Shares of Manchester-based molecular diagnostics company Genedrive rose as much as 20% on Wednesday after it announced that “expanded product validation requirements have now been completed ” for its COV19-ID Kit.
Genedrive said it has now filed for approval to sell the product in the United Kingdom under the new Coronavirus Test Device Approvals (CTDA) regulations.
The Genedrive COV19-ID kit is a rapid molecular diagnostic test that delivers positive results as quickly as 7.5 minutes and negative results in 17 minutes.
The firm said in a stock exchange statement: “Genedrive plc … announces that, further to the announcement on 29 November 2021 confirming submission for CE-IVD certification for the Genedrive COV19-ID Kit, expanded product validation requirements have now been completed and the company has filed for approval to sell the product in the United Kingdom under the new Coronavirus Test Device Approvals (CTDA) regulations.
“CTDA regulations came into effect on 1 Nov 2021 and place specific registration, review and performance requirements on suppliers of COVID-19 diagnostic products into the United Kingdom.
“The expanded clinical validation sample cohort required for CTDA approval was referenced against the Thermo Fisher TaqPath COVID-19 RT-PCR test.
“In the 264 samples, specificity was 98%, and sensitivity was 98% in samples with viral load >500 copies per ml.
“This cohort included samples of confirmed Omicron variant, all of which were successfully detected.
“The sensitivity and specificity of the Genedrive COV19-ID assay on the entire cohort met the current requirements of the UK’s MHRA Target Product Profile for SARS-CoV-2 Point-of-Care molecular diagnostic tests.”
Genedrive CEO David Budd said: “CTDA performance data builds on the data already generated for CE certification, and demonstrates that the product meets the expanded UK requirements for Point-of-Care COVID-19 molecular tests.
“The next milestone is approval by the Department of Health and Social Care, however, no assured timeline is provided on how long the review under CTDA regulations will take, given a current backlog in their reviews.
“We have confidence in our data and the application is another positive step that allows us now to progress UK focused commercial discussions.”