LONDON - Genedrive plc (AIM: GDR), a company specializing in point of care pharmacogenetic testing, has announced the publication of a clinical study in the Journal of Molecular Biology, showcasing the superior performance of its CYP2C19-ID Kit over traditional laboratory testing and other point of care platforms.
The study assessed the Genedrive CYP2C19-ID Kit, a UK Conformity Assessed certified product recommended by The National Institute for Health and Care Excellence (NICE) for CYP2C19 genotype guided prescribing of the antiplatelet drug clopidogrel used in ischemic stroke (IS) and transient ischemic attack (TIA) cases. The test operates using a non-invasive cheek swab and quickly identifies genetic variants of the CYP2C19 gene, which affect a patient's response to clopidogrel.
In a cohort of 202 patients, the Genedrive CYP2C19-ID Kit delivered results faster, with higher accuracy in loss-of-function (LOF) variant identification, and had a lower test fail rate compared to laboratory testing. The kit demonstrated a 100% sensitivity and specificity rate, with a failure rate of 0.98%, which is three times lower than that of laboratory testing. Notably, the kit identified LOF variants in seven patients that would not have been detected by an alternative point of care platform or laboratory methods that focus on fewer LOF variants.
The study concludes that the Genedrive system offers an accurate, rapid, and non-invasive testing method that can be effectively used in clinical settings as a point of care test.
Gino Miele, CEO of Genedrive plc, expressed satisfaction with the clinical performance of their product. He emphasized the kit's potential to improve patient outcomes, provide equitable healthcare access, and reduce healthcare costs. With endorsements from NICE and a positive value assessment from the Scottish Health Technology Group, the company anticipates leveraging these results to expand both domestically and internationally in the pharmacogenetics sector.
The information for this report is based on a press release statement.
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