genedrive plc, said : "This is the second
time we have had the opportunity to work with NICE on
recommendations for pharmacogenetic testing and I am pleased that
they are very much in-line and supportive of our strategy in point
of care pharmacogenomics for emergency care. The Company remains
focused on achieving release and UKCA approval of the Genedrive
CYP2C19 ID Kit in advance of the final NICE guidance publication
date. Our product has a number of performance and workflow features
including ready-to-go room temperature reagents, rapid turnaround
time, extended genomic variant coverage and integration capability
with hospital data management systems that will foster its adoption
and uptake compared to alternatives."
POC has a key advantage over laboratory-based testing, providing
results in one hour, which is useful in cases of transient
ischaemic attack ("TIA") and minor stroke, due to the requirement
for a result in less than 24 hours to commence correct treatment.
Many lab-based tests return a result within 72 hours or longer. POC
testing is thus an appropriate way to minimise or eliminate any
period of potentially inappropriate treatment whilst awaiting
results. There is also an advantage of POC in patients who have
non-minor IS but cannot take aspirin.
There are approximately 100,000 strokes and 60,000 TIAs each
year in the UK alone. Clopidogrel with aspirin is the most commonly
prescribed antiplatelet medication used to reduce the risk of
secondary events following a stroke or milder related conditions
like IS. Clopidogrel is a pro-drug that requires conversion into an
active form by an enzyme called CYP2C19. Genotyping of CYP2C19
allows targeting of more suitable treatment for the individual
based on their personal metaboliser status.
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 / Oliver Duckworth
finnCap (Joint Broker) +44 (0)20 7220 0500
Geoff Nash / Alice Lane
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 the
diagnosis of infectious diseases and for use in patient
stratification (genotyping), pathogen detection and other
indications.
About Clopidogrel
Clopidogrel is a drug that is given to ischemic stroke patients
to prevent further clot formation. The CYP2C19 gene is involved in
a metabolic pathway in the liver that converts Clopidogrel to its
active form. Clopidogrel is less effective in individuals with
certain genetic CYP2C19 variants because they may not metabolise
Clopidogrel fully. As a consequence, it has a reduced impact on
lowering the risk of a further stroke. Genedrive's CYP2C19 ID Kit
can provide guidance on which patients will respond to Clopidogrel.
Patients with gene variants that result in reduced or loss of
function of CYP2C19 can be given alternative treatments.
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