Genedrive PLC – NICE recommends CYP2C19 genotyping

Genedrive plc (AIM: GDR), a leading provider of point-of-care molecular diagnostics, has announced that the UK’s National Institute for Health and Care Excellence (NICE) is advising in a draft guideline that CYP2C19 genotyping should be performed prior to administering clopidogrel for managing ischemic stroke (IS) patients.

NICE’s specialist diagnostics assessment committee has carefully assessed the clinical and financial implications of genetic testing. It determined that CYP2C19 genetic testing approaches are likely to reduce costs and extend life expectancy in comparison to no testing at all. Evaluating patients for clopidogrel resistance can lead to alternative treatments and improved clinical outcomes.

Even though the Genedrive® CYP2C19 ID test is currently under development, the NICE Committee factored its anticipated performance and cost into their clinical and economic models, which are detailed in the Committee Papers available in the public consultation documents. The Genedrive POC test demonstrated the highest likelihood of being the most cost-effective solution for all circumstances, compared to lab-based or other POC methods. Nevertheless, given the Genedrive® CYP2C19 ID test’s final performance data and UK registration under UKCA marking are still pending, the NICE Committee noted that they could not yet endorse its clinical application. The company is looking forward to the UKCA marking of the Genedrive CYP2C19 test before NICE’s final report, set to be released in October, at which point NICE can amend the Genedrive CYP2C19-ID Kit’s recommendation.

Public consultation will commence today, 19 May, and is slated to close on 9 June 2023. NICE’s final guideline will be issued after this period.

David Budd, CEO of genedrive plc, shared his satisfaction with the ongoing collaboration with NICE for the second time regarding pharmacogenetic testing recommendations, expressing that their endorsement aligns well with the company’s strategy in point-of-care pharmacogenomics for emergency care. Budd remains committed to obtaining the Genedrive CYP2C19 ID Kit’s release and UKCA approval before the final NICE guideline’s release.

Point-of-care testing, with its one-hour results, has a significant advantage over lab-based testing, especially in cases of transient ischemic attack (TIA) and minor stroke, where the treatment needs to start within 24 hours. Lab-based tests can take up to 72 hours or more to return results, so point-of-care testing can effectively reduce or eliminate the period of potentially inappropriate treatment while waiting for results.

In the UK alone, there are roughly 100,000 strokes and 60,000 TIAs annually. Clopidogrel with aspirin is the most commonly prescribed medication to lower the risk of secondary events post-stroke or minor IS conditions. The drug Clopidogrel is a pro-drug that needs to be converted into an active form by an enzyme called CYP2C19. Genotyping of CYP2C19 allows for personalized treatment based on an individual’s metabolizer status.

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