Screening patients to assess their clopidogrel resistance status will allow for alternative treatments

Genedrive – a molecular diagnostics company – has announced that the National Institute for Health and Care Excellence (NICE) has recommended that its CYP2C19 genotyping candidate should be incorporated before clopidogrel administration during the management of ischemic stroke (IS) patients, in the context of research.

The process involved the NICE diagnostics assessment committee reviewing the clinical and economic impact of genetic testing. This included laboratory-based and point-of-care tests, and resulted in the conclusion that CYP2C19 genetic testing strategies would increase life expectancy compared with no testing.

The CYP2C19 test, which is still in development, has not yet been registered in the UK under UKCA marking, but Genedrive is expecting that to be resolved prior to NICE’s final report – currently scheduled for later this year.

David Budd, CEO at Genedrive, explained: “This is the second time we have had the opportunity to work with NICE on recommendations for pharmacogenetic testing and I am pleased that they are very much in-line and supportive of our strategy in point of care pharmacogenomics for emergency care.”

He added: “The Company remains focused on achieving release and UKCA approval of the Genedrive CYP2C19 ID Kit in advance of the final NICE guidance publication date. Our product has a number of performance and workflow features including ready-to-go room temperature reagents, rapid turnaround time, extended genomic variant coverage and integration capability with hospital data management systems that will foster its adoption and uptake compared to alternatives.”

Across the UK, approximately 100,000 patients have strokes and 60,000 have mini-strokes every year.