Genedrive jumps on draft NICE testing guidance

The AIM-traded firm said the NICE diagnostics assessment committee conducted a systematic review of the clinical and economic impact of genetic testing, considering both laboratory-based and point-of-care (POC) tests.

It said the committee concluded that CYP2C19 genetic testing strategies were likely to yield cost savings, and improve life expectancy when compared to no testing.

By screening patients to determine their clopidogrel resistance status, alternative treatments could be considered, leading to better clinical outcomes.

While Genedrive's CYP2C19 ID test is currently in development, the NICE committee incorporated its predicted performance and pricing into its clinical and economic models, and a comprehensive review of the test was included in the committee papers within the public consultation documents

Notably, the Genedrive POC test exhibited the highest probability of being the most cost-effective solution across all scenarios, the firm said, surpassing both lab-based and other POC alternatives.

It did note, however, that since the final performance data for the Genedrive CYP2C19 ID test was not yet available and the product had not been registered under UKCA marking, the NICE committee said no recommendation for clinical use could be made at this time.

However, Genedrive said it expected to obtain UKCA marking for the Genedrive CYP2C19 test before NICE's final report, which was currently scheduled for October.

At that point, NICE would have the option to update the recommendation for the Genedrive CYP2C19-ID kit.

The final guidance from NICE would be released following a public consultation period that started on Friday, and would conclude on 9 June.

“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,” said chief executive officer David Budd.

“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.”

At 1541 BST, shares in Genedrive were up 8.88% at 22.32p.

Reporting by Josh White for Sharecast.com.