Rns Out!31 Jul 2024 07:01
NICE recommends the GenedriveĀ® CYP2C19-ID Kit in final guidance
GenedriveĀ® CYP2C19-ID test chosen as the preferred platform for point-of-care genotype testing
prior to clopidogrel treatment for stroke patients in the NHS
genedrive plc (AIM: GDR), the point-of-care pharmacogenetic testing company, is pleased to announce that following on from the draft guidance issued in April 2024, the UK's National Institute for Health and Care Excellence ("NICE") has recommended in its final guidance that CYP2C19 genotyping should be used to guide clopidogrel use after Ischaemic Stroke ("IS") or Transient Ischaemic Attack ("TIA"), and that the GenedriveĀ® CYP2C19-ID test should be used as the test of choice for point-of-care strategies.
The guidance has been published today and can be found at: https://www.nice.org.uk/guidance/dg59.
With UKCA certification for the product already achieved, completion of the DEVOTE clinical phase, and today's final guidance from NICE recommending the GenedriveĀ® CYP2C19 ID kit for use in point-of-care settings, the Company will now actively pursue commercialisation in the UK and Middle Eastern countries where device registration is enabled by UKCA certification, and is fully prepared to supply and meet the anticipated demand.
The GenedriveĀ® CYP2C19-ID point-of-care genetic test uses a single, non-invasive cheek swab sample, and rapidly identifies six important genetic variants of the CYP2C19 gene, five of which are instrumental in the loss of metabolism function. The GenedriveĀ® System automatically interprets the information for the clinician, allowing prompt administration of an optimised treatment plan.
Whilst positioned primarily for enabling near-patient testing, the GenedriveĀ® System is also suitable for traditional laboratory testing paradigms as a more affordable alternative to laboratory platforms where sample throughput requirements do not necessitate high-scale batch processing.
The specialist NICE diagnostics assessment committee systematically reviewed the clinical and economic impact of CYP2C19 genetic testing, including both laboratory-based and point-of-care tests, concluding that CYP2C19 genetic testing strategies will be beneficial to people with loss-of-function CYP2C19 variants with alternative antiplatelet treatment and is also cost effective compared with not testing regardless of which alternative antiplatelet therapy people have.
In addition to being dominant in cost effectiveness models, NICE recommends the GenedriveĀ® as the point-of-care platform of choice for CYP2C19 genotyping strategies in the NHS. The decision was based on several differentiating features of the GenedriveĀ® technology;
- its greater coverage of genetic variants compared to the other point-of-care system assessed, permitting increased equitable access to healthcare across ethnic populations;
- no requirement for cold-chain storage logistics and
Sign In
Follow the stocks
