Clopidogrel genotype testing after ischemic stroke or transient ischemic attack - NICE publication d1 Mar 2023 11:09
A few are forgetting Genedrive is no one trick pony - if anything the stroke test will be bigger than AHIL (as many have eluded to). Test due for completion Q1 2023, IVDR approval to be sought, and NICE publication of results due 16th August 2023.
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 costeffective 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 antiplatelet 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.
Best wishes,
Stephen11.
Sign In
Follow the stocks
