REG - Genedrive PLC - NICE recommends CYP2C19 genotyping

GenedriveAnnouncement

19/05/2023 07:00

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RNS Number : 9399Z  Genedrive PLC  19 May 2023

genedrive plc

("genedrive" or the "Company")

 

NICE recommends CYP2C19 genotyping for clopidogrel treatment

Genedrive® 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("NICE") has recommended in draft guidance that CYP2C19 genotyping should be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® 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® 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
(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 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 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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