Genedrive PLC NICE includes CYP2C19-ID Kit in new programme (6925W)
August 22 2022 - 1:00AM
UK Regulatory
TIDMGDR
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
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(R) 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(R) 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 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 +44 (0)20 7933 8780 or genedrive@walbrookpr.com
Relations)
Anna Dunphy +44 (0)7876 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. 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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