REG - Genedrive PLC - NICE includes CYP2C19-ID Kit in new programme

GenedriveAnnouncement

22/08/2022 07:00

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RNS Number : 6925W  Genedrive PLC  22 August 2022

genedrive plc

("genedrive" or the "Company")

 

NICE includes Genedrive CYP2C19-ID Kit in new Diagnostics Assessment Programme

 

genedrive plc (AIM: GDR), the near patient molecular diagnostics company,
announces that the UK's National Institute for Health and Clinical Excellence
('NICE') has commenced an evaluation of CYP2C19 genotype testing for
Clopidogrel treatment, via a new NICE Diagnostics Assessment Programme
('DAP').  Genedrive's CYP2C19 ID Kit, currently in development, has been
included in the assessment.  Both of genedrive's new emergency Point of Care
genetic screening tests are now included in new NICE reviews, following the
MT-RNR1 DAP announcement on 16 June 2022.

 

https://www.nice.org.uk/guidance/indevelopment/gid-dg10054/documents
(https://www.nice.org.uk/guidance/indevelopment/gid-dg10054/documents)

 

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 do
not metabolize 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.

 

The Genedrive® CYP2C19 test is a simple, rapid point of care test, with no
requirement for result interpretation and provides results in a clinically
actionable timeframe. The genedrive test has been designed to have extended
coverage across ethnic populations, which is important because the frequency
of the various CYP2C19 related genetic changes differs across ethnicities.

 

David Budd, CEO of genedrive plc, said: "We are pleased to be included as a
participant in this latest NICE DAP programme. The review is very timely for
us, given the current development of our new CYP2C19 ID Point of Care test.
The clinical landscape for genotype-guided antiplatelet therapy has advanced
in the last two years, with a growing number of pharmacogenetic clinical
bodies recommending genotype-guided Clopidogrel administration. These
guidelines and ongoing supporting factors such as this new NICE review serve
to mature the market and ultimately can create a faster rate of adoption for
new products such as our new Genedrive® CYP2C19 ID Kit."

 

DAP evaluations are designed to provide robust recommendations on the use of
new products, which is presented in the form of NICE guidance, and to promote
rapid and consistent adoption of clinically innovative and cost-effective
diagnostic technologies in the NHS. The DAP will assess the clinical and
cost-effectiveness of Clopidogrel genotype testing, including any advantages
of point of care testing vs central lab-based testing, in order to make
recommendations on its use in the NHS.

 

The international CPIC guideline
(https://cpicpgx.org/guidelines/guideline-for-clopidogrel-and-cyp2c19/) for
Clopidogrel and CYP2C19 was recently updated (January 2022). The guidelines
are based on clinical evidence and peer-reviewed literature. The clinical
landscape for genetically guided anti-platelet therapy can be considered to be
at a more advanced stage compared to many other genetic areas. Genedrive's new
CYP2C19 Kit is targeted for completion in Q1 2023 and will require approval
under the new IVDR regulations.

 

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

 finnCap (Joint Broker)                              +44 (0)20 7220 0500
 Geoff Nash / Kate Bannatyne / Alice Lane

 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
(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. The Company has assays on market for
the detection of MT-RNR1, HCV, certain military biological targets, and a high
throughput SARS-CoV-2 assay.  The Company recently released a point of care
test for Covid-19.

 

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