Genedrive PLC (AIM:GDR) Genedrive® CYP2C19-ID Kit performance published

Superior performance to laboratory test and alternative available point of care platforms

genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, announces that the clinical performance of its CYP2C19-ID Kit has been published in the Journal of Molecular Biology. The publication is available at https://www.jmdjournal.org/article/S1525-1578(24)00312-X/fulltext.

Background to the Genedrive® CYP2C19 test

The Genedrive® CYP2C19 ID point of care genetic test is UK Conformity Assessed (“UKCA”) certified and is recommended by The National Institute for Health and Care Excellence (“NICE”) as the Point of Care (“PoC”) test of choice for use in the NHS for CYP2C19 genotype guided prescribing of Clopidogrel in Ischaemic stroke (IS) and Transient Ischaemic Attack (TIA).  It 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 antiplatelet drug clopidogrel which can be prescribed in Ischemic Stroke (“IS”) and Transient Ischaemic Attack (“TIA”). Some of these important LOF variants are more prevalent in specific ethnic groups and are not included in targets in any other point of care CYP2C19 genotyping platform.  The test reports CYP2C19 DNA variant information to the clinician and allows for prompt consideration of an alternative treatment plan for the circa 30% of individuals carrying CYP2C19 DNA variants which result in them being less likely to respond to clopidogrel.

Study Results

In the clinical study, CYP2C19 DNA variants in patients presenting in the acute emergency care setting were tested with the Genedrive® CYP2C19-ID test and results compared with those obtained by reference laboratory platform testing, with testing on a separate laboratory platform in instances where there was disagreement in test results.

In summary, in a cohort of 202 patients, in addition to being substantially less expensive than the laboratory platform, the Genedrive® CYP2C19 ID Kit outperformed laboratory testing with respect to (1) speed to result, (2) accuracy of LOF identification and (3) test fail rate.  Sensitivity and specificity of the CYP2C19 ID Kit was 100%, with failure rate of 0.98% (three times lower than laboratory testing).  In addition, the laboratory test platform returned incorrect results for eight samples (4%).  Importantly, the Genedrive® CYP2C19 ID Kit identified seven patients harbouring LOF variants that would not have been detected using an alternative POC CYP2C19 genotyping platform which focuses on two specific LOF variants compared to five targeted by the Genedrive® test, or laboratory genotyping methods which also focus on these two LOF variants.  Requirement for freezer storage of reagents of this alternative platform is also an implementation barrier in acute clinical settings that the Genedrive® technology circumvents.    

This study confirms “that the Genedrive® System is able to provide an accurate, rapid, non-invasive alternative to standard laboratory testing and can be used as a point of care test in the clinical environment.”

Gino Miele, CEO of genedrive plc, said: “We are delighted with the clinical performance of our CYP2C19 ID Kit reported in this publication.  With recommendation by NICE as the PoC test of choice for CYP2C19 genotyping in IS/TIA in NHS England, dominant health economic modelling by NICE, positive value assessment by the Scottish Health Technology Group, together with this study evidencing superior performance compared to laboratory testing and by extrapolation our nearest competitor product, we are well positioned to capitalise on the emerging clinical pharmacogenetics area of point of care CYP2C19 genotyped-guided clopidogrel treatment both domestically and internationally, ultimately enabling better patient outcomes, improving equitable access to healthcare and positively impacting healthcare financial burdens.”

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