Shares of Manchester-based molecular diagnostics company Genedrive rose about 10% after it announced the UK’s National Institute for Health and Care Excellence (NICE) has recommended in draft guidance that Genedrive’s CYP2C19 genotyping “should be used before clopidogrel administration” in the management of ischemic stroke (IS) patients.
“The specialist NICE diagnostics assessment committee systematically reviewed the clinical and economic impact of genetic testing, including both laboratory-based and point-of-care (POC) tests, concluding that CYP2C19 genetic testing strategies are likely to save costs and increase life expectancy compared with no testing,” said Genedrive.
“Screening patients to assess their clopidogrel resistance status allows for alternative treatments and better clinical outcomes.
“Although the Genedrive CYP2C19 ID test is in development, the NICE Committee included its predicted performance and pricing in its clinical and economic models and a thorough review is included in the Committee Papers in the public consultation documents.
“The Genedrive POC test had the highest probability of being the most cost effective for all scenarios compared to lab based or other POC solutions.
“Since final performance data for the Genedrive CYP2C19 ID test is not yet available; and the product has not yet been registered in the UK under UKCA marking, the NICE Committee reasonably comments that no recommendation can yet be made for clinical use.
“The company is anticipating UKCA marking of the Genedrive CYP2C19 test prior to NICE’s final report, currently scheduled for October. At that time, NICE will have the option to update the recommendation on the Genedrive CYP2C19-ID Kit.
“NICE’s final guidance will follow the public consultation period which opens today, 19 May, and is scheduled to close on 9 June 2023.”
Genedrive CEO David Budd said: “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.
“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.”