RE: RNS21 May 2024 11:11
Ey CYP2C19-ID test performance milestone achieved
genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, is pleased to announce that a key milestone has been met in The Development and Validation of Technology for Time Critical Genomic Testing ("DEVOTE") programme for its CYP2C19-ID kit. The programme has now passed the patient numbers required for a subsequent submission for an in vitro diagnostics CE certification ("CE-IVD"), which is still anticipated in early 2025.
The Genedrive® CYP2C19-ID point of care genetic test is UK Conformity Assessed ("UKCA") certified, uses a single, non-invasive cheek swab sample, and rapidly identifies several important genetic variants of the CYP2C19 gene (Loss Of Function ("LoF")), which are instrumental in an individual's response to the drug clopidogrel which can be prescribed in Ischemic Stroke ("IS") and Transient Ischaemic Attack ("TIA"). The test automatically interprets the CYP2C19 DNA variant information for the clinician and allows for prompt administration of an alternative treatment plan for the circa 30% of individuals that are less likely to respond favourably to clopidogrel.
DEVOTE is an all-comer study in which CYP2C19 DNA variants in patients presenting in the acute emergency care setting are tested with the Genedrive® CYP2C19-ID test and results compared with those obtained by reference laboratory platform testing, with testing on a third laboratory platform in instances where there is disagreement in test results. In the tests run to date the Genedrive® CYP2C19-ID test has out-performed the reference laboratory-based test with respect to coverage of LoF variants and accuracy (correct identification of variant).
The DEVOTE programme, through its lead partner the University of Manchester ("UoM"), has supported the Company's requirement for assessing performance in acute care patients and provided valuable supporting infrastructure to assess the real-world clinical performance of time-critical clinical tests in NHS settings. The study addresses clinical requirements of the In Vitro Diagnostic Medical Devices Regulation ("IVDR") for CE-IVD submission and subsequent commercialisation in those countries recognising CE-IVD, in addition to current UKCA certification allowing UK commercialisation.
Approximately 30% of patients in the cohort harboured CYP2C19 LoF variants as expected. The Genedrive® CYP2C19 test outperformed the laboratory test with respect to accuracy of identification of LoF alleles, and broader inclusion of LoF alleles. Genedrive® CYP2C19-ID test results are available in ~70 minutes.
The UK's National Institute for Health and Care Excellence ("NICE") has recommended in draft guidance, that the Genedrive® CYP2C19-ID test should be used as the point-of-care test of choice in the NHS before clopidogrel administration in the management of IS and TIA patients (https://www.nice.org.uk/guidance/indevelopment/gid-d